Investigation of Antidepressant Efficacy of Oral Ketamine Treatment

• Status: Unknown status
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of Vienna
• Treatments: Antidepressive Agents; Ketamine; Midazolam

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.