Major Depressive Disorder
Conditions
Keywords
Major Depressive Disorder, MDD, Depression
Brief summary
This is a 6-month, open-label, flexible-dose study evaluating Desvenlafaxine Succinate Sustained-Release (DVS SR) in the Treatment of Child and Adolescent Outpatients with Major Depressive Disorder (MDD).
Interventions
DRUGDVS SR
Subjects will receive a flexible-dose of 20, 25, 35, or 50 mg/day as prescribed by the investigator
Sponsors
Pfizer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
7 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Completed study B2061032 and who in the investigator's opinion, would benefit from long term treatment with DVS SR * Willingness and ability to comply with scheduled visits, treatment plan, and procedures
Exclusion criteria
* Requires precaution against suicide * Not in generally healthy medical condition * Poor compliance with study drug or study procedures during participation in study B2061032
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With a Treatment-emergent Adverse Event (TEAE) | From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030 | A TEAE was defined as an event that was absent before treatment and emerged or worsened during the treatment period. |
| Percentage of Participants With a Treatment-emergent Adverse Event (TEAE) (Combination Group) | From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030 | A TEAE was defined as an event that was absent before treatment and emerged or worsened during the treatment period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Score From Baseline to Week 26 on the Clinical Global Impression-Severity (CGI-S) Scale, Based on Observed Cases | From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030 | The Clinical Global Impression (CGI) Scale is a tool that summarizes all available patient data, including history, symptoms, behavior, and the impact of the symptoms on ability to function. The scale consists of 2 measures: the CGI-S, which rates the severity of illness from 1 to 7, and the CGI-Improvement Scale, which assesses improvement in illness since baseline. The CGI-S is a 7-point scale a clinician uses to rate a patient's severity of illness. Scores range from 1 to 7, with 1 indicating normal, not at all ill and 7, among the most extremely ill patients. Higher score on the CGI-S indicates greater severity of illness. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032. |
| Change in Score From Baseline to Week 26 on the Clinical Global Impression-Severity (CGI-S) Scale, Based on Observed Cases (Combination Group) | From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030 | The Clinical Global Impression (CGI) Scale is a tool that summarizes all available patient data, including history, symptoms, behavior, and the impact of the symptoms on ability to function. The scale consists of 2 measures: the CGI-S, which rates the severity of illness from 1 to 7, and the CGI-Improvement Scale, which assesses improvement in illness since baseline. The CGI-S is a 7-point scale a clinician uses to rate a patient's severity of illness. Scores range from 1 to 7, with 1 indicating normal, not at all ill and 7, among the most extremely ill patients. Higher score on the CGI-S indicates greater severity of illness. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032. |
| Percentage of Participants With a Response of Very Much Improved or Much Improved on the Clinical Global Impression-Improvement (CGI-I) Scale at Week 26, Based on Observed Cases | From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030 | The Clinical Global Impression (CGI) Scale is a tool that summarizes all available patient data, including history, symptoms, behavior, and the impact of the symptoms on ability to function. The scale consists of 2 measures: the CGI-Severity scale, which rates the severity of illness from 1 to 7, and the CGI-I scale, which assesses improvement in illness since baseline. The CGI-I is a 7-point scale a clinician uses to assess improvement in a patient's illness relative to baseline. Scores range from 1 to 7, with 1 representing very much improved and 7 representing very much worse; a value of 0 meant not assessed. Lower score indicates greater improvement. Response on the CGI-I defined as the CGI-I scores of 1 or 2. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032. |
