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Buprenorphine for Treatment Resistant Depression (BUP-TRD)

This study has been completed.
Sponsor:
Collaborator:
National Alliance for Research on Schizophrenia and Depression
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01407575
First received: July 29, 2011
Last updated: February 18, 2016
Last verified: February 2016
Results First Received: January 5, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Depression
Depressive Disorder
Depressive Disorder, Major
Interventions: Drug: Buprenorphine
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
Buprenorphine Buprenorphine: low-dose buprenorphine (range 0.2 mg/day -- 1.6 mg/day)
Placebo Placebo: matched placebo

Participant Flow:   Overall Study
    Buprenorphine     Placebo  
STARTED     7     6  
COMPLETED     5     5  
NOT COMPLETED     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.
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Reporting Groups
  Description
Buprenorphine Buprenorphine: low-dose buprenorphine (range 0.2 mg/day -- 1.6 mg/day)
Placebo Placebo: matched placebo
Total Total of all reporting groups

Baseline Measures
    Buprenorphine     Placebo     Total  
Number of Participants  
[units: participants]
  7     6     13  
Age  
[units: years]
Mean (Standard Deviation)
  53.92  (15.88)     64.59  (5.01)     59.66  (12.17)  
Gender  
[units: participants]
     
Female     2     3     5  
Male     5     3     8  



  Outcome Measures
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1.  Primary:   Montgomery Asberg Depression Rating Scale   [ Time Frame: 6 weeks ]

2.  Primary:   Blood Pressure   [ Time Frame: 6 weeks ]

3.  Primary:   UKU Side Effect Rating Scale   [ Time Frame: 6 weeks ]

4.  Primary:   Heart Rate   [ Time Frame: 6 weeks ]

5.  Primary:   Weight   [ Time Frame: 6 weeks ]

6.  Secondary:   Brief Symptom Inventory -- Anxiety Subscale   [ Time Frame: 6 weeks ]

7.  Secondary:   Positive and Negative Affect Scale   [ Time Frame: 6 weeks ]


  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: Jordan F. Karp, MD
Organization: University of Pittsburgh
phone: 412-246-6048
e-mail: karpjf@upmc.edu



Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01407575     History of Changes
Other Study ID Numbers: BUP-TRD
Study First Received: July 29, 2011
Results First Received: January 5, 2016
Last Updated: February 18, 2016
Health Authority: United States: Food and Drug Administration