Ketamine hydrochloride for Major depressive disorder | Treatment-resistant depression

Inclusion criteria

• {"criterion_text":"- Participant is willing and able to give informed consent for participation in the study."}
• {"criterion_text":"- Male and Female, aged 18-70."}
• {"criterion_text":"- Women of childbearing potential (WOCBP) must use at least 1 highly effective method of contraception. Highly effective methods of contraception are those which have a failure rate of <1% (when implemented consistently and correctly) and include: Intrauterine device (IUD), Bilateral tubal ligation, bilateral salpingectomy, or bilateral tubal occlusive procedure, Hormonal contraceptives (eg, oral, patch, or injectable), A double-barrier protection method (eg, condom, sponge, or vaginal diaphragm with spermicide cream, foam, or gel); abstinence from heterosexual intercourse is accepted if this is the participant’s usual lifestyle."}
• {"criterion_text":"- Diagnosed with major depressive disorder (according to SCID5-CV scale)."}
• {"criterion_text":"- Affected by treatment resistant depression (defined as at least 2 different antidepressant agents used without success)."}
• {"criterion_text":"- Adequacy of the score for anesthesia."}

Exclusion criteria

• {"criterion_text":"- Chronic neurological disease."}
• {"criterion_text":"- Participants with a known hypersensitivity to ketamine or any of its excipients will be excluded from the study"}
• {"criterion_text":"- Participants with any contraindications to the use of ketamine, such as a history of severe cardiovascular conditions (e.g., uncontrolled hypertension, significant arrhythmias), intracranial hypertension, or severe liver impairment, will also be excluded to prevent potential adverse events."}
• {"criterion_text":"- Intellectual disability"}
• {"criterion_text":"- Contraindications to the electroconvulsive therapy (severe aortic valve stenosis, implantable cardiac defibrillators, uncontrolled hypertension, clinically significant respiratory, renal or hepatic disease, abdominal aortic aneurysm, endocrine disorders, neuromuscular diseases, space occupying brain lesions, stroke in the last 6 months),"}
• {"criterion_text":"- Contraindications to the electroconvulsive therapy (severe aortic valve stenosis, implantable cardiac defibrillators, implantable electronic devises, uncontrolled hypertension, clinically significant respiratory, renal or hepatic disease, abdominal aortic aneurism, endocrine disorders, neuromuscular disease, space-occupying brain lesions, stroke in the last 6 months)."}
• {"criterion_text":"- Patients with Alcohol Use Disorder or Substance Use Disorder or Substance Abuse history in the past year,"}
• {"criterion_text":"- Pregnancy and lactation"}
• {"criterion_text":"- Cardiovascular conditions"}
• {"criterion_text":"- Any other Psychiatric Disorders, other than MDD"}
• {"criterion_text":"- Hepatic impairment"}

Primary endpoints

• {"endpoint_text":"- The primary endpoint is the mean change in depressive symptoms, as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS), from baseline to Day 28 (Week 4 +/- 4 days). This will assess the short-term efficacy of the treatment.","definition_or_measurement_approach":"Measured by the Montgomery-Åsberg Depression Rating Scale (MADRS); primary measure is mean change from baseline to Day 28 (Week 4 +/- 4 days)."}

Secondary endpoints

• {"endpoint_text":"- The secondary endpoints include changes in suicidal ideation, anxiety symptoms, cognitive function, dissociative and psychotic symptoms, and neurochemical markers. Suicidal ideation will be measured by the Beck Scale for Suicide Ideation (BSSI), with mean change from baseline to Week 4 and Week 12 as the primary outcome of interest. Anxiety symptoms will be assessed using the Hamilton Anxiety Rating Scale (HAM-A), with evaluations conducted from baseline through Week 12 to capture changes across","definition_or_measurement_approach":"Suicidal ideation: measured by Beck Scale for Suicide Ideation (BSSI), mean change from baseline to Week 4 and Week 12. Anxiety symptoms: assessed using HAM-A with evaluations from baseline through Week 12. Other listed domains (cognitive function, dissociative/psychotic symptoms, neurochemical markers) are to be evaluated as described but specific measurement instruments for all domains are not fully specified in the provided text."}

Italy

Earliest CTIS Part Ii Submission Date

20-01-2025

Latest Decision Or Authorization Date

02-03-2026

Processing Time Days

406

Number Of Sites

1

Number Of Participants

30

Primary sponsor

Full Name

Universita' Vita-salute S. Raffaele

Organisation Type

Educational Institution

Country Of Registered Address

Italy

Third parties

• {"country":"","full_name":"Ministero della Ricerca e dell'Università - PRIN - 20227EA9AN","duties_or_roles":"Source of monetary support","organisation_type":""}