ELEKT-D: Electroconvulsive Therapy (ECT) vs. Ketamine in Patients With Treatment Resistant Depression (TRD) (ELEKT-D)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03113968|
Recruitment Status : Recruiting
First Posted : April 14, 2017
Last Update Posted : October 10, 2018
|Condition or disease||Intervention/treatment||Phase|
|Treatment Resistant Depression Electroconvulsive Therapy ECT Ketamine Psychiatric Disorder Depression Major Depressive Disorder Major Depressive Episode Unipolar Depression||Procedure: electroconvulsive therapy (ECT) Drug: Ketamine||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||400 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||unblinded prospective randomized open-label|
|Masking:||None (Open Label)|
|Masking Description:||Due to the nature of the study treatments it is not possible to blind patients or investigators.|
|Official Title:||ELEKT-D: Electroconvulsive Therapy (ECT) vs. Ketamine in Patients With Treatment Resistant Depression (TRD)|
|Actual Study Start Date :||April 7, 2017|
|Estimated Primary Completion Date :||March 1, 2021|
|Estimated Study Completion Date :||April 1, 2022|
Active Comparator: electroconvulsive therapy (ECT)
Treatments will be given 3 times a week up to a total of 9 treatments over 3 - 5 weeks. Initial ECT treatment is Right Unilateral (RUL) ultra-brief pulse at 6X seizure threshold. Seizure threshold and dose can be increased per investigator and patient discretion.
Procedure: electroconvulsive therapy (ECT)
ECT is a procedure done under general anesthesia where small electric currents are passed through the brain, intentionally triggering a brief seizure. Patients who have not responded to antidepressant medications may be candidates for ECT. ECT is FDA approved for treatment resistant depression.
Active Comparator: ketamine infusion
Treatments will be given 2 times a week up to a total of 6 treatment over 3 - 5 weeks. Initial standard dose will be 0.5 mg/kg infusion over 40 min. The dose can be modified if clinically warranted per investigator and patient discretion.
Ketamine is a medication that is used as a short acting anesthetic in pediatric and adult medicine. Subanesthetic (low) doses will be given to patients via infusion in order to assess whether it helps with depression symptoms in patients who have not responded to antidepressant therapy. Ketamine is not FDA approved for this indication and its effectiveness in treatment resistant depression has not been proven. Prior studies have indicated that subanesthetic doses of ketamine may be helpful for treatment resistant depression.
- Patient reported response to treatment [ Time Frame: Acute Study Phase (Baseline Visit to End of Treatment Visit) - approximately 3-5 weeks ]Response is defined as at least a 50% improvement in Baseline QIDS-SR-16 score at End of Treatment Visit. The End of Treatment Visit will occur 3-5 weeks after the Baseline Visit.
- Clinician reported response to treatment [ Time Frame: Acute Study Phase (Baseline Visit to End of Treatment Visit) - approximately 3-5 weeks ]Number of patients with an improvement in their Baseline MADRS score at the End of Treatment Visit. The End of Treatment Visit will occur 3-5 weeks after the Baseline Visit.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03113968
|Contact: Kelly Brezina, BSN||(216) firstname.lastname@example.org|
|United States, Connecticut|
|Yale School of Medicine||Recruiting|
|New Haven, Connecticut, United States, 06510|
|Contact: Jane Wanyiri, RN 203-764-9131 email@example.com|
|Principal Investigator: Gerard Sanacora, MD, PhD|
|Sub-Investigator: Samuel Wilkinson, Md|
|United States, New York|
|New York, New York, United States, 10029|
|Contact: Mora Grehl 212-241-8538 firstname.lastname@example.org|
|Principal Investigator: James Murrough, MD|
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
|Contact: Kelly Bryant 216-363-2492 email@example.com|
|Principal Investigator: Roman Dale, MD|
|Sub-Investigator: Murat Altinay, MD|
|United States, Texas|
|Baylor College of Medicine||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Sidra Iqbal 713-798-5541 firstname.lastname@example.org|
|Principal Investigator: Sanjay Mathew, MD|
|Sub-Investigator: Ali Abbas Asghar-Ali, MD|
|Principal Investigator:||Amit Anand, MD||The Cleveland Clinic|