Investigation of antidepressant efficacy of oral ketamine treatment

Phase 1

• Conditions: Major depressive episode (Major depressive disorder, Biploar disorder); Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2016-002068-14-AT
• Lead Sponsor: Medical University of Vienna

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-11-29
• Last Update Posted: 29 November 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

(i)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)
(ii)Hamilton depression rating scale score = 19
(iii)Willingness and competence to sign the informed consent form
(iv)Age 18 to 64 years
(v)Stable psychopharmacological treatment for 10 days (except benzodiazepines)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

(i)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.
(ii)Prior use of ketamine
(iii)Pregnancy/Breast feeding
(iv)Instable arterial hypertension >170/110mmHg
(v)Hepatic dysfunction
(vi)Hyperthyreosis
(vii)History of glaucoma
(viii)Neurodegenerative disorders
(ix)Any unstable medical illness
(x)History of substance abuse within the past 12 months
(xi)History of psychosis
(xii)Failure to comply with the study protocol or to follow the instructions of the investigating team
(xiii)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 & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified