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Buprenorphine for Treatment Resistant Depression (BUP-TRD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01407575
Recruitment Status : Completed
First Posted : August 2, 2011
Results First Posted : March 17, 2016
Last Update Posted : April 11, 2017
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Depression
Depressive Disorder
Depressive Disorder, Major
Interventions: Drug: Buprenorphine
Drug: Placebo

  Participant Flow

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
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 

  Baseline Characteristics

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
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 
Overall Participants Analyzed 
[Units: Participants]
 7   6   13 
[Units: Years]
Mean (Standard Deviation)
 53.92  (15.88)   64.59  (5.01)   59.66  (12.17) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
Female      2  28.6%      3  50.0%      5  38.5% 
Male      5  71.4%      3  50.0%      8  61.5% 

  Outcome Measures

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

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

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: Jordan F. Karp, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01407575     History of Changes
Other Study ID Numbers: BUP-TRD
First Submitted: July 29, 2011
First Posted: August 2, 2011
Results First Submitted: January 5, 2016
Results First Posted: March 17, 2016
Last Update Posted: April 11, 2017