Official Title: “Randomised Controlled Trial of Electroconvulsive Therapy (ECT) With Pharmacotherapy or Pharmacotherapy Alone in Relapse Prevention of Depression”

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

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: January 2011

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.

Intervention(s) in this Clinical Trial

• Procedure: Electroconvulsive therapy
  • unilateral briefpulse ECT weekly for the first 6 weeks thereafter every 2 weeks for a total of one year
• Drug: venlafaxine
  • extended release target dose of 300mg/day duration of one year
• Drug: Lithium
  • serum concentration 0,5-0,8 mmol/L, one year duration

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: ECT+pharmacotherapy
  • 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
• Active Comparator: pharmacotherapy
  • venlafaxine target dose 300mg/day Lithium 0,5-0,8 mmol/L

Primary Measures

• MADRS >20, psychiatric hospitalization or suicide
  • Time Frame: 1 year, all patients assessed at 2,6 and 12 months
    Safety Issue?: No

Secondary Measures

• Mini Mental State Examination
  • Time Frame: 2,6 and 12 months
    Safety Issue?: Yes
• ADAS-cog
  • Time Frame: 2,6 and 12 months
    Safety Issue?: Yes
• Autobiographical Memory Inventory -Short Form (AMI-SF)
  • Time Frame: 2,6 and 12 months patients treated in Örebro
    Safety Issue?: Yes
• Clinical Global Impression-Severity
  • Time Frame: 2,6 and 12 months
    Safety Issue?: No
• Udvalg for Kliniske Undersogelser (UKU)
  • Time Frame: 2, 6 and 12 months
    Safety Issue?: Yes
• MADRS-S Montgomery Asberg Depression Rating scale- self assessment
  • Time Frame: weekly for 6 weeks thereafter every 2 weeks for a total of one year
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Örebro County Council

Overall Clinical Trial Officials and Contacts

Ingemar Engstrom, MD, PhD Principal Investigator County Council of Orebro, University of Orebro, Sweden  

Overall Contact: Ingemar Engström, MD, PhD +4619602588 ingemar.engstrom@orebroll.se

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00627887

Study ID Number: ISRCTN40355220

ClinicalTrials.gov Identifier: NCT00627887

Health Authority: Sweden: The National Board of Health and