Comparing the Effects of Four Types of Electroconvulsive Therapy on Mood and Thinking in People With Depression

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT00487500
First received: June 15, 2007
Last updated: August 15, 2014
Last verified: June 2007
  Purpose

This study will compare four types of electroconvulsive therapy to determine if they differ in their effects on mood, thinking, brain activity, and biochemistry in people with major depressive disorder.


Condition Intervention Phase
Depression
Device: Electroconvulsive Therapy (ECT)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Affective and Cognitive Consequences of ECT

Resource links provided by NLM:


Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:
  • Short-term antidepressant efficacy [ Time Frame: Measured immediately post-treatment and 2, 4, and 6 months post-treatment ] [ Designated as safety issue: No ]
    Primary outcome reflected change in HRSD depression symptom scores.

  • Specific acute, short-term, and long-term objective and subjective cognitive outcome measures (e.g., autobiographical amnesia, global self-rating of amnesia) [ Time Frame: Measured immediately post-treatment and 2, 4, and 6 months post-treatment ] [ Designated as safety issue: Yes ]
    Specific neuropsychological measures were preselected as primary in safety analyses


Secondary Outcome Measures:
  • Antidepressant efficacy [ Time Frame: Measured immediately post-treatment and 2, 4, and 6 months post-treatment ] [ Designated as safety issue: No ]
    Treatment groups were also compared in rates of response and remission, as well as post-treatment relapse.

  • Assessments of functional outcomes [ Time Frame: Measured immediately post-treatment and 2, 4, and 6 months post-treatment ] [ Designated as safety issue: Yes ]
    Repeated measurement using the SF-36

  • Memory, non-memory, and executive functions (acute, short-term, and long-term measures) [ Time Frame: Measured immediately post-treatment and 2, 4, and 6 months post-treatment ] [ Designated as safety issue: Yes ]
    Remaining measures in the neuropsychological battery other than those pre-selected as primary outcome measures


Enrollment: 180
Study Start Date: December 1998
Study Completion Date: May 2005
Primary Completion Date: December 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ultrabrief, Right Unilateral ECT
Right unilateral ECT administered with an ultrabrief pulse width (0.3 ms), at a dose 6 times the initial seizure threshold
Device: Electroconvulsive Therapy (ECT)
Electroconvulsive therapy involves applying a small electrical charge to the scalp while the patient is anesthetized and provoking a short-lasting generalized seizure
Other Name: shock therapy
Experimental: Ultrabrief, Bilateral ECT (2.5 X ST)
Bilateral (frontotemporal) ECT with an ultrabrief pulse width with dosage 2.5 times the initial seizure threshold
Device: Electroconvulsive Therapy (ECT)
Electroconvulsive therapy involves applying a small electrical charge to the scalp while the patient is anesthetized and provoking a short-lasting generalized seizure
Other Name: shock therapy
Active Comparator: Brief Pulse, Right Unilateral ECT
Right unilateral ECT, with a standard brief pulse (1.5 ms), with dosage 6 times the initial seizure threshold
Device: Electroconvulsive Therapy (ECT)
Electroconvulsive therapy involves applying a small electrical charge to the scalp while the patient is anesthetized and provoking a short-lasting generalized seizure
Other Name: shock therapy
Active Comparator: Brief Pulse, Bilateral ECT
Bilateral (frontotemporal) ECT with a standard brief pulse (1.5 ms), with dosage 2.5 times the initial seizure threshold
Device: Electroconvulsive Therapy (ECT)
Electroconvulsive therapy involves applying a small electrical charge to the scalp while the patient is anesthetized and provoking a short-lasting generalized seizure
Other Name: shock therapy

Detailed Description:

Major depressive disorder (MDD) is a serious condition that can interfere with a person's ability to work, study, sleep, eat, and enjoy activities that were once pleasurable. Depression may occur only once in a lifetime, but usually occurs several times. There are several types of medications and therapies that have been successful in improving symptoms of depression. Electroconvulsive therapy (ECT) has been particularly successful in treating individuals whose depression is severe or life threatening or who cannot take antidepressant medication. In ECT, electrodes are placed at precise locations on the head to deliver electrical impulses. The stimulation causes a brief seizure within the brain. The person receiving ECT does not consciously experience the electrical stimulus and does not feel pain. This study will compare four types of ECT to determine if they differ in their effects on mood, thinking, brain activity, and biochemistry in people with MDD.

Participants in this double-blind study will be randomly assigned to receive one of four types of ECT. Treatments will occur three times a week for 2 to 6 weeks, depending on each participant's individual needs. All participants will stop taking any psychiatric medications at least 5 days before receiving ECT. Before beginning each ECT session, participants will be interviewed by study staff about their current psychiatric condition, any psychological problems they have had, any history of psychological problems in their families, their medical history, and their attitudes about receiving ECT. A family member may also be asked to participate in some interviews. In addition, before each treatment, monitoring sensors will be placed on each participant's head and other areas of the body and a blood pressure cuff will be placed on an arm. These devices will be used to monitor each participant's brain waves, heart, and blood pressure before, during, and after treatment.

Because ECT entails the use of general anesthesia, participants will not eat for at least 8 hours before each treatment. An intravenous catheter will be placed in participants' arms to administer the anesthesia and a muscle relaxant. Just before receiving ECT, participants will be asked to remember a set of information. Upon waking after treatment, participants will be asked to recall or recognize this material and complete a set of brief neuropsychological tasks. Electroencephalogram (EEG) tests (to measure electrical activity of the brain), transcranial magnetic stimulation (TMS) (to measure muscle activity), blood collection, and magnetic resonance imaging (MRI) tests (to image the inside of the body) will be performed at selected sessions and follow-up visits to assess outcomes. Follow-up interviews will be held via telephone every 2 weeks for 2 months post-treatment, and then monthly for the remainder of the year. Follow-up neuropsychological tests will also be administered at Months 2, 4, and 6 post-treatment.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of major depressive disorder
  • Pretreatment score of at least 18 on the Hamilton Rating Scale for Depression
  • Able to tolerate psychotropic washout and no psychotropic medication, other than lorazepam (up to 3 mg/d PRN), during the study
  • Recommended to receive ECT

Exclusion Criteria:

  • History of schizophrenia, schizoaffective disorder, other functional psychosis, or rapid cycling bipolar disorder
  • Secondary diagnosis of a delirium, dementia, or amnestic disorder, or epilepsy
  • Pregnant
  • History of neurological illness other than conditions associated with psychotropic exposure (e.g., tardive dyskinesia)
  • History of alcohol or substance abuse within the year prior to study entry
  • History of ECT within the 6 months prior to study entry
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00487500

Locations
United States, New York
New York State Psychiatric Institute
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
Investigators
Principal Investigator: Harold A. Sackeim, PhD New York State Psychiatric Institute
  More Information

Publications:
Sackeim, H. A.: The convulsant and anticonvulsant properties of electroconvulsive therapy: towards a focal form of brain stimulation. Clinical Neuroscience Review, 2004, 4:39-57.

Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00487500     History of Changes
Other Study ID Numbers: #3482, 5R01MH035636
Study First Received: June 15, 2007
Last Updated: August 15, 2014
Health Authority: United States: Federal Government

Keywords provided by New York State Psychiatric Institute:
Major Depressive Disorder
Electroconvulsive Therapy

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mental Disorders
Mood Disorders

ClinicalTrials.gov processed this record on October 23, 2014