Vasomotor Symptoms
Conditions
Brief summary
Desvenlafaxine succinate (DVS SR) is a serotonin and norepinephrine reuptake inhibitor (SNRI). It is a nonhormonal option for the treatment of Vasomotor Symptoms (VMS) associated with menopause. Nausea is the most common adverse event that is observed in clinical studies and is the main reason for discontinuation during the first week of therapy. Other adverse events (headache, nausea, and dizziness) associated with DVS SR have been noted to occur when subjects abruptly discontinue the medication. The purpose of this study is to evaluate several titration and tapering regimens of DVS SR to ensure a better tolerability profile at the start and completion of treatment. In addition, this study will provide a long posttreatment follow-up to assess any symptoms after treatment is discontinued.
Interventions
Titration 100 mg
DRUGPlacebo
Tapering placebo
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Generally healthy, postmenopausal woman who seeks treatment for hot flushes. * Meets 1 of the following: At least 12 months of spontaneous amenorrhea; At least 6 months of spontaneous amenorrhea with serum follicle-stimulating hormone (FSH) levels \> 40 mIU/mL; At least 6 weeks postsurgical bilateral oophorectomy (with or without hysterectomy). Hysterectomized without bilateral oophorectomy and with serum FSH levels \>40 mIU/mL.
Exclusion criteria
* History of a seizure disorder other than a single childhood febrile seizure. * History or presence of clinically important hepatic or renal disease or other medical disease. * Presence or recent history of major depressive disorder, bipolar disorder, psychotic disorder, or generalized anxiety disorder requiring therapy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| DESS Total Score at End of Second Week of Tapering | Week 18 | DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article. The DESS total score is the sum of the number of new symptoms and old (but worse) symptoms (1) and 0 for old and unchanged symptom, absent, or old symptom but improved for a total possible range of 0 to 43. A higher score indicates more symptoms. |
| DESS Total Score at 1 Week After the End of Tapering | Week 19 | DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article. The DESS total score is the sum of the number of new symptoms and old (but worse) symptoms (1) and 0 for old and unchanged symptom, absent, or old symptom but improved for a total possible range of 0 to 43. A higher score indicates more symptoms. |
| Number of Participants With Nausea During the First 2 Weeks of Treatment | Baseline up to Week 2 | Nausea by spontaneous reports to the investigators was counted if it was reported during first 2 weeks of treatment, and it was not seen before the first dose of treatment, or if it was seen before the first dose and the symptoms got worse. If multiple incidences occurred on the same participant during the 2 weeks, only 1 incidence was counted. |
| Discontinuation Emergent Signs and Symptoms (DESS) Total Score at the End of First Week of Tapering | Week 17 | DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article. The DESS total score is the sum of the number of new symptoms and old (but worse) symptoms (1) and 0 for old and unchanged symptom, absent, or old symptom but improved for a total possible range of 0 to 43. A higher score indicates more symptoms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Each DESS at the End of Second Week of Tapering | Week 18 | DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article. |
| Number of Participants With Each DESS One Week After End of Tapering | Week 19 | DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article. |
| Number of Participants Showing Satisfaction With Tolerability at the End of Tapering | Week 19 | Satisfaction with tolerability (lack of bothersomeness) was assessed using a questionnaire via an IVRS/IWRS and evaluated based on participants' response of extremely satisfied, satisfied, neutral, dissatisfied or extremely dissatisfied with the study medication. |
| Menopause Symptoms-treatment Satisfaction Questionnaire (MS-TSQ) Score | Week 16 | MS-TSQ is a questionnaire assessing participants' degree of satisfaction with regard to the test article which was administered to the participants via an IVRS/IWRS. The questionnaire comprised 8 questions and each was rated on a scale from 0 (extremely dissatisfied) to 4 (extremely satisfied). |
| Change From Baseline in Menopause-specific Quality of Life Questionnaire (MenQOL) Score at Week 4, Week 8, Week 12 and Week 16 | Baseline, Week 4, Week 8, Week 12 and Week 16 | MenQOL questionnaire assessed how bothered participants were with 31 symptoms. It contains domains: vasomotor (items 1-3); psychosocial (items 4-10); physical (items 11-26); sexual (items 27-29); in addition to nausea and indigestion. 31 individual symptoms are rated on a scale of 0 (not at all bothered) to 6 (extremely bothered). Total possible score ranged from 0 to 186. MenQOL summary score was calculated as mean of four domain scores (Physical function, Psychosocial function, Sexual function and Vasomotor function) ranging from 1 to 8, with higher scores indicating worse quality of life. |
| Number of Participants Showing Satisfaction With Tolerability During the First Two Weeks of Treatment | Week 1 and Week 2 | Satisfaction with tolerability (lack of bothersomeness) was assessed using a questionnaire via an interactive voice response system (IVRS)/interactive web based response system (IWRS), and evaluated based on participants' response of extremely satisfied, satisfied, neutral, dissatisfied or extremely dissatisfied with the study medication. |
| Number of Participants With Other Spontaneously Reported Adverse Events (AEs) in First 2 Weeks of Treatment | Baseline up to Week 2 | Any untoward medical occurrence in a participant who received study drug was considered an AE, without regard to possibility of causal relationship. |
| Percentage of Participants Discontinuing Treatment Due to AEs in First 2 Weeks of Treatment | Baseline up to Week 2 | Any untoward medical occurrence in a participant who received study drug was considered an AE, without regard to possibility of causal relationship. |
| Number of Participants With Each DESS at the End of First Week of Tapering | Week 17 | DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Mean Age of the Participants in Tapering Phase | Week 17 | Participants were re-randomized to tapering phase after OL phase. |
| Gender of the Participants in Tapering Phase | Week 17 | Participants were re-randomized to tapering phase after OL phase. |
Countries
Canada, United States
Participant flow
Pre-assignment details
A total of 500 participants were randomized to the study, of which 7 were not treated due to other unspecified reasons. A second randomization occurred for the taper phase.
