Paroxetine/Bupropion in Suicide Attempters/Ideators With Major Depression

This study has been terminated.
(Interim analysis showed differential treatment effects.)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT00429169
First received: January 29, 2007
Last updated: December 18, 2012
Last verified: December 2012
Results First Received: December 11, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Depression
Interventions: Drug: Paroxetine
Drug: Bupropion

  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
Recruitment dates were 2/2005-7/2009 with follow-up completed in January 2010.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
N=101 subjects enrolled, but N=23 did not return after enrollment, so N=78 were randomized.

Reporting Groups
  Description
Paroxetine Participants will receive paroxetine for 8 weeks
Bupropion Participants will receive bupropion for 8 weeks

Participant Flow:   Overall Study
    Paroxetine     Bupropion  
STARTED     38     40  
COMPLETED     36 [1]   38 [2]
NOT COMPLETED     2     2  
Lost to Follow-up                 0                 1  
Ineligibility discovered after entry                 2                 1  
[1] 2 subjects excluded due to re-diagnosis/ineligibility.
[2] 2 subjects excluded: re-diagnosis/ineligibility (1), and did not return after randomization (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
Paroxetine Participants will receive paroxetine for 8 weeks
Bupropion Participants will receive bupropion for 8 weeks
Total Total of all reporting groups

Baseline Measures
    Paroxetine     Bupropion     Total  
Number of Participants  
[units: participants]
  36     38     74  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     36     38     74  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  35.2  ± 12.8     37.9  ± 11.9     36.4  ± 12.7  
Gender  
[units: participants]
     
Female     21     21     42  
Male     15     17     32  
Region of Enrollment  
[units: participants]
     
United States     36     38     74  



  Outcome Measures
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1.  Primary:   Go-No go Test   [ Time Frame: Measured at Baseline and Week 8 ]

2.  Primary:   Scale for Suicidal Ideation   [ Time Frame: Baseline and Week 8 ]

3.  Primary:   Occurrence of Suicidal Ideation or Acts Necessitating a Change in Treatment   [ Time Frame: Measured at Month 6 ]

4.  Secondary:   Brain Activity Measured by BOLD Signal With fMRI During a Reward Processing Task.   [ Time Frame: Baseline and Week 8. ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  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
  1. Significant dropout meant the number of subjects with analyzable data was smaller than the number enrolled.
  2. An interim analysis of this pilot study showed differential treatment effects so a decision was made to stop enrollment early.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Michael F. Grunebaum, MD
Organization: Columbia University/NYSPI
phone: 212-543-5842
e-mail: mfg14@columbia.edu


Publications of Results:

Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00429169     History of Changes
Other Study ID Numbers: #5933R, K23MH076049, DSIR 8KRT-AT
Study First Received: January 29, 2007
Results First Received: December 11, 2012
Last Updated: December 18, 2012
Health Authority: United States: Federal Government