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TerminatedNot applicableResults posted

Use of Ketamine to Enhance Electroconvulsive Therapy (ECT) in Depression

NCT01309581 · James Murrough

Closed to entry
Status
Not accepting participants
Not applicable
Phase
3
Target enrolment
1
Study sites
1 US states

What it is testing

Summary

The primary objectives of this study are to investigate the potential for ketamine anesthesia to increase the antidepressant efficacy of Electroconvulsive therapy (ECT) and to decrease acute ECT-induced adverse cognitive effects.

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

  • Hamilton Rating Scale for Depression-24 (HRSD24)

    Measured over Change from beginning of ECT treatment to end; on average 3 weeks

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 65 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: 1. Male or female patients: 18 to 59 years 2. Women of childbearing potential must agree to use a medically accepted means of contraception for the duration of the study 3. DSM IV MINI diagnosis of major depressive episode (MDD), unipolar or bipolar 4. Pretreatment 24-item Hamilton Rating Scale for Depression score \> 21 5. ECT is clinically indicated 6. Patient has the capacity to provide informed consent. Exclusion Criteria: 1. DSM-IV diagnosis of schizophrenia, schizoaffective disorder, or mental retardation 2. Current primary diagnosis of anxiety disorder, obsessive- compulsive disorder, or eating disorder that precedes the onset of the current episode of depression 3. Current diagnosis of delirium, dementia, or amnestic disorder 4. Baseline Mini Mental State Exam (MMSE) score \< 24 and a total score falling two standard deviations below the age- and education-adjusted mean 5. Any active general medical condition or CNS disease which can affect cognition or response to treatment 6. Current (within the past three months) diagnosis of active substance dependence, or active substance abuse within the past week 7. Lifetime history of ketamine or PCP abuse or dependence 8. ECT within three months 9. The presence of any known or suspected contraindication to methohexital or ketamine including but not limited to known allergic reactions to these agents, uncontrolled hypertension arrhythmia severe coronary artery disease and porphyria 10. Pregnancy

Where

1 study site

FacilityCityRegionCountry
Icahn School of Medicine at Mount SinaiNew YorkNew YorkUnited States

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.

NCT01309581 on ClinicalTrials.gov →

Last updated in the registry 2013-08-30. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits