Comparing the Effects of Four Types of Electroconvulsive Therapy on Mood and Thinking in People With Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): Electroconvulsive Therapy (ECT)
Intervention type(s): Device
Intervention description(s): Electroconvulsive therapy involves applying a small electrical charge to the scalp while the patient is anesthetized and provoking a short-lasting generalized seizure
Other intervention name(s): shock therapy
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Major Depressive Disorder; Electroconvulsive Therapy