| Percentage of Participants With a Response of Very Much Improved or Much Improved on the Clinical Global Impression-Improvement (CGI-I) Scale at Week 26, Based on Observed Cases (Combination Group) | From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030 | The Clinical Global Impression (CGI) Scale is a tool that summarizes all available patient data, including history, symptoms, behavior, and the impact of the symptoms on ability to function. The scale consists of 2 measures: the CGI-Severity scale, which rates the severity of illness from 1 to 7, and the CGI-I scale, which assesses improvement in illness since baseline. The CGI-I is a 7-point scale a clinician uses to assess improvement in a patient's illness relative to baseline. Scores range from 1 to 7, with 1 representing very much improved and 7 representing very much worse; a value of 0 meant not assessed. Lower score indicates greater improvement. Response on the CGI-I defined as the CGI-I scores of 1 or 2. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032. |
| Change From Baseline to Week 26 in Total Score on the Children's Depression Rating Scale, Revised (CDRS-R), Based on Observed Cases | From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030 | The CDRS-R consists of 17 items. The total score is the sum of responses to the 17 items and ranges from 17 to 113. Lower total scores indicate lower intensity of symptoms. Remission on the CDRS-R was defined as a CDRS-R score \<=28. It was recommended that the CDRS-R be performed prior to the Clinical Global Impression assessments. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032. |
| Percentage of Participants by Score on the Clinical Global Impression-Improvement (CGI-I) Scale, Based on Observed Cases (Combination Group) | From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030 | The Clinical Global Impression (CGI) Scale is a tool that summarizes all available patient data, including history, symptoms, behavior, and the impact of the symptoms on ability to function. The scale consists of 2 measures: the CGI-Severity scale, which rates the severity of illness from 1 to 7, and the CGI-I scale, which assesses improvement in illness since baseline. The CGI-I is a 7-point scale used a clinician uses to assess improvement in a patient's illness relative to baseline. Scores range from 1 to 7, with 1 representing very much improved and 7 representing very much worse; a value of 0 meant not assessed. Lower score indicates greater improvement. Response on the CGI-I defined as the CGI-I scores of 1 or 2. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032. |
| Percentage of Participants With Remission at Week 26, Based on Score on the Children's Depression Rating Scale, Revised (CDRS-R), <=28 and on Observed Cases | From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030 | Remission on the CDRS-R was defined as a CDRS-R score \<=28. The CDRS-R consists of 17 items. The total score is the sum of responses to the 17 items and ranges from 17 to 113. Lower total s cores indicate lower intensity of symptoms. |
| Percentage of Participants With Remission at Week 26, Based on a Score on the Children's Depression Rating Scale, Revised (CDRS-R), <=28 and on Observed Cases (Combination Group) | From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030 | Remission on the CDRS-R was defined as a CDRS-R score \<=28. The CDRS-R consists of 17 items. The total score is the sum of responses to the 17 items and ranges from 17 to 113. Lower total s cores indicate lower intensity of symptoms. |
| Percentage of Participants by Score on the Clinical Global Impression-Improvement (CGI-I) Scale, Based on Observed Cases | From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030 | The Clinical Global Impression (CGI) Scale is a tool that summarizes all available patient data, including history, symptoms, behavior, and the impact of the symptoms on ability to function. The scale consists of 2 measures: the CGI-Severity scale, which rates the severity of illness from 1 to 7, and the CGI-I scale, which assesses improvement in illness since baseline. The CGI-I is a 7-point scale used a clinician uses to assess improvement in a patient's illness relative to baseline. Scores range from 1 to 7, with 1 representing very much improved and 7 representing very much worse; a value of 0 meant not assessed. Lower score indicates greater improvement. Response on the CGI-I defined as the CGI-I scores of 1 or 2. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032. |
| Change From Baseline to Week 26 in Total Score on the Children's Depression Rating Scale, Revised (CDRS-R), Based on Observed Cases (Combination Group) | From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030 | The CDRS-R consists of 17 items. The total score is the sum of responses to the 17 items and ranges from 17 to 113. Lower total scores indicate lower intensity of symptoms. Remission on the CDRS-R was defined as a CDRS-R score \<=28. It was recommended that the CDRS-R be performed prior to the Clinical Global Impression assessments. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032. |
Countries
Chile, United States
Participant flow
Pre-assignment details
A total of 304 participants completed study B2061032, 283 of whom were enrolled in the current extension study, B2061030, and 281 received treatment.
