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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00045916 |
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.
Condition | Intervention | Phase |
---|---|---|
Depression Depressive Disorder Bipolar Disorder |
Procedure: High dosage electroconvulsive therapy Drug: Nortriptyline Drug: Venlafaxine Drug: Lithium Procedure: Low dosage electroconvulsive therapy |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Optimization of Electroconvulsive Therapy |
Enrollment: | 340 |
Study Start Date: | February 2001 |
Study Completion Date: | December 2006 |
Primary Completion Date: | December 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
High dosage ECT + nortriptyline: Experimental
Participants will receive nortriptyline and high dosage ECT. If the ECT is effective participants will receive lithium after ECT treatment.
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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: Lithium
Participants will receive lithium.
|
High dosage ECT + venlafaxine: Experimental
Participants will receive venlafaxine and high dosage ECT. If the ECT is effective participants will receive lithium after ECT treatment.
|
Procedure: High dosage electroconvulsive therapy
Participants will receive high dosage right unilateral ECT at six times the seizure threshold.
Drug: Venlafaxine
Participants will receive venlafaxine.
Drug: Lithium
Participants will receive lithium.
|
High dosage ECT + placebo: Placebo Comparator
Participants will receive placebo and high dosage ECT. If the ECT is effective participants will receive lithium after ECT treatment weeks.
|
Procedure: High dosage electroconvulsive therapy
Participants will receive high dosage right unilateral ECT at six times the seizure threshold.
Drug: Lithium
Participants will receive lithium.
|
Low dosage ECT + nortriptyline: Experimental
Participants will receive nortriptyline and high dosage ECT. If the ECT is effective participants will receive lithium after ECT treatment.
|
Drug: Nortriptyline
Participants will receive nortriptyline.
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.
|
Low dosage ECT + venlafaxine: Experimental
Participants will receive venlafaxine and low dosage ECT. If the ECT is effective participants will receive lithium after ECT treatment.
|
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.
|
Low dosage ECT + placebo: Experimental
Participants will receive placebo and low dosage ECT. If the ECT is effective participants will receive lithium after ECT treatment weeks.
|
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.
|
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Missouri | |
Washington University | |
St. Louis, Missouri, United States, 63110 | |
United States, New York | |
New York State Psychiatric Institute at Columbia University | |
New York, New York, United States, 10032 | |
United States, North Carolina | |
Wake Forest University | |
Winston-Salem, North Carolina, United States, 27103 | |
United States, Pennsylvania | |
Western Psychiatric Institute and Clinic | |
Pittsburgh, Pennsylvania, United States, 15213 |
Study Chair: | Harold A. Sackeim, PhD | New York State Psychiatric Institute and Columbia University |
Responsible Party: | New York State Psychiatric Institute and Columbia University ( Harold A. Sackeim, PhD ) |
Study ID Numbers: | R01 MH61609, DSIR 83-ATSO |
Study First Received: | September 13, 2002 |
Last Updated: | October 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00045916 History of Changes |
Health Authority: | United States: Federal Government |
Electroconvulsive therapy Antidepressive Agents |
Neurotransmitter Agents Tranquilizing Agents Depression Adrenergic Agents Bipolar Disorder Psychotropic Drugs Central Nervous System Depressants Lithium Carbonate Antimanic Agents Antipsychotic Agents Depressive Disorder Serotonin Uptake Inhibitors |
Serotonin Antidepressive Agents, Tricyclic Behavioral Symptoms Affective Disorders, Psychotic Mental Disorders Venlafaxine Nortriptyline Mood Disorders Psychotic Disorders Antidepressive Agents, Second-Generation Lithium Antidepressive Agents |
Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Adrenergic Agents Molecular Mechanisms of Pharmacological Action Adrenergic Uptake Inhibitors Physiological Effects of Drugs Psychotropic Drugs Affective Disorders, Psychotic Pathologic Processes Mental Disorders Therapeutic Uses Venlafaxine Nortriptyline Antidepressive Agents, Second-Generation Antidepressive Agents |
Lithium Disease Depression Tranquilizing Agents Bipolar Disorder Central Nervous System Depressants Antipsychotic Agents Depressive Disorder Antimanic Agents Serotonin Uptake Inhibitors Pharmacologic Actions Antidepressive Agents, Tricyclic Behavioral Symptoms Serotonin Agents Mood Disorders |