Studying the antidepressant effects of intravenous ketamine in patients with major depressive disorder

Phase 2

Recruiting

• Conditions: Major Depressive Disorder; Mental Health - Depression

• Registration Number: ACTRN12615000566538
• Lead Sponsor: ational University of Singapore

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-06-02
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Major depressive episode according to DSM-IV-TR Disorders
- Montgomery-Asberg Depression Rating Scale score of at least 20
- On stable doses of oral antidepressant medication
- Ability to provide informed consent

Exclusion Criteria

- Any unstable medical condition or clinically relevant abnormality that is likely to compromise study conduct, evaluation or safety
- Schizophrenia and other psychotic disorders, bipolar disorder, obsessive-compulsive disorder, eating disorder, substance-related disorders
- Drug allergy to ketamine or scopolamine
- Use of adjunct medications for depression and TCAs
- Pregnant or breast-feeding women
- Inability to follow procedures in the study protocol for any reason

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in depression severity pre- and post-intervention using Montgomery-Asberg Depression Rating Scale[Baseline, day 1 and day 3 after each infusion, and weekly up to 6 weeks.]

Secondary Outcome Measures

Name	Time	Method
Clinical Global Impressions Scale[Baseline, day 1 and day 3 after each infusion, and weekly up to 6 weeks.<br>];Quick Inventory of Depressive Symptamatology[Baseline, day 1 and day 3 after each infusion, and weekly up to 6 weeks.<br>];Brief Psychiatric Rating Scale[Baseline, day 1 and day 3 after each infusion, and weekly up to 6 weeks.<br>];Young Mania Rating Scale[Baseline, day 1 and day 3 after each infusion, and weekly up to 6 weeks.];Hamilton Anxiety Rating Scale[Baseline, day 1 and day 3 after each infusion, and weekly up to 6 weeks.];Functional connectivity with magnetic resonance imaging[Baseline and post second infusion.]