Participants by arm
| Arm | Count |
|---|---|
| Placebo/DVS-SR Participants received placebo tablets in previous study B2061032 and desvenlafaxine succinate sustained-release (DVS-SR) in flexible dosing ranging from 20 to 50 mg in extension study B2061030. | 91 |
| DVS-SR, Low Dose/DVS-SR Participants received DVS-SR in weight-based dosing (20, 25, or 35 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030. | 93 |
| DVS-SR, High Dose/DVS-SR Participants received DVS-SR in weight-based dosing (25, 35, or 50 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030. | 97 |
| Total | 281 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 5 | 8 | 12 |
| Overall Study | Insufficient clinical response | 3 | 2 | 0 |
| Overall Study | Lost to Follow-up | 5 | 9 | 7 |
| Overall Study | Medication error/not related to AE | 0 | 1 | 0 |
| Overall Study | No longer willing to participate | 7 | 7 | 13 |
| Overall Study | Other | 3 | 2 | 4 |
| Overall Study | Protocol Violation | 2 | 1 | 2 |
| Overall Study | Started but did not receive treatment | 1 | 0 | 1 |
Baseline characteristics
| Characteristic | Total | Placebo/DVS-SR | DVS-SR, Low Dose/DVS-SR | DVS-SR, High Dose/DVS-SR |
|---|---|---|---|---|
| Age, Customized 12 to 17 years | 194 Participants | 63 Participants | 67 Participants | 64 Participants |
| Age, Customized 7 to 11 years | 87 Participants | 28 Participants | 26 Participants | 33 Participants |
| Race/Ethnicity, Customized Asian | 2 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Black or African American | 71 Participants | 20 Participants | 23 Participants | 28 Participants |
| Race/Ethnicity, Customized Other | 21 Participants | 8 Participants | 4 Participants | 9 Participants |
| Race/Ethnicity, Customized White | 187 Participants | 62 Participants | 65 Participants | 60 Participants |
| Sex: Female, Male Female | 155 Participants | 43 Participants | 52 Participants | 60 Participants |
| Sex: Female, Male Male | 126 Participants | 48 Participants | 41 Participants | 37 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 | 60 / 91 | 57 / 93 | 58 / 97 | 175 / 281 |
| serious Total, serious adverse events | 4 / 91 | 6 / 93 | 3 / 97 | 13 / 281 |
Outcome results
Primary
Percentage of Participants With a Treatment-emergent Adverse Event (TEAE)
A TEAE was defined as an event that was absent before treatment and emerged or worsened during the treatment period.
Time frame: From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
Population: All participants who received at least 1 dose of study drug in study B2061030
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo/DVS-SR | Percentage of Participants With a Treatment-emergent Adverse Event (TEAE) | 78.0 Percentage of participants |
| DVS-SR, Low Dose/DVS-SR | Percentage of Participants With a Treatment-emergent Adverse Event (TEAE) | 73.1 Percentage of participants |
| DVS-SR, High Dose/DVS-SR | Percentage of Participants With a Treatment-emergent Adverse Event (TEAE) | 71.1 Percentage of participants |
Primary
Percentage of Participants With a Treatment-emergent Adverse Event (TEAE) (Combination Group)
A TEAE was defined as an event that was absent before treatment and emerged or worsened during the treatment period.
Time frame: From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
Population: All participants who received at least 1 dose of study drug in study B2061030
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo/DVS-SR | Percentage of Participants With a Treatment-emergent Adverse Event (TEAE) (Combination Group) | 74.0 Percentage of participants |
Secondary
Change From Baseline to Week 26 in Total Score on the Children's Depression Rating Scale, Revised (CDRS-R), Based on Observed Cases
The CDRS-R consists of 17 items. The total score is the sum of responses to the 17 items and ranges from 17 to 113. Lower total scores indicate lower intensity of symptoms. Remission on the CDRS-R was defined as a CDRS-R score \<=28. It was recommended that the CDRS-R be performed prior to the Clinical Global Impression assessments. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.
