Controlled-release Paroxetine in Major Depressive Disorder (Double-blind, Placebo-controlled Study)

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00866294
First received: March 19, 2009
Last updated: March 17, 2011
Last verified: March 2011
Results First Received: October 14, 2010  
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
Conditions: Depressive Disorder
Major Depressive Disorder (MDD)
Interventions: Drug: paroxetine IR 10mg tablet
Drug: paroxetine IR 20mg tablet
Drug: matched placebo to paroxetine IR 10mg or 20mg
Drug: Paroxetine CR 12.5mg tablet
Drug: Paroxetine CR 25mg tablet
Drug: matched placebo to paroxetine CR 12.5mg or 25mg

  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
Participants who had completed all the study procedures (up to the post-study examinations) were defined as per protocol completers.

Reporting Groups
  Description
Placebo Placebo matched to the controlled release formulation (CR) of paroxetine and placebo matched to the immediate release formulation (IR) of paroxetine were administered orally once daily from the start of the treatment phase (8 weeks) through the end of the taper phase (0-3 weeks).
Paroxetine CR An initial dose of 12.5 or 25 milligrams (mg)/day of paroxetine CR was administered orally once daily in the first week of the treatment phase. Thereafter, 25-50 mg/day was administered once daily for 7 weeks. In the second week, participants who started the treatment from 12.5 mg/day were forced to receive the uptitrated dose of 25 mg/day, and participants who started the treatment from 25 mg/day were maintained at the same dose level. The dose level was increased by 12.5 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed. During the taper phase, the last dose level in the treatment phase was reduced by 12.5 mg/day at weekly intervals to the final dose level of 12.5 mg/day to complete the treatment.
Paroxetine IR An initial dose of 10 or 20 mg/day of paroxetine IR was administered orally once daily in the first week of the treatment phase. Thereafter, 20-40 mg/day was administered once daily for 7 weeks. In the second week, participants who started the treatment from 10 mg/day were forced to receive the uptitrated dose of 20 mg/day, and participants who started the treatment from 20 mg/day were maintained at the same dose level. The dose level was increased by 10 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed. During the taper phase, the last dose level in the treatment phase was reduced by 10 mg/day at weekly intervals to the final dose level of 10 mg/day to complete the treatment.

Participant Flow:   Overall Study
    Placebo     Paroxetine CR     Paroxetine IR  
STARTED     172     161     83  
COMPLETED     139     141     72  
NOT COMPLETED     33     20     11  
Adverse Event                 12                 13                 9  
Lack of Efficacy                 7                 1                 0  
Protocol Violation                 2                 0                 0  
Met Protocol-defined Stopping Criteria                 5                 1                 1  
Lost to Follow-up                 1                 3                 0  
Physician Decision                 6                 2                 1  



  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 Placebo matched to the controlled release formulation (CR) of paroxetine and placebo matched to the immediate release formulation (IR) of paroxetine were administered orally once daily from the start of the treatment phase (8 weeks) through the end of the taper phase (0-3 weeks).
Paroxetine CR An initial dose of 12.5 or 25 milligrams (mg)/day of paroxetine CR was administered orally once daily in the first week of the treatment phase. Thereafter, 25-50 mg/day was administered once daily for 7 weeks. In the second week, participants who started the treatment from 12.5 mg/day were forced to receive the uptitrated dose of 25 mg/day, and participants who started the treatment from 25 mg/day were maintained at the same dose level. The dose level was increased by 12.5 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed. During the taper phase, the last dose level in the treatment phase was reduced by 12.5 mg/day at weekly intervals to the final dose level of 12.5 mg/day to complete the treatment.
Paroxetine IR An initial dose of 10 or 20 mg/day of paroxetine IR was administered orally once daily in the first week of the treatment phase. Thereafter, 20-40 mg/day was administered once daily for 7 weeks. In the second week, participants who started the treatment from 10 mg/day were forced to receive the uptitrated dose of 20 mg/day, and participants who started the treatment from 20 mg/day were maintained at the same dose level. The dose level was increased by 10 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed. During the taper phase, the last dose level in the treatment phase was reduced by 10 mg/day at weekly intervals to the final dose level of 10 mg/day to complete the treatment.
Total Total of all reporting groups

Baseline Measures
    Placebo     Paroxetine CR     Paroxetine IR     Total  
Number of Participants  
[units: participants]
  172     161     83     416  
Age  
[units: Years]
Mean ± Standard Deviation
  36.8  ± 10.04     36.4  ± 11.36     35.5  ± 10.38     36.4  ± 10.62  
Gender  
[units: Participants]
       
Female     94     86     48     228  
Male     78     75     35     188  
Race/Ethnicity, Customized [1]
[units: participants]
       
Asian - East Asian Heritage     17     20     10     47  
Asian - Japanese Heritage     154     138     73     365  
[1] The number of participants is based on the Full Analysis Set (FAS), consisting of all participants who entered the treatment phase, excluding those who had taken no dose of the investigational product for the treatment phase and those who had no data on the Hamilton Depression Rating Scale (HAM-D) total score after the start of the treatment phase.



  Outcome Measures
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1.  Primary:   Adjusted Mean Change From Baseline in the Hamilton Depression Rating Scale (HAM-D; 17 Items) Total Score at Week 8   [ Time Frame: Baseline (Week 0) and Week 8 ]

2.  Secondary:   Mean Change From Baseline in the HAM-D Total Score at Weeks 1, 2, 3, 4, 6, and 8   [ Time Frame: Baseline (Week 0); Weeks 1, 2, 3, 4, 6, and 8 ]

3.  Secondary:   Percentage of HAM-D Responders at Weeks 4 and 8   [ Time Frame: Weeks 4 and 8 ]

4.  Secondary:   Percentage of HAM-D Remitters at Weeks 4 and 8   [ Time Frame: Weeks 4 and 8 ]

5.  Secondary:   Mean Change From Baseline in the Clinical Global Impression-Severity of Illness (CGI-SI) Scores at Weeks 1, 2, 3, 4, 6, and 8   [ Time Frame: Baseline (Week 0); Weeks 1, 2, 3, 4, 6, and 8 ]

6.  Secondary:   Percentage of Responders Based on the Clinical Global Impression-Global Improvement (CGI-GI) Scores at Weeks 4 and 8   [ Time Frame: Weeks 4 and 8 ]


  Serious Adverse Events


  Other Adverse Events


  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.


Limitations and Caveats
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
No text entered.  


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


No publications provided by GlaxoSmithKline

Publications automatically indexed to this study:

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00866294     History of Changes
Other Study ID Numbers: 112810
Study First Received: March 19, 2009
Results First Received: October 14, 2010
Last Updated: March 17, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare
South Korea: Food and Drug Administration