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Buprenorphine for Late-Life Treatment Resistant Depression (BUILD)

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ClinicalTrials.gov Identifier: NCT01071538
Recruitment Status : Completed
First Posted : February 19, 2010
Results First Posted : March 17, 2016
Last Update Posted : March 9, 2018
Sponsor:
Collaborators:
National Institutes of Health (NIH)
Reckitt Benckiser LLC
National Center for Research Resources (NCRR)
Information provided by (Responsible Party):
Jordan F. Karp, University of Pittsburgh

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Depression
Intervention Drug: Buprenorphine
Enrollment 15
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Buprenorphine
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Older adults with treatment resistant depression will receive buprenorphine up to 1.6 mg/day for 8 weeks. Discontinuation of the buprenorphine will occur during weeks 9-12.

Buprenorphine: Sublingual buprenorphine 0.2 mg will be used for the first week. The dose will be increased by 0.2 mg/week based on safety and clinical response up to a maximal dose of 1.6 mg/day.

Period Title: Overall Study
Started 15
Completed 13
Not Completed 2
Arm/Group Title Buprenorphine
Hide Arm/Group Description

Older adults with treatment resistant depression will receive buprenorphine up to 1.6 mg/day for 8 weeks. Discontinuation of the buprenorphine will occur during weeks 9-12.

Buprenorphine: Sublingual buprenorphine 0.2 mg will be used for the first week. The dose will be increased by 0.2 mg/week based on safety and clinical response up to a maximal dose of 1.6 mg/day.

Overall Number of Baseline Participants 15
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants
60.7  (5.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Female
8
  53.3%
Male
7
  46.7%
1.Primary Outcome
Title Montgomery Asberg Depression Rating Scale
Hide Description measure of depression severity theoretical scale range 0-60 Lower values represent better outcome
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Buprenorphine
Hide Arm/Group Description:

Older adults with treatment resistant depression will receive buprenorphine up to 1.6 mg/day for 8 weeks. Discontinuation of the buprenorphine will occur during weeks 9-12.

Buprenorphine: Sublingual buprenorphine 0.2 mg will be used for the first week. The dose will be increased by 0.2 mg/week based on safety and clinical response up to a maximal dose of 1.6 mg/day.

Overall Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: units on a scale
9.5  (9.5)
2.Primary Outcome
Title Blood Pressure
Hide Description Blood Pressure- systolic and diastolic 140/90 or lower is considered normal and indicates a better outcome.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Buprenorphine
Hide Arm/Group Description:

Older adults with treatment resistant depression will receive buprenorphine up to 1.6 mg/day for 8 weeks. Discontinuation of the buprenorphine will occur during weeks 9-12.

Buprenorphine: Sublingual buprenorphine 0.2 mg will be used for the first week. The dose will be increased by 0.2 mg/week based on safety and clinical response up to a maximal dose of 1.6 mg/day.

Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: mm Hg
systolic blood pressure 122.5  (23.0)
diastolic blood pressure 70.5  (12.1)
3.Primary Outcome
Title UKU Side Effect Rating Scale
Hide Description measure of side effects 46 items with scores of 0,1,2,3 possible. Theoretical range 0-138 Lower scores indicate fewer side effects
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Buprenorphine
Hide Arm/Group Description:

Older adults with treatment resistant depression will receive buprenorphine up to 1.6 mg/day for 8 weeks. Discontinuation of the buprenorphine will occur during weeks 9-12.

Buprenorphine: Sublingual buprenorphine 0.2 mg will be used for the first week. The dose will be increased by 0.2 mg/week based on safety and clinical response up to a maximal dose of 1.6 mg/day.

Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: units on a scale
6.2  (3.5)
4.Primary Outcome
Title Heart Rate
Hide Description Heart Rate (Beats per minute) 60-100 beats per minute is considered normal lower heart rate represent healthier outcome
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Buprenorphine
Hide Arm/Group Description:

Older adults with treatment resistant depression will receive buprenorphine up to 1.6 mg/day for 8 weeks. Discontinuation of the buprenorphine will occur during weeks 9-12.

Buprenorphine: Sublingual buprenorphine 0.2 mg will be used for the first week. The dose will be increased by 0.2 mg/week based on safety and clinical response up to a maximal dose of 1.6 mg/day.

Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: beats per minute
72.7  (9.9)
5.Secondary Outcome
Title Brief Symptom Inventory -- Anxiety Subscale
Hide Description measure of anxiety Lower numbers indicate better outcome Theoretical Range 0-2.4
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Buprenorphine
Hide Arm/Group Description:

Older adults with treatment resistant depression will receive buprenorphine up to 1.6 mg/day for 8 weeks. Discontinuation of the buprenorphine will occur during weeks 9-12.

Buprenorphine: Sublingual buprenorphine 0.2 mg will be used for the first week. The dose will be increased by 0.2 mg/week based on safety and clinical response up to a maximal dose of 1.6 mg/day.

Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.6  (0.8)
6.Secondary Outcome
Title Positive and Negative Affect Scale
Hide Description

Positive Affect Score: Scores can range from 10 - 50, with higher scores representing higher levels of positive affect.

Negative Affect Score: Scores can range from 10 - 50, with lower scores representing lower levels of negative affect.

Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Buprenorphine
Hide Arm/Group Description:

Older adults with treatment resistant depression will receive buprenorphine up to 1.6 mg/day for 8 weeks. Discontinuation of the buprenorphine will occur during weeks 9-12.

Buprenorphine: Sublingual buprenorphine 0.2 mg will be used for the first week. The dose will be increased by 0.2 mg/week based on safety and clinical response up to a maximal dose of 1.6 mg/day.

Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: units on a scale
Positive affect subscale 29.4  (12.0)
Negative affect subscale 15.5  (6.7)
7.Secondary Outcome
Title Pain Numeric Rating Scale (20 Item)
Hide Description measure of average physical pain score range 0-20 Higher scores indicate worse outcome
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Buprenorphine
Hide Arm/Group Description:

Older adults with treatment resistant depression will receive buprenorphine up to 1.6 mg/day for 8 weeks. Discontinuation of the buprenorphine will occur during weeks 9-12.

Buprenorphine: Sublingual buprenorphine 0.2 mg will be used for the first week. The dose will be increased by 0.2 mg/week based on safety and clinical response up to a maximal dose of 1.6 mg/day.

Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: units on a scale
4.6  (5.2)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Buprenorphine
Hide Arm/Group Description

Older adults with treatment resistant depression will receive buprenorphine up to 1.6 mg/day for 8 weeks. Discontinuation of the buprenorphine will occur during weeks 9-12.

Buprenorphine: Sublingual buprenorphine 0.2 mg will be used for the first week. The dose will be increased by 0.2 mg/week based on safety and clinical response up to a maximal dose of 1.6 mg/day.

All-Cause Mortality
Buprenorphine
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Buprenorphine
Affected / at Risk (%) # Events
Total   0/15 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Buprenorphine
Affected / at Risk (%) # Events
Total   1/15 (6.67%)    
Gastrointestinal disorders   
constipation   1/15 (6.67%)  1
Indicates events were collected by systematic assessment
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
Layout table for Results Point of Contact information
Name/Title: Jordan F. Karp, MD
Organization: University of Pittsburgh
Phone: 412-246-6048
EMail: karpjf@upmc.edu
Layout table for additonal information
Responsible Party: Jordan F. Karp, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01071538    
Other Study ID Numbers: BUILD
KL2RR024154 ( U.S. NIH Grant/Contract )
First Submitted: February 17, 2010
First Posted: February 19, 2010
Results First Submitted: January 7, 2016
Results First Posted: March 17, 2016
Last Update Posted: March 9, 2018