Information source: GlaxoSmithKline
ClinicalTrials. gov processed this data on August 23, 2015
Condition(s) targeted: Depressive Disorder
Intervention: paroxetine 10mg tablet (Drug); paroxetine 20mg tablet (Drug); matched placebo to paroxetine 10mg (Drug); matched placebo to paroxetine 20mg (Drug)
Phase: Phase 4
Status: Terminated
Sponsored by: GlaxoSmithKline
Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline
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.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Change From Baseline in the Children's Depression Rating Scale - Revised (CDRS-R) Total Score at Week 8
Secondary outcome: Change From Baseline in the CDRS-R Total Score at 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
Change From Baseline in the Clinical Global Impression - Severity of Illness (CGI-SI) Score at 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
Eligibility
Minimum age: 7 Years. Maximum age: 17 Years. Gender(s): Both.
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 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
- 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.
Locations and Contacts
GSK Investigational Site, Aichi 453-0015, Japan
GSK Investigational Site, Aichi 474-8710, Japan
GSK Investigational Site, Aichi 479-0837, Japan
GSK Investigational Site, Aichi 445-0064, Japan
GSK Investigational Site, Fukui 910-1193, Japan
GSK Investigational Site, Fukuoka 836-0004, Japan
GSK Investigational Site, Fukuoka 802-0064, Japan
GSK Investigational Site, Fukuoka 810-0001, Japan
GSK Investigational Site, Fukuoka 800-0207, Japan
GSK Investigational Site, Hokkaido 002-8029, Japan
GSK Investigational Site, Hyogo 653-0841, Japan
GSK Investigational Site, Hyogo 661-0002, Japan
GSK Investigational Site, Hyogo 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 861-8002, Japan
GSK Investigational Site, Kumamoto 862-0920, Japan
GSK Investigational Site, Kumamoto 860-8556, Japan
GSK Investigational Site, Nagano 390-8510, Japan
GSK Investigational Site, Nara 634-8522, Japan
GSK Investigational Site, Nara 631-0036, Japan
GSK Investigational Site, Okayama 710-0057, Japan
GSK Investigational Site, Osaka 596-0076, Japan
GSK Investigational Site, Osaka 545-8586, Japan
GSK Investigational Site, Osaka 560-0082, Japan
GSK Investigational Site, Osaka 534-0021, Japan
GSK Investigational Site, Shizuoka 410-2295, Japan
GSK Investigational Site, Tokushima 770-8076, Japan
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.
Starting date: March 2009
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