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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00812812
First received: December 18, 2008
Last updated: August 29, 2013
Last verified: August 2013
  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
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>

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Change From Baseline in the Children's Depression Rating Scale -Revised (CDRS-R) Total Score at Week 8 [ Time Frame: Baseline and Week 8 ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Change From Baseline in the CDRS-R Total Score at Weeks 1, 2, 3, 4, and 6 [ Time Frame: Baseline and Weeks 1, 2, 3, 4, and 6 ] [ Designated as safety issue: No ]
    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.

  • Number of Clinical Global Impression - Global Improvement (CGI-GI) Responders at Weeks 1, 2, 3, 4, 6, and 8 [ Time Frame: Weeks 1, 2, 3, 4, 6, and 8 ] [ Designated as safety issue: No ]
    CGI-GI is assessed on an 8-grade scale: 0, not assessed; 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; and 7, very much worse. CGI-GI was assessed by the investigator. Participants who were rated as 1 (very much improved) or 2 (much improved) were categorized as CGI-GI responders.

  • Change From Baseline in the Clinical Global Impression - Severity of Illness (CGI-SI) Score at Weeks 1, 2, 3, 4, 6, and 8 [ Time Frame: Baseline and Weeks 1, 2, 3, 4, 6, and 8 ] [ Designated as safety issue: No ]
    CGI-SI is assessed on an 8-grade scale: 0, not assessed; 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; and 7, among the most extremely ill. CGI-SI was assessed by the investigator. The change from Baseline in CGI-SI score was calculated as the score at Weeks 1, 2, 3, 4, 6, and 8 minus the score at Baseline.

  • Plasma Paroxetine Concentrations at 12 Hours and 24 Hours After Administration of Study Drug at Week 8 or Withdrawal [ Time Frame: Week 8 or Withdrawal (up to Week 8) ] [ Designated as safety issue: No ]
    Summary statistics for the plasma paroxetine concentrations at each time point were calculated by the dosage just before blood sampling using data from participants in whom plasma samples were collected at either 12 hours (plus or minus 2 hours) or 24 hours (plus or minus 2 hours) after the last administration of the study drug at Week 8 or Withdrawal (up to Week 8).


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
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00812812

Locations
Japan
GSK Investigational Site
Aichi, Japan, 474-8710
GSK Investigational Site
Aichi, Japan, 479-0837
GSK Investigational Site
Aichi, Japan, 445-0064
GSK Investigational Site
Aichi, Japan, 453-0015
GSK Investigational Site
Fukui, Japan, 910-1193
GSK Investigational Site
Fukuoka, Japan, 810-0001
GSK Investigational Site
Fukuoka, Japan, 802-0064
GSK Investigational Site
Fukuoka, Japan, 836-0004
GSK Investigational Site
Fukuoka, Japan, 800-0207
GSK Investigational Site
Hokkaido, Japan, 002-8029
GSK Investigational Site
Hyogo, Japan, 661-0002
GSK Investigational Site
Hyogo, Japan, 673-8501
GSK Investigational Site
Hyogo, Japan, 653-0841
GSK Investigational Site
Ishikawa, Japan, 921-8163
GSK Investigational Site
Kagawa, Japan, 765-8501
GSK Investigational Site
Kanagawa, Japan, 220-0004
GSK Investigational Site
Kanagawa, Japan, 210-0006
GSK Investigational Site
Kanagawa, Japan, 244-0816
GSK Investigational Site
Kumamoto, Japan, 862-0920
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
Okayama, Japan, 710-0057
GSK Investigational Site
Osaka, Japan, 534-0021
GSK Investigational Site
Osaka, Japan, 560-0082
GSK Investigational Site
Osaka, Japan, 545-8586
GSK Investigational Site
Osaka, Japan, 596-0076
GSK Investigational Site
Shizuoka, Japan, 410-2295
GSK Investigational Site
Tokushima, Japan, 770-8076
GSK Investigational Site
Tokyo, Japan, 107-0052
GSK Investigational Site
Tokyo, Japan, 107-0062
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
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: August 29, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by GlaxoSmithKline:
paroxetine
selective serotonin reuptake inhibitor
CDRS-R
children and adolescents

Additional relevant MeSH terms:
Depression
Depressive Disorder
Disease
Behavioral Symptoms
Mental Disorders
Mood Disorders
Pathologic Processes
Paroxetine
Antidepressive Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014