DepressionPhase 4NCT02200406

Desvenlafaxine in Opioid-Dependent Patients

A Phase 4 study testing Desvenlafaxine in people with Depression and Opioid Dependence, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Depression, Opioid Dependence, Methadone Treatment
What is being tested?: Desvenlafaxine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 18 participants
Where: 1 siteCanada
Study dates: Jul 2014to Jan 2017
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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)

Who cannot join

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;

Show all 11Show fewer

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

Trial locations and contacts

1 site in 1 country.

Canada1 site

Centre de recherche du Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, H2X0A9

Other trials in Canada

About this study

Official title: An Open-Label Pilot Study of Desvenlafaxine for Opioid-Dependent Patients With Comorbid Depression

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.

Read the 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.

Conditions: Depression, Opioid Dependence, Methadone Treatment
Being tested: Desvenlafaxine
Keywords: Desvenlafaxine, Opioid-dependent, Addiction, Depression, Methadone, Comorbidity
Medical subject headings: Depression, Opioid-Related Disorders, Behavior, Addictive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DesvenlafaxineDrug
Also called PRISTIQ
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.

Study groups in NCT02200406
Study group	Role	What they receive
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. Receives: Drug: Desvenlafaxine

What is being measured

The primary outcome is the main question the study is designed to answer.

Tolerability: Systematic Assessment for Treatment Emergent Events (SAFTEE)
Safety and adverse effects with the Systematic Assessment for Treatment Emergent Events (SAFTEE)
Measured: 8 weeks

Secondary outcomes (9)

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.
Measured: 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.
Measured: 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
Measured: 8 weeks
Feasibility: Proportion of persons screened who are eligible and enrolled
Proportion of persons screened who are eligible and enrolled
Measured: 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
Measured: 8 weeks
Effect of Desvenlafaxine administration on QT/QTc interval prolongation
It will be assessed by electrocardiograms (upper limit for safety should be 500ms).
Measured: 4 weeks
Feasibility: Proportion of scheduled study visits completed and biological samples collected
Proportion of scheduled study visits completed and biological samples collected
Measured: 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.
Measured: 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
Measured: 2 - 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2014Jan 2017

First posted25 Jul 2014 (estimated)
Study startJul 2014
Primary completionJan 2017
Study completionJan 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for DepressionStudies of the same condition, open and under way.
More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02200406
Sponsor's protocol ID: WI187002
Other IDs: Pfizer Reference Award Number
Status last verified: Aug 2017
First submitted: 22 Jul 2014
Last updated: 23 Oct 2020
Results posted: No
Data monitoring committee: Yes

Publications

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.
PubMed 29738425

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 23 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label Pilot Study of Desvenlafaxine for Opioid-Dependent Patients With Comorbid Depression
ClinicalTrials.gov ID: NCT02200406
Acronym / sponsor ID: WI187002
Conditions: Depression, Opioid Dependence, Methadone Treatment
Keywords: Desvenlafaxine, Opioid-dependent, Addiction, Depression, Methadone, Comorbidity
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
Collaborators: Pfizer
Study start: Jul 2014
Primary completion: Jan 2017 (actual)
Study completion: Jan 2017 (actual)
First posted: 25 Jul 2014 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Desvenlafaxine	Other	Drug: 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.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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;

Key exclusion criteria (11 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DesvenlafaxineAlso: PRISTIQAll 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.	Drug	Desvenlafaxine

Primary outcome

Tolerability: Systematic Assessment for Treatment Emergent Events (SAFTEE)
Time frame: 8 weeks
Safety and adverse effects with the Systematic Assessment for Treatment Emergent Events (SAFTEE)

9 secondary outcomes

effect of Desvenlafaxine on depressive symptoms
Time frame: 8 weeks
effect of Desvenlafaxine on depressive symptoms
Time frame: 8 weeks
Response to treatment
Time frame: 8 weeks
Feasibility: Proportion of persons screened who are eligible and enrolled
Time frame: Baseline
Treatment adherence
Time frame: 8 weeks
Effect of Desvenlafaxine administration on QT/QTc interval prolongation
Time frame: 4 weeks
Feasibility: 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)
Time frame: 4 weeks
Methadone dose adjustments
Time frame: 2 - 4 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2020.
Derived from this study: PubMed 29738425El 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Didier Jutras-Aswad, M.D., M.Sc. principal investigator

Centre hospitalier de l'Université de Montréal (CHUM)

Suzanne Brissette, M.D., M.Sc. study chair

Centre hospitalier de l'Université de Montréal (CHUM)

Julie Bruneau, M.D., M.Sc. study chair

Centre hospitalier de l'Université de Montréal (CHUM)

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Desvenlafaxine in people with Depression and Opioid Dependence, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tolerability: Systematic Assessment for Treatment Emergent Events (SAFTEE) (time frame: 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02200406, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2020.