Time frame: From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
Population: All participants who had a CDRS-R evaluation at Baseline of study B2061030 (Week 8 of study B2061032), took at least 1 dose of study drug, and had at least 1 CDRS-R evaluation after the first dose of study drug in B2061030.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo/DVS-SR | Change From Baseline to Week 26 in Total Score on the Children's Depression Rating Scale, Revised (CDRS-R), Based on Observed Cases | -6.79 Units on a scale | Standard Deviation 12.05 |
| DVS-SR, Low Dose/DVS-SR | Change From Baseline to Week 26 in Total Score on the Children's Depression Rating Scale, Revised (CDRS-R), Based on Observed Cases | -10.72 Units on a scale | Standard Deviation 10.8 |
| DVS-SR, High Dose/DVS-SR | Change From Baseline to Week 26 in Total Score on the Children's Depression Rating Scale, Revised (CDRS-R), Based on Observed Cases | -8.57 Units on a scale | Standard Deviation 13.01 |
Secondary
Change From Baseline to Week 26 in Total Score on the Children's Depression Rating Scale, Revised (CDRS-R), Based on Observed Cases (Combination Group)
The CDRS-R consists of 17 items. The total score is the sum of responses to the 17 items and ranges from 17 to 113. Lower total scores indicate lower intensity of symptoms. Remission on the CDRS-R was defined as a CDRS-R score \<=28. It was recommended that the CDRS-R be performed prior to the Clinical Global Impression assessments. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.
Time frame: From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
Population: All participants who had a CDRS-R evaluation at Baseline of study B2061030 (Week 8 of study B2061032), took at least 1 dose of study drug, had at least 1 CDRS-R evaluation after the first dose of study drug in B2061030, and were available for evaluation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo/DVS-SR | Change From Baseline to Week 26 in Total Score on the Children's Depression Rating Scale, Revised (CDRS-R), Based on Observed Cases (Combination Group) | -8.63 Units on a scale | Standard Deviation 12.03 |
Secondary
Change in Score From Baseline to Week 26 on the Clinical Global Impression-Severity (CGI-S) Scale, Based on Observed Cases
The Clinical Global Impression (CGI) Scale is a tool that summarizes all available patient data, including history, symptoms, behavior, and the impact of the symptoms on ability to function. The scale consists of 2 measures: the CGI-S, which rates the severity of illness from 1 to 7, and the CGI-Improvement Scale, which assesses improvement in illness since baseline. The CGI-S is a 7-point scale a clinician uses to rate a patient's severity of illness. Scores range from 1 to 7, with 1 indicating normal, not at all ill and 7, among the most extremely ill patients. Higher score on the CGI-S indicates greater severity of illness. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.
Time frame: From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
Population: All participants who had a Children's Depression Rating Scale-Revised (CDRS-R) evaluation at Baseline of study B2061030 (Week 8 of study B2061032), took at least 1 dose of study drug, and had at least 1 CDRS-R evaluation after the first dose of study drug in B2061030.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo/DVS-SR | Change in Score From Baseline to Week 26 on the Clinical Global Impression-Severity (CGI-S) Scale, Based on Observed Cases | -1.02 Units on a scale | Standard Deviation 1.18 |
| DVS-SR, Low Dose/DVS-SR | Change in Score From Baseline to Week 26 on the Clinical Global Impression-Severity (CGI-S) Scale, Based on Observed Cases | -1.44 Units on a scale | Standard Deviation 1.12 |
| DVS-SR, High Dose/DVS-SR | Change in Score From Baseline to Week 26 on the Clinical Global Impression-Severity (CGI-S) Scale, Based on Observed Cases | -0.70 Units on a scale | Standard Deviation 1.37 |
Secondary
Change in Score From Baseline to Week 26 on the Clinical Global Impression-Severity (CGI-S) Scale, Based on Observed Cases (Combination Group)
The Clinical Global Impression (CGI) Scale is a tool that summarizes all available patient data, including history, symptoms, behavior, and the impact of the symptoms on ability to function. The scale consists of 2 measures: the CGI-S, which rates the severity of illness from 1 to 7, and the CGI-Improvement Scale, which assesses improvement in illness since baseline. The CGI-S is a 7-point scale a clinician uses to rate a patient's severity of illness. Scores range from 1 to 7, with 1 indicating normal, not at all ill and 7, among the most extremely ill patients. Higher score on the CGI-S indicates greater severity of illness. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.
