NCT00045916

Optimizing Electroconvulsive Therapy for Depression

Optimization of Electroconvulsive Therapy

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 340 (actual)
• Sponsor: New York State Psychiatric Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the effectiveness of electroconvulsive therapy (ECT) administered with medication for the treatment of a major depressive episode (unipolar or bipolar) and will compare two types of ECT.

Detailed description

This study addresses 2 issues in the optimization of ECT in patients with major depression: whether patients treated with ECT should receive concurrent treatment with antidepressant medications, and the relative efficacy and side effects of high dosage right unilateral (RUL) ECT compared to low dosage bilateral (BL) ECT. This study has 2 phases. In Phase I, patients are randomized to receive nortriptyline, venlafaxine (Effexor), or placebo while they simultaneously receive either high dosage RUL ECT or low dosage BL ECT. Patients have an electrocardiogram (EKG), a chest x-ray, medical and neurological examinations, and blood tests. Memory function is assessed before and after ECT. Whenever feasible, patients are withdrawn from all prior psychotropic medication before the start of ECT. ECT is administered 3 times per week to inpatients and twice a week to outpatients. Patients continue ECT until they are asymptomatic or until there is a plateau in improvement over 2 treatments. Patients who respond to ECT enter Phase II and add lithium to either nortriptyline or venlafaxine within 1-3 days of the last ECT. Clinical and side effect evaluations and blood level determinations are conducted weekly for the first month, every 2 weeks until Week 12, and every 4 weeks for the remaining 12 weeks. Following any indication of relapse, patients are monitored more intensively and are re-evaluated within 1 week. The neurocognitive battery is readministered to all patients at 2 and 6 months after the acute ECT course, regardless of ECT clinical outcome.

Conditions

• Depression
• Depressive Disorder
• Bipolar Disorder

Interventions

Type	Name	Description
PROCEDURE	High dosage electroconvulsive therapy	Participants will receive high dosage right unilateral ECT at six times the seizure threshold.
DRUG	Nortriptyline	Participants will receive nortriptyline.
DRUG	Venlafaxine	Participants will receive venlafaxine.
DRUG	Lithium	Participants will receive lithium.
PROCEDURE	Low dosage electroconvulsive therapy	Participants will receive low dosage bilateral ECT at one and a half times the seizure threshold.

Timeline

• Start date: 2001-02-01
• Primary completion: 2006-12-01
• Completion: 2006-12-01
• First posted: 2002-09-17
• Last updated: 2013-08-13

Locations

4 sites across 1 country: United States