A 6-Month Open-Label Extension Study to the B2061014 Study to Evaluate the Safety, Tolerability and Efficacy of DVS SR in the Treatment of Children and Adolescents With MDD

Phase 3

Completed

• Conditions: Major Depressive Disorder
• Interventions: Drug: DVS SR

• Registration Number: NCT01371721
• Lead Sponsor: Pfizer

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-06-09
• Study First Submitted QC: 2011-06-10
• Study First Posted: 2011-06-13
• Study Start: 2012-02
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Results First Submitted: 2016-04-19
• Status Verified: 2016-12
• Results First Submitted QC: 2016-12-16
• Last Update Submitted: 2016-12-16
• Results First Posted: 2017-02-08
• Last Update Posted: 2017-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 269

Inclusion Criteria

• Completed study B2061014 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

• Subject requires precaution against suicide
• Subject not in a generally healthy condition

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Desvenlafaxine Succinate Sustained-Release	DVS SR	-

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Experiencing a Treatment Emergent Adverse Event	Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Remission as Determined by a CDRS-R Score of ≤28 at Week 26 Based on Observed Cases	Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study	Clinician-rated interview-based scale (with both child and parent or guardian) to assess 17 distinct symptom areas to derive an index of depression severity. Discrepancies between informants' responses were resolved by using most impaired rating given by valid informant. Rated on a 7-point scale; range from 1 (no impairment) to 7 (indicates greater impairment). Total score calculated as sum of the 17 items (range 1 to 119); higher score indicates greater impairment. Adjusted mean presented.
Change From Baseline at Week 26 in the Children's Depression Rating Scale, Revised (CDRS-R) Total Score Based on Observed Cases	Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study	Clinician-rated interview-based scale (with both child and parent or guardian) to assess 17 distinct symptom areas to derive an index of depression severity. Discrepancies between informants' responses were resolved by using most impaired rating given by valid informant. Rated on a 7-point scale; range from 1 (no impairment) to 7 (indicates greater impairment). Total score calculated as sum of the 17 items (range 1 to 119); higher score indicates greater impairment. Adjusted mean presented.
Change From Baseline at Week 26 in the Clinical Global Impression of Severity (CGI-S) Score Based on Observed Cases	Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study	A 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected. Change: score at observation minus score at baseline. Adjusted mean presented.
Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Week 26 Based on Observed Cases	Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study	A 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.
Percentage of Participants With a Clinical Global Impression, Improvement (CGI-I) Response Defined as a Score of 'Very Much Improved' or 'Much Improved' at Week 26	Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study	A 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Higher score = more affected.

Trial Locations

Locations (34)

Harmonex Neuroscience Research, Inc.; 🇺🇸 Dothan, Alabama, United States

Dedicated Clinical Research; 🇺🇸 Goodyear, Arizona, United States

University of Arizona Clinical and Translational Science Center (CATS); 🇺🇸 Tucson, Arizona, United States

University of Arizona College of Medicine Dept of Psychiatry; 🇺🇸 Tucson, Arizona, United States

Arkansas Psychiatric Clinic Clinical Research Trials, P.A.; 🇺🇸 Little Rock, Arkansas, United States

ATP Clinical Research, Incorporated; 🇺🇸 Costa Mesa, California, United States

Behavioral Research Specialists, LLC; 🇺🇸 Glendale, California, United States

Synergy Clinical Research Center; 🇺🇸 National City, California, United States

Neuropsychiatric Research Center of Orange County; 🇺🇸 Orange, California, United States

Pacific Clinical Research Medical Group; 🇺🇸 Orange, California, United States

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