Time frame: From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
Population: All participants who had a Children's Depression Rating Scale-Revised (CDRS-R) evaluation at Baseline of study B2061030 (Week 8 of study B2061032), took at least 1 dose of study drug, had at least 1 CDRS-R evaluation after the first dose of study drug in B2061030, and were available for evaluation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo/DVS-SR | Change in Score From Baseline to Week 26 on the Clinical Global Impression-Severity (CGI-S) Scale, Based on Observed Cases (Combination Group) | -1.05 Units on a scale | Standard Deviation 1.26 |
Secondary
Percentage of Participants by Score on the Clinical Global Impression-Improvement (CGI-I) Scale, Based on Observed Cases
The Clinical Global Impression (CGI) Scale is a tool that summarizes all available patient data, including history, symptoms, behavior, and the impact of the symptoms on ability to function. The scale consists of 2 measures: the CGI-Severity scale, which rates the severity of illness from 1 to 7, and the CGI-I scale, which assesses improvement in illness since baseline. The CGI-I is a 7-point scale used a clinician uses to assess improvement in a patient's illness relative to baseline. Scores range from 1 to 7, with 1 representing very much improved and 7 representing very much worse; a value of 0 meant not assessed. Lower score indicates greater improvement. Response on the CGI-I defined as the CGI-I scores of 1 or 2. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.
Time frame: From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
Population: All participants who had a Children's Depression Rating Scale-Revised (CDRS-R) evaluation at Baseline of study B2061030 (Week 8 of study B2061032), took at least 1 dose of study drug, and had at least 1 CDRS-R evaluation after the first dose of study drug in B2061030.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo/DVS-SR | Percentage of Participants by Score on the Clinical Global Impression-Improvement (CGI-I) Scale, Based on Observed Cases | Week 26: Much improved | 33.3 Percentage of participants |
| Placebo/DVS-SR | Percentage of Participants by Score on the Clinical Global Impression-Improvement (CGI-I) Scale, Based on Observed Cases | Week 26: Minimally worse | 1.6 Percentage of participants |
| Placebo/DVS-SR | Percentage of Participants by Score on the Clinical Global Impression-Improvement (CGI-I) Scale, Based on Observed Cases | Week 26: No change | 1.6 Percentage of participants |
| Placebo/DVS-SR | Percentage of Participants by Score on the Clinical Global Impression-Improvement (CGI-I) Scale, Based on Observed Cases | Week 26: Very much improved | 54.0 Percentage of participants |
| Placebo/DVS-SR | Percentage of Participants by Score on the Clinical Global Impression-Improvement (CGI-I) Scale, Based on Observed Cases | Week 26: Very much worse | 0.0 Percentage of participants |
| Placebo/DVS-SR | Percentage of Participants by Score on the Clinical Global Impression-Improvement (CGI-I) Scale, Based on Observed Cases | Week 26: Much worse | 0.0 Percentage of participants |
| Placebo/DVS-SR | Percentage of Participants by Score on the Clinical Global Impression-Improvement (CGI-I) Scale, Based on Observed Cases | Week 26: Minimally improved | 9.5 Percentage of participants |
| DVS-SR, Low Dose/DVS-SR | Percentage of Participants by Score on the Clinical Global Impression-Improvement (CGI-I) Scale, Based on Observed Cases | Week 26: No change | 0.0 Percentage of participants |
