Investigation of Antidepressant Efficacy of Oral Ketamine Treatment

NCT ID: NCT02992496

Last Updated: 2019-09-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-24
• Study Completion Date: 2020-12-31

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.

Conditions

Major Depressive Episode

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Ketamine treatment group

Each patient will undergo six treatment sessions with 1mg/kg oral ketamine over 2 weeks.

Group Type: ACTIVE_COMPARATOR

Ketamine

Intervention Type: DRUG

1mg/kg, 6 applications over 2 weeks

Control group

Each patient will undergo six treatment sessions with 0.03mg/kg oral midazolam over 2 weeks

Group Type: ACTIVE_COMPARATOR

Midazolam Hydrochloride

Intervention Type: DRUG

0.03mg/kg, 6 applications over 2 weeks

Interventions

Ketamine

1mg/kg, 6 applications over 2 weeks

Intervention Type: DRUG

Midazolam Hydrochloride

0.03mg/kg, 6 applications over 2 weeks

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Rupert Lanzenberger

Assoc.-Prof., MD PD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Psychiatry and Psychotherapy, Medical University of Vienna

Vienna, , Austria

Site Status: RECRUITING

Countries

Austria

Facility Contacts

Rupert Lanzenberger, A/Prof.

Role: primary

rupert.lanzenberger@meduniwien.ac.at

+43 40400 ext. 35760

Other Identifiers

v1.2_20161024

Identifier Type: -

Identifier Source: org_study_id