Investigation of antidepressant efficacy of oral ketamine treatment

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-002068-14-AT

Enrollment

Registered

2016-11-29

Start date

2017-01-03

Completion date

Unknown

Last updated

2021-11-29

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

Conditions

Major depressive episode (Major depressive disorder, Biploar disorder)

Interventions

Trade Name: Ketamin-hameln Pharmaceutical Form: Solution for injection/infusion INN or Proposed INN: Ketamine hydrochloride Other descriptive name: KETAMINE HYDROCHLORIDE Concentration unit: mg/ml mil

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the antidepressant efficacy of oral ketamine in patients suffering from a major depressive episode in a double-blinded randomized and controlled study design.;Secondary Objective: To assess the tolerability and clinical utility of oral ketamine administration.;Primary end point(s): Montgomery-Åsberg Depression Rating Scale (MADRS);Timepoint(s) of evaluation of this end point: before each treatment session, 24h after the first treatment session, and one and two weeks after the last treatment session	—

Measure

Time frame

Main Objective: To assess the antidepressant efficacy of oral ketamine in patients suffering from a major depressive episode in a double-blinded randomized and controlled study design.;Secondary Objective: To assess the tolerability and clinical utility of oral ketamine administration.;Primary end point(s): Montgomery-Åsberg Depression Rating Scale (MADRS);Timepoint(s) of evaluation of this end point: before each treatment session, 24h after the first treatment session, and one and two weeks after the last treatment session

—

Secondary

Measure	Time frame
Secondary end point(s): CADSS (Clinician Administered Dissociative States Scale);Timepoint(s) of evaluation of this end point: CADSS: 30 minutes after the first and last drug application	—

Countries

Austria

Contacts

Public ContactDpt of Psychiatry and Psychotherapy

Medical University of Vienna

biol-psychiatry@meduniwien.ac.at004314040035680

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026