CompletedN/Aketamine

A Naturalistic Study of Ketamine for Treatment Resistant Mood Disorders

NCT ID

NCT04226963

Target Enrollment

80 participants

Start Date

2019-12-04

Est. Completion

2022-07-04

About This Study

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.

Conditions Studied

Treatment Resistant DepressionBipolar DepressionKetamineMajor Depressive Disorder

Interventions

•Ketamine

Eligibility

Age:18 Years - 90 Years

Healthy Volunteers:No

View full eligibility criteria

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

Study Locations (1)

Department of Psychiatry, Medical University of Gdańsk