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Unknown statusPhase 2

Investigation of Antidepressant Efficacy of Oral Ketamine Treatment

NCT02992496 · Medical University of Vienna

Closed to entry
Status
Not accepting participants
Phase 2
Phase
60
Target enrolment
1
Study sites
Outside the US

What it is testing

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Montgomery-Åsberg Depression Rating Scale (MADRS)

    Measured over 1 week

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 64 Years
Ages
All
Sex
Not accepted
Healthy volunteers
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.

Where

1 study site

FacilityCityRegionCountry
Department of Psychiatry and Psychotherapy, Medical University of ViennaViennaAustria

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT02992496 on ClinicalTrials.gov →

Last updated in the registry 2019-09-03. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits