Ketamine Therapy Among Patients With Treatment-resistant Depression: a Randomised, Double-blind, Placebo-controlled Trial: Pilot Phase

HREC 15009

This study is a Randomized Controlled Trial, investigating the safety and efficacy of administration of ketamine as a potential treatment for depression.

2015-03-01

2015-07-01

2015-09-01

Completed

Early phase I

10

Individuals will be eligible for enrolment on the basis of: * major depressive disorder for at least three months duration * an inadequate response to at least 2 adequate antidepressants * MADRS ≥ 20 Patients will be excluded on the basis of: * History of psychosis * History of bipolar disorder * Any unstable medical or neurologic condition * Any Axis I disorder other than MDD judged to be primary presenting problem * Planned major changes to psychotropic medication * Significant risk of suicide * Planned or probable use of ECT * Age under 16 years, or 16-17 years without parental consent * Substance abuse or dependence in previous 6 months * Any history of abuse of ketamine or phencyclidine * Contraindication to the use of ketamine * Planned use of ketamine * Women of childbearing potential not taking reliable contraception * Likely non-compliance with trial treatment * Other condition judged by the treating clinician as likely to impact on the ability of the participant to complete the trial

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 10, 'type': 'ACTUAL'}}

2023-03-30