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Adult Trials: 18+ Years
- 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)
- 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
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- Montréal, Quebec
| Descriptive Information | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Brief Title ICMJE | Desvenlafaxine in Opioid-Dependent Patients | |||||||||||||||
| Official Title ICMJE | An Open-Label Pilot Study of Desvenlafaxine for Opioid-Dependent Patients With Comorbid Depression | |||||||||||||||
| 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. | |||||||||||||||
| Detailed Description | 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. | |||||||||||||||
| Study Type ICMJE | Interventional | |||||||||||||||
| Study Phase ICMJE | Phase 4 | |||||||||||||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||||||||||||||
| Condition ICMJE |
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| Intervention ICMJE | Drug: 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. Other Name: PRISTIQ | |||||||||||||||
| Study Arms ICMJE | Desvenlafaxine
Intervention: Drug: Desvenlafaxine | |||||||||||||||
| Publications * | El Hage C, Ghabrash MF, Dubreucq S, Brissette S, Lespérance F, Lespérance 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. | |||||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||||||||||||||
| Recruitment Information | ||||||||||||||||
| Recruitment Status ICMJE | Completed | |||||||||||||||
| Actual Enrollment ICMJE | 18 | |||||||||||||||
| Original Estimated Enrollment ICMJE | 20 | |||||||||||||||
| Actual Study Completion Date ICMJE | January 2017 | |||||||||||||||
| Actual Primary Completion Date | January 2017 (Final data collection date for primary outcome measure) | |||||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | |||||||||||||||
| Accepts Healthy Volunteers ICMJE | No | |||||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||||||||||||||
| Listed Location Countries ICMJE | Canada | |||||||||||||||
| Removed Location Countries | ||||||||||||||||
| Administrative Information | ||||||||||||||||
| NCT Number ICMJE | NCT02200406 | |||||||||||||||
| Other Study ID Numbers ICMJE | WI187002 Pfizer Reference Award Number ( Other Grant/Funding Number: WI187002 ) | |||||||||||||||
| Has Data Monitoring Committee | Yes | |||||||||||||||
| U.S. FDA-regulated Product | Not Provided | |||||||||||||||
| IPD Sharing Statement ICMJE | Not Provided | |||||||||||||||
| Responsible Party | Centre hospitalier de l'Université de Montréal (CHUM) | |||||||||||||||
| Study Sponsor ICMJE | Centre hospitalier de l'Université de Montréal (CHUM) | |||||||||||||||
| Collaborators ICMJE | Pfizer | |||||||||||||||
| Investigators ICMJE |
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| PRS Account | Centre hospitalier de l'Université de Montréal (CHUM) | |||||||||||||||
| Verification Date | August 2017 | |||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||||||||||||||