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The Effects of Wellbutrin (Bupropion) on Residual and Cognitive Symptoms in SSRI-treated Depression

This study has been completed.
Sponsor:
Collaborator:
National Association for Research on Schizophrenia and Affective Disorders.
Information provided by (Responsible Party):
Beth L. Murphy MD, PhD, Mclean Hospital
ClinicalTrials.gov Identifier:
NCT00125957
First received: August 1, 2005
Last updated: August 5, 2014
Last verified: August 2014
Results First Received: June 11, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Depression
Major Depressive Disorder
Unipolar Depression
Interventions: Drug: Wellbutrin
Drug: Placebo

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Wellbutrin First, Then Placebo Subjects randomly assigned to the Wellbutrin first, then Placebo group will receive 100mg BID of Wellbutrin at the first visit following intake (Week 0).Subjects will be increased to 150mg Wellbutrin BID at Week 1 unless moderate/severe side effects are reported. If subject and rater classify 1+ symptom as severe or 2+ symptoms as moderate, subject will continue on 100mg of bupropion qAM. If subject and rater classify 1+ symptom as moderate or 2+ mild as moderate, subject will continue on Wellbutrin 100mg BID. At Week 4, subjects will cross-over to placebo and will continue to take placebo until Week 8.
Placebo First, Then Wellbutrin Subjects randomly assigned to the Placebo first, then Wellbutrin group will receive placebo until Week 4 when they will cross-over to active drug. At Week 4, subjects will be assigned 100mg Wellbutrin BID. At Week 5, Subjects will be increased to 150mg Wellbutrin BID unless moderate/severe side effects are reported. If subject and rater classify 1+ symptom as severe or 2+ symptoms as moderate, subject will continue on 100mg of Wellbutrin qAM. If subject and rater classify 1+ symptom as moderate or 2+ mild as moderate, subject will continue on bupropion 100mg BID. Subject will continue on the assigned dosage until Week 8 of study.

Participant Flow for 2 periods

Period 1:   First Intervention (3 Weeks)
    Wellbutrin First, Then Placebo     Placebo First, Then Wellbutrin  
STARTED     15     17  
COMPLETED     15     17  
NOT COMPLETED     0     0  

Period 2:   Second Intervention (3 Weeks)
    Wellbutrin First, Then Placebo     Placebo First, Then Wellbutrin  
STARTED     15     17  
COMPLETED     15     17  
NOT COMPLETED     0     0  



  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.
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Reporting Groups
  Description
Wellbutrin-Placebo Study subjects randomly assigned to this arm of the study will begin on active drug (100 mg twice daily (BID) of Wellbutrin) at week 1. At week 2, active drug is increased to 150mg BID unless subject reports one or more symptoms that are classified as moderate-severe. At week 4, subjects cross over to placebo for remainder of study. Subjects continue on placebo until end of study at week 8.
Placebo-Wellbutrin Subjects randomly assigned to this arm are given placebo at week 1. They will continue on placebo until week 4, at which time they will cross-over to Wellbutrin 100 mg twice daily (BID). At week 5, active drug is increased to 150mg BID unless subject reports one or more symptoms that are classified as moderate-severe. Subjects continue on active drug until end of study at week 8.
Total Total of all reporting groups

Baseline Measures
    Wellbutrin-Placebo     Placebo-Wellbutrin     Total  
Number of Participants  
[units: participants]
  15     17     32  
Age  
[units: years]
Mean ( Full Range )
  49  
  ( 18 to 65 )  
  47  
  ( 22 to 63 )  
  48  
  ( 18 to 65 )  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     14     17     31  
>=65 years     1     0     1  
Gender  
[units: participants]
     
Female     9     8     17  
Male     6     9     15  
Region of Enrollment  
[units: participants]
     
United States     15     17     32  



  Outcome Measures
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1.  Primary:   Montgomery-Asberg Depression Rating Scale (MADRS)   [ Time Frame: Baseline and follow-up ]

2.  Primary:   Hamilton Depression Rating Scale (HAM-D)   [ Time Frame: Baseline and follow-up ]


  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 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: Dr. Beth Murphy
Organization: McLean Hospital
phone: 617-855-2000 ext 2297
e-mail: bmurphy5@partners.org


No publications provided


Responsible Party: Beth L. Murphy MD, PhD, Mclean Hospital
ClinicalTrials.gov Identifier: NCT00125957     History of Changes
Other Study ID Numbers: 2005P-000502
Study First Received: August 1, 2005
Results First Received: June 11, 2014
Last Updated: August 5, 2014
Health Authority: United States: Institutional Review Board