Participants by arm
| Arm | Count |
|---|---|
| DVS 25 mg, Then 100 mg DVS 25 mg tablet taken orally daily for one week and placebo matched to 100 mg and 50 mg (double blind titration phase); then 100 mg for 15 week OL phase. | 126 |
| DVS 25/50 mg, Then 100 mg DVS 25 mg tablet taken orally for first 4 days followed by 50 mg for next 3 days for the first week and placebo matched to 100 mg (double blind titration phase); then 100 mg for 15 week OL phase. | 121 |
| DVS 50 mg, Then 100 mg DVS 50 mg tablet taken orally daily for one week and placebo matched to 100 mg and 25 mg (double blind titration phase); then 100 mg for 15 week OL phase. | 124 |
| DVS 100 mg, Then 100 mg DVS 100 mg tablet taken orally daily for one week and placebo matched to 25 mg and 50 mg (double blind titration phase); then 100 mg for 15 week OL phase. | 122 |
| Total | 493 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 |
|---|---|---|---|---|---|---|---|---|---|
| Between Titration and Open Label Phase | Did not enter the open label phase | 0 | 2 | 0 | 2 | 0 | 0 | 0 | 0 |
| Double Blind Tapering Phase | Adverse Event | 0 | 0 | 0 | 0 | 1 | 1 | 2 | 4 |
| Double Blind Tapering Phase | Investigator request | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Double Blind Tapering Phase | Lack of Efficacy | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Double Blind Tapering Phase | Other | 0 | 0 | 0 | 0 | 1 | 0 | 2 | 2 |
| Double Blind Tapering Phase | Withdrawal by Subject | 0 | 0 | 0 | 0 | 2 | 2 | 3 | 0 |
| Double Blind Titration Phase | Adverse Event | 3 | 2 | 5 | 12 | 0 | 0 | 0 | 0 |
| Double Blind Titration Phase | Other | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Double Blind Titration Phase | Protocol Violation | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Double Blind Titration Phase | Withdrawal by Subject | 1 | 1 | 0 | 2 | 0 | 0 | 0 | 0 |
| Open Label Phase | Adverse Event | 5 | 14 | 6 | 7 | 0 | 0 | 0 | 0 |
| Open Label Phase | Lack of Efficacy | 4 | 2 | 3 | 0 | 0 | 0 | 0 | 0 |
| Open Label Phase | Lost to Follow-up | 5 | 7 | 5 | 4 | 0 | 0 | 0 | 0 |
| Open Label Phase | Other | 4 | 8 | 7 | 8 | 0 | 0 | 0 | 0 |
| Open Label Phase | Protocol Violation | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 0 |
| Open Label Phase | Withdrawal by Subject | 3 | 3 | 2 | 1 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | DVS 25 mg, Then 100 mg | DVS 25/50 mg, Then 100 mg | DVS 50 mg, Then 100 mg | DVS 100 mg, Then 100 mg | Total |
|---|---|---|---|---|---|
| Age Continuous | 54.52 Years STANDARD_DEVIATION 5.01 | 54.40 Years STANDARD_DEVIATION 6.37 | 53.98 Years STANDARD_DEVIATION 5.16 | 53.48 Years STANDARD_DEVIATION 5.27 | 54.10 Years STANDARD_DEVIATION 5.47 |
| Sex: Female, Male Female | 126 Participants | 121 Participants | 124 Participants | 122 Participants | 493 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 50 / 126 | 55 / 121 | 57 / 124 | 73 / 122 | 340 / 461 | 74 / 101 | 64 / 94 | 67 / 87 | 79 / 102 |
| serious Total, serious adverse events | 0 / 126 | 0 / 121 | 0 / 124 | 0 / 122 | 3 / 461 | 0 / 101 | 0 / 94 | 0 / 87 | 1 / 102 |
Outcome results
Primary
DESS Total Score at 1 Week After the End of Tapering
DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article. The DESS total score is the sum of the number of new symptoms and old (but worse) symptoms (1) and 0 for old and unchanged symptom, absent, or old symptom but improved for a total possible range of 0 to 43. A higher score indicates more symptoms.
Time frame: Week 19
Population: Tapering population included all participants who had completed at least 6 weeks of treatment and taken at least 1 dose of double-blind test article during the tapering phase. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure at the specified time point for each group respectively.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DVS 25 mg, Then 100 mg | DESS Total Score at 1 Week After the End of Tapering | 3.22 Units on a scale | Standard Deviation 4.82 |
| DVS 25/50 mg, Then 100 mg | DESS Total Score at 1 Week After the End of Tapering | 4.11 Units on a scale | Standard Deviation 5.77 |
| DVS 50 mg, Then 100 mg | DESS Total Score at 1 Week After the End of Tapering | 1.70 Units on a scale | Standard Deviation 3.16 |
| DVS 100 mg, Then 100 mg | DESS Total Score at 1 Week After the End of Tapering | 1.78 Units on a scale | Standard Deviation 3.2 |
Comparison: For DVS 50 mg QOD, ANOVA was used to compare the DESS score between each tapering regimen and the control regimen (no tapering) for the titration population, where treatment was kept as the factor.p-value: 0.078ANOVA
Comparison: For DVS 50/25 mg, ANOVA was used to compare the DESS score between each tapering regimen and the control regimen (no tapering) for the titration population, where treatment was kept as the factor.p-value: 0.005ANOVA
Comparison: For DVS 50mg/Placebo, ANOVA was used to compare the DESS score between each tapering regimen and the control regimen (no tapering) for the titration population, where treatment was kept as the factor.p-value: 0.929ANOVA
Primary
DESS Total Score at End of Second Week of Tapering
DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article. The DESS total score is the sum of the number of new symptoms and old (but worse) symptoms (1) and 0 for old and unchanged symptom, absent, or old symptom but improved for a total possible range of 0 to 43. A higher score indicates more symptoms.
Time frame: Week 18
Population: Tapering population included all participants who had completed at least 6 weeks of treatment and taken at least 1 dose of double-blind test article during the tapering phase. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure at the specified time point for each group respectively.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DVS 25 mg, Then 100 mg | DESS Total Score at End of Second Week of Tapering | 1.19 Units on a scale | Standard Deviation 1.96 |
| DVS 25/50 mg, Then 100 mg | DESS Total Score at End of Second Week of Tapering | 2.44 Units on a scale | Standard Deviation 5.53 |
| DVS 50 mg, Then 100 mg | DESS Total Score at End of Second Week of Tapering | 4.46 Units on a scale | Standard Deviation 6.44 |
| DVS 100 mg, Then 100 mg | DESS Total Score at End of Second Week of Tapering | 2.44 Units on a scale | Standard Deviation 4.96 |
Comparison: For DVS 50 mg QOD, ANOVA was used to compare the DESS score between each tapering regimen and the control regimen (no tapering) for the titration population, where treatment was kept as the factorp-value: 0.092ANOVA
Comparison: For DVS 50/25 mg, ANOVA was used to compare the DESS score between each tapering regimen and the control regimen (no tapering) for the titration population, where treatment was kept as the factorp-value: 0.997ANOVA
Comparison: For DVS 50 mg/Placebo, ANOVA was used to compare the DESS score between each tapering regimen and the control regimen (no tapering) for the titration population, where treatment was kept as the factorp-value: 0.009ANOVA
Primary
Discontinuation Emergent Signs and Symptoms (DESS) Total Score at the End of First Week of Tapering
DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article. The DESS total score is the sum of the number of new symptoms and old (but worse) symptoms (1) and 0 for old and unchanged symptom, absent, or old symptom but improved for a total possible range of 0 to 43. A higher score indicates more symptoms.
