Paxil Japanese Post Marketing Paediatric Study in Depression (Double-blind, Placebo Controlled Study)
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>
1 other identifier
interventional
56
1 country
33
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Mar 2009
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 18, 2008
CompletedFirst Posted
Study publicly available on registry
December 22, 2008
CompletedStudy Start
First participant enrolled
March 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2011
CompletedResults Posted
Study results publicly available
October 13, 2011
CompletedJanuary 13, 2017
November 1, 2016
1.9 years
December 18, 2008
September 8, 2011
November 29, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in the Children's Depression Rating Scale -Revised (CDRS-R) Total Score at 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.
Baseline and Week 8
Secondary Outcomes (4)
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
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 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
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)
Study Arms (2)
paroxetine group
EXPERIMENTALparoxetine 10-40mg/day
placebo group
PLACEBO COMPARATORmatched placebo to paroxetine
Interventions
Eligibility Criteria
You may qualify if:
- 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)
- 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 12.
- 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.
You may not qualify if:
- run-in period:
- Patients who in the investigator's judgment presented with a clinically predominant Axis I disorder other than MDD (e.g. dysthymic disorder, eating disorders, Specific phobia, PTSD, OCD, Panic disorder, etc)
- Patients with any history of a psychotic episode or psychotic disorder (including schizophrenia ), or complication of these diseases.
- Patients with a history of a bipolar disorder, or complication of these diseases.
- Patients with Attention-Deficit, or Hyperactivity Disorder
- Patients with Mental Retardation or Pervasive Development Disorder
- Patients diagnosed with Substance Abuse or Dependence within 12 weeks prior to the Screening visit
- Patients with past treatment experience with the investigational drug (i.e. paroxetine)
- Patients treated with electroconvulsive therapy in the immediate 12 weeks prior to the Screening visit
- Patients with past history of serotonin syndrome and neuroleptic malignant syndrome.
- Patients with CDRS-R score of "suicidal ideation" of 3 or greater. Or patients whose C-SSRS assessment suggests that they are or have been at significant risk for harming themselves or have actually harmed themselves, or who, in the opinion of the chief investigator (subinvestigator), are at significant risk for harming self.
- Patients with past history of suicide attempt, self harm(excluding "no suicidal intent " ), or an intentional overdose (excluding obviously unintentional overdose)
- Patients who have been treated with other clinical trial investigational drug (including post-marketing clinical trial) in the immediate past 3 months of the Week -2 visit.
- Patients who have taken antidepressant medication 1 week prior to screening.
- Patients with complicated disease of glaucoma.
- +14 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (33)
GSK Investigational Site
Aichi, 445-0064, Japan
GSK Investigational Site
Aichi, 453-0015, Japan
GSK Investigational Site
Aichi, 474-8710, Japan
GSK Investigational Site
Aichi, 479-0837, Japan
GSK Investigational Site
Fukui, 910-1193, Japan
GSK Investigational Site
Fukuoka, 800-0207, Japan
GSK Investigational Site
Fukuoka, 802-0064, Japan
GSK Investigational Site
Fukuoka, 810-0001, Japan
GSK Investigational Site
Fukuoka, 836-0004, Japan
GSK Investigational Site
Hokkaido, 002-8029, Japan
GSK Investigational Site
Hyōgo, 653-0841, Japan
GSK Investigational Site
Hyōgo, 661-0002, Japan
GSK Investigational Site
Hyōgo, 673-8501, Japan
GSK Investigational Site
Ishikawa, 921-8163, Japan
GSK Investigational Site
Kagawa, 765-8501, Japan
GSK Investigational Site
Kanagawa, 210-0006, Japan
GSK Investigational Site
Kanagawa, 220-0004, Japan
GSK Investigational Site
Kanagawa, 244-0816, Japan
GSK Investigational Site
Kumamoto, 860-8556, Japan
GSK Investigational Site
Kumamoto, 861-8002, Japan
GSK Investigational Site
Kumamoto, 862-0920, Japan
GSK Investigational Site
Nagano, 390-8510, Japan
GSK Investigational Site
Nara, 631-0036, Japan
GSK Investigational Site
Nara, 634-8522, Japan
GSK Investigational Site
Okayama, 710-0057, Japan
GSK Investigational Site
Osaka, 534-0021, Japan
GSK Investigational Site
Osaka, 545-8586, Japan
GSK Investigational Site
Osaka, 560-0082, Japan
GSK Investigational Site
Osaka, 596-0076, Japan
GSK Investigational Site
Shizuoka, 410-2295, Japan
GSK Investigational Site
Tokushima, 770-8076, Japan
GSK Investigational Site
Tokyo, 107-0052, Japan
GSK Investigational Site
Tokyo, 107-0062, Japan
Related Publications (1)
GSK has concluded that it is not feasible to publish this study in a peer-reviewed scientific journal because the nature of the study is unlikely to be of interest to a journal. GSK is providing the attached study results summary with a conclusion.
BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 18, 2008
First Posted
December 22, 2008
Study Start
March 1, 2009
Primary Completion
February 1, 2011
Study Completion
February 1, 2011
Last Updated
January 13, 2017
Results First Posted
October 13, 2011
Record last verified: 2016-11
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.