Desvenlafaxine in Opioid-Dependent Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2017-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Background: Although substitution therapy has been shown to be highly effective to retain opioid-dependent patients in treatment and reduce drug use, this population is afflicted by numerous conditions including depression. Unfortunately, studies published thus far have reported inconsistent or no difference in response between placebo therapy and antidepressants such as selective serotonin reuptake inhibitors. Objective: To assess the feasibility of Desvenlafaxine (DESV) administration among opioid-dependent subjects and explore its effect on depressive symptoms. Methods: Open-label pilot trial of 8 weeks of DESV 50-100 mg/day in 20 methadone-maintained individuals with comorbid depressive symptoms at the Centre hospitalier de l'Université de Montréal. Significance: This pilot study will lay down the foundation on which a larger multisite clinical trial could be conducted to examine DESV as new treatment for opioid-dependent population with comorbid depression.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

MetAbolism vaRiability of VEnLafaxine

NCT02590185

Major Depressive Disorders

UNKNOWN NA

Study of Desvenlafaxine in Treating Major Depressive Disorder.

NCT04364997

Major Depressive Disorder

COMPLETED PHASE3

Effect of Antidepressants on White Matter Structure

NCT01492621

Major Depression

UNKNOWN PHASE4

A Study of Sustained-Release Desvenlafaxine Hydrochloride for the Treatment of Major Depressive Disorder

NCT01977378

Major Depressive Disorder

UNKNOWN PHASE2/PHASE3

Study Evaluating Venlafaxine Extended Release in Elderly Depressed Patients

NCT00247429

Depressive Syndrome Anxiety

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

To assess the feasibility, tolerability and acceptability of 8 weeks of Desvenlafaxine (DESV) administration among opioid-dependent subjects in a methadone-maintenance program, we will collect detailed information on compliance to DESV treatment, side effects, methadone plasma levels, methadone dose changes and QTc measures.

To explore the effects of DESV on depressive symptoms among opioid-dependent subjects on methadone-maintenance treatment. The severity and symptoms of depression will be evaluated by using the MADRS, the HRDS, and the CGI scale.

To explore the effects of DESV on substance use, anxiety, craving, quality of life and suicidal risk.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Depression Opioid Dependence Methadone Treatment

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Desvenlafaxine

* Open-label pilot study
* Desvenlafaxine will be administered during 56 consecutive days
* Desvenlafaxine will be administered in the morning at a 50 mg dose during weeks 1 and 2, and at 50-100 mg doses (based on the study psychiatrist's judgment) during the 6 following weeks.

Group Type OTHER

Desvenlafaxine

Intervention Type DRUG

All subjects will receive 50 mg of the medication during week 1 and 2, then 50-100 mg (based on the psychiatrist judgment) for the following 6 weeks. Subjects who experience significant adverse reactions with the 100mg dose during weeks 2 to 4 could return to the lower dose of 50 mg if judged clinically appropriate by the study psychiatrist.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Desvenlafaxine

All subjects will receive 50 mg of the medication during week 1 and 2, then 50-100 mg (based on the psychiatrist judgment) for the following 6 weeks. Subjects who experience significant adverse reactions with the 100mg dose during weeks 2 to 4 could return to the lower dose of 50 mg if judged clinically appropriate by the study psychiatrist.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

PRISTIQ

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* DSM-IV-TR criteria for opioid dependence;
* Subject is on methadone treatment in the substitution program for at least 4 weeks;
* Subject is aged between 18 and 65 years old;
* subject meets the DSM-V TR criteria for major depressive episode, according to the study psychiatrist and confirmed by the Mini International Neuropsychiatric Interview (MINI);
* Subject reports a score of 20 or higher on the MADRS;
* Subject is eligible for and consents to the study;
* subject is able to give valid, informed consent;
* subject is able to speak and read French or English (grade-nine level of language required)

Exclusion Criteria

* Unstable medical illness, defined as any medical illness which has not been well-controlled with standard-of-care medications;
* Severe psychiatric condition (e.g., current acute psychosis, past or current hypomania/mania) based on the MINI;
* Pregnancy or breastfeeding;
* Inability to use a medically acceptable form of contraception throughout the study duration. A medically acceptable form of contraception is either: (1) contraceptive pill or intrauterine device or depot hormonal preparation (ring, injection, implant); and/or (2) a barrier method of contraception such as diaphragm, sponge with spermicide or condom;
* Subject currently takes another antidepressant;
* Treatment with Desvenlafaxine at any time in the past;
* Known hypersensitivity to venlafaxine;
* Subject is undergoing psychotherapies for current depression (support therapy or counseling are allowed);
* Subject failed to respond to two or more Health-Canada-approved antidepressants during current episode;
* Unstable Axis-II personality disorder or other Axis-II disorder which has been the primary focus of treatment in the past 3 months, as ascertained by a study psychiatrists;
* Medical diagnosis of kidney and/or liver failure

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No