Time frame: Week 17
Population: The tapering population included all participants who had completed at least 6 weeks of treatment and taken at least 1 dose of double-blind test article during the tapering phase.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DVS 25 mg, Then 100 mg | Discontinuation Emergent Signs and Symptoms (DESS) Total Score at the End of First Week of Tapering | 2.26 Units on a scale | Standard Deviation 3.46 |
| DVS 25/50 mg, Then 100 mg | Discontinuation Emergent Signs and Symptoms (DESS) Total Score at the End of First Week of Tapering | 2.28 Units on a scale | Standard Deviation 3.59 |
| DVS 50 mg, Then 100 mg | Discontinuation Emergent Signs and Symptoms (DESS) Total Score at the End of First Week of Tapering | 1.84 Units on a scale | Standard Deviation 3.36 |
| DVS 100 mg, Then 100 mg | Discontinuation Emergent Signs and Symptoms (DESS) Total Score at the End of First Week of Tapering | 7.07 Units on a scale | Standard Deviation 7.13 |
Comparison: For DVS 50 mg QOD, analysis of variance (ANOVA) was used to compare the DESS score between each tapering regimen and the control regimen (no tapering) for the titration population, where treatment was kept as the factor.p-value: <0.001ANOVA
Comparison: For DVS 50/25 mg, ANOVA was used to compare the DESS score between each tapering regimen and the control regimen (no tapering) for the titration population, where treatment was kept as the factor.p-value: <0.001ANOVA
Comparison: For DVS 50 mg/Placebo, ANOVA was used to compare the DESS score between each tapering regimen and the control regimen (no tapering) for the titration population, where treatment was kept as the factor.p-value: <0.001ANOVA
Primary
Number of Participants With Nausea During the First 2 Weeks of Treatment
Nausea by spontaneous reports to the investigators was counted if it was reported during first 2 weeks of treatment, and it was not seen before the first dose of treatment, or if it was seen before the first dose and the symptoms got worse. If multiple incidences occurred on the same participant during the 2 weeks, only 1 incidence was counted.
Time frame: Baseline up to Week 2
Population: The titration population included all randomly assigned participants who had taken at least 1 dose of double-blind test article during the double-blind titration period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DVS 25 mg, Then 100 mg | Number of Participants With Nausea During the First 2 Weeks of Treatment | 24 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Nausea During the First 2 Weeks of Treatment | 31 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Nausea During the First 2 Weeks of Treatment | 28 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Nausea During the First 2 Weeks of Treatment | 43 Participants |
Comparison: Overall comparison was made between each titration regimen and the control regimen (100 mg).p-value: 0.024Chi-squared
Secondary
Change From Baseline in Menopause-specific Quality of Life Questionnaire (MenQOL) Score at Week 4, Week 8, Week 12 and Week 16
MenQOL questionnaire assessed how bothered participants were with 31 symptoms. It contains domains: vasomotor (items 1-3); psychosocial (items 4-10); physical (items 11-26); sexual (items 27-29); in addition to nausea and indigestion. 31 individual symptoms are rated on a scale of 0 (not at all bothered) to 6 (extremely bothered). Total possible score ranged from 0 to 186. MenQOL summary score was calculated as mean of four domain scores (Physical function, Psychosocial function, Sexual function and Vasomotor function) ranging from 1 to 8, with higher scores indicating worse quality of life.
Time frame: Baseline, Week 4, Week 8, Week 12 and Week 16
Population: The OL population included all participants who had taken at least 1 dose of open label test article. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the time points for each group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DVS 25 mg, Then 100 mg | Change From Baseline in Menopause-specific Quality of Life Questionnaire (MenQOL) Score at Week 4, Week 8, Week 12 and Week 16 | Baseline | 4.46 Units on a scale | Standard Deviation 1.2 |
| DVS 25 mg, Then 100 mg | Change From Baseline in Menopause-specific Quality of Life Questionnaire (MenQOL) Score at Week 4, Week 8, Week 12 and Week 16 | Week 4 (n=385) | 2.99 Units on a scale | Standard Deviation 1.09 |
| DVS 25 mg, Then 100 mg | Change From Baseline in Menopause-specific Quality of Life Questionnaire (MenQOL) Score at Week 4, Week 8, Week 12 and Week 16 | Week 8 (n=364) | 2.85 Units on a scale | Standard Deviation 1.08 |
| DVS 25 mg, Then 100 mg | Change From Baseline in Menopause-specific Quality of Life Questionnaire (MenQOL) Score at Week 4, Week 8, Week 12 and Week 16 | Week 12 (n=354) | 2.76 Units on a scale | Standard Deviation 1.06 |
| DVS 25 mg, Then 100 mg | Change From Baseline in Menopause-specific Quality of Life Questionnaire (MenQOL) Score at Week 4, Week 8, Week 12 and Week 16 | Week 16 (n=277) | 2.67 Units on a scale | Standard Deviation 1.17 |
Comparison: Comparison was made between the difference in the means from the baseline value and post-baseline (Week 4) value with 0.p-value: <0.001t-test, 2 sided
Comparison: Comparison was made between the difference in the means from the baseline value and post-baseline (Week 8) value with 0.p-value: <0.001t-test, 2 sided
Comparison: Comparison was made between the difference in the means from the base value and post-baseline (Week 12) value with 0.p-value: <0.001t-test, 2 sided
Comparison: Comparison was made between the difference in the means from the baseline value and post-baseline (Week 16) value with 0.p-value: <0.001t-test, 2 sided
Secondary
Menopause Symptoms-treatment Satisfaction Questionnaire (MS-TSQ) Score
MS-TSQ is a questionnaire assessing participants' degree of satisfaction with regard to the test article which was administered to the participants via an IVRS/IWRS. The questionnaire comprised 8 questions and each was rated on a scale from 0 (extremely dissatisfied) to 4 (extremely satisfied).
