Depressive Disorder, Major
Conditions
Keywords
major depressive disorder, MDD, depression
Brief summary
This study will assess the safety, tolerability and efficacy of desvenlafaxine succinate sustained release (DVS SR) in subjects with major depressive disorder.
Detailed description
The primary objective of this study is to investigate the efficacy, safety and tolerability of desvenlafaxine succinate sustained release (DVS SR) in Chinese, Taiwanese, South Korean, and Indian subjects with major depressive disorder (MDD) receiving daily doses of 50 mg, 100 mg, or 200 mg. The secondary objective is to obtain additional information regarding the efficacy of DVS SR in subjects with MDD receiving daily doses of 50 mg, 100 mg, or 200 mg. Additional objectives include obtaining general and functional quality of life outcome data.
Interventions
DRUGDVS SR
Arm 1: 50mg DVS SR tablet, QD, 8 weeks treatment with 2 week taper Arm 2: 100mg DVS SR tablet, QD, 8 weeks treatment with 2 week taper Arm 3: 200mg DVS SR tablet, QD, 8 weeks treatment with 2 week taper
DRUGParoxetine
20 mg Paroxetine capsule, QD, 8 weeks treatment with 2 week taper
Sponsors
Wyeth is now a wholly owned subsidiary of Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Primary Inclusion Criteria: 1. Outpatient men and women at least 18 years of age. 2. Have a primary diagnosis of MDD based on the criteria in the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM IV), single or recurrent episode, without psychotic features. 3. Have a HAM D17 total score ≥20 at the screening and baseline (study day 1) visit. Primary
Exclusion criteria
1. Treatment with DVS SR at any time in the past. 2. Significant risk of suicide based on clinical judgment, including common suicidal thoughts and suicide having been considered as a possible solution even without specific plans or intent. 3. Any unstable hepatic, renal, pulmonary, cardiovascular (including uncontrolled hypertension), ophthalmologic, neurologic, or any other medical condition that might confound the study or put the subject at greater risk during study participation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Responders With a 50% or Greater Decrease From Baseline on the Hamilton Rating Scale for Depression, 17-item (HAM-D17) | 8 weeks | HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), with 0=none/absent and 4=most severe, for a maximum total score of 50. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Global Impressions Scale-Severity of Illness (CGI-S) Scores | 8 weeks | CGI-S is a global rating scale that measures the severity of a subject's disease. Using a 7-point scale, the clinician rates the severity of the patient's mental illness at the time of the assessment, relative to the clinician's experience with subjects who have the same diagnosis (1= normal, not at all ill; 7= among the most extremely ill). |
| Montgomery and Asberg Depression Rating Scale (MADRS) Total Score Mean Change From Baseline | Baseline and 8 weeks | Measures the overall severity of depressive symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). |
| Clinical Global Impressions Scale-Improvement (CGI-I) Scores | 8 weeks | CGI-I is a global rating scale that measures disease improvement. Using a 7-point scale, the clinician rates how much the subject's illness has improved or worsened relative to the baseline status (1= very much improved; 7= very much worse). |
| Hamilton Rating Scale for Depression, 6-item (HAM-D6) Score Mean Change From Baseline | 8 weeks | HAM-D6: standardized, clinician-administered rating scale is a subset of the HAM-D17 that assesses 6 items associated with major depression. The scale uses HAM-D17 items 1, 2, 7, 8, 10 and 13. Item 13 is scored 0 to 2 (0=none/absent to 2=most severe) and all others are scored 0 to 4 (0=none/absent to 4=most severe). Total score ranges from 0 to 22; higher score indicates more depression. |
| Covi Anxiety Scale Score Mean Change From Baseline | 8 weeks | Covi anxiety scale measures the severity of anxiety symptoms on 3 items: verbal report, behavior and somatic complaints. Each dimension is assessed using a 5-point scale: 1 = not at all, 2 = somewhat, 3 = moderately, 4 = considerably, 5 = Very much. Total score ranges from 3 to 15; higher score indicates more anxiety. |
| Visual Analog Scale-pain Intensity (VAS-PI) Score Mean Change From Baseline | 8 weeks | The VAS-PI is a self-rated visual analog scale for the assessment of pain. Scores on the VAS-PI range from 0 (no pain) to 10 (worst possible pain). A decrease in VAS-PI overall scores indicates a subject's assessment of an improvement in pain. |
Countries
China, India, South Korea, Taiwan
Participant flow
Recruitment details
Subjects were recruited in China, India, South Korea and Taiwan from July 2007 to December 2008.
