Investigation of Antidepressant Efficacy of Oral Ketamine Treatment

Major Depressive Episode Clinical Trial

Official title:

Investigation of Antidepressant Efficacy of Oral Ketamine Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02992496
• Other study ID #: v1.2_20161024
• Status: Recruiting
• Phase: Phase 2
• Start date: April 24, 2017
• Est. completion date: December 2020

Study information

• Verified date: August 2019
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Major Depressive Episode

Intervention

Drug:
• Ketamine
1mg/kg, 6 applications over 2 weeks
• Midazolam Hydrochloride
0.03mg/kg, 6 applications over 2 weeks

Locations

Country	Name	City	State
Austria	Department of Psychiatry and Psychotherapy, Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Montgomery-Åsberg Depression Rating Scale (MADRS)		1 week
Secondary	Clinician Administered Dissociative States Scale (CADSS)		2 weeks
Secondary	Hamilton Depression Rating Scale		1 week