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Behavioral Intervention
ACT + Ketamine for Alcoholism and Depression
N/A
Waitlist Available
Led By Nicolas Garel, MD MSc
Research Sponsored by Centre hospitalier de l'Université de Montréal (CHUM)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Accept to abstain from driving or operating heavy machinery
Have a diagnosis of treatment-resistant unipolar or bipolar depression (TRD) defined as the failure to respond to at least two adequate trials of psychotropics with Level 1 evidence against bipolar or unipolar depression
Must not have
Non-English or non-French speaking
Depressive symptoms have previously demonstrated non-response to esketamine or ketamine in the current major depressive episode
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from enrollment to the end of the follow-up (6 months)
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to investigate the effectiveness of combining ketamine treatment with Acceptance and Commitment Therapy (ACT) for patients with both Treatment-Resistant Depression (TRD) and Alcohol Use Disorder (
Who is the study for?
This trial is for individuals with both alcohol use disorder (AUD) and treatment-resistant depression (TRD), where traditional treatments haven't worked. It's aimed at those who struggle with alcohol as a trigger for depression or vice versa, and are looking for new ways to manage these conditions.
What is being tested?
The study tests adding Acceptance and Commitment Therapy (ACT) to ketamine treatment. ACT is a type of psychotherapy that helps patients accept their thoughts without judgment, which could extend the benefits of ketamine on depressive symptoms while also tackling AUD.
What are the potential side effects?
Ketamine may cause side effects like disorientation, dizziness, nausea, elevated blood pressure, and in rare cases, dependency. The psychological nature of ACT means it has fewer physical side effects but can bring up challenging emotions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I agree not to drive or operate heavy machinery.
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I have depression that hasn't improved after trying at least two different treatments.
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I am approved for IV ketamine treatment for depression and alcohol use disorder.
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I am currently experiencing a depressive episode despite trying at least two different recommended treatments.
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I am between 18 and 70 years old.
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I can safely receive ketamine.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not speak English or French.
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My depression did not improve with esketamine or ketamine treatment.
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I cannot regularly visit the ketamine clinic.
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I have risk factors for bleeding in the brain.
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I cannot or will not stop taking benzodiazepines before ketamine infusion.
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I cannot or will not stop taking memantine or lamotrigine during treatments.
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I am pregnant, breastfeeding, or can become pregnant and won't use birth control during the study.
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I have had seizures, but not from fever.
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My thyroid levels are not normal and untreated.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from enrollment to the end of the follow-up (6 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from enrollment to the end of the follow-up (6 months)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Patient adherence
Secondary study objectives
Attrition rate
Consent rate
Cost of the intervention (Resource utilization)
+5 moreOther study objectives
Change in functioning
Change in quality of life
Clinician-administered scale for reduction in depressive symptoms
+8 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Acceptance and Commitment Therapy (ACT)Experimental Treatment1 Intervention
20 consecutive participants who will receive 8 sessions of Acceptance and Commitment Therapy (ACT) at our research site or virtually.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Acceptance and Commitment Therapy
2010
Completed Phase 1
~1490
Find a Location
Who is running the clinical trial?
Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor
380 Previous Clinical Trials
131,569 Total Patients Enrolled
Nicolas Garel, MD MScPrincipal InvestigatorCentre Hospitalier de l'Université de Montréal