Investigation of Antidepressant Efficacy of Oral Ketamine Treatment

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02992496

Enrollment

Registered

2016-12-14

Start date

2017-04-24

Completion date

2020-12-31

Last updated

2019-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depressive Episode

Brief summary

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.

Interventions

DRUGKetamine

1mg/kg, 6 applications over 2 weeks

DRUGMidazolam Hydrochloride

0.03mg/kg, 6 applications over 2 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

ALL

Age

18 Years to 64 Years

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.

Design outcomes

Primary

Measure	Time frame
Montgomery-Åsberg Depression Rating Scale (MADRS)	1 week

Secondary

Measure	Time frame
Hamilton Depression Rating Scale	1 week
Clinician Administered Dissociative States Scale (CADSS)	2 weeks

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026