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| Sponsor: | GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00812812 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Major Depressive Disorder Depressive Disorder |
Drug: paroxetine 10mg tablet Drug: paroxetine 20mg tablet Drug: matched placebo to paroxetine 10mg Drug: matched placebo to paroxetine 20mg |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | 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> |
| Enrollment: | 56 |
| Study Start Date: | March 2009 |
| Study Completion Date: | February 2011 |
| Primary Completion Date: | February 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: paroxetine group
paroxetine 10-40mg/day
|
Drug: paroxetine 10mg tablet
1 or 2 tablet(s) once a day
Other Name: Paxil
Drug: paroxetine 20mg tablet
1 tablet once a day
Other Name: Paxil
Drug: matched placebo to paroxetine 10mg
2 tablets once a day
Drug: matched placebo to paroxetine 20mg
1 tablet once a day
|
|
Placebo Comparator: placebo group
matched placebo to paroxetine
|
Drug: matched placebo to paroxetine 10mg
2 tablets once a day
Drug: matched placebo to paroxetine 20mg
1 tablet once a day
|
Eligibility| Ages Eligible for Study: | 7 Years to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
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
run-in period:
A subject will not be eligible for inclusion to this study if any of the following criteria applies at start of run-in period:
treatment period: Subjects for whom any of the following categories apply at Week 0 (start of the treatment period) will not be progressed to the treatment phase.
Contacts and Locations| Japan | |
| GSK Investigational Site | |
| Aichi, Japan, 453-0015 | |
| GSK Investigational Site | |
| Aichi, Japan, 445-0064 | |
| GSK Investigational Site | |
| Fukui, Japan, 910-1193 | |
| GSK Investigational Site | |
| Fukuoka, Japan, 800-0207 | |
| GSK Investigational Site | |
| Fukuoka, Japan, 836-0004 | |
| GSK Investigational Site | |
| Fukuoka, Japan, 810-0001 | |
| GSK Investigational Site | |
| Hokkaido, Japan, 002-8029 | |
| GSK Investigational Site | |
| Hyogo, Japan, 673-8501 | |
| GSK Investigational Site | |
| Kanagawa, Japan, 210-0006 | |
| GSK Investigational Site | |
| Kumamoto, Japan, 861-8002 | |
| GSK Investigational Site | |
| Kumamoto, Japan, 860-8556 | |
| GSK Investigational Site | |
| Nagano, Japan, 390-8510 | |
| GSK Investigational Site | |
| Nara, Japan, 634-8522 | |
| GSK Investigational Site | |
| Nara, Japan, 631-0036 | |
| GSK Investigational Site | |
| Osaka, Japan, 560-0082 | |
| GSK Investigational Site | |
| Osaka, Japan, 534-0021 | |
| GSK Investigational Site | |
| Osaka, Japan, 596-0076 | |
| GSK Investigational Site | |
| Osaka, Japan, 545-8586 | |
| GSK Investigational Site | |
| Tokyo, Japan, 107-0062 | |
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
| Responsible Party: | Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure |
| ClinicalTrials.gov Identifier: | NCT00812812 History of Changes |
| Other Study ID Numbers: | 112487 |
| Study First Received: | December 18, 2008 |
| Results First Received: | September 8, 2011 |
| Last Updated: | October 27, 2011 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
|
paroxetine selective serotonin reuptake inhibitor CDRS-R children and adolescents |
|
Depressive Disorder Depression Depressive Disorder, Major Mood Disorders Mental Disorders Behavioral Symptoms Paroxetine Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Serotonin Agents Physiological Effects of Drugs Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs Central Nervous System Agents Therapeutic Uses |