Major Depressive Disorder Clinical Trial
Official title:
Continuation ECT Vs Pharmacotherapy--Efficacy And Safety
NCT number | NCT00000375 |
Other study ID # | MH55495 |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | November 2, 1999 |
Last updated | December 19, 2005 |
Start date | February 1997 |
Verified date | December 2005 |
Source | National Institute of Mental Health (NIMH) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 0 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: Patients must have: Major depressive disorder that is responsive to acute phase ECT. |
Country | Name | City | State |
---|---|---|---|
United States | New Jersey Medical School | Newark | New Jersey |
Lead Sponsor | Collaborator |
---|---|
National Institute of Mental Health (NIMH) |
United States,
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