Paxil Japanese Post Marketing Paediatric Study in Depression (Double-blind, Placebo Controlled Study)

NCT ID: NCT00812812

Last Updated: 2017-01-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2011-02-28

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.

Conditions

Depressive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

paroxetine group

paroxetine 10-40mg/day

Group Type: EXPERIMENTAL

paroxetine 10mg tablet

Intervention Type: DRUG

1 or 2 tablet(s) once a day

paroxetine 20mg tablet

Intervention Type: DRUG

1 tablet once a day

matched placebo to paroxetine 10mg

Intervention Type: DRUG

2 tablets once a day

matched placebo to paroxetine 20mg

Intervention Type: DRUG

1 tablet once a day

placebo group

matched placebo to paroxetine

Group Type: PLACEBO_COMPARATOR

matched placebo to paroxetine 10mg

Intervention Type: DRUG

2 tablets once a day

matched placebo to paroxetine 20mg

Intervention Type: DRUG

1 tablet once a day

Interventions

paroxetine 10mg tablet

1 or 2 tablet(s) once a day

Intervention Type: DRUG

paroxetine 20mg tablet

1 tablet once a day

Intervention Type: DRUG

matched placebo to paroxetine 10mg

2 tablets once a day

Intervention Type: DRUG

matched placebo to paroxetine 20mg

1 tablet once a day

Intervention Type: DRUG

Other Intervention Names

Paxil; Paxil

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 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.

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:

• 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.
• Patients with convulsive disorders such as epilepsy or past history of these diseases.
• Patients regularly using drugs (e.g. NSAIDs) that would increase the risk of haemorrhage, or patients with bleeding tendency or haemorrhagic diathesis.
• Patients with severe renal and hepatic disorder.
• Patients with serious organic disorder in the brain.
• Patients with chronic hepatitis type B and/or C which is positive of hepatitis B surface antigen (HBsAg) and/or hepatitis C antibody.
• Patients with a current history of carcinoma or malignant tumor, or complication of these diseases.
• Female patients who are pregnant, lactating, or who might be pregnant, or who wish to be pregnant during the study period
• Patients in the opinion of the chief investigator (subinvestigator) judged as not eligible for the study.
• Patients with clinical significant comorbid impulsivity symptoms.(e.g. Personality Disorder, Conduct Disorder)

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.

• Patients with CDRS-R score of "suicidal ideation" of 3 or greater, or patients who, in the opinion of the chief investigator (sub investigator), are at significant risk for harming self
• Patients with variation of the CDRS-R total raw summary score at Week 0 of +/-25% or greater compared to that of Week -2.
• Patients with drug compliance of Drug 1 (run-in placebo) from Week -2 to Week 0 less than 80%.
• Patients, in the opinion of the chief investigator (sub investigator) judged as not appropriate for the study.

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Aichi, , Japan

GSK Investigational Site

Aichi, , Japan

GSK Investigational Site

Aichi, , Japan

GSK Investigational Site

Aichi, , Japan

GSK Investigational Site

Fukui, , Japan

GSK Investigational Site

Fukuoka, , Japan

GSK Investigational Site

Fukuoka, , Japan

GSK Investigational Site

Fukuoka, , Japan

GSK Investigational Site

Fukuoka, , Japan

GSK Investigational Site

Hokkaido, , Japan

GSK Investigational Site

Hyōgo, , Japan

GSK Investigational Site

Hyōgo, , Japan

GSK Investigational Site

Hyōgo, , Japan

GSK Investigational Site

Ishikawa, , Japan

GSK Investigational Site

Kagawa, , Japan

GSK Investigational Site

Kanagawa, , Japan

GSK Investigational Site

Kanagawa, , Japan

GSK Investigational Site

Kanagawa, , Japan

GSK Investigational Site

Kumamoto, , Japan

GSK Investigational Site

Kumamoto, , Japan

GSK Investigational Site

Kumamoto, , Japan

GSK Investigational Site

Nagano, , Japan

GSK Investigational Site

Nara, , Japan

GSK Investigational Site

Nara, , Japan

GSK Investigational Site

Okayama, , Japan

GSK Investigational Site

Osaka, , Japan

GSK Investigational Site

Osaka, , Japan

GSK Investigational Site

Osaka, , Japan

GSK Investigational Site

Osaka, , Japan

GSK Investigational Site

Shizuoka, , Japan

GSK Investigational Site

Tokushima, , Japan

GSK Investigational Site

Tokyo, , Japan

GSK Investigational Site

Tokyo, , Japan

Countries

Japan

References

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.

Reference Type: BACKGROUND

Study Documents

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Annotated Case Report Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

https://www.clinicalstudydatarequest.com

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Other Identifiers

112487

Identifier Type: -

Identifier Source: org_study_id