Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00045916
Status:
COMPLETED
Last Update Posted:
2013-08-13
First Post:
2002-09-13
Brief Title:
Optimizing Electroconvulsive Therapy for Depression
Sponsor:
New York State Psychiatric Institute
Organization:
New York State Psychiatric Institute
Study Overview
Official Title:
Optimization of Electroconvulsive Therapy
Status:
COMPLETED
Status Verified Date:
2008-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will evaluate the effectiveness of electroconvulsive therapy ECT administered with medication for the treatment of a major depressive episode unipolar or bipolar and will compare two types of ECT
Detailed Description:
This study addresses 2 issues in the optimization of ECT in patients with major depression whether patients treated with ECT should receive concurrent treatment with antidepressant medications and the relative efficacy and side effects of high dosage right unilateral RUL ECT compared to low dosage bilateral BL ECT
This study has 2 phases In Phase I patients are randomized to receive nortriptyline venlafaxine Effexor or placebo while they simultaneously receive either high dosage RUL ECT or low dosage BL ECT Patients have an electrocardiogram EKG a chest x-ray medical and neurological examinations and blood tests Memory function is assessed before and after ECT Whenever feasible patients are withdrawn from all prior psychotropic medication before the start of ECT ECT is administered 3 times per week to inpatients and twice a week to outpatients Patients continue ECT until they are asymptomatic or until there is a plateau in improvement over 2 treatments
Patients who respond to ECT enter Phase II and add lithium to either nortriptyline or venlafaxine within 1-3 days of the last ECT Clinical and side effect evaluations and blood level determinations are conducted weekly for the first month every 2 weeks until Week 12 and every 4 weeks for the remaining 12 weeks Following any indication of relapse patients are monitored more intensively and are re-evaluated within 1 week The neurocognitive battery is readministered to all patients at 2 and 6 months after the acute ECT course regardless of ECT clinical outcome
This study has 2 phases In Phase I patients are randomized to receive nortriptyline venlafaxine Effexor or placebo while they simultaneously receive either high dosage RUL ECT or low dosage BL ECT Patients have an electrocardiogram EKG a chest x-ray medical and neurological examinations and blood tests Memory function is assessed before and after ECT Whenever feasible patients are withdrawn from all prior psychotropic medication before the start of ECT ECT is administered 3 times per week to inpatients and twice a week to outpatients Patients continue ECT until they are asymptomatic or until there is a plateau in improvement over 2 treatments
Patients who respond to ECT enter Phase II and add lithium to either nortriptyline or venlafaxine within 1-3 days of the last ECT Clinical and side effect evaluations and blood level determinations are conducted weekly for the first month every 2 weeks until Week 12 and every 4 weeks for the remaining 12 weeks Following any indication of relapse patients are monitored more intensively and are re-evaluated within 1 week The neurocognitive battery is readministered to all patients at 2 and 6 months after the acute ECT course regardless of ECT clinical outcome
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01MH061609 | NIH | None | None |
| DSIR 83-ATSO | US NIH GrantContract | None | httpsreporternihgovquickSearchR01MH061609 |