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CompletedPhase 4Results posted

Ketamine as an Augmentation Strategy for Electroconvulsive Therapy (ECT) in Depression

NCT01881763 · Northwell Health

Closed to entry
Status
Not accepting participants
Phase 4
Phase
31
Target enrolment
1
Study sites
1 US states

What it is testing

Summary

The study aims to compare outcomes of Electroconvulsive Therapy (ECT) using ketamine versus methohexital anesthesia in depressed patients. The investigators hypothesize that patients who receive ketamine anesthesia during ECT will achieve remission status faster than those receiving methohexital anesthesia. Also, at the end of the ECT course subjects will display fewer cognitive side effects compared to those treated with methohexital anesthesia.

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 (HRSD) Improvement

    Measured over Days required to achieve remission (on average 3-4 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 70 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: 1. Male or female subjects 18 to 70 years of age 2. Diagnostic Statistical Manual (DSM) IV diagnosis of Major Depression (296.3), unipolar without psychotic features or Bipolar I or Bipolar II Depression without psychotic features confirmed by Structured Clinical Interview for DSM-IV (SCID-IV) interview 3. Pretreatment 24-item Hamilton Rating Scale for Depression score \> 21 4. Subjects must have an initial score of at least 20 on the Montgomery-Asbergers Depression Rating Scale (MADRS) at screen 5. ECT is clinically indicated 6. Patient is competent to provide informed consent Exclusion Criteria: 1. Lifetime DSM-IV diagnosis of schizophrenia, schizoaffective disorder, psychotic depression or any other psychotic disorder as defined in the DSM-IV 2. Current (within the last year) 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 amnesiac disorder 4. Diagnosis of Mental Retardation 5. Baseline Mini Mental State Exam (MMSE) score \< 21 or a total score falling two standard deviations below the age- and education-adjusted mean, whichever is less 6. Any active general medical condition or central nervous system (CNS) disease which can affect cognition or response to treatment 7. Current (within the past three months) diagnosis of active substance dependence, or active substance abuse within the past week 8. Lifetime history of ketamine or phencyclidine (PCP) abuse or dependence 9. ECT within three months 10. 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 11. Pregnancy 12. Status 4 or greater according to the criteria of the American Society of Anesthesiologists 13. MRI contraindications

Where

1 study site

FacilityCityRegionCountry
Zucker Hillside HospitalGlen OaksNew 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.

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NCT01881763 on ClinicalTrials.gov →

Last updated in the registry 2023-03-09. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits