Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000375
Status:
COMPLETED
Last Update Posted:
2005-12-20
First Post:
1999-11-02
Brief Title:
Continuation Electroconvulsive Therapy Vs Medication to Prevent Relapses in Patients With Major Depressive Disorder
Sponsor:
National Institute of Mental Health NIMH
Organization:
National Institute of Mental Health NIMH
Study Overview
Official Title:
Continuation ECT Vs Pharmacotherapy--Efficacy And Safety
Status:
COMPLETED
Status Verified Date:
2005-12
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:
The purpose of this study is to compare the safety and effectiveness of two treatments to prevent relapses in seriously ill patients with major depressive disorder MDD who have responded to electroconvulsive therapy ECT Patients will either continue to receive ECT continuation electroconvulsive therapy C-ECT or they will be treated with antidepressant medications
ECT is a highly effective treatment for MDD however relapses are a major concern To prevent relapse in patients who have responded to ECT the common treatment is antidepressants as continuation therapy following the initial therapy in order to continue treating the disorder Relapses however can still occur even after antidepressant continuation therapy This study will evaluate a potent antidepressant combination in order to prevent relapse C-ECT is another option that needs to be tested
If the patient responds to the first round of ECT heshe will be assigned randomly like tossing a coin to either continue receiving ECT or to receive an antidepressant combination of nortriptyline plus lithium NOR-Li for 6 months The patient will have psychological tests before shortly after and 3 months after the first round of ECT and at the end of the 6-month continuation trial Patients will be monitored for symptoms and side effects All patients will have urine tests to test for drug abuse
An individual may be eligible for this study if heshe
Has major depressive disorder and responds positively to ECT treatment and is 18 to 80 years old
ECT is a highly effective treatment for MDD however relapses are a major concern To prevent relapse in patients who have responded to ECT the common treatment is antidepressants as continuation therapy following the initial therapy in order to continue treating the disorder Relapses however can still occur even after antidepressant continuation therapy This study will evaluate a potent antidepressant combination in order to prevent relapse C-ECT is another option that needs to be tested
If the patient responds to the first round of ECT heshe will be assigned randomly like tossing a coin to either continue receiving ECT or to receive an antidepressant combination of nortriptyline plus lithium NOR-Li for 6 months The patient will have psychological tests before shortly after and 3 months after the first round of ECT and at the end of the 6-month continuation trial Patients will be monitored for symptoms and side effects All patients will have urine tests to test for drug abuse
An individual may be eligible for this study if heshe
Has major depressive disorder and responds positively to ECT treatment and is 18 to 80 years old
Detailed Description:
To define the role of continuation electroconvulsive therapy C-ECT in relapse-prevention of seriously ill patients with major depressive disorder MDD To determine the relative efficacy and safety of C-ECT in comparison to the traditional approach of continuation pharmacotherapy C-PHARM to prevent relapses of MDD
Electroconvulsive therapy ECT is a highly effective treatment for MDD that is helpful for patients with the most severe forms of affective illness however relapse after successful acute phase ECT or pharmacotherapy remains a major public health problem To prevent relapse in patients with MDD who have responded to ECT the common practice is to prescribe an antidepressant eg a tricyclic TCA a selective serotonin reuptake inhibitor SSRI or lithium as continuation therapy Recent studies show an alarmingly high relapse rate after ECT despite conventional continuation pharmacotherapy C-PHARM Continuation ECT C-ECT is also in widespread clinical use however its efficacy and safety have never been rigorously tested
Investigators at four sites Mayo Clinic UMDNJ-New Jersey Medical School Zucker Hillside Hospital and University of Texas SW Medical Center Dallas randomize patients to receive either C-ECT or an aggressive pharmacological strategy nortriptyline and lithium in combination NOR-Li for 6 months following response to acute phase ECT Raters at each site evaluate symptoms and side effects On the basis of edited videotapes obtained at regular intervals a site-independent blinded evaluator also assesses symptoms A neuropsychological battery is administered prior to acute phase ECT shortly after the ECT course 3 months after the end of the acute phase treatment and at the end of the 6-month continuation trial These continuation therapies are compared in their effects on relapse cognitive performance global functioning side effects and perceived health status NOR and Li levels are optimized by blood level monitoring Bilateral ECT at progressively increasing intervals are used for C-ECT Methods are included to ensure the integrity of clinical diagnoses symptom severity assessment data collection and entry and treatment delivery In all patients surreptitious use of prescription or recreational drugs is monitored by urine testing
Electroconvulsive therapy ECT is a highly effective treatment for MDD that is helpful for patients with the most severe forms of affective illness however relapse after successful acute phase ECT or pharmacotherapy remains a major public health problem To prevent relapse in patients with MDD who have responded to ECT the common practice is to prescribe an antidepressant eg a tricyclic TCA a selective serotonin reuptake inhibitor SSRI or lithium as continuation therapy Recent studies show an alarmingly high relapse rate after ECT despite conventional continuation pharmacotherapy C-PHARM Continuation ECT C-ECT is also in widespread clinical use however its efficacy and safety have never been rigorously tested
Investigators at four sites Mayo Clinic UMDNJ-New Jersey Medical School Zucker Hillside Hospital and University of Texas SW Medical Center Dallas randomize patients to receive either C-ECT or an aggressive pharmacological strategy nortriptyline and lithium in combination NOR-Li for 6 months following response to acute phase ECT Raters at each site evaluate symptoms and side effects On the basis of edited videotapes obtained at regular intervals a site-independent blinded evaluator also assesses symptoms A neuropsychological battery is administered prior to acute phase ECT shortly after the ECT course 3 months after the end of the acute phase treatment and at the end of the 6-month continuation trial These continuation therapies are compared in their effects on relapse cognitive performance global functioning side effects and perceived health status NOR and Li levels are optimized by blood level monitoring Bilateral ECT at progressively increasing intervals are used for C-ECT Methods are included to ensure the integrity of clinical diagnoses symptom severity assessment data collection and entry and treatment delivery In all patients surreptitious use of prescription or recreational drugs is monitored by urine testing
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