Pre-assignment details
After a 4 to 21 day screening period, eligible subjects were treated for up to 8 weeks.
Participants by arm
| Arm | Count |
|---|---|
| DVS SR 50 Desvenlafaxine Succinate Sustained-Release (DVS SR) 50 mg/day | 203 |
| DVS SR 100 Desvenlafaxine Succinate Sustained-Release (DVS SR) 100 mg/day | 203 |
| DVS SR 200 Desvenlafaxine Succinate Sustained-Release (DVS SR) 200 mg/day | 205 |
| Paroxetine 20 Paroxetine 20 mg/day | 196 |
| Total | 807 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 22 | 12 | 30 | 19 |
| Overall Study | Compliance | 3 | 2 | 1 | 2 |
| Overall Study | Failed to return | 1 | 3 | 2 | 2 |
| Overall Study | Lack of Efficacy | 2 | 6 | 2 | 0 |
| Overall Study | Lost to Follow-up | 10 | 6 | 6 | 5 |
| Overall Study | Physician Decision | 0 | 0 | 1 | 0 |
| Overall Study | Protocol Violation | 2 | 3 | 3 | 1 |
| Overall Study | Withdrawal by Subject | 8 | 14 | 20 | 18 |
| Overall Study | Withdrawal of Informed Consent | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | DVS SR 50 | DVS SR 100 | DVS SR 200 | Paroxetine 20 | Total |
|---|---|---|---|---|---|
| Age Continuous | 38.63 years STANDARD_DEVIATION 12.96 | 39.26 years STANDARD_DEVIATION 13.22 | 39.26 years STANDARD_DEVIATION 14.69 | 38.27 years STANDARD_DEVIATION 13.22 | 38.86 years STANDARD_DEVIATION 13.53 |
| Sex: Female, Male Female | 125 Participants | 129 Participants | 118 Participants | 117 Participants | 489 Participants |
| Sex: Female, Male Male | 78 Participants | 74 Participants | 87 Participants | 79 Participants | 318 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 128 / 203 | 128 / 203 | 140 / 205 | 134 / 196 |
| serious Total, serious adverse events | 4 / 203 | 1 / 203 | 5 / 205 | 2 / 196 |
Outcome results
Primary
Percentage of Responders With a 50% or Greater Decrease From Baseline on the Hamilton Rating Scale for Depression, 17-item (HAM-D17)
HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), with 0=none/absent and 4=most severe, for a maximum total score of 50.
Time frame: 8 weeks
Population: The intent-to-treat (ITT) population included all subjects randomly assigned to treatment who had a baseline HAM-D17 evaluation, took at least 1 dose of double-blind test article, and had at least 1 postbaseline HAM-D17 evaluation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DVS SR 50 | Percentage of Responders With a 50% or Greater Decrease From Baseline on the Hamilton Rating Scale for Depression, 17-item (HAM-D17) | 63 percentage of responders |
| DVS SR 100 | Percentage of Responders With a 50% or Greater Decrease From Baseline on the Hamilton Rating Scale for Depression, 17-item (HAM-D17) | 67 percentage of responders |
| DVS SR 200 | Percentage of Responders With a 50% or Greater Decrease From Baseline on the Hamilton Rating Scale for Depression, 17-item (HAM-D17) | 63 percentage of responders |
| Paroxetine 20 | Percentage of Responders With a 50% or Greater Decrease From Baseline on the Hamilton Rating Scale for Depression, 17-item (HAM-D17) | 66 percentage of responders |
95% CI: [-12.62, 6.37]
95% CI: [-8.5, 10.25]
95% CI: [-11.68, 7.33]
Secondary
Clinical Global Impressions Scale-Improvement (CGI-I) Scores
CGI-I is a global rating scale that measures disease improvement. Using a 7-point scale, the clinician rates how much the subject's illness has improved or worsened relative to the baseline status (1= very much improved; 7= very much worse).
