UnknownPhase 2ketamine
Investigation of Antidepressant Efficacy of Oral Ketamine Treatment
Sponsored by Medical University of Vienna
NCT ID
NCT02992496
Target Enrollment
60 participants
Start Date
2017-04-24
Est. Completion
2020-12
About This Study
The purpose of this double-blind, controlled, randomized study is to investigate the antidepressant efficacy of oral ketamine treatment in patients suffering from a major depressive episode.
Conditions Studied
Interventions
- •Ketamine
- •Midazolam Hydrochloride
Eligibility
Age:18 Years - 64 Years
Healthy Volunteers:No
View full eligibility criteria
Inclusion Criteria: * Diagnosis of a major depressive episode in the scope of a major depressive or bipolar disorder supported by a Structured Clinical Interview for DSM-IV-TR (SCID) * Hamilton depression rating scale score ≥ 19 * Willingness and competence to sign the informed consent form * Stable psychopharmacological treatment for 10 days (except benzodiazepines) Exclusion Criteria: * Initiation of a new antidepressant or mood stabilizing treatment (pharmacological, physical or psychotherapeutic) with adequate dosage (as defined by the minimum recommended dose in the respective prescribing information) within 4 weeks prior to inclusion * Prior use of ketamine * Pregnancy/Breast feeding * Instable arterial hypertension \>170/110mmHg * Hepatic dysfunction * Hyperthyreosis * History of glaucoma * Neurodegenerative disorders * Any unstable medical illness * History of substance abuse within the past 12 months * History of psychosis * Failure to comply with the study protocol or to follow the instructions of the investigating team * Current treatment with one of the following drugs: clopidogrel, carbamazepine, valproate, barbiturates, memantine, modafinil, disulfiram, amiodarone, ranolazine, phenytoin, verapamil, fibrates, antiretroviral agents, antimicrobial chemotherapeutics, azole antifungals, glucocorticoids, cyclosporine, valeriana/garlic/grapefruit preparations, St. John's wort.
Study Locations (1)
Department of Psychiatry and Psychotherapy, Medical University of Vienna
Vienna, Austria