Investigation of Antidepressant Efficacy of Oral Ketamine Treatment

Phase 2

• Conditions: Major Depressive Episode
• Interventions: Drug: Midazolam Hydrochloride; Drug: Ketamine

• Registration Number: NCT02992496
• Lead Sponsor: Medical University of Vienna

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-12-12
• Study First Submitted QC: 2016-12-13
• Study First Posted: 2016-12-14
• Study Start: 2017-04-24
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-30
• Last Update Posted: 2019-09-03
• Primary Completion: 2020-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Midazolam Hydrochloride	Each patient will undergo six treatment sessions with 0.03mg/kg oral midazolam over 2 weeks
Ketamine treatment group	Ketamine	Each patient will undergo six treatment sessions with 1mg/kg oral ketamine over 2 weeks.

Primary Outcome Measures

Name	Time	Method
Montgomery-Åsberg Depression Rating Scale (MADRS)	1 week

Secondary Outcome Measures

Name	Time	Method
Hamilton Depression Rating Scale	1 week
Clinician Administered Dissociative States Scale (CADSS)	2 weeks

Trial Locations

Locations (1)

Department of Psychiatry and Psychotherapy, Medical University of Vienna; 🇦🇹 Vienna, Austria