Investigation of Antidepressant Efficacy of Oral Ketamine Treatment

Study Overview
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Brief Summary
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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.

Official Title
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Investigation of Antidepressant Efficacy of Oral Ketamine Treatment

Conditions
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Major Depressive Episode

Intervention / Treatment
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* Drug: Ketamine
* Drug: Midazolam Hydrochloride


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ketamine treatment group<br>Each patient will undergo six treatment sessions with 1mg/kg oral ketamine over 2 weeks. | Drug: Ketamine<br>* 1mg/kg, 6 applications over 2 weeks<br>|
| Active Comparator: Control group<br>Each patient will undergo six treatment sessions with 0.03mg/kg oral midazolam over 2 weeks | Drug: Midazolam Hydrochloride<br>* 0.03mg/kg, 6 applications over 2 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Montgomery-Åsberg Depression Rating Scale (MADRS) |  | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinician Administered Dissociative States Scale (CADSS) |  | 2 weeks | 
| Hamilton Depression Rating Scale |  | 1 week |