Depression
Conditions
Keywords
Major Depressive Disorder, Electroconvulsive Therapy
Brief summary
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.
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.
Interventions
Electroconvulsive therapy involves applying a small electrical charge to the scalp while the patient is anesthetized and provoking a short-lasting generalized seizure
Sponsors
National Institute of Mental Health (NIMH)
New York State Psychiatric Institute
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Short-term antidepressant efficacy | Measured immediately post-treatment and 2, 4, and 6 months post-treatment | 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) | Measured immediately post-treatment and 2, 4, and 6 months post-treatment | Specific neuropsychological measures were preselected as primary in safety analyses |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Antidepressant efficacy | Measured immediately post-treatment and 2, 4, and 6 months post-treatment | Treatment groups were also compared in rates of response and remission, as well as post-treatment relapse. |
| Assessments of functional outcomes | Measured immediately post-treatment and 2, 4, and 6 months post-treatment | Repeated measurement using the SF-36 |
| Memory, non-memory, and executive functions (acute, short-term, and long-term measures) | Measured immediately post-treatment and 2, 4, and 6 months post-treatment | Remaining measures in the neuropsychological battery other than those pre-selected as primary outcome measures |
Countries
United States
Outcome results
None listed