Time frame: 8 weeks
Population: The intent-to-treat (ITT) population included all subjects randomly assigned to treatment who had a baseline HAM-D17 evaluation, took at least 1 dose of double-blind test article, and had at least 1 postbaseline HAM-D17 evaluation. Number of participants analyzed reflects the final on-therapy population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DVS SR 50 | Clinical Global Impressions Scale-Improvement (CGI-I) Scores | Final - Score 5 (Minimally worse) | 8 subjects |
| DVS SR 50 | Clinical Global Impressions Scale-Improvement (CGI-I) Scores | Final - Score 6 (Much worse) | 4 subjects |
| DVS SR 50 | Clinical Global Impressions Scale-Improvement (CGI-I) Scores | Final - Score 1 (Very much improved) | 72 subjects |
| DVS SR 50 | Clinical Global Impressions Scale-Improvement (CGI-I) Scores | Final - Score 2 (Much improved) | 64 subjects |
| DVS SR 50 | Clinical Global Impressions Scale-Improvement (CGI-I) Scores | Final - Score 3 (Minimally improved) | 36 subjects |
| DVS SR 50 | Clinical Global Impressions Scale-Improvement (CGI-I) Scores | Final - Score 4 (No change) | 16 subjects |
| DVS SR 50 | Clinical Global Impressions Scale-Improvement (CGI-I) Scores | Final - Score 7 (Very Much worse) | 0 subjects |
| DVS SR 100 | Clinical Global Impressions Scale-Improvement (CGI-I) Scores | Final - Score 7 (Very Much worse) | 0 subjects |
| DVS SR 100 | Clinical Global Impressions Scale-Improvement (CGI-I) Scores | Final - Score 3 (Minimally improved) | 34 subjects |
| DVS SR 100 | Clinical Global Impressions Scale-Improvement (CGI-I) Scores | Final - Score 5 (Minimally worse) | 6 subjects |
| DVS SR 100 | Clinical Global Impressions Scale-Improvement (CGI-I) Scores | Final - Score 2 (Much improved) | 64 subjects |
| DVS SR 100 | Clinical Global Impressions Scale-Improvement (CGI-I) Scores | Final - Score 6 (Much worse) | 1 subjects |
| DVS SR 100 | Clinical Global Impressions Scale-Improvement (CGI-I) Scores | Final - Score 4 (No change) | 17 subjects |
| DVS SR 100 | Clinical Global Impressions Scale-Improvement (CGI-I) Scores | Final - Score 1 (Very much improved) | 78 subjects |
| DVS SR 200 | Clinical Global Impressions Scale-Improvement (CGI-I) Scores | Final - Score 4 (No change) | 26 subjects |
| DVS SR 200 | Clinical Global Impressions Scale-Improvement (CGI-I) Scores | Final - Score 5 (Minimally worse) | 10 subjects |
| DVS SR 200 | Clinical Global Impressions Scale-Improvement (CGI-I) Scores | Final - Score 1 (Very much improved) | 79 subjects |
| DVS SR 200 | Clinical Global Impressions Scale-Improvement (CGI-I) Scores | Final - Score 6 (Much worse) | 0 subjects |
| DVS SR 200 | Clinical Global Impressions Scale-Improvement (CGI-I) Scores | Final - Score 3 (Minimally improved) | 28 subjects |
| DVS SR 200 | Clinical Global Impressions Scale-Improvement (CGI-I) Scores | Final - Score 7 (Very Much worse) | 0 subjects |
| DVS SR 200 | Clinical Global Impressions Scale-Improvement (CGI-I) Scores | Final - Score 2 (Much improved) | 53 subjects |
| Paroxetine 20 | Clinical Global Impressions Scale-Improvement (CGI-I) Scores | Final - Score 6 (Much worse) | 2 subjects |
