Skip to content
CompletedN/A

A Naturalistic Study of Ketamine for Treatment Resistant Mood Disorders

NCT04226963 · GDKet · Medical University of Gdansk

Closed to entry
Status
Not accepting participants
Not applicable
Phase
80
Target enrolment
1
Study sites
Outside the US

What it is testing

Summary

This study aims to openly test the long-term safety, tolerability and effectiveness of repeated administration of IV, nasal spray and oral ketamine for treatment-resistant mood disorders.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Incidence of adverse events assessed by Clinical-Administered Dissociative Symptoms Scale (CADSS)

    Measured over Baseline through week 5

  • Incidence of adverse events assessed by 4-items positive symptoms subscale of Brief Psychiatric Rating Scale (BPRS)

    Measured over Baseline through week 5

  • Incidence of adverse events assessed by body temperature (oral measurements)

    Measured over Baseline through week 5

  • Incidence of adverse events assessed by blood pressure

    Measured over Baseline through week 5

  • Incidence of adverse events assessed by respiration rate

    Measured over Baseline through week 5

  • Incidence of adverse events assessed by pulse

    Measured over Baseline through week 5

  • Incidence of adverse events assessed by blood oxygen saturation

    Measured over Baseline through week 5

  • Incidence of adverse events assessed by weight

    Measured over Baseline and week 5

  • Incidence of adverse events assessed by height

    Measured over Baseline

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 90 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: 1. Major depressive disorder (MDD) or bipolar disorder (BD) diagnosis as provided by DSM-5 criteria 2. TRD defined as the patient does not reach remission within the 8 week trial of an antidepressant or combination at a therapeutic dose of at least two trials of first-line evidence-based treatments and/or electroconvulsive therapy (ECT) Exclusion Criteria: 1. Pregnancy and lactation 2. Hypersensitivity to ketamine 3. Uncontrolled hypertension 4. Other uncontrolled somatic diseases that may impact safety per investigators judgement

Where

1 study site

FacilityCityRegionCountry
Department of Psychiatry, Medical University of GdańskGdanskPoland

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT04226963 on ClinicalTrials.gov →

Last updated in the registry 2023-09-28. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits