A 6-Month Extension Study To The B2061032 Study To Evaluate The Safety, Tolerability, And Efficacy Of DVS SR In The Treatment Of Child And Adolescent Outpatients With MDD

Study Overview
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Brief Summary
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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).

Official Title
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A 6-month, Open-label, Multi-center, Flexible Dose Extension Study To The B2061032 Study To Evaluate The Safety, Tolerability And Efficacy Of Desvenlafaxine Succinate Sustained Release (Dvs Sr) Tablets In The Treatment Of Children And Adolescent Outpatients With Major Depressive Disorder

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Drug: DVS SR


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Desvenlafaxine Succinate Sustained-Release<br> | Drug: DVS SR<br>* Subjects will receive a flexible-dose of 20, 25, 35, or 50 mg/day as prescribed by the investigator<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030 | 
| 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. | From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030 | 
| 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. | From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030 | 
| 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. | From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030 | 
| 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. | From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030 | 
| 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. | From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030 | 
| 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. | From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030 | 
| 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. | From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030 | 
| 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. | From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030 | 
| 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. | From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030 | 
| 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. | From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Major Depressive Disorder, MDD, Depression