| DVS-SR, Low Dose/DVS-SR | Percentage of Participants by Score on the Clinical Global Impression-Improvement (CGI-I) Scale, Based on Observed Cases | Week 26: Very much improved | 73.7 Percentage of participants |
| DVS-SR, Low Dose/DVS-SR | Percentage of Participants by Score on the Clinical Global Impression-Improvement (CGI-I) Scale, Based on Observed Cases | Week 26: Much improved | 21.1 Percentage of participants |
| DVS-SR, Low Dose/DVS-SR | Percentage of Participants by Score on the Clinical Global Impression-Improvement (CGI-I) Scale, Based on Observed Cases | Week 26: Minimally improved | 5.3 Percentage of participants |
| DVS-SR, Low Dose/DVS-SR | Percentage of Participants by Score on the Clinical Global Impression-Improvement (CGI-I) Scale, Based on Observed Cases | Week 26: Minimally worse | 0.0 Percentage of participants |
| DVS-SR, Low Dose/DVS-SR | Percentage of Participants by Score on the Clinical Global Impression-Improvement (CGI-I) Scale, Based on Observed Cases | Week 26: Much worse | 0.0 Percentage of participants |
| DVS-SR, Low Dose/DVS-SR | Percentage of Participants by Score on the Clinical Global Impression-Improvement (CGI-I) Scale, Based on Observed Cases | Week 26: Very much worse | 0.0 Percentage of participants |
| DVS-SR, High Dose/DVS-SR | Percentage of Participants by Score on the Clinical Global Impression-Improvement (CGI-I) Scale, Based on Observed Cases | Week 26: Minimally worse | 0.0 Percentage of participants |
| DVS-SR, High Dose/DVS-SR | Percentage of Participants by Score on the Clinical Global Impression-Improvement (CGI-I) Scale, Based on Observed Cases | Week 26: Much improved | 35.7 Percentage of participants |
| DVS-SR, High Dose/DVS-SR | Percentage of Participants by Score on the Clinical Global Impression-Improvement (CGI-I) Scale, Based on Observed Cases | Week 26: Very much worse | 0.0 Percentage of participants |
| DVS-SR, High Dose/DVS-SR | Percentage of Participants by Score on the Clinical Global Impression-Improvement (CGI-I) Scale, Based on Observed Cases | Week 26: Much worse | 0.0 Percentage of participants |
| DVS-SR, High Dose/DVS-SR | Percentage of Participants by Score on the Clinical Global Impression-Improvement (CGI-I) Scale, Based on Observed Cases | Week 26: No change | 0.0 Percentage of participants |
| DVS-SR, High Dose/DVS-SR | Percentage of Participants by Score on the Clinical Global Impression-Improvement (CGI-I) Scale, Based on Observed Cases | Week 26: Minimally improved | 10.7 Percentage of participants |
| DVS-SR, High Dose/DVS-SR | Percentage of Participants by Score on the Clinical Global Impression-Improvement (CGI-I) Scale, Based on Observed Cases | Week 26: Very much improved | 53.6 Percentage of participants |
Secondary
Percentage of Participants by Score on the Clinical Global Impression-Improvement (CGI-I) Scale, Based on Observed Cases (Combination Group)
The Clinical Global Impression (CGI) Scale is a tool that summarizes all available patient data, including history, symptoms, behavior, and the impact of the symptoms on ability to function. The scale consists of 2 measures: the CGI-Severity scale, which rates the severity of illness from 1 to 7, and the CGI-I scale, which assesses improvement in illness since baseline. The CGI-I is a 7-point scale used a clinician uses to assess improvement in a patient's illness relative to baseline. Scores range from 1 to 7, with 1 representing very much improved and 7 representing very much worse; a value of 0 meant not assessed. Lower score indicates greater improvement. Response on the CGI-I defined as the CGI-I scores of 1 or 2. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.
