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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: November 29, 2016
Last verified: November 2016
Results First Received: September 8, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Participant, Care Provider, 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 
Overall Participants Analyzed 
[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]
Count of Participants
     
Female      18  66.7%      16  55.2%      34  60.7% 
Male      9  33.3%      13  44.8%      22  39.3% 
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
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Time Frame Serious adverse events (SAEs) and non-serious AEs were collected during the treatment (8 weeks at maximum) and taper phases (3 weeks at maximum). SAEs were also collected during the follow-up phase (2 weeks after the last dose of investigational product).
Additional Description 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 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.

Serious Adverse Events
    Placebo   Paroxetine
Total, Serious Adverse Events     
# participants affected / at risk   0/27 (0.00%)   0/29 (0.00%) 




  Other Adverse Events
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Time Frame Serious adverse events (SAEs) and non-serious AEs were collected during the treatment (8 weeks at maximum) and taper phases (3 weeks at maximum). SAEs were also collected during the follow-up phase (2 weeks after the last dose of investigational product).
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   5%  

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 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.

Other Adverse Events
    Placebo   Paroxetine
Total, Other (not including serious) Adverse Events     
# participants affected / at risk   9/27 (33.33%)   9/29 (31.03%) 
Infections and infestations     
Nasopharyngitis † 1     
# participants affected / at risk   4/27 (14.81%)   6/29 (20.69%) 
Influenza † 1     
# participants affected / at risk   2/27 (7.41%)   1/29 (3.45%) 
Nervous system disorders     
Headache † 1     
# participants affected / at risk   0/27 (0.00%)   2/29 (6.90%) 
Psychiatric disorders     
Suicidal ideation † 1     
# participants affected / at risk   3/27 (11.11%)   0/29 (0.00%) 
Reproductive system and breast disorders     
Dysmenorrhoea † 1     
# participants affected / at risk   2/27 (7.41%)   1/29 (3.45%) 
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA version 13.1



  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