A Randomised, Double-blind, Placebo Controlled, Parallel Group , Flexible Dose Study to Evaluate the Efficacy and Safety of Paxil® Tablets in Children and Adolescents With Major Depressive Disorder<Post-marketing Clinical Study>
Overview
- Phase
- Phase 4
- Intervention
- matched placebo to paroxetine 10mg
- Conditions
- Depressive Disorder
- Sponsor
- GlaxoSmithKline
- Enrollment
- 56
- Locations
- 1
- Primary Endpoint
- Change From Baseline in the Children's Depression Rating Scale -Revised (CDRS-R) Total Score at Week 8
- Status
- Terminated
- Last Updated
- 9 years ago
Overview
Brief Summary
This study is designed to compare the efficacy of oral paroxetine 10 to 40 mg/day (initial dose:10 mg/day) versus placebo administered once daily (after evening meal) for 8 weeks in children and adolescents with major depressive disorder (MDD) based on the change from baseline to Week 8/end-of-study in the CDRS-R total score in a randomized, double-blind, placebo-controlled parallel-group study.
Investigators
Eligibility Criteria
Inclusion Criteria
- •run-in period: A subject will be considered eligible for the study only if all of the following criteria apply at start of placebo run-in period.
- •Patients who are diagnosed with the following depressive disorders according to the DSM-IV-TR criteria, and currently presents with a depressive episodes. Depressive disorders: MDD, single episode (296.2), MDD, recurrent (296.3)
- •7 years and older and under 18 years old (at the time of consent obtained)
- •Patients with a total raw summary score on the CDRS-R of 45 or greater at the Week -2 visit.
- •Patients whose legally acceptable representative (e.g., caretaker, custodian) is able to give written consent to participation to this study. Patients aged 12 and above at the time of consent obtained should be able to sign the informed consent on one's own. Efforts should be exerted in obtaining the informed assent in writing from patients aged less than
- •Patients with ideal body weight +/- 2SD
- •Gender: Male or female
- •treatment period:
- •Subjects who meet the following criteria at Week 0 (Baseline) may be progressed to the Treatment period:
- •Patients with a total raw summary score on the CDRS-R at Week 0 visit of 45 or greater.
Exclusion Criteria
- Not provided
Arms & Interventions
paroxetine group
paroxetine 10-40mg/day
Intervention: matched placebo to paroxetine 10mg
paroxetine group
paroxetine 10-40mg/day
Intervention: paroxetine 10mg tablet
paroxetine group
paroxetine 10-40mg/day
Intervention: paroxetine 20mg tablet
paroxetine group
paroxetine 10-40mg/day
Intervention: matched placebo to paroxetine 20mg
placebo group
matched placebo to paroxetine
Intervention: matched placebo to paroxetine 10mg
placebo group
matched placebo to paroxetine
Intervention: matched placebo to paroxetine 20mg
Outcomes
Primary Outcomes
Change From Baseline in the Children's Depression Rating Scale -Revised (CDRS-R) Total Score at Week 8
Time Frame: Baseline and Week 8
The CDRS-R has been widely used for the evaluation of children and adolescents with major depressive disorder (MDD). The CDRS-R total score is the sum of the responses to 17 questions. Each question is graded on a 5- or 7-point scale. The highest possible score is 113 (the most severe measure of depression), and the lowest is 17 (not suffering from depression). CDRS-R scores were assessed by the investigator. The change from Baseline in the CDRS-R total score was calculated as the total score at Week 8 minus the total score at Baseline. The data were adjusted with the total score at Baseline.
Secondary Outcomes
- Plasma Paroxetine Concentrations at 12 Hours and 24 Hours After Administration of Study Drug at Week 8 or Withdrawal(Week 8 or Withdrawal (up to Week 8))
- Number of Clinical Global Impression - Global Improvement (CGI-GI) Responders at Weeks 1, 2, 3, 4, 6, and 8(Weeks 1, 2, 3, 4, 6, and 8)
- Change From Baseline in the CDRS-R Total Score at Weeks 1, 2, 3, 4, and 6(Baseline and Weeks 1, 2, 3, 4, and 6)
- Change From Baseline in the Clinical Global Impression - Severity of Illness (CGI-SI) Score at Weeks 1, 2, 3, 4, 6, and 8(Baseline and Weeks 1, 2, 3, 4, 6, and 8)