Time frame: From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
Population: All participants who had a Children's Depression Rating Scale-Revised (CDRS-R) evaluation at Baseline of study B2061030 (Week 8 of study B2061032), took at least 1 dose of study drug, had at least 1 CDRS-R evaluation after the first dose of study drug in B2061030, and were available for evaluation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo/DVS-SR | Percentage of Participants by Score on the Clinical Global Impression-Improvement (CGI-I) Scale, Based on Observed Cases (Combination Group) | Week 26: Very much improved | 60.2 Percentage of participants |
| Placebo/DVS-SR | Percentage of Participants by Score on the Clinical Global Impression-Improvement (CGI-I) Scale, Based on Observed Cases (Combination Group) | Week 26: Much improved | 30.1 Percentage of participants |
| Placebo/DVS-SR | Percentage of Participants by Score on the Clinical Global Impression-Improvement (CGI-I) Scale, Based on Observed Cases (Combination Group) | Week 26: Minimally improved | 8.5 Percentage of participants |
| Placebo/DVS-SR | Percentage of Participants by Score on the Clinical Global Impression-Improvement (CGI-I) Scale, Based on Observed Cases (Combination Group) | Week 26: No change | 0.6 Percentage of participants |
| Placebo/DVS-SR | Percentage of Participants by Score on the Clinical Global Impression-Improvement (CGI-I) Scale, Based on Observed Cases (Combination Group) | Week 26: Minimally worse | 0.6 Percentage of participants |
| Placebo/DVS-SR | Percentage of Participants by Score on the Clinical Global Impression-Improvement (CGI-I) Scale, Based on Observed Cases (Combination Group) | Week 26: Much worse | 0.0 Percentage of participants |
| Placebo/DVS-SR | Percentage of Participants by Score on the Clinical Global Impression-Improvement (CGI-I) Scale, Based on Observed Cases (Combination Group) | Week 26: Very much worse | 0.0 Percentage of participants |
Secondary
Percentage of Participants With a Response of Very Much Improved or Much Improved on the Clinical Global Impression-Improvement (CGI-I) Scale at Week 26, Based on Observed Cases
The Clinical Global Impression (CGI) Scale is a tool that summarizes all available patient data, including history, symptoms, behavior, and the impact of the symptoms on ability to function. The scale consists of 2 measures: the CGI-Severity scale, which rates the severity of illness from 1 to 7, and the CGI-I scale, which assesses improvement in illness since baseline. The CGI-I is a 7-point scale a clinician uses to assess improvement in a patient's illness relative to baseline. Scores range from 1 to 7, with 1 representing very much improved and 7 representing very much worse; a value of 0 meant not assessed. Lower score indicates greater improvement. Response on the CGI-I defined as the CGI-I scores of 1 or 2. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.
