Investigation of Antidepressant Efficacy of Oral Ketamine Treatment

Medical University of Vienna

Status and phase: Unknown; Phase 2

Conditions: Major Depressive Episode

Treatments: Drug: Midazolam Hydrochloride; Drug: Ketamine

Study type: Interventional

Funder types: Other

Identifiers

NCT02992496

v1.2_20161024

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Ketamine treatment group

Active Comparator group

Description:

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

Treatment:

Drug: Ketamine

Control group

Active Comparator group

Description:

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

Treatment:

Drug: Midazolam Hydrochloride