Time frame: Week 16
Population: The OL population included all participants who had taken at least 1 dose of open label test article. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure at the specified time point for each group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DVS 25 mg, Then 100 mg | Menopause Symptoms-treatment Satisfaction Questionnaire (MS-TSQ) Score | Effect on quality of sleep | 2.59 Units on a scale | Standard Deviation 1.18 |
| DVS 25 mg, Then 100 mg | Menopause Symptoms-treatment Satisfaction Questionnaire (MS-TSQ) Score | Effect on mood or emotions | 3.02 Units on a scale | Standard Deviation 0.86 |
| DVS 25 mg, Then 100 mg | Menopause Symptoms-treatment Satisfaction Questionnaire (MS-TSQ) Score | Effect on interest in sex | 2.37 Units on a scale | Standard Deviation 1 |
| DVS 25 mg, Then 100 mg | Menopause Symptoms-treatment Satisfaction Questionnaire (MS-TSQ) Score | Effect on ability to concentrate | 2.67 Units on a scale | Standard Deviation 0.84 |
| DVS 25 mg, Then 100 mg | Menopause Symptoms-treatment Satisfaction Questionnaire (MS-TSQ) Score | Tolerability to side effects | 3.04 Units on a scale | Standard Deviation 0.94 |
| DVS 25 mg, Then 100 mg | Menopause Symptoms-treatment Satisfaction Questionnaire (MS-TSQ) Score | Overall satisfaction | 2.81 Units on a scale | Standard Deviation 1.1 |
| DVS 25 mg, Then 100 mg | Menopause Symptoms-treatment Satisfaction Questionnaire (MS-TSQ) Score | Ability to control hot flushes during the day | 2.64 Units on a scale | Standard Deviation 1.19 |
| DVS 25 mg, Then 100 mg | Menopause Symptoms-treatment Satisfaction Questionnaire (MS-TSQ) Score | Ability to control hot flushes during the night | 2.71 Units on a scale | Standard Deviation 1.26 |
Secondary
Number of Participants Showing Satisfaction With Tolerability at the End of Tapering
Satisfaction with tolerability (lack of bothersomeness) was assessed using a questionnaire via an IVRS/IWRS and evaluated based on participants' response of extremely satisfied, satisfied, neutral, dissatisfied or extremely dissatisfied with the study medication.
Time frame: Week 19
Population: Tapering population included all participants who had completed at least 6 weeks of treatment and taken at least 1 dose of double-blind test article during the tapering phase. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure at the specified time point for each group respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DVS 25 mg, Then 100 mg | Number of Participants Showing Satisfaction With Tolerability at the End of Tapering | Satisfied | 16 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants Showing Satisfaction With Tolerability at the End of Tapering | Dissatisfied | 10 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants Showing Satisfaction With Tolerability at the End of Tapering | Extremely satisfied | 10 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants Showing Satisfaction With Tolerability at the End of Tapering | Neutral | 10 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants Showing Satisfaction With Tolerability at the End of Tapering | Extremely dissatisfied | 7 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants Showing Satisfaction With Tolerability at the End of Tapering | Neutral | 5 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants Showing Satisfaction With Tolerability at the End of Tapering | Satisfied | 23 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants Showing Satisfaction With Tolerability at the End of Tapering | Extremely satisfied | 12 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants Showing Satisfaction With Tolerability at the End of Tapering | Dissatisfied | 7 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants Showing Satisfaction With Tolerability at the End of Tapering | Extremely dissatisfied | 5 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants Showing Satisfaction With Tolerability at the End of Tapering | Neutral | 5 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants Showing Satisfaction With Tolerability at the End of Tapering | Extremely dissatisfied | 3 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants Showing Satisfaction With Tolerability at the End of Tapering | Dissatisfied | 3 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants Showing Satisfaction With Tolerability at the End of Tapering | Satisfied | 19 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants Showing Satisfaction With Tolerability at the End of Tapering | Extremely satisfied | 10 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants Showing Satisfaction With Tolerability at the End of Tapering | Satisfied | 19 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants Showing Satisfaction With Tolerability at the End of Tapering | Dissatisfied | 5 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants Showing Satisfaction With Tolerability at the End of Tapering | Extremely dissatisfied | 6 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants Showing Satisfaction With Tolerability at the End of Tapering | Neutral | 7 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants Showing Satisfaction With Tolerability at the End of Tapering | Extremely satisfied | 18 Participants |
Secondary
Number of Participants Showing Satisfaction With Tolerability During the First Two Weeks of Treatment
Satisfaction with tolerability (lack of bothersomeness) was assessed using a questionnaire via an interactive voice response system (IVRS)/interactive web based response system (IWRS), and evaluated based on participants' response of extremely satisfied, satisfied, neutral, dissatisfied or extremely dissatisfied with the study medication.
Time frame: Week 1 and Week 2
Population: The titration population included all randomly assigned participants who had taken at least 1 dose of double-blind test article during the double-blind titration period. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the time points for each group respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DVS 25 mg, Then 100 mg | Number of Participants Showing Satisfaction With Tolerability During the First Two Weeks of Treatment | Week 1: Extremely dissatisfied (n=124,119,120,111) | 2 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants Showing Satisfaction With Tolerability During the First Two Weeks of Treatment | Week 1: Extremely satisfied (n=124,119,120,111) | 54 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants Showing Satisfaction With Tolerability During the First Two Weeks of Treatment | Week 2: Neutral (n=115,105,113,94) | 17 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants Showing Satisfaction With Tolerability During the First Two Weeks of Treatment | Week 2: Dissatisfied (n=115,105,113,94) | 3 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants Showing Satisfaction With Tolerability During the First Two Weeks of Treatment | Week 2: Extremely satisfied (n=115,105,113,94) | 50 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants Showing Satisfaction With Tolerability During the First Two Weeks of Treatment | Week 1: Satisfied (n=124,119,120,111) | 47 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants Showing Satisfaction With Tolerability During the First Two Weeks of Treatment | Week 2: Extremely dissatisfied (n=115,105,113,94) | 2 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants Showing Satisfaction With Tolerability During the First Two Weeks of Treatment | Week 1: Neutral (n=124,119,120,111) | 20 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants Showing Satisfaction With Tolerability During the First Two Weeks of Treatment | Week 1: Dissatisfied (n=124,119,120,111) | 1 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants Showing Satisfaction With Tolerability During the First Two Weeks of Treatment | Week 2: Satisfied (n=115,105,113,94) | 43 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants Showing Satisfaction With Tolerability During the First Two Weeks of Treatment | Week 1: Extremely dissatisfied (n=124,119,120,111) | 3 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants Showing Satisfaction With Tolerability During the First Two Weeks of Treatment | Week 1: Satisfied (n=124,119,120,111) | 48 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants Showing Satisfaction With Tolerability During the First Two Weeks of Treatment | Week 1: Dissatisfied (n=124,119,120,111) | 6 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants Showing Satisfaction With Tolerability During the First Two Weeks of Treatment | Week 1: Neutral (n=124,119,120,111) | 13 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants Showing Satisfaction With Tolerability During the First Two Weeks of Treatment | Week 2: Extremely dissatisfied (n=115,105,113,94) | 0 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants Showing Satisfaction With Tolerability During the First Two Weeks of Treatment | Week 2: Dissatisfied (n=115,105,113,94) | 4 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants Showing Satisfaction With Tolerability During the First Two Weeks of Treatment | Week 2: Neutral (n=115,105,113,94) | 17 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants Showing Satisfaction With Tolerability During the First Two Weeks of Treatment | Week 2: Satisfied (n=115,105,113,94) | 35 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants Showing Satisfaction With Tolerability During the First Two Weeks of Treatment | Week 1: Extremely satisfied (n=124,119,120,111) | 49 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants Showing Satisfaction With Tolerability During the First Two Weeks of Treatment | Week 2: Extremely satisfied (n=115,105,113,94) | 49 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants Showing Satisfaction With Tolerability During the First Two Weeks of Treatment | Week 2: Extremely dissatisfied (n=115,105,113,94) | 0 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants Showing Satisfaction With Tolerability During the First Two Weeks of Treatment | Week 1: Neutral (n=124,119,120,111) | 28 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants Showing Satisfaction With Tolerability During the First Two Weeks of Treatment | Week 2: Extremely satisfied (n=115,105,113,94) | 46 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants Showing Satisfaction With Tolerability During the First Two Weeks of Treatment | Week 2: Satisfied (n=115,105,113,94) | 41 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants Showing Satisfaction With Tolerability During the First Two Weeks of Treatment | Week 1: Extremely satisfied (n=124,119,120,111) | 40 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants Showing Satisfaction With Tolerability During the First Two Weeks of Treatment | Week 1: Dissatisfied (n=124,119,120,111) | 8 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants Showing Satisfaction With Tolerability During the First Two Weeks of Treatment | Week 2: Dissatisfied (n=115,105,113,94) | 8 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants Showing Satisfaction With Tolerability During the First Two Weeks of Treatment | Week 1: Satisfied (n=124,119,120,111) | 43 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants Showing Satisfaction With Tolerability During the First Two Weeks of Treatment | Week 1: Extremely dissatisfied (n=124,119,120,111) | 1 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants Showing Satisfaction With Tolerability During the First Two Weeks of Treatment | Week 2: Neutral (n=115,105,113,94) | 18 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants Showing Satisfaction With Tolerability During the First Two Weeks of Treatment | Week 2: Neutral (n=115,105,113,94) | 15 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants Showing Satisfaction With Tolerability During the First Two Weeks of Treatment | Week 1: Satisfied (n=124,119,120,111) | 39 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants Showing Satisfaction With Tolerability During the First Two Weeks of Treatment | Week 1: Extremely satisfied (n=124,119,120,111) | 33 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants Showing Satisfaction With Tolerability During the First Two Weeks of Treatment | Week 2: Extremely dissatisfied (n=115,105,113,94) | 0 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants Showing Satisfaction With Tolerability During the First Two Weeks of Treatment | Week 2: Dissatisfied (n=115,105,113,94) | 1 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants Showing Satisfaction With Tolerability During the First Two Weeks of Treatment | Week 1: Neutral (n=124,119,120,111) | 19 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants Showing Satisfaction With Tolerability During the First Two Weeks of Treatment | Week 2: Satisfied (n=115,105,113,94) | 40 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants Showing Satisfaction With Tolerability During the First Two Weeks of Treatment | Week 2: Extremely satisfied (n=115,105,113,94) | 38 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants Showing Satisfaction With Tolerability During the First Two Weeks of Treatment | Week 1: Extremely dissatisfied (n=124,119,120,111) | 4 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants Showing Satisfaction With Tolerability During the First Two Weeks of Treatment | Week 1: Dissatisfied (n=124,119,120,111) | 16 Participants |
