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

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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (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
Enrollment 56
Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title Placebo Paroxetine
Hide Arm/Group Description Participants took placebo once daily in the treatment phase (8 weeks) and the taper phase (0 to 3 weeks). 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.
Period Title: Overall Study
Started 27 29
Completed 24 25
Not Completed 3 4
Reason Not Completed
Adverse Event             2             1
Lack of Efficacy             1             0
Lost to Follow-up             0             1
Withdrawal by Subject             0             2
Arm/Group Title Placebo Paroxetine Total
Hide Arm/Group Description Participants took placebo once daily in the treatment phase (8 weeks) and the taper phase (0 to 3 weeks). 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 of all reporting groups
Overall Number of Baseline Participants 27 29 56
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 27 participants 29 participants 56 participants
14.8  (2.62) 14.4  (1.99) 14.6  (2.30)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 29 participants 56 participants
Female
18
  66.7%
16
  55.2%
34
  60.7%
Male
9
  33.3%
13
  44.8%
22
  39.3%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 27 participants 29 participants 56 participants
27 29 56
1.Primary Outcome
Title Change From Baseline in the Children's Depression Rating Scale -Revised (CDRS-R) Total Score at Week 8
Hide Description 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.
Time Frame Baseline and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): all participants who entered the treatment phase, but excluding participants without the target indication, participants who received no tablet of the treatment phase medication, or participants who had no post-baseline CDRS-R data. The analysis was performed on the last observation carried forward (LOCF) dataset.
Arm/Group Title Placebo Paroxetine
Hide Arm/Group Description:
Participants took placebo once daily in the treatment phase (8 weeks) and the taper phase (0 to 3 weeks).
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.
Overall Number of Participants Analyzed 27 29
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
-11.9  (2.54) -16.5  (2.45)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Paroxetine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.198
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -4.6
Confidence Interval (2-Sided) 95%
-11.7 to 2.5
Estimation Comments Mean difference was estimated as paroxetine minus placebo.
2.Secondary Outcome
Title Change From Baseline in the CDRS-R Total Score at Weeks 1, 2, 3, 4, and 6
Hide Description 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.
Time Frame Baseline and Weeks 1, 2, 3, 4, and 6
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. The analysis was performed on the observed case (OC) dataset. Participants whose observation was missing at a particular visit were not included in the analysis for that week.
Arm/Group Title Placebo Paroxetine
Hide Arm/Group Description:
Participants took placebo once daily in the treatment phase (8 weeks) and the taper phase (0 to 3 weeks).
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.
Overall Number of Participants Analyzed 27 29
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
Week 1, n=27, 29 -4.6  (1.10) -5.4  (1.06)
Week 2, n=26, 29 -4.9  (1.56) -8.8  (1.48)
Week 3, n=24, 28 -10.6  (1.90) -12.0  (1.76)
Week 4, n=25, 27 -12.5  (2.24) -14.6  (2.15)
Week 6, n=24, 26 -14.2  (2.21) -15.7  (2.12)
3.Secondary Outcome
Title Number of Clinical Global Impression - Global Improvement (CGI-GI) Responders at Weeks 1, 2, 3, 4, 6, and 8
Hide Description 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.
Time Frame Weeks 1, 2, 3, 4, 6, and 8
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. The analysis was performed on the OC dataset. Participants whose observation was missing at a particular visit were not included in the analysis for that week. The analysis of data at Week 8 was also performed on the LOCF dataset.
Arm/Group Title Placebo Paroxetine
Hide Arm/Group Description:
Participants took placebo once daily in the treatment phase (8 weeks) and the taper phase (0 to 3 weeks).
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.
Overall Number of Participants Analyzed 27 29
Measure Type: Number
Unit of Measure: participants
Week 1, n=27, 29 4 4
Week 2, n=26, 29 4 7
Week 3, n=24, 28 7 9
Week 4, n=25, 27 13 12
Week 6, n=24, 26 12 13
Week 8 (OC), n=24, 25 11 14
Week 8 (LOCF), n=27, 29 11 15
4.Secondary Outcome
Title Change From Baseline in the Clinical Global Impression - Severity of Illness (CGI-SI) Score at Weeks 1, 2, 3, 4, 6, and 8
Hide Description 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.
Time Frame Baseline and Weeks 1, 2, 3, 4, 6, and 8
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. The analysis was performed on the OC dataset. Participants whose observation was missing at a particular visit were not included in the analysis for that week. The analysis of data at Week 8 was also performed on the LOCF dataset.
Arm/Group Title Placebo Paroxetine
Hide Arm/Group Description:
Participants took placebo once daily in the treatment phase (8 weeks) and the taper phase (0 to 3 weeks).
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.
Overall Number of Participants Analyzed 27 29
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Week 1, n=27, 29 -0.1  (0.32) -0.2  (0.41)
Week 2, n=26, 29 -0.1  (0.48) -0.5  (0.69)
Week 3, n=24, 28 -0.3  (0.62) -0.6  (0.57)
Week 4, n=25, 27 -0.5  (0.82) -0.7  (0.76)
Week 6, n=24, 26 -0.5  (0.66) -0.8  (0.82)
Week 8 (OC), n=24, 25 -0.5  (0.72) -1.0  (0.89)
Week 8 (LOCF), n=27, 29 -0.4  (0.75) -0.9  (0.88)
5.Secondary Outcome
Title Plasma Paroxetine Concentrations at 12 Hours and 24 Hours After Administration of Study Drug at Week 8 or Withdrawal
Hide Description 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).
Time Frame Week 8 or Withdrawal (up to Week 8)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received paroxetine and 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).
Arm/Group Title Paroxetine
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: nanograms per milliliter (ng/mL)
paroxetine 10 mg, 12 hours, n=4 4.4683  (2.16507)
paroxetine 10 mg, 24 hours, n=3 8.9713  (7.81518)
paroxetine 20 mg, 12 hours, n=1 49.5820  (0)
paroxetine 20 mg, 24 hours, n=3 18.2713  (9.78765)
paroxetine 30 mg, 12 hours, n=2 64.4285  (23.34372)
paroxetine 40 mg, 12 hours, n=3 108.9133  (9.01693)
paroxetine 40 mg, 24 hours, n=2 67.9855  (4.08778)
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).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Paroxetine
Hide Arm/Group Description Participants took placebo once daily in the treatment phase (8 weeks) and the taper phase (0 to 3 weeks). 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.
All-Cause Mortality
Placebo Paroxetine
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Paroxetine
Affected / at Risk (%) Affected / at Risk (%)
Total   0/27 (0.00%)   0/29 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Paroxetine
Affected / at Risk (%) Affected / at Risk (%)
Total   9/27 (33.33%)   9/29 (31.03%) 
Infections and infestations     
Nasopharyngitis  1  4/27 (14.81%)  6/29 (20.69%) 
Influenza  1  2/27 (7.41%)  1/29 (3.45%) 
Nervous system disorders     
Headache  1  0/27 (0.00%)  2/29 (6.90%) 
Psychiatric disorders     
Suicidal ideation  1  3/27 (11.11%)  0/29 (0.00%) 
Reproductive system and breast disorders     
Dysmenorrhoea  1  2/27 (7.41%)  1/29 (3.45%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA version 13.1
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.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
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.
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00812812     History of Changes
Other Study ID Numbers: 112487
First Submitted: December 18, 2008
First Posted: December 22, 2008
Results First Submitted: September 8, 2011
Results First Posted: October 13, 2011
Last Update Posted: January 13, 2017