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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
Results First Received: September 8, 2011  
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
Condition: Depressive Disorder
Interventions: Drug: paroxetine 10mg tablet
Drug: paroxetine 20mg tablet
Drug: matched placebo to paroxetine 10mg
Drug: matched placebo to paroxetine 20mg

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
This study consisted of 3 phases: a 2-week placebo run-in phase, an 8-week treatment phase, and a 0- to 3-week taper phase. In the run-in phase, placebo was administered once daily for 2 weeks. In the treatment phase, paroxetine or placebo was orally administered once daily for 8 weeks. In the taper phase, the dose was gradually reduced.

Reporting Groups
  Description
Placebo Participants took placebo once daily in the treatment phase (8 weeks) and the taper phase (0 to 3 weeks).
Paroxetine Paroxetine at the initial dose of 10 milligrams (mg) was orally administered once daily for the first 2 weeks of the treatment phase (total of 8 weeks). During the next 6 weeks, paroxetine 10 to 20 mg for participants aged 7 to 11 years or 10 to 40 mg for participants aged 12 to 17 years was orally administered. The dose was up-titrated by one level at a time (an increment of 10 mg/day) at intervals of at least 2 weeks based on clinical judgment. During the taper phase, (0 to 3 weeks), the last dose level in the treatment phase was reduced by 10 mg/day at intervals of 1 week to the final dose level of 10 mg/day.

Participant Flow:   Overall Study
    Placebo     Paroxetine  
STARTED     27     29  
COMPLETED     24     25  
NOT COMPLETED     3     4  
Adverse Event                 2                 1  
Lack of Efficacy                 1                 0  
Lost to Follow-up                 0                 1  
Withdrawal by Subject                 0                 2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Participants took placebo once daily in the treatment phase (8 weeks) and the taper phase (0 to 3 weeks).
Paroxetine Paroxetine at the initial dose of 10 milligrams (mg) was orally administered once daily for the first 2 weeks of the treatment phase. In the next 6 weeks, paroxetine 10 to 20 mg for participants aged 7 to 11 years or 10 to 40 mg for participants aged 12 to 17 years was orally administered. The dose was up-titrated by one level at a time (an increment of 10 mg/day) at intervals of at least 2 weeks based on clinical judgment. During the taper phase (0 to 3 weeks), the last dose level in the treatment phase was reduced by 10 mg/day at intervals of 1 week to the final dose level of 10 mg/day.
Total Total of all reporting groups

Baseline Measures
    Placebo     Paroxetine     Total  
Number of Participants  
[units: participants]
  27     29     56  
Age  
[units: Years]
Mean ± Standard Deviation
  14.8  ± 2.62     14.4  ± 1.99     14.6  ± 2.30  
Gender  
[units: Participants]
     
Female     18     16     34  
Male     9     13     22  
Race/Ethnicity, Customized  
[units: participants]
  27     29     56  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in the Children's Depression Rating Scale -Revised (CDRS-R) Total Score at Week 8   [ Time Frame: Baseline and Week 8 ]

2.  Secondary:   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 ]

3.  Secondary:   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 ]

4.  Secondary:   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 ]

5.  Secondary:   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) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


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