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

Phase 4

Completed

• Conditions: Depressive Disorder, Major
• Interventions: Procedure: Electroconvulsive therapy; Drug: venlafaxine; Drug: Lithium

• Registration Number: NCT00627887
• Lead Sponsor: Örebro County Council

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-01-04
• Study First Submitted QC: 2008-02-25
• Study First Posted: 2008-03-04
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-20
• Last Update Posted: 2012-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ECT+pharmacotherapy	Electroconvulsive therapy	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.
ECT+pharmacotherapy	venlafaxine	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.
ECT+pharmacotherapy	Lithium	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.
pharmacotherapy	Lithium	Venlafaxine target dose 300mg/day; Lithium 0,5-0,8 mmol/L.
pharmacotherapy	venlafaxine	Venlafaxine target dose 300mg/day; Lithium 0,5-0,8 mmol/L.

Primary Outcome Measures

Name	Time	Method
MADRS >20, psychiatric hospitalization or suicide	1 year, all patients assessed if MADRS-S > 20 and at 2,6 and 12 months

Secondary Outcome Measures

Name	Time	Method
Mini Mental State Examination	2,6 and 12 months
ADAS-cog	2,6 and 12 months
Autobiographical Memory Inventory -Short Form (AMI-SF)	2,6 and 12 months patients treated in Örebro
Clinical Global Impression-Severity	2,6 and 12 months
Udvalg for Kliniske Undersogelser (UKU)	2, 6 and 12 months
MADRS-S Montgomery Asberg Depression Rating scale- self assessment	weekly for 6 weeks thereafter every 2 weeks for a total of one year

Trial Locations

Locations (3)

Psychiatric clinic; 🇸🇪 Orebro, Sweden

Psychiatric Clinic; 🇸🇪 Uppsala, Sweden

Löwenströmska sjukhuset; 🇸🇪 Stockholm, Sweden