DepressionPhase 4NCT00487500
Comparing the Effects of Four Types of Electroconvulsive Therapy on Mood and Thinking in People With Depression
A Phase 4 study testing Electroconvulsive Therapy (ECT) in people with Depression, run by New York State Psychiatric Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Depression
- What is being tested?
- Electroconvulsive Therapy (ECT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 1998to May 2005
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
New York State Psychiatric Institute
New York, New York, 10032
About this study
Official title: Affective and Cognitive Consequences of ECT
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.
Read the 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.
- Conditions
- Depression
- Being tested
- Electroconvulsive Therapy (ECT)
- Keywords
- Major Depressive Disorder, Electroconvulsive Therapy
- Medical subject headings
- Depression, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electroconvulsive Therapy (ECT)Device
Also called shock therapy
Electroconvulsive therapy involves applying a small electrical charge to the scalp while the patient is anesthetized and provoking a short-lasting generalized seizure
| Study group | Role | What they receive |
|---|---|---|
| Ultrabrief, Right Unilateral ECT | Experimental | Right unilateral ECT administered with an ultrabrief pulse width (0.3 ms), at a dose 6 times the initial seizure threshold Receives: Device: Electroconvulsive Therapy (ECT) |
| Ultrabrief, Bilateral ECT (2.5 X ST) | Experimental | Bilateral (frontotemporal) ECT with an ultrabrief pulse width with dosage 2.5 times the initial seizure threshold Receives: Device: Electroconvulsive Therapy (ECT) |
| Brief Pulse, Right Unilateral ECT | Active comparator | Right unilateral ECT, with a standard brief pulse (1.5 ms), with dosage 6 times the initial seizure threshold Receives: Device: Electroconvulsive Therapy (ECT) |
| Brief Pulse, Bilateral ECT | Active comparator | Bilateral (frontotemporal) ECT with a standard brief pulse (1.5 ms), with dosage 2.5 times the initial seizure threshold Receives: Device: Electroconvulsive Therapy (ECT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short-term antidepressant efficacy
Primary outcome reflected change in HRSD depression symptom scores.
Measured: Measured immediately post-treatment and 2, 4, and 6 months post-treatment
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
Measured: Measured immediately post-treatment and 2, 4, and 6 months post-treatment
Secondary outcomes (3)
Antidepressant efficacy
Treatment groups were also compared in rates of response and remission, as well as post-treatment relapse.
Measured: Measured immediately post-treatment and 2, 4, and 6 months post-treatment
Assessments of functional outcomes
Repeated measurement using the SF-36
Measured: Measured immediately post-treatment and 2, 4, and 6 months post-treatment
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
Measured: Measured immediately post-treatment and 2, 4, and 6 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2007 (estimated)
- Study startDec 1998
- Primary completionDec 2002
- Study completionMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Harold A. Sackeim, PhD, Principal investigator, New York State Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00487500
- Sponsor's protocol ID
- #3482
- Other IDs
- 5R01MH035636
- Status last verified
- Jun 2007
- First submitted
- 15 Jun 2007
- Last updated
- 18 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
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.
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.
PubMed 19756236
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Affective and Cognitive Consequences of ECT
- ClinicalTrials.gov ID
- NCT00487500
- Acronym / sponsor ID
- #3482
- Conditions
- Depression
- Keywords
- Major Depressive Disorder, Electroconvulsive Therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Dec 1998
- Primary completion
- Dec 2002 (actual)
- Study completion
- May 2005 (actual)
- First posted
- 18 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Ultrabrief, Right Unilateral ECT | Experimental | Device: Electroconvulsive Therapy (ECT)Right unilateral ECT administered with an ultrabrief pulse width (0.3 ms), at a dose 6 times the initial seizure threshold |
| Ultrabrief, Bilateral ECT (2.5 X ST) | Experimental | Device: Electroconvulsive Therapy (ECT)Bilateral (frontotemporal) ECT with an ultrabrief pulse width with dosage 2.5 times the initial seizure threshold |
| Brief Pulse, Right Unilateral ECT | Active comparator | Device: Electroconvulsive Therapy (ECT)Right unilateral ECT, with a standard brief pulse (1.5 ms), with dosage 6 times the initial seizure threshold |
| Brief Pulse, Bilateral ECT | Active comparator | Device: Electroconvulsive Therapy (ECT)Bilateral (frontotemporal) ECT with a standard brief pulse (1.5 ms), with dosage 2.5 times the initial seizure threshold |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electroconvulsive Therapy (ECT)Also: shock therapyElectroconvulsive therapy involves applying a small electrical charge to the scalp while the patient is anesthetized and provoking a short-lasting generalized seizure | Device | Brief Pulse, Bilateral ECT, Brief Pulse, Right Unilateral ECT, Ultrabrief, Bilateral ECT (2.5 X ST), Ultrabrief, Right Unilateral ECT |
Primary outcome
Short-term antidepressant efficacy
Time frame: 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)
Time frame: Measured immediately post-treatment and 2, 4, and 6 months post-treatment
Specific neuropsychological measures were preselected as primary in safety analyses
3 secondary outcomes
Antidepressant efficacy
Time frame: Measured immediately post-treatment and 2, 4, and 6 months post-treatment
Assessments of functional outcomes
Time frame: Measured immediately post-treatment and 2, 4, and 6 months post-treatment
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2014.
- Results publicationSackeim, 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 publication: PubMed 19756236Sackeim 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harold A. Sackeim, PhD principal investigator
New York State Psychiatric Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Electroconvulsive Therapy (ECT) in people with Depression, run by New York State Psychiatric Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short-term antidepressant efficacy (time frame: Measured immediately post-treatment and 2, 4, and 6 months post-treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00487500, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2014.