Randomised Controlled Trial of Electroconvulsive Therapy (ECT) in Relapse Prevention of Depression

Örebro County Council

Status and phase: Completed; Phase 4

Conditions: Depressive Disorder, Major

Treatments: Procedure: Electroconvulsive therapy; Drug: venlafaxine; Drug: Lithium

Study type: Interventional

Funder types: Other

Identifiers

NCT00627887

ISRCTN40355220

Details and patient eligibility

About

The purpose of the study is to determine if continuation electroconvulsive therapy (ECT) is safe and effective in relapse prevention of depression.

Full description

Randomized multicenter clinical trial with two parallel groups. Patients with major depression (unipolar or bipolar), who have remitted with electroconvulsive therapy (ECT) are eligible. All patients receive pharmacotherapy (venlafaxine target dose 300mg/day, and lithium target dose 0,5-0,8 mmol/L). The intervention is continuation unilateral ECT weekly for the first 6 weeks thereafter every 2 weeks for one year. Depressive relapse is the primary outcome measure.

Enrollment: 56 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. MINI-PLUS verified major depressive episode (unipolar or bipolar).
2. ECT within the last 3 weeks.
3. Either Remission defined as MADRS < 10 or
4. Response defined as MADRS < 15 combined with patient assessed CGI-I of at least much improved

Exclusion criteria

1. Schizophrenia or Schizoaffective disorder
2. Addiction or Dependence
3. Kidney disease that contraindicates lithium treatment
4. Vascular or heart disease that contraindicates venlafaxine treatment
5. Uncontrolled Epilepsia
6. Age less that 18
7. Pregnancy or Lactation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

56 participants in 2 patient groups

ECT+pharmacotherapy

Experimental group

Description:

Unilateral brief pulse ECT weekly for 6 weeks thereafter every 2 weeks; Venlafaxine target dose 300mg/day; Lithium target dose 0,5-0,8 mmol/L.

Treatment:

Drug: Lithium

Drug: venlafaxine

Procedure: Electroconvulsive therapy

pharmacotherapy

Active Comparator group

Description:

Venlafaxine target dose 300mg/day; Lithium 0,5-0,8 mmol/L.

Treatment:

Drug: Lithium

Drug: venlafaxine