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

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12615000566538
• Date of registration: 02/06/2015
• Prospective Registration: Yes
• Primary sponsor: National University of Singapore
• Public title: Studying the antidepressant effects of intravenous ketamine in patients with major depressive disorder
• Scientific title: Studying the antidepressant effects of intravenous ketamine in patients with major depressive disorder
• Date of first enrolment: 04/06/2015
• Target sample size: 30
• Recruitment status: Recruiting
• URL: https://anzctr.org.au/ACTRN12615000566538.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial;
• Phase: Phase 2 / Phase 3

Countries of recruitment

Singapore

Contacts

• Name: Dr Johnson Fam

• Name: Dr Johnson Fam

Key inclusion & exclusion criteria

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

Age minimum: 21 Years
Age maximum: 65 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Major Depressive Disorder;
Major Depressive Disorder

Mental Health - Depression

Intervention(s)

Intravenous Ketamine 0.5mg/kg infusion once per week for 2 weeks

Primary Outcome(s)

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(s)

Quick Inventory of Depressive Symptamatology[Baseline, day 1 and day 3 after each infusion, and weekly up to 6 weeks.
]

Brief Psychiatric 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.]

Hamilton Anxiety Rating Scale[Baseline, day 1 and day 3 after each infusion, and weekly up to 6 weeks.]

Clinical Global Impressions Scale[Baseline, day 1 and day 3 after each infusion, and weekly up to 6 weeks.
]

Young Mania Rating Scale[Baseline, day 1 and day 3 after each infusion, and weekly up to 6 weeks.]

Secondary ID(s)

Nil

Source(s) of Monetary Support

National University of Singapore

Secondary Sponsor(s)

National University Hospital

Ethics review

Status: Approved
Approval date:
Contact:

NHG Domain Specific Review Board