Secondary
Number of Participants With Each DESS at the End of First Week of Tapering
DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article.
Time frame: Week 17
Population: The tapering population included all participants who had completed at least 6 weeks of treatment and taken at least 1 dose of double-blind test article during the tapering phase.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Agitation | 1 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Fever | 2 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Shaking, trembling | 4 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Burning, numbness, tingling sensations | 5 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Sudden outbursts of anger | 3 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Forgetfulness or problems with memory | 6 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Dizziness, lightheadedness, sensation of spinning | 18 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Nose running | 3 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Uncontrolled mouth/tongue movements | 1 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Headaches | 8 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Shortness of breath, gasping for air | 1 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Blurred vision | 4 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Stomach cramps | 6 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Increased dreaming or nightmares | 14 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Restless feeling in legs | 5 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Unusual visual sensations | 1 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Trouble sleeping, insomnia | 13 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Increased saliva in mouth | 0 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Sore eyes | 3 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Chills | 3 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Bouts of crying or tearfulness | 5 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Irritability | 6 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Unusual sensitivity to sound | 1 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Elevated mood, feeling high | 1 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Sweating more than usual | 23 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Mood swings | 4 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Nervousness or anxiety | 2 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Vomiting | 4 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Diarrhea | 7 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Muscle aches or pains | 5 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Fatigue, tiredness | 9 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Ringing or noises in the ears | 6 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Sudden worsening of mood | 3 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Muscle cramps, spasms, or twitching | 5 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Unusual tastes or smells | 1 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Confusion or trouble concentrating | 5 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Unsteady gait or incoordination | 4 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Muscle tension or stiffness | 6 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Feeling unreal or detached | 6 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Problems with speech or speaking clearly | 3 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Sudden panic or anxiety attacks | 0 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Nausea | 14 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Stomach bloating | 5 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Nausea | 7 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Sudden outbursts of anger | 4 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Nervousness or anxiety | 5 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Nose running | 3 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Stomach cramps | 4 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Problems with speech or speaking clearly | 2 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Diarrhea | 3 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Restless feeling in legs | 4 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Stomach bloating | 6 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Ringing or noises in the ears | 2 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Unusual sensitivity to sound | 5 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Shaking, trembling | 4 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Sore eyes | 3 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Shortness of breath, gasping for air | 3 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Dizziness, lightheadedness, sensation of spinning | 7 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Elevated mood, feeling high | 0 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Bouts of crying or tearfulness | 3 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Unsteady gait or incoordination | 1 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Fatigue, tiredness | 11 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Vomiting | 1 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Feeling unreal or detached | 2 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Unusual visual sensations | 0 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Fever | 0 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Uncontrolled mouth/tongue movements | 1 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Forgetfulness or problems with memory | 6 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Burning, numbness, tingling sensations | 3 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Headaches | 5 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Trouble sleeping, insomnia | 11 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Increased dreaming or nightmares | 13 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Increased saliva in mouth | 0 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Sweating more than usual | 19 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Irritability | 6 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Chills | 2 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Mood swings | 5 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Blurred vision | 4 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Sudden worsening of mood | 6 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Muscle aches or pains | 8 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Unusual tastes or smells | 2 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Muscle cramps, spasms, or twitching | 6 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Sudden panic or anxiety attacks | 2 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Muscle tension or stiffness | 6 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Confusion or trouble concentrating | 4 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Agitation | 7 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Uncontrolled mouth/tongue movements | 0 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Agitation | 6 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Blurred vision | 2 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Bouts of crying or tearfulness | 6 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Burning, numbness, tingling sensations | 3 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Chills | 3 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Confusion or trouble concentrating | 2 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Diarrhea | 4 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Dizziness, lightheadedness, sensation of spinning | 9 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Elevated mood, feeling high | 0 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Fatigue, tiredness | 6 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Feeling unreal or detached | 1 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Fever | 1 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Forgetfulness or problems with memory | 3 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Headaches | 9 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Increased dreaming or nightmares | 12 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Increased saliva in mouth | 0 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Irritability | 6 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Mood swings | 4 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Muscle aches or pains | 3 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Muscle cramps, spasms, or twitching | 2 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Muscle tension or stiffness | 7 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Nausea | 5 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Nervousness or anxiety | 7 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Nose running | 3 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Problems with speech or speaking clearly | 0 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Restless feeling in legs | 0 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Ringing or noises in the ears | 6 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Shaking, trembling | 2 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Shortness of breath, gasping for air | 1 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Sore eyes | 5 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Stomach bloating | 5 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Stomach cramps | 0 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Sudden outbursts of anger | 2 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Sudden panic or anxiety attacks | 0 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Sudden worsening of mood | 4 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Sweating more than usual | 14 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Trouble sleeping, insomnia | 8 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Unsteady gait or incoordination | 0 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Unusual sensitivity to sound | 1 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Unusual tastes or smells | 1 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Unusual visual sensations | 0 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Vomiting | 0 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Nausea | 28 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Agitation | 18 