Study Evaluating Desvenlafaxine Succinate Sustained-Release (DVS SR) In The Treatment Of Children And Adolescent Outpatients With Major Depressive Disorder
- Conditions
- Major Depressive DisorderTherapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
- Registration Number
- EUCTR2008-002064-34-Outside-EU/EEA
- Lead Sponsor
- Pfizer Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- 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.
Are the trial subjects under 18? yes
Number of subjects for this age range: 269
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
•Subject requires precaution against suicide.
•Subject not in generally healthy medical condition.
•Poor compliance with study drug or study procedures during participation in study B2061014.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the long-term safety and tolerability of DVS SR in the treatment of children and adolescents with MDD.;Secondary Objective: To evaluate the efficacy of DVS SR in the treatment of children and adolescents with MDD.;Primary end point(s): 1. Non-Serious Treatment Emergent Adverse Event;Timepoint(s) of evaluation of this end point: 1. up to week 26
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 2. CDRS-R Total Score Change From Baseline<br>3. CGI-I Score<br>4. CGI-S Score Change From Baseline<br>5. CGI-I response (Score of 1 or 2)<br>6. Remission on the CDRS-R (Score < 28);Timepoint(s) of evaluation of this end point: 2. week 26<br>3. week 26<br>4. week 26<br>5. week 26<br>6. week 26