A Phase 4 interventional study of Desvenlafaxine in Depression, Opioid Dependence and Methadone Treatment, sponsored by Centre hospitalier de l'Université de Montréal (CHUM). Completed at 1 site in Canada. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-10-23.
Sponsored by Centre hospitalier de l'Université de Montréal (CHUM) · Phase 4, Interventional, and Treatment
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.
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.
1,412 studies on the registry are indexed under Opioid-Related Disorders; 290 are open to participants now.
This study's enrollment of 18 is below the median of 63 across 1,124 interventional studies indexed under Opioid-Related Disorders.
Browse Opioid-Related Disorders studies →Centre hospitalier de l'Université de Montréal (CHUM) is the lead sponsor of 370 studies on the registry; 110 are open to participants now.
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Exclusion Criteria:
* 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
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
Tolerability: Systematic Assessment for Treatment Emergent Events (SAFTEE)
Safety and adverse effects with the Systematic Assessment for Treatment Emergent Events (SAFTEE)
Time frame: 8 weeks
effect of Desvenlafaxine on depressive symptoms
Responders will be determined by a 50% reduction in (Hamilton Depression Rating Scale) HAM-D scores, and remitters will be determined based on scores of ≤7.
Time frame: 8 weeks
effect of Desvenlafaxine on depressive symptoms
Responders will be determined by a 50% reduction in the Montgomery-Asberg Depression Scale (MADRS) scores, and remitters will be determined based on scores of 10.
Time frame: 8 weeks
Response to treatment
A favorable response will be defined as a score of 1 or 2 (very much or much improved) on the Clinical Global Impression CGI-I subscale
Time frame: 8 weeks
Feasibility: Proportion of persons screened who are eligible and enrolled
Proportion of persons screened who are eligible and enrolled
Time frame: Baseline
Treatment adherence
Compliance will be evaluated at each in-person follow-up visit. Treatment adherence will be calculated as the total number of tablets dispensed minus the number returned, divided by the total number of tablets dispensed
Time frame: 8 weeks
Effect of Desvenlafaxine administration on QT/QTc interval prolongation
It will be assessed by electrocardiograms (upper limit for safety should be 500ms).
Time frame: 4 weeks
Feasibility: Proportion of scheduled study visits completed and biological samples collected
Proportion of scheduled study visits completed and biological samples collected
Time frame: 8 weeks
Potential for drug interactions between methadone and antidepressants - Effect of Desvenlafaxine on methadone serum level (pharmacokinetic variability)
Change from baseline in methadone serum level. We will assessed the methadone serum level at baseline and after a month of treatment.
Time frame: 4 weeks
Methadone dose adjustments
Change from baseline in methadone dose. Each dose adjustment occurring during the trial will be noted at each follow-up visit
Time frame: 2 - 4 weeks
Substance use
number of days of substance use as assessed with The Time Line Follow-Back (TFLB), urine-drug testing and alcohol-breathalyzer testing.
Time frame: 8 weeks
Effect of Desvenlafaxine on anxiety
Change from Baseline in anxiety and mood. It will be assessed with the Hamilton Anxiety Rating Scale (HAM-A)
Time frame: 8 weeks
Effect of Desvenlafaxine on blood pressure and heart rate
Change from Baseline in Systolic Blood Pressure and heart rate
Time frame: 8 weeks
Effect of Desvenlafaxine on opioid craving
Assessed with the abbreviated Heroin Craving Questionnaire (HCQ) - Change from Baseline in Craving.
Time frame: 8 weeks
Effect of Desvenlafaxine on quality of life
Change from baseline in Quality of life. It will be assessed with the World Health Organization Quality of Life questionnaire (WHOQOL-BREF)
Time frame: 8 weeks
Effect of Desvenlafaxine on disability
Change from baseline in disability. It will be assessed with the Sheehan Disability Scale (SDS)
Time frame: 8 weeks
Effect of Desvenlafaxine on suicidal behaviour
Change from Baseline in suicidal behaviour. It will be assessed with the Columbia-Suicide Severity Rating Scale (CSSRS)
Time frame: 8 weeks
Effect of Desvenlafaxine on testosterone level
Change from Baseline in testosterone.
Time frame: 4 weeks
This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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Centre hospitalier de l'Université de Montréal (CHUM)