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.
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 Whenever feasible, patients are withdrawn from all prior psychotropic medication before the start of ECT.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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
340
Participants will receive high dosage right unilateral ECT at six times the seizure threshold.
Participants will receive nortriptyline.
Participants will receive venlafaxine.
Washington University
St Louis, Missouri, United States
New York State Psychiatric Institute at Columbia University
New York, New York, United States
Wake Forest University
Winston-Salem, North Carolina, United States
Western Psychiatric Institute and Clinic
Pittsburgh, Pennsylvania, United States
Neurocognitive battery
Time frame: Measured at baseline and at 2 and 6 months after the acute ECT course
Clinical evaluations, side effect evaluations, and blood level determinations
Time frame: Measured weekly for the first month, every 2 weeks until Week 12, and every 4 weeks for the remaining 12 weeks
Memory function
Time frame: Measured before and after ECT
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Participants will receive lithium.
Participants will receive low dosage bilateral ECT at one and a half times the seizure threshold.