Clinical Trials Directory

Trials / Completed

CompletedNCT00627887

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

Randomised Controlled Trial of Electroconvulsive Therapy (ECT) With Pharmacotherapy or Pharmacotherapy Alone in Relapse Prevention of Depression

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
56 (actual)
Sponsor
Örebro County Council · Other Government
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREElectroconvulsive therapyunilateral briefpulse ECT weekly for the first 6 weeks thereafter every 2 weeks for a total of one year
DRUGvenlafaxineextended release target dose of 300mg/day duration of one year
DRUGLithiumserum concentration 0,5-0,8 mmol/L, one year duration

Timeline

Start date
2008-01-01
Primary completion
2012-05-01
Completion
2012-05-01
First posted
2008-03-04
Last updated
2012-06-22

Locations

4 sites across 1 country: Sweden

Source: ClinicalTrials.gov record NCT00627887. Inclusion in this directory is not an endorsement.