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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00812812
Recruitment Status : Terminated
First Posted : December 22, 2008
Results First Posted : October 13, 2011
Last Update Posted : January 13, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Tracking Information
First Submitted Date  ICMJE December 18, 2008
First Posted Date  ICMJE December 22, 2008
Results First Submitted Date  ICMJE September 8, 2011
Results First Posted Date  ICMJE October 13, 2011
Last Update Posted Date January 13, 2017
Study Start Date  ICMJE March 2009
Actual Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 8, 2011)
Change From Baseline in the Children's Depression Rating Scale -Revised (CDRS-R) Total Score at Week 8 [ Time Frame: Baseline and 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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 18, 2008)
To compare the efficacy of paroxetine versus placebo administered once daily (after evening meal) for 8 weeks in children and adolescents with MDD based on the change from baseline to Week 8/end-of-study in the CDRS-R total score [ Time Frame: 8weeks ]
Change History Complete list of historical versions of study NCT00812812 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 8, 2011)
  • 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 ]
    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 ]
    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 ]
    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) ]
    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).
Original Secondary Outcome Measures  ICMJE
 (submitted: December 18, 2008)
  • To compare the safety of paroxetine versus placebo administered once daily (after evening meal) for 8 weeks in children and adolescents with MDD [ Time Frame: 8weeks ]
  • To assess the plasma concentrations of paroxetine administered orally at Week 8 or withdrawal in subjects with MDD. [ Time Frame: 8weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Paxil Japanese Post Marketing Paediatric Study in Depression (Double-blind, Placebo Controlled Study)
Official Title  ICMJE 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>
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Depressive Disorder
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: paroxetine group
    paroxetine 10-40mg/day
    Interventions:
    • Drug: paroxetine 10mg tablet
    • Drug: paroxetine 20mg tablet
    • Drug: matched placebo to paroxetine 10mg
    • Drug: matched placebo to paroxetine 20mg
  • Placebo Comparator: placebo group
    matched placebo to paroxetine
    Interventions:
    • Drug: matched placebo to paroxetine 10mg
    • Drug: matched placebo to paroxetine 20mg
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 12, 2011)
56
Original Estimated Enrollment  ICMJE
 (submitted: December 18, 2008)
130
Actual Study Completion Date  ICMJE February 2011
Actual Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 7 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00812812
Other Study ID Numbers  ICMJE 112487
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Responsible Party GlaxoSmithKline
Study Sponsor  ICMJE GlaxoSmithKline
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP