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New treatment option for Depression - Major Depressive Disorder
Official title ACT_for Alcohol Use Disorder and Depression
ClinicalTrials.gov ID: NCT06620276
What this study is testing
What is Ketamine?
Ketamine is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for depression - major depressive disorder.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Alcohol use disorders (AUDs) and depressive disorders frequently coexist, complicating the clinical management of patients suffering from them. Taken separately, these two disorders have a significant prevalence in the population, and a recent meta-analysis concluded that coexistence could reach 1 in 5 patients (20.8%).
- Time commitment: about 12 months
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Provision of written informed consent after reading and understanding the patient information handout
- Alcohol Use Disorder (AUD) diagnosed by a trained psychiatrist
- Diagnosis of treatment resistant unipolar or bipolar depression, defined as failure to respond to ≥2 adequate trials per Canadian national depression...
- Willingness to engage in 8 weekly psychotherapy sessions
- No changes to psychotropic medications during treatment
You likely can't join if
- Current participation in other evidence based psychotherapeutic interventions for mood disorders or substance abuse
- Inability to commit to the study protocol due to professional or personal obligations
- Non English or non French speaking
- Psychiatric comorbidity likely to take precedence over AUD or TRD
- Acute psychotic disorder or acute psychotic symptoms
- Current or prior substance abuse or dependence other than AUD (except caffeine or nicotine)
See the full eligibility criteria
- Provision of written informed consent after reading and understanding the patient information handout
- Alcohol Use Disorder (AUD) diagnosed by a trained psychiatrist
- Diagnosis of treatment resistant unipolar or bipolar depression, defined as failure to respond to ≥2 adequate trials per Canadian national depression guidelines
- Willingness to engage in 8 weekly psychotherapy sessions
- No changes to psychotropic medications during treatment
- Average daily ethanol consumption of at least moderate risk as per WHO risk levels (Men: \>40 to 60 g per day or \>2.9 to 4.3 drinks / Women: \>20 to 40 g per day or \>1.4 to 2.9 drinks)
- Bipolar or unipolar depressive episode (DSM5), current episode, with MADRS ≥ 20
- Age 18 to 70 years
- Agreement to abstain from consuming grapefruit juice on ketamine infusion days
- Agreement to abstain from driving or operating heavy machinery after infusions until the next day
- Current participation in other evidence based psychotherapeutic interventions for mood disorders or substance abuse
- Inability to commit to the study protocol due to professional or personal obligations
- Non English or non French speaking
- Psychiatric comorbidity likely to take precedence over AUD or TRD
- Acute psychotic disorder or acute psychotic symptoms
- Current or prior substance abuse or dependence other than AUD (except caffeine or nicotine)
- Non response to esketamine or ketamine during the current depressive episode
- Known intellectual disability or autism spectrum disorder
- Inability to attend regular visits to the CHUM Neuromodulation clinic
- Depression secondary to stroke, cancer, or severe medical conditions
- Risk factors for intracranial hemorrhage (trauma, aneurysm, neurosurgery)
- Uncontrolled hypertension or significant coronary or cerebrovascular disease
- Renal or hepatic impairment
- Pregnant, lactating, or of childbearing potential without approved contraception use during ketamine treatment, with a negative urine pregnancy test required at baseline
- Abnormal liver function tests (AST or ALT ≥ 3 times upper normal limit)
- Clinically significant abnormal ECG results
- Unstable thyroid hormone levels or uncorrected hypo or hyper thyroidism
- Any unstable or clinically significant condition judged by the study physician to interfere with treatment
- Positive toxicology screen for drugs not prescribed
- Unwillingness to abstain from benzodiazepines, narcotics, or NMDA antagonists (including memantine and lamotrigine) 12 hours before infusions
- Known intolerance or hypersensitivity to ketamine
- Significant hearing impairment not improved by aids
- Any recent significant decline in exercise tolerance
The study team makes the final eligibility decision.
Where it's taking place
- Montreal, Quebec, Canada
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Montreal, Quebec, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.