💬In plain words
What the trial is, and whether it could suit you
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%). This comorbidity represents a considerable challenge, particularly in cases of treatment-resistant depression (TRD), where patients do not respond to conventional pharmacological interventions.
Since alcohol can act as a powerful trigger for depressive symptoms, and conversely, a depressive state increases the risk of alcohol abuse, the question of intervention sequence is also of clinical interest: should priority be given to treating TRD, AUD or both simultaneously? This question raises a major issue for healthcare professionals, as current conventional therapeutic ap
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion 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
Exclusion Criteria:
* 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
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