| Paroxetine 20 | Clinical Global Impressions Scale-Improvement (CGI-I) Scores | Final - Score 1 (Very much improved) | 72 subjects |
| Paroxetine 20 | Clinical Global Impressions Scale-Improvement (CGI-I) Scores | Final - Score 7 (Very Much worse) | 0 subjects |
| Paroxetine 20 | Clinical Global Impressions Scale-Improvement (CGI-I) Scores | Final - Score 2 (Much improved) | 59 subjects |
| Paroxetine 20 | Clinical Global Impressions Scale-Improvement (CGI-I) Scores | Final - Score 3 (Minimally improved) | 37 subjects |
| Paroxetine 20 | Clinical Global Impressions Scale-Improvement (CGI-I) Scores | Final - Score 4 (No change) | 17 subjects |
| Paroxetine 20 | Clinical Global Impressions Scale-Improvement (CGI-I) Scores | Final - Score 5 (Minimally worse) | 4 subjects |
Comparison: Final on-therapy populationp-value: 0.714Cochran-Mantel-Haenszel
Comparison: Final on-therapy populationp-value: 0.653Cochran-Mantel-Haenszel
Comparison: Final on-therapy populationp-value: 0.881Cochran-Mantel-Haenszel
Secondary
Clinical Global Impressions Scale-Severity of Illness (CGI-S) Scores
CGI-S is a global rating scale that measures the severity of a subject's disease. Using a 7-point scale, the clinician rates the severity of the patient's mental illness at the time of the assessment, relative to the clinician's experience with subjects who have the same diagnosis (1= normal, not at all ill; 7= among the most extremely ill).
Time frame: 8 weeks
Population: The intent-to-treat (ITT) population included all subjects randomly assigned to treatment who had a baseline HAM-D17 evaluation, took at least 1 dose of double-blind test article, and had at least 1 postbaseline HAM-D17 evaluation. Number of participants analyzed reflects the final on-therapy population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DVS SR 50 | Clinical Global Impressions Scale-Severity of Illness (CGI-S) Scores | Final - Score 4 (Moderately ill) | 29 subjects |
| DVS SR 50 | Clinical Global Impressions Scale-Severity of Illness (CGI-S) Scores | Final - Score 5 (Markedly ill) | 24 subjects |
| DVS SR 50 | Clinical Global Impressions Scale-Severity of Illness (CGI-S) Scores | Final - Score 1 (Normal, not at all ill) | 40 subjects |
| DVS SR 50 | Clinical Global Impressions Scale-Severity of Illness (CGI-S) Scores | Final - Score 6 (Severely ill) | 5 subjects |
| DVS SR 50 | Clinical Global Impressions Scale-Severity of Illness (CGI-S) Scores | Final - Score 7 (Among the most extremely ill) | 0 subjects |
| DVS SR 50 | Clinical Global Impressions Scale-Severity of Illness (CGI-S) Scores | Final - Score 2 (Borderline mentally ill) | 49 subjects |
| DVS SR 50 | Clinical Global Impressions Scale-Severity of Illness (CGI-S) Scores | Final - Score 3 (Mildly ill) | 53 subjects |
| DVS SR 100 | Clinical Global Impressions Scale-Severity of Illness (CGI-S) Scores | Final - Score 5 (Markedly ill) | 18 subjects |
| DVS SR 100 | Clinical Global Impressions Scale-Severity of Illness (CGI-S) Scores | Final - Score 1 (Normal, not at all ill) | 50 subjects |
| DVS SR 100 | Clinical Global Impressions Scale-Severity of Illness (CGI-S) Scores | Final - Score 4 (Moderately ill) | 30 subjects |
