Continuation Electroconvulsive Therapy Vs Medication to Prevent Relapses in Patients With Major Depressive Disorder
| Status: | Completed |
|---|---|
| Conditions: | Depression, Depression, Major Depression Disorder (MDD) |
| Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 10/14/2017 |
| Start Date: | February 1997 |
Continuation ECT Vs Pharmacotherapy--Efficacy And Safety
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, he/she 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 he/she:
Has major depressive disorder and responds positively to ECT treatment and is 18 to 80 years
old.
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, he/she 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 he/she:
Has major depressive disorder and responds positively to ECT treatment and is 18 to 80 years
old.
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 (e.g., 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.
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 (e.g., 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.
Inclusion Criteria:
Patients must have:
Major depressive disorder that is responsive to acute phase ECT.
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