Time frame: From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
Population: All participants who had a Children's Depression Rating Scale-Revised (CDRS-R) evaluation at Baseline of study B2061030 (Week 8 of study B2061032), took at least 1 dose of study drug, and had at least 1 CDRS-R evaluation after the first dose of study drug in B2061030.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo/DVS-SR | Percentage of Participants With a Response of Very Much Improved or Much Improved on the Clinical Global Impression-Improvement (CGI-I) Scale at Week 26, Based on Observed Cases | 87.3 Percentage of participants |
| DVS-SR, Low Dose/DVS-SR | Percentage of Participants With a Response of Very Much Improved or Much Improved on the Clinical Global Impression-Improvement (CGI-I) Scale at Week 26, Based on Observed Cases | 94.7 Percentage of participants |
| DVS-SR, High Dose/DVS-SR | Percentage of Participants With a Response of Very Much Improved or Much Improved on the Clinical Global Impression-Improvement (CGI-I) Scale at Week 26, Based on Observed Cases | 89.3 Percentage of participants |
Secondary
Percentage of Participants With a Response of Very Much Improved or Much Improved on the Clinical Global Impression-Improvement (CGI-I) Scale at Week 26, Based on Observed Cases (Combination Group)
The Clinical Global Impression (CGI) Scale is a tool that summarizes all available patient data, including history, symptoms, behavior, and the impact of the symptoms on ability to function. The scale consists of 2 measures: the CGI-Severity scale, which rates the severity of illness from 1 to 7, and the CGI-I scale, which assesses improvement in illness since baseline. The CGI-I is a 7-point scale a clinician uses to assess improvement in a patient's illness relative to baseline. Scores range from 1 to 7, with 1 representing very much improved and 7 representing very much worse; a value of 0 meant not assessed. Lower score indicates greater improvement. Response on the CGI-I defined as the CGI-I scores of 1 or 2. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.
Time frame: From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
Population: All participants who had a Children's Depression Rating Scale-Revised (CDRS-R) evaluation at Baseline of study B2061030 (Week 8 of study B2061032), took at least 1 dose of study drug, had at least 1 CDRS-R evaluation after the first dose of study drug in B2061030, and were available for evaluation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo/DVS-SR | Percentage of Participants With a Response of Very Much Improved or Much Improved on the Clinical Global Impression-Improvement (CGI-I) Scale at Week 26, Based on Observed Cases (Combination Group) | 90.3 Percentage of participants |
Secondary
Percentage of Participants With Remission at Week 26, Based on a Score on the Children's Depression Rating Scale, Revised (CDRS-R), <=28 and on Observed Cases (Combination Group)
Remission on the CDRS-R was defined as a CDRS-R score \<=28. The CDRS-R consists of 17 items. The total score is the sum of responses to the 17 items and ranges from 17 to 113. Lower total s cores indicate lower intensity of symptoms.
Time frame: From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
Population: All participants who had a CDRS-R evaluation at Baseline of study B2061030 (Week 8 of study B2061032), took at least 1 dose of study drug, had at least 1 CDRS-R evaluation after the first dose of study drug in B2061030, and were available for evaluation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo/DVS-SR | Percentage of Participants With Remission at Week 26, Based on a Score on the Children's Depression Rating Scale, Revised (CDRS-R), <=28 and on Observed Cases (Combination Group) | 79.0 Percentage of participants |
Secondary
Percentage of Participants With Remission at Week 26, Based on Score on the Children's Depression Rating Scale, Revised (CDRS-R), <=28 and on Observed Cases
Remission on the CDRS-R was defined as a CDRS-R score \<=28. The CDRS-R consists of 17 items. The total score is the sum of responses to the 17 items and ranges from 17 to 113. Lower total s cores indicate lower intensity of symptoms.
Time frame: From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
Population: All participants who had a CDRS-R evaluation at Baseline of study B2061030 (Week 8 of study B2061032), took at least 1 dose of study drug, and had at least 1 CDRS-R evaluation after the first dose of study drug in B2061030.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo/DVS-SR | Percentage of Participants With Remission at Week 26, Based on Score on the Children's Depression Rating Scale, Revised (CDRS-R), <=28 and on Observed Cases | 73.0 Percentage of participants |
| DVS-SR, Low Dose/DVS-SR | Percentage of Participants With Remission at Week 26, Based on Score on the Children's Depression Rating Scale, Revised (CDRS-R), <=28 and on Observed Cases | 89.5 Percentage of participants |
| DVS-SR, High Dose/DVS-SR | Percentage of Participants With Remission at Week 26, Based on Score on the Children's Depression Rating Scale, Revised (CDRS-R), <=28 and on Observed Cases | 75.0 Percentage of participants |