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Sudden outbursts of anger | 11 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Muscle tension or stiffness | 18 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Muscle cramps, spasms, or twitching | 12 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Unusual tastes or smells | 4 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Sudden panic or anxiety attacks | 9 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Muscle aches or pains | 19 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Mood swings | 19 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Burning, numbness, tingling sensations | 9 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Sudden worsening of mood | 22 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Irritability | 26 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Increased saliva in mouth | 4 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Bouts of crying or tearfulness | 24 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Sweating more than usual | 44 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Increased dreaming or nightmares | 35 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Headaches | 28 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Vomiting | 11 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Trouble sleeping, insomnia | 37 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Forgetfulness or problems with memory | 12 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Fever | 4 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Feeling unreal or detached | 20 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Uncontrolled mouth/tongue movements | 0 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Fatigue, tiredness | 24 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Elevated mood, feeling high | 13 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Unusual visual sensations | 10 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Unsteady gait or incoordination | 16 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Dizziness, lightheadedness, sensation of spinning | 41 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Diarrhea | 20 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Blurred vision | 13 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Shortness of breath, gasping for air | 6 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Shaking, trembling | 11 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Unusual sensitivity to sound | 7 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Sore eyes | 8 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Ringing or noises in the ears | 14 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Restless feeling in legs | 4 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Confusion or trouble concentrating | 21 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Stomach bloating | 19 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Problems with speech or speaking clearly | 6 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Nose running | 7 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Chills | 9 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Stomach cramps | 11 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS at the End of First Week of Tapering | Nervousness or anxiety | 19 Participants |
Secondary
Number of Participants With Each DESS at the End of Second Week of Tapering
DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article.
Time frame: Week 18
Population: Tapering population included all participants who had completed at least 6 weeks of treatment and taken at least 1 dose of double-blind test article during the tapering phase. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure at the specified time point for each group respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Mood swings | 3 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Unusual visual sensations | 0 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Restless feeling in legs | 4 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Vomiting | 0 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Elevated mood, feeling high | 3 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Agitation | 6 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Blurred vision | 2 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Nausea | 3 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Dizziness, lightheadedness, sensation of spinning | 2 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Bouts of crying or tearfulness | 2 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Burning, numbness, tingling sensations | 0 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Ringing or noises in the ears | 1 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Diarrhea | 2 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Chills | 1 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Confusion or trouble concentrating | 0 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Irritability | 5 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Shaking, trembling | 1 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Muscle tension or stiffness | 1 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Shortness of breath, gasping for air | 0 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Increased saliva in mouth | 1 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Sore eyes | 2 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Nervousness or anxiety | 4 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Stomach bloating | 1 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Increased dreaming or nightmares | 4 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Stomach cramps | 2 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Sudden outbursts of anger | 4 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Muscle aches or pains | 2 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Headaches | 4 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Sudden panic or anxiety attacks | 0 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Nose running | 1 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Sudden worsening of mood | 6 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Forgetfulness or problems with memory | 1 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Sweating more than usual | 19 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Trouble sleeping, insomnia | 8 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Fever | 0 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Uncontrolled mouth/tongue movements | 0 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Problems with speech or speaking clearly | 0 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Unsteady gait or incoordination | 0 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Feeling unreal or detached | 0 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Unusual sensitivity to sound | 0 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Muscle cramps, spasms, or twitching | 7 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Unusual tastes or smells | 1 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Fatigue, tiredness | 3 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Muscle cramps, spasms, or twitching | 3 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Stomach bloating | 5 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Unusual visual sensations | 0 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Nervousness or anxiety | 6 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Elevated mood, feeling high | 3 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Fever | 0 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Vomiting | 0 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Restless feeling in legs | 4 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Unsteady gait or incoordination | 7 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Stomach cramps | 3 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Agitation | 4 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Dizziness, lightheadedness, sensation of spinning | 12 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Muscle tension or stiffness | 8 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Blurred vision | 6 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Headaches | 5 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Trouble sleeping, insomnia | 9 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Sudden outbursts of anger | 5 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Bouts of crying or tearfulness | 5 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Irritability | 10 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Diarrhea | 2 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Mood swings | 7 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Burning, numbness, tingling sensations | 2 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Problems with speech or speaking clearly | 3 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Unusual tastes or smells | 1 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Sudden panic or anxiety attacks | 3 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Chills | 3 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Ringing or noises in the ears | 4 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Confusion or trouble concentrating | 7 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Uncontrolled mouth/tongue movements | 1 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Nausea | 6 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Forgetfulness or problems with memory | 6 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Fatigue, tiredness | 12 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Shaking, trembling | 3 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Sudden worsening of mood | 5 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Increased saliva in mouth | 1 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Nose running | 5 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Shortness of breath, gasping for air | 2 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Muscle aches or pains | 8 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Feeling unreal or detached | 5 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Unusual sensitivity to sound | 5 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Sore eyes | 4 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Sweating more than usual | 17 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Increased dreaming or nightmares | 5 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Agitation | 10 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Muscle cramps, spasms, or twitching | 6 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Muscle tension or stiffness | 7 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Nausea | 15 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Nervousness or anxiety | 12 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Nose running | 4 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Problems with speech or speaking clearly | 4 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Restless feeling in legs | 4 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Ringing or noises in the ears | 6 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Shaking, trembling | 3 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Shortness of breath, gasping for air | 1 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Sore eyes | 3 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Stomach bloating | 6 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Stomach cramps | 4 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Sudden outbursts of anger | 12 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Sudden panic or anxiety attacks | 5 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Sudden worsening of mood | 18 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Sweating more than