UnknownPhase 2ketamine

Investigation of Antidepressant Efficacy of Oral Ketamine Treatment

Sponsored by Medical University of Vienna

NCT ID
NCT02992496
Target Enrollment
60 participants
Start Date
2017-04-24
Est. Completion
2020-12

About This Study

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 Studied

Major Depressive Episode

Interventions

  • Ketamine
  • Midazolam Hydrochloride

Eligibility

Age:18 Years - 64 Years
Healthy Volunteers:No
View full 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.

Study Locations (1)

Department of Psychiatry and Psychotherapy, Medical University of Vienna
Vienna, Austria

This trial is not recruiting

This study is currently not accepting new participants.

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Data Source
ClinicalTrials.gov

Last updated from source