NCT02200406

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for phase_4 depression

Timeline
Completed

Started Jul 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

July 22, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 25, 2014

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

October 23, 2020

Status Verified

August 1, 2017

Enrollment Period

2.5 years

First QC Date

July 22, 2014

Last Update Submit

October 21, 2020

Conditions

DepressionOpioid DependenceMethadone Treatment

Keywords

DesvenlafaxineOpioid-dependentAddictionDepressionMethadoneComorbidity

Outcome Measures

Primary Outcomes (1)

  • Tolerability: Systematic Assessment for Treatment Emergent Events (SAFTEE)

    Safety and adverse effects with the Systematic Assessment for Treatment Emergent Events (SAFTEE)

    8 weeks

Secondary Outcomes (9)

  • effect of Desvenlafaxine on depressive symptoms

    8 weeks

  • effect of Desvenlafaxine on depressive symptoms

    8 weeks

  • Response to treatment

    8 weeks

  • Feasibility: Proportion of persons screened who are eligible and enrolled

    Baseline

  • Treatment adherence

    8 weeks

  • +4 more secondary outcomes

Other Outcomes (8)

  • Substance use

    8 weeks

  • Effect of Desvenlafaxine on anxiety

    8 weeks

  • Effect of Desvenlafaxine on blood pressure and heart rate

    8 weeks

  • +5 more other outcomes

Study Arms (1)

Desvenlafaxine

OTHER

* 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.

Drug: Desvenlafaxine

Interventions

DesvenlafaxineDRUG

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.

Also known as: PRISTIQ
Desvenlafaxine

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre de recherche du Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, H2X0A9, Canada

Location

Related Publications (1)

  • El Hage C, Ghabrash MF, Dubreucq S, Brissette S, Lesperance F, Lesperance P, Ouellet-Plamondon C, Bruneau J, Jutras-Aswad D. A pilot, open-label, 8-week study evaluating desvenlafaxine for treatment of major depression in methadone-maintained individuals with opioid use disorder. Int Clin Psychopharmacol. 2018 Sep;33(5):268-273. doi: 10.1097/YIC.0000000000000223.

    PMID: 29738425DERIVED

MeSH Terms

Conditions

DepressionOpioid-Related DisordersBehavior, Addictive

Interventions

Desvenlafaxine Succinate

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorNarcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersCompulsive BehaviorImpulsive Behavior

Intervention Hierarchy (Ancestors)

CyclohexanolsHexanolsFatty AlcoholsAlcoholsOrganic ChemicalsCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsPhenolsBenzene DerivativesHydrocarbons, AromaticLipids

Study Officials

  • Didier Jutras-Aswad, M.D., M.Sc.

    Centre hospitalier de l'Université de Montréal (CHUM)

    PRINCIPAL INVESTIGATOR

  • Suzanne Brissette, M.D., M.Sc.

    Centre hospitalier de l'Université de Montréal (CHUM)

    STUDY CHAIR

  • Julie Bruneau, M.D., M.Sc.

    Centre hospitalier de l'Université de Montréal (CHUM)

    STUDY CHAIR

  • Paul Lespérance, M.D., M.Sc.

    Centre hospitalier de l'Université de Montréal (CHUM)

    STUDY CHAIR

  • Clairélaine Ouellet-Plamondon, M.D.

    Centre hospitalier de l'Université de Montréal (CHUM)

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2014

First Posted

July 25, 2014

Study Start

July 1, 2014

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

October 23, 2020

Record last verified: 2017-08

Locations

CA(1)