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

Primary Purpose

Depression

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Electroconvulsive Therapy (ECT)
Sponsored by
New York State Psychiatric Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Major Depressive Disorder, Electroconvulsive Therapy

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • New York State Psychiatric Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

Active Comparator

Arm Label

Ultrabrief, Right Unilateral ECT

Ultrabrief, Bilateral ECT (2.5 X ST)

Brief Pulse, Right Unilateral ECT

Brief Pulse, Bilateral ECT

Arm Description

Right unilateral ECT administered with an ultrabrief pulse width (0.3 ms), at a dose 6 times the initial seizure threshold

Bilateral (frontotemporal) ECT with an ultrabrief pulse width with dosage 2.5 times the initial seizure threshold

Right unilateral ECT, with a standard brief pulse (1.5 ms), with dosage 6 times the initial seizure threshold

Bilateral (frontotemporal) ECT with a standard brief pulse (1.5 ms), with dosage 2.5 times the initial seizure threshold

Outcomes

Primary Outcome Measures

Short-term antidepressant efficacy
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)
Specific neuropsychological measures were preselected as primary in safety analyses

Secondary Outcome Measures

Antidepressant efficacy
Treatment groups were also compared in rates of response and remission, as well as post-treatment relapse.
Assessments of functional outcomes
Repeated measurement using the SF-36
Memory, non-memory, and executive functions (acute, short-term, and long-term measures)
Remaining measures in the neuropsychological battery other than those pre-selected as primary outcome measures

Full Information

First Posted
June 15, 2007
Last Updated
August 15, 2014
Sponsor
New York State Psychiatric Institute
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00487500
Brief Title
Comparing the Effects of Four Types of Electroconvulsive Therapy on Mood and Thinking in People With Depression
Official Title
Affective and Cognitive Consequences of ECT
Study Type
Interventional

2. Study Status

Record Verification Date
June 2007
Overall Recruitment Status
Completed
Study Start Date
December 1998 (undefined)
Primary Completion Date
December 2002 (Actual)
Study Completion Date
May 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New York State Psychiatric Institute
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Major Depressive Disorder, Electroconvulsive Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ultrabrief, Right Unilateral ECT
Arm Type
Experimental
Arm Description
Right unilateral ECT administered with an ultrabrief pulse width (0.3 ms), at a dose 6 times the initial seizure threshold
Arm Title
Ultrabrief, Bilateral ECT (2.5 X ST)
Arm Type
Experimental
Arm Description
Bilateral (frontotemporal) ECT with an ultrabrief pulse width with dosage 2.5 times the initial seizure threshold
Arm Title
Brief Pulse, Right Unilateral ECT
Arm Type
Active Comparator
Arm Description
Right unilateral ECT, with a standard brief pulse (1.5 ms), with dosage 6 times the initial seizure threshold
Arm Title
Brief Pulse, Bilateral ECT
Arm Type
Active Comparator
Arm Description
Bilateral (frontotemporal) ECT with a standard brief pulse (1.5 ms), with dosage 2.5 times the initial seizure threshold
Intervention Type
Device
Intervention Name(s)
Electroconvulsive Therapy (ECT)
Other Intervention Name(s)
shock therapy
Intervention Description
Electroconvulsive therapy involves applying a small electrical charge to the scalp while the patient is anesthetized and provoking a short-lasting generalized seizure
Primary Outcome Measure Information:
Title
Short-term antidepressant efficacy
Description
Primary outcome reflected change in HRSD depression symptom scores.
Time Frame
Measured immediately post-treatment and 2, 4, and 6 months post-treatment
Title
Specific acute, short-term, and long-term objective and subjective cognitive outcome measures (e.g., autobiographical amnesia, global self-rating of amnesia)
Description
Specific neuropsychological measures were preselected as primary in safety analyses
Time Frame
Measured immediately post-treatment and 2, 4, and 6 months post-treatment
Secondary Outcome Measure Information:
Title
Antidepressant efficacy
Description
Treatment groups were also compared in rates of response and remission, as well as post-treatment relapse.
Time Frame
Measured immediately post-treatment and 2, 4, and 6 months post-treatment
Title
Assessments of functional outcomes
Description
Repeated measurement using the SF-36
Time Frame
Measured immediately post-treatment and 2, 4, and 6 months post-treatment
Title
Memory, non-memory, and executive functions (acute, short-term, and long-term measures)
Description
Remaining measures in the neuropsychological battery other than those pre-selected as primary outcome measures
Time Frame
Measured immediately post-treatment and 2, 4, and 6 months post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harold A. Sackeim, PhD
Organizational Affiliation
New York State Psychiatric Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York State Psychiatric Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Citations:
Citation
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.
Results Reference
result
PubMed Identifier
19756236
Citation
Sackeim HA, Prudic J, Nobler MS, Fitzsimons L, Lisanby SH, Payne N, Berman RM, Brakemeier EL, Perera T, Devanand DP. Effects of pulse width and electrode placement on the efficacy and cognitive effects of electroconvulsive therapy. Brain Stimul. 2008 Apr;1(2):71-83. doi: 10.1016/j.brs.2008.03.001. Erratum In: Brain Stimul. 2008 Jul;1(3):A2.
Results Reference
result

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

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