| DVS SR 100 | Clinical Global Impressions Scale-Severity of Illness (CGI-S) Scores | Final - Score 3 (Mildly ill) | 46 subjects |
| DVS SR 100 | Clinical Global Impressions Scale-Severity of Illness (CGI-S) Scores | Final - Score 7 (Among the most extremely ill) | 1 subjects |
| DVS SR 100 | Clinical Global Impressions Scale-Severity of Illness (CGI-S) Scores | Final - Score 6 (Severely ill) | 2 subjects |
| DVS SR 100 | Clinical Global Impressions Scale-Severity of Illness (CGI-S) Scores | Final - Score 2 (Borderline mentally ill) | 53 subjects |
| DVS SR 200 | Clinical Global Impressions Scale-Severity of Illness (CGI-S) Scores | Final - Score 3 (Mildly ill) | 34 subjects |
| DVS SR 200 | Clinical Global Impressions Scale-Severity of Illness (CGI-S) Scores | Final - Score 5 (Markedly ill) | 19 subjects |
| DVS SR 200 | Clinical Global Impressions Scale-Severity of Illness (CGI-S) Scores | Final - Score 4 (Moderately ill) | 38 subjects |
| DVS SR 200 | Clinical Global Impressions Scale-Severity of Illness (CGI-S) Scores | Final - Score 2 (Borderline mentally ill) | 47 subjects |
| DVS SR 200 | Clinical Global Impressions Scale-Severity of Illness (CGI-S) Scores | Final - Score 1 (Normal, not at all ill) | 53 subjects |
| DVS SR 200 | Clinical Global Impressions Scale-Severity of Illness (CGI-S) Scores | Final - Score 7 (Among the most extremely ill) | 0 subjects |
| DVS SR 200 | Clinical Global Impressions Scale-Severity of Illness (CGI-S) Scores | Final - Score 6 (Severely ill) | 6 subjects |
| Paroxetine 20 | Clinical Global Impressions Scale-Severity of Illness (CGI-S) Scores | Final - Score 7 (Among the most extremely ill) | 1 subjects |
| Paroxetine 20 | Clinical Global Impressions Scale-Severity of Illness (CGI-S) Scores | Final - Score 5 (Markedly ill) | 15 subjects |
| Paroxetine 20 | Clinical Global Impressions Scale-Severity of Illness (CGI-S) Scores | Final - Score 6 (Severely ill) | 7 subjects |
| Paroxetine 20 | Clinical Global Impressions Scale-Severity of Illness (CGI-S) Scores | Final - Score 1 (Normal, not at all ill) | 42 subjects |
| Paroxetine 20 | Clinical Global Impressions Scale-Severity of Illness (CGI-S) Scores | Final - Score 2 (Borderline mentally ill) | 49 subjects |
| Paroxetine 20 | Clinical Global Impressions Scale-Severity of Illness (CGI-S) Scores | Final - Score 3 (Mildly ill) | 51 subjects |
| Paroxetine 20 | Clinical Global Impressions Scale-Severity of Illness (CGI-S) Scores | Final - Score 4 (Moderately ill) | 27 subjects |
Comparison: Final on-therapy populationp-value: 0.45Cochran-Mantel-Haenszel
Comparison: Final on-therapy populationp-value: 0.452Cochran-Mantel-Haenszel
Comparison: Final on-therapy populationp-value: 0.85Cochran-Mantel-Haenszel
Secondary
Covi Anxiety Scale Score Mean Change From Baseline
Covi anxiety scale measures the severity of anxiety symptoms on 3 items: verbal report, behavior and somatic complaints. Each dimension is assessed using a 5-point scale: 1 = not at all, 2 = somewhat, 3 = moderately, 4 = considerably, 5 = Very much. Total score ranges from 3 to 15; higher score indicates more anxiety.
