Investigation of Antidepressant Efficacy of Oral Ketamine Treatment

Investigation of Antidepressant Efficacy of Oral Ketamine Treatment

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.

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.