usual | 23 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Trouble sleeping, insomnia | 22 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Uncontrolled mouth/tongue movements | 0 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Unsteady gait or incoordination | 5 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Unusual sensitivity to sound | 3 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Unusual tastes or smells | 4 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Unusual visual sensations | 3 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Vomiting | 5 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Blurred vision | 7 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Bouts of crying or tearfulness | 18 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Burning, numbness, tingling sensations | 3 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Chills | 8 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Confusion or trouble concentrating | 11 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Diarrhea | 5 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Dizziness, lightheadedness, sensation of spinning | 21 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Elevated mood, feeling high | 5 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Fatigue, tiredness | 14 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Feeling unreal or detached | 9 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Fever | 1 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Irritability | 18 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Forgetfulness or problems with memory | 4 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Headaches | 8 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Increased dreaming or nightmares | 10 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Increased saliva in mouth | 2 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Mood swings | 14 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Muscle aches or pains | 9 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Elevated mood, feeling high | 3 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Unusual tastes or smells | 1 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Unusual sensitivity to sound | 2 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Problems with speech or speaking clearly | 1 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Fatigue, tiredness | 11 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Unsteady gait or incoordination | 3 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Uncontrolled mouth/tongue movements | 1 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Nose running | 7 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Feeling unreal or detached | 3 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Trouble sleeping, insomnia | 19 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Sweating more than usual | 23 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Muscle tension or stiffness | 7 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Fever | 1 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Sudden worsening of mood | 8 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Mood swings | 5 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Sudden panic or anxiety attacks | 1 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Nervousness or anxiety | 8 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Forgetfulness or problems with memory | 2 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Sudden outbursts of anger | 8 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Stomach cramps | 0 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Nausea | 4 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Headaches | 4 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Irritability | 13 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Stomach bloating | 5 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Sore eyes | 5 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Muscle cramps, spasms, or twitching | 5 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Increased dreaming or nightmares | 8 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Shortness of breath, gasping for air | 4 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Shaking, trembling | 3 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Chills | 4 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Muscle aches or pains | 7 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Confusion or trouble concentrating | 4 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Burning, numbness, tingling sensations | 4 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Bouts of crying or tearfulness | 6 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Increased saliva in mouth | 4 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Diarrhea | 1 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Blurred vision | 3 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Agitation | 9 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Ringing or noises in the ears | 2 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Dizziness, lightheadedness, sensation of spinning | 7 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Vomiting | 0 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Unusual visual sensations | 2 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS at the End of Second Week of Tapering | Restless feeling in legs | 4 Participants |
Secondary
Number of Participants With Each DESS One Week After End of Tapering
DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article.
Time frame: Week 19
Population: Tapering population included all participants who had completed at least 6 weeks of treatment and taken at least 1 dose of double-blind test article during the tapering phase. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure at the specified time point for each group respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Vomiting | 1 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Nervousness or anxiety | 9 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Nausea | 5 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Fever | 2 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Uncontrolled mouth/tongue movements | 0 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Muscle tension or stiffness | 5 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Muscle cramps, spasms, or twitching | 5 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Forgetfulness or problems with memory | 5 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Trouble sleeping, insomnia | 12 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Muscle aches or pains | 5 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Mood swings | 4 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Irritability | 11 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Burning, numbness, tingling sensations | 2 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Increased saliva in mouth | 0 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Increased dreaming or nightmares | 7 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Unusual visual sensations | 0 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Sweating more than usual | 21 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Sudden worsening of mood | 7 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Chills | 3 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Unusual tastes or smells | 1 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Sudden panic or anxiety attacks | 1 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Sudden outbursts of anger | 4 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Confusion or trouble concentrating | 6 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Blurred vision | 2 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Stomach cramps | 2 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Stomach bloating | 3 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Diarrhea | 3 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Agitation | 6 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Sore eyes | 3 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Shortness of breath, gasping for air | 1 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Dizziness, lightheadedness, sensation of spinning | 13 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Unusual sensitivity to sound | 1 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Shaking, trembling | 3 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Headaches | 4 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Elevated mood, feeling high | 1 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Unsteady gait or incoordination | 4 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Ringing or noises in the ears | 3 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Restless feeling in legs | 1 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Fatigue, tiredness | 9 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Bouts of crying or tearfulness | 7 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Problems with speech or speaking clearly | 0 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Nose running | 1 Participants |
| DVS 25 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Feeling unreal or detached | 6 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Ringing or noises in the ears | 8 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Agitation | 4 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Blurred vision | 0 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Bouts of crying or tearfulness | 7 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Burning, numbness, tingling sensations | 9 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Chills | 3 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Confusion or trouble concentrating | 7 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Diarrhea | 3 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Dizziness, lightheadedness, sensation of spinning | 17 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Elevated mood, feeling high | 2 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Fatigue, tiredness | 10 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Feeling unreal or detached | 5 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Fever | 0 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Forgetfulness or problems with memory | 3 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Headaches | 11 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Increased dreaming or nightmares | 10 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Increased saliva in mouth | 1 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Irritability | 9 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Mood swings | 5 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Muscle aches or pains | 8 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Muscle cramps, spasms, or twitching | 5 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Muscle tension or stiffness | 9 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Sweating more than usual | 19 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Nausea | 5 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Nervousness or anxiety | 10 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Nose running | 2 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Problems with speech or speaking clearly | 2 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Restless feeling in legs | 6 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Shaking, trembling | 3 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Shortness of breath, gasping for air | 1 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Sore eyes | 4 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Stomach bloating | 4 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Stomach cramps | 3 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Sudden outbursts of