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

• ClinicalTrials.gov Identifier: NCT01371721
• Recruitment Status: Completed
• First Posted: June 13, 2011
• Results First Posted: February 8, 2017
• Last Update Posted: February 8, 2017
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Tracking Information

• First Submitted Date: June 9, 2011
• First Posted Date: June 13, 2011
• Results First Submitted Date: April 19, 2016
• Results First Posted Date: February 8, 2017
• Last Update Posted Date: February 8, 2017
• Study Start Date: February 2012
• Actual Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: December 16, 2016): Percentage of Participants Experiencing a Treatment Emergent Adverse Event [ Time Frame: Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study ]
• Original Primary Outcome Measures (submitted: June 10, 2011): Change from baseline to final on-therapy visit in the Children's Depression Rating Scale, Revised (CDRS-R) total score [ Time Frame: 6 months ]

Current Secondary Outcome Measures (submitted: December 16, 2016)

• Change From Baseline at Week 26 in the Children's Depression Rating Scale, Revised (CDRS-R) Total Score Based on Observed Cases [ Time Frame: 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 [ Time Frame: 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 With a Clinical Global Impression, Improvement (CGI-I) Response Defined as a Score of 'Very Much Improved' or 'Much Improved' at Week 26 [ Time Frame: 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.
• Percentage of Participants With Remission as Determined by a CDRS-R Score of ≤28 at Week 26 Based on Observed Cases [ Time Frame: 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.
• Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Week 26 Based on Observed Cases [ Time Frame: 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.

Original Secondary Outcome Measures (submitted: June 10, 2011)

• Clinical Global Impression - Improvement (CGI-I) score at the final on-therapy visit [ Time Frame: 6 months ]
• Clinical Global Impression - Severity (CGI-S) score change from baseline at the final on-therapy visit [ Time Frame: 6 months ]
• Clinical Global Impression - Improvement (CGI-I) response (score of 1 or 2) [ Time Frame: 6 months ]
• Remission on the Children's Depression Rating Scale, Revised (CDRS-R) (score <=28) [ Time Frame: 6 months ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• Official Title: A 6 Month, Open Label, Multi Center, Flexible Dose Extension Study To The B2061014 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
• 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 Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Major Depressive Disorder

Intervention

Drug: DVS SR

Subjects will receive a flexible-dose of 20, 25, 35 or 50 mg/day as prescribed by the investigator.

Study Arms

Experimental: Desvenlafaxine Succinate Sustained-Release

Intervention: Drug: DVS SR

• Publications *: Atkinson S, Thurman L, Ramaker S, Buckley G, Jones SR, England R, Wajsbrot D. Safety, Tolerability, and Efficacy of Desvenlafaxine in Children and Adolescents with Major Depressive Disorder: Results from Two Open-Label Extension Trials. CNS Spectr. 2019 Oct;24(5):496-506. doi: 10.1017/S1092852918001128.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 16, 2016): 269
• Original Estimated Enrollment (submitted: June 10, 2011): 333
• Actual Study Completion Date: October 2015
• Actual Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 7 Years to 17 Years (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Mexico, United States

Administrative Information

• NCT Number: NCT01371721
• Other Study ID Numbers: B2061031; 3151A6-3357 ( Other Identifier: Alias Study Number ); 2008-002064-34 ( EudraCT Number )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Pfizer
• Study Sponsor: Pfizer
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: December 2016