Time frame: 8 weeks
Population: The intent-to-treat (ITT) population included all subjects randomly assigned to treatment who had a baseline HAM-D17 evaluation, took at least 1 dose of double-blind test article, and had at least 1 postbaseline HAM-D17 evaluation. Number of participants analyzed reflects the final on-therapy population.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| DVS SR 50 | Covi Anxiety Scale Score Mean Change From Baseline | -1.23 scores on a scale |
| DVS SR 100 | Covi Anxiety Scale Score Mean Change From Baseline | -1.28 scores on a scale |
| DVS SR 200 | Covi Anxiety Scale Score Mean Change From Baseline | -1.17 scores on a scale |
| Paroxetine 20 | Covi Anxiety Scale Score Mean Change From Baseline | -1.24 scores on a scale |
Secondary
Hamilton Rating Scale for Depression, 6-item (HAM-D6) Score Mean Change From Baseline
HAM-D6: standardized, clinician-administered rating scale is a subset of the HAM-D17 that assesses 6 items associated with major depression. The scale uses HAM-D17 items 1, 2, 7, 8, 10 and 13. Item 13 is scored 0 to 2 (0=none/absent to 2=most severe) and all others are scored 0 to 4 (0=none/absent to 4=most severe). Total score ranges from 0 to 22; higher score indicates more depression.
Time frame: 8 weeks
Population: The intent-to-treat (ITT) population included all subjects randomly assigned to treatment who had a baseline HAM-D17 evaluation, took at least 1 dose of double-blind test article, and had at least 1 postbaseline HAM-D17 evaluation. Number of participants analyzed reflects the final on-therapy population.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| DVS SR 50 | Hamilton Rating Scale for Depression, 6-item (HAM-D6) Score Mean Change From Baseline | -6.50 scores on a scale |
| DVS SR 100 | Hamilton Rating Scale for Depression, 6-item (HAM-D6) Score Mean Change From Baseline | -6.51 scores on a scale |
| DVS SR 200 | Hamilton Rating Scale for Depression, 6-item (HAM-D6) Score Mean Change From Baseline | -6.42 scores on a scale |
| Paroxetine 20 | Hamilton Rating Scale for Depression, 6-item (HAM-D6) Score Mean Change From Baseline | -6.58 scores on a scale |
Secondary
Montgomery and Asberg Depression Rating Scale (MADRS) Total Score Mean Change From Baseline
Measures the overall severity of depressive symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).
Time frame: Baseline and 8 weeks
Population: The intent-to-treat (ITT) population included all subjects randomly assigned to treatment who had a baseline HAM-D17 evaluation, took at least 1 dose of double-blind test article, and had at least 1 postbaseline HAM-D17 evaluation. Number of participants analyzed reflects the final on-therapy population.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| DVS SR 50 | Montgomery and Asberg Depression Rating Scale (MADRS) Total Score Mean Change From Baseline | -16.84 units on a scale |
| DVS SR 100 | Montgomery and Asberg Depression Rating Scale (MADRS) Total Score Mean Change From Baseline | -17.84 units on a scale |
| DVS SR 200 | Montgomery and Asberg Depression Rating Scale (MADRS) Total Score Mean Change From Baseline | -16.81 units on a scale |
| Paroxetine 20 | Montgomery and Asberg Depression Rating Scale (MADRS) Total Score Mean Change From Baseline | -16.54 units on a scale |
Secondary
Visual Analog Scale-pain Intensity (VAS-PI) Score Mean Change From Baseline
The VAS-PI is a self-rated visual analog scale for the assessment of pain. Scores on the VAS-PI range from 0 (no pain) to 10 (worst possible pain). A decrease in VAS-PI overall scores indicates a subject's assessment of an improvement in pain.
Time frame: 8 weeks
Population: The intent-to-treat (ITT) population included all subjects randomly assigned to treatment who had a baseline HAM-D17 evaluation, took at least 1 dose of double-blind test article, and had at least 1 postbaseline HAM-D17 evaluation. Number of participants analyzed reflects the final on-therapy population.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| DVS SR 50 | Visual Analog Scale-pain Intensity (VAS-PI) Score Mean Change From Baseline | -11.69 scores on a scale |
| DVS SR 100 | Visual Analog Scale-pain Intensity (VAS-PI) Score Mean Change From Baseline | -10.00 scores on a scale |
| DVS SR 200 | Visual Analog Scale-pain Intensity (VAS-PI) Score Mean Change From Baseline | -9.10 scores on a scale |
| Paroxetine 20 | Visual Analog Scale-pain Intensity (VAS-PI) Score Mean Change From Baseline | -9.52 scores on a scale |