Last updated: September 1, 2023
Sponsor: Bo Hu
Overall Status: Completed
Phase
2/3
Condition
Depression (Major/severe)
Kleptomania
Depression
Treatment
Ketamine
electroconvulsive therapy (ECT)
Clinical Study ID
NCT03113968
ELEKT-D
Ages 21-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Written informed consent before any study related procedures are performed
- Inpatients or outpatients referred by their providers for ECT treatment and eligiblefor ECT treatment
- Males/females at least 21 years of age but no older than 75 years of age
- Meet DSM-5 criteria for Major Depressive Episode as determined by both: A. a clinician's diagnostic evaluation and B. confirmed with the MINI InternationalNeuropsychiatric Interview (MINI 7.0.2)
- A current depressive episode that has lasted a minimum of 4 weeks
- Meet all of the following criteria on symptom rating scales at screening: A. Montgomery Asberg Depression Rating Scale (MADRS) score >20 B. Young Mania RatingScale (YMRS) of ≤ 5 C. Montreal Cognitive Assessment (MoCA) of ≥18
- Have had ≥2 adequate trials of antidepressants or augmentation strategies during theirlifetime. An adequate trial is defined as 4 weeks of medication at the minimum FDAapproved dose. This will be equal to a trial rating of 3 or more.
- In the opinion of the investigator, the patient is willing and able to comply withscheduled visits, treatment plan, and other trial procedures for the duration of thestudy
Exclusion
Exclusion Criteria:
- Meet DSM-5 criteria for bipolar disorder, schizophrenia, schizophreniform disorder,schizoaffective disorder, mental retardation, or pervasive developmental disorder
- Meets any exclusion criteria for ECT or ketamine treatment as described in theclinical guidelines or according to investigator judgment
- The patient is pregnant or breast feeding
- The patient has a severe medical illness or severe neurological disorder
- The patient has a known ketamine allergy or is taking a medication that may interactwith ketamine
- Diagnosis of major depressive disorder with psychotic features during the currentdepressive episode
- Unable to give informed consent
- Was previously enrolled/randomized into the trial
Study Design
Total Participants: 403
Treatment Group(s): 2
Primary Treatment: Ketamine
Phase: 2/3
Study Start date:
April 07, 2017
Estimated Completion Date:
November 17, 2022
Study Description
Connect with a study center
Yale School of Medicine
New Haven, Connecticut 06510
United StatesSite Not Available
Johns Hopkins University School of Medicine
Baltimore, Maryland 21205
United StatesSite Not Available
Mount Sinai
New York, New York 10029
United StatesSite Not Available
Cleveland Clinic
Cleveland, Ohio 44195
United StatesSite Not Available
Baylor College of Medicine
Houston, Texas 77030
United StatesSite Not Available
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