Continuation Electroconvulsive Therapy Vs Medication to Prevent Relapses in Patients With Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 4

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, 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.
    

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 (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.
    

Intervention name(s): Nortriptyline-lithium (NOR-Li); Bilateral electroconvulsive therapy (ECT); Continuation therapy; Continuation ECT
Intervention type(s): Drug; Procedure; Drug; Behavioral
Intervention MeSH terms: Nortriptyline
Allocation: Randomized
Masking: Single
Primary purpose: Treatment
Keywords: Adult; Antidepressive Agents; Depressive Disorder; Electroconvulsive Therapy; Female; Human; Lithium; Male; Nortriptyline; Serotonin Uptake Inhibitors; Antidepressive Agents -- *therapeutic use; Antidepressive Agents -- adverse effects; Lithium -- *therapeutic use; Lithium -- adverse effects; Nortriptyline -- *therapeutic use; Nortriptyline -- adverse effects