Investigation of Antidepressant Efficacy of Oral Ketamine Treatment

August 30, 2019 updated by: Rupert Lanzenberger, Medical University of Vienna
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Recruiting
        • Department of Psychiatry and Psychotherapy, Medical University of Vienna
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Ketamine treatment group
Each patient will undergo six treatment sessions with 1mg/kg oral ketamine over 2 weeks.
Drug: Ketamine
1mg/kg, 6 applications over 2 weeks
ACTIVE_COMPARATOR: Control group
Each patient will undergo six treatment sessions with 0.03mg/kg oral midazolam over 2 weeks
Drug: Midazolam Hydrochloride
0.03mg/kg, 6 applications over 2 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Montgomery-Åsberg Depression Rating Scale (MADRS)
Time Frame: 1 week
1 week

Secondary Outcome Measures

Outcome Measure
Time Frame
Clinician Administered Dissociative States Scale (CADSS)
Time Frame: 2 weeks
2 weeks
Hamilton Depression Rating Scale
Time Frame: 1 week
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 24, 2017

Primary Completion (ANTICIPATED)

December 1, 2020

Study Completion (ANTICIPATED)

December 1, 2020

Study Registration Dates

First Submitted

December 12, 2016

First Submitted That Met QC Criteria

December 13, 2016

First Posted (ESTIMATE)

December 14, 2016

Study Record Updates

Last Update Posted (ACTUAL)

September 3, 2019

Last Update Submitted That Met QC Criteria

August 30, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • v1.2_20161024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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