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Incomplete Response in Late-Life Depression: Getting to Remission With Buprenorphine

NCT02263248 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2018-07-26

No results posted yet for this study

Summary

The Investigators are conducting a research study to learn about the safety and benefit of using a medication called buprenorphine for patient with difficult to treat depression . This research study is testing whether combining two medications will be effective in treating depression when initial treatment with just one antidepressant does not relieve the depressive symptoms ; this is what is called " difficult to treat depression " or " treatment resistant depression ". The two medication the investigators are using are " an anti-depressant medication called venlafaxine XR ( the generic form of Effexor ) and buprenorphine . Buprenorphine is a medication that is FDA approved for the treatment of opioid dependence. The investigators are testing whether adding buprenorphine to venlafaxine enhances treatment response.

Conditions

Interventions

DRUG

venlafaxine

slow titration to a maximum of 300 mg per day. will remain on venlafaxine XR for upto 32 weeks.

DRUG

buprenorphine

randomized to either buprenorphine or placebo, dose range from 0.2 mg qd/ to 1.2 mg qd

DRUG

placebo

patients will remain on venlafaxine XR and be randomzied to receive either placebo or buprenorphine for 8 weeks. at the end of 8 weeks those who did not receive buprenorphine will be given an opportunity to try it.

Sponsors & Collaborators

  • Reckitt Benckiser LLC

    collaborator INDUSTRY

  • Centre for Addiction and Mental Health

    lead OTHER

Principal Investigators

  • Daniel M Blumberger, MD · CAMH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2017-01-19
Completion
2018-05-01

Countries

  • Canada

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02263248 on ClinicalTrials.gov