anger | 3 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Sudden panic or anxiety attacks | 5 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Sudden worsening of mood | 4 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Trouble sleeping, insomnia | 13 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Uncontrolled mouth/tongue movements | 1 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Unsteady gait or incoordination | 5 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Unusual sensitivity to sound | 2 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Unusual tastes or smells | 3 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Unusual visual sensations | 3 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Vomiting | 0 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Ringing or noises in the ears | 0 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Fatigue, tiredness | 2 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Dizziness, lightheadedness, sensation of spinning | 2 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Sudden outbursts of anger | 3 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Blurred vision | 0 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Chills | 1 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Unusual tastes or smells | 0 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Sudden panic or anxiety attacks | 2 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Shaking, trembling | 0 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Unsteady gait or incoordination | 0 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Problems with speech or speaking clearly | 0 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Sudden worsening of mood | 5 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Feeling unreal or detached | 1 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Burning, numbness, tingling sensations | 0 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Sweating more than usual | 4 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Shortness of breath, gasping for air | 1 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Nausea | 0 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Increased dreaming or nightmares | 0 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Diarrhea | 1 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Headaches | 3 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Unusual sensitivity to sound | 0 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Increased saliva in mouth | 1 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Sore eyes | 1 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Agitation | 6 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Irritability | 7 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Unusual visual sensations | 0 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Restless feeling in legs | 3 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Trouble sleeping, insomnia | 5 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Mood swings | 6 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Nose running | 3 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Forgetfulness or problems with memory | 2 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Stomach bloating | 1 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Muscle aches or pains | 5 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Elevated mood, feeling high | 0 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Confusion or trouble concentrating | 4 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Bouts of crying or tearfulness | 2 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Muscle cramps, spasms, or twitching | 1 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Nervousness or anxiety | 5 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Fever | 0 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Vomiting | 0 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Uncontrolled mouth/tongue movements | 0 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Muscle tension or stiffness | 3 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Stomach cramps | 0 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Muscle tension or stiffness | 2 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Uncontrolled mouth/tongue movements | 0 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Nausea | 1 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Blurred vision | 1 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Nervousness or anxiety | 3 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Fatigue, tiredness | 8 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Nose running | 1 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Problems with speech or speaking clearly | 0 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Elevated mood, feeling high | 0 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Unsteady gait or incoordination | 1 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Restless feeling in legs | 1 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Dizziness, lightheadedness, sensation of spinning | 0 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Ringing or noises in the ears | 0 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Shaking, trembling | 1 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Diarrhea | 1 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Unusual visual sensations | 1 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Shortness of breath, gasping for air | 0 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Sore eyes | 2 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Confusion or trouble concentrating | 2 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Unusual sensitivity to sound | 1 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Stomach bloating | 4 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Agitation | 5 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Stomach cramps | 2 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Chills | 3 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Vomiting | 0 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Sudden outbursts of anger | 5 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Sudden panic or anxiety attacks | 2 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Burning, numbness, tingling sensations | 2 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Unusual tastes or smells | 0 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Sudden worsening of mood | 5 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Headaches | 5 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Sweating more than usual | 12 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Increased dreaming or nightmares | 3 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Bouts of crying or tearfulness | 3 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Increased saliva in mouth | 1 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Irritability | 6 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Forgetfulness or problems with memory | 3 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Mood swings | 4 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Trouble sleeping, insomnia | 7 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Muscle aches or pains | 3 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Fever | 0 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Muscle cramps, spasms, or twitching | 1 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Each DESS One Week After End of Tapering | Feeling unreal or detached | 3 Participants |
Secondary
Number of Participants With Other Spontaneously Reported Adverse Events (AEs) in First 2 Weeks of Treatment
Any untoward medical occurrence in a participant who received study drug was considered an AE, without regard to possibility of causal relationship.
Time frame: Baseline up to Week 2
Population: The titration population included all randomly assigned participants who had taken at least 1 dose of double-blind test article during the double-blind titration period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DVS 25 mg, Then 100 mg | Number of Participants With Other Spontaneously Reported Adverse Events (AEs) in First 2 Weeks of Treatment | 67 Participants |
| DVS 25/50 mg, Then 100 mg | Number of Participants With Other Spontaneously Reported Adverse Events (AEs) in First 2 Weeks of Treatment | 69 Participants |
| DVS 50 mg, Then 100 mg | Number of Participants With Other Spontaneously Reported Adverse Events (AEs) in First 2 Weeks of Treatment | 72 Participants |
| DVS 100 mg, Then 100 mg | Number of Participants With Other Spontaneously Reported Adverse Events (AEs) in First 2 Weeks of Treatment | 80 Participants |
Secondary
Percentage of Participants Discontinuing Treatment Due to AEs in First 2 Weeks of Treatment
Any untoward medical occurrence in a participant who received study drug was considered an AE, without regard to possibility of causal relationship.
Time frame: Baseline up to Week 2
Population: The titration population included all randomly assigned participants who had taken at least 1 dose of double-blind test article during the double-blind titration period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DVS 25 mg, Then 100 mg | Percentage of Participants Discontinuing Treatment Due to AEs in First 2 Weeks of Treatment | 4.0 Percentage of participants |
| DVS 25/50 mg, Then 100 mg | Percentage of Participants Discontinuing Treatment Due to AEs in First 2 Weeks of Treatment | 9.1 Percentage of participants |
| DVS 50 mg, Then 100 mg | Percentage of Participants Discontinuing Treatment Due to AEs in First 2 Weeks of Treatment | 6.5 Percentage of participants |
| DVS 100 mg, Then 100 mg | Percentage of Participants Discontinuing Treatment Due to AEs in First 2 Weeks of Treatment | 14.8 Percentage of participants |
Comparison: Overall comparison was made between each titration regimen and the control regimen (100 mg).p-value: 0.017Chi-squared
Other Pre-specified
Gender of the Participants in Tapering Phase
Participants were re-randomized to tapering phase after OL phase.
Time frame: Week 17
Population: The tapering population included all participants who had completed at least 6 weeks of treatment and taken at least 1 dose of double-blind test article during the tapering phase.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DVS 25 mg, Then 100 mg | Gender of the Participants in Tapering Phase | Male | 0 Participants |
| DVS 25 mg, Then 100 mg | Gender of the Participants in Tapering Phase | Female | 101 Participants |
| DVS 25/50 mg, Then 100 mg | Gender of the Participants in Tapering Phase | Male | 0 Participants |
| DVS 25/50 mg, Then 100 mg | Gender of the Participants in Tapering Phase | Female | 94 Participants |
| DVS 50 mg, Then 100 mg | Gender of the Participants in Tapering Phase | Female | 87 Participants |
| DVS 50 mg, Then 100 mg | Gender of the Participants in Tapering Phase | Male | 0 Participants |
| DVS 100 mg, Then 100 mg | Gender of the Participants in Tapering Phase | Female | 102 Participants |
| DVS 100 mg, Then 100 mg | Gender of the Participants in Tapering Phase | Male | 0 Participants |
Other Pre-specified
Mean Age of the Participants in Tapering Phase
Participants were re-randomized to tapering phase after OL phase.
Time frame: Week 17
Population: The tapering population included all participants who had completed at least 6 weeks of treatment and taken at least 1 dose of double-blind test article during the tapering phase.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DVS 25 mg, Then 100 mg | Mean Age of the Participants in Tapering Phase | 53.72 Years | Standard Deviation 5.02 |
| DVS 25/50 mg, Then 100 mg | Mean Age of the Participants in Tapering Phase | 54.56 Years | Standard Deviation 5.21 |
| DVS 50 mg, Then 100 mg | Mean Age of the Participants in Tapering Phase | 54.20 Years | Standard Deviation 6.31 |
| DVS 100 mg, Then 100 mg | Mean Age of the Participants in Tapering Phase | 54.14 Years | Standard Deviation 5.09 |