Optimizing Electroconvulsive Therapy for Depression

August 9, 2013 updated by: New York State Psychiatric Institute

Optimization of Electroconvulsive Therapy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Whenever feasible, patients are withdrawn from all prior psychotropic medication before the start of ECT.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.

Study Type

Interventional

Enrollment (Actual)

340

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Washington University
    • New York
      • New York, New York, United States, 10032
        • New York State Psychiatric Institute at Columbia University
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27103
        • Wake Forest University
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Western Psychiatric Institute and Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Major depressive episode (unipolar or bipolar)
  • Pre-ECT score of 20 or higher on Hamilton Rating Scale for Depression
  • Able to withdraw psychotropic drugs (up to 3 mg/day lorazepam allowed)
  • ECT indicated

Exclusion Criteria:

  • Schizophrenia, schizoaffective disorder, or other psychosis
  • Amnestic disorder, dementia, or delirium
  • Pregnancy
  • Epilepsy
  • Current alcohol or substance abuse or dependence
  • CNS disease or brain injury not associated with psychotropic drug exposure
  • ECT in the past 6 months
  • Medical contraindication for treatment with either nortriptyline or venlafaxine, including allergy to amitriptyline, nortriptyline, or venlafaxine; narrow angle glaucoma; sinus node disease; bundle branch disease; myocardial infarction; coronary artery bypass or angioplasty; or angina
  • Type I antiarrhythmic medication
  • Supine blood pressure >= 170 mmHg systolic or >= 105 mmHg diastolic at 3 readings over 2 days

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High dosage ECT + nortriptyline
Participants will receive nortriptyline 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: Nortriptyline
Participants will receive nortriptyline.
Drug: Lithium
Participants will receive lithium.
Experimental: High dosage ECT + venlafaxine
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: Lithium
Participants will receive lithium.
Drug: Venlafaxine
Participants will receive venlafaxine.
Placebo Comparator: High dosage ECT + placebo
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.
Experimental: Low dosage ECT + nortriptyline
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.
Experimental: Low dosage ECT + venlafaxine
Participants will receive venlafaxine and low dosage ECT. If the ECT is effective participants will receive lithium after ECT treatment.
Drug: Lithium
Participants will receive lithium.
Drug: Venlafaxine
Participants will receive venlafaxine.
Procedure: Low dosage electroconvulsive therapy
Participants will receive low dosage bilateral ECT at one and a half times the seizure threshold.
Experimental: Low dosage ECT + placebo
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Neurocognitive battery
Time Frame: Measured at baseline and at 2 and 6 months after the acute ECT course
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
Measured weekly for the first month, every 2 weeks until Week 12, and every 4 weeks for the remaining 12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Memory function
Time Frame: Measured before and after ECT
Measured before and after ECT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

New York State Psychiatric Institute

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Study Chair: Harold A. Sackeim, PhD, New York State Psychiatric Institute and Columbia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2001

Primary Completion (Actual)

December 1, 2006

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

September 13, 2002

First Submitted That Met QC Criteria

September 16, 2002

First Posted (Estimate)

September 17, 2002

Study Record Updates

Last Update Posted (Estimate)

August 13, 2013

Last Update Submitted That Met QC Criteria

August 9, 2013

Last Verified

October 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • #3891
  • DSIR 83-ATSO (National Institute of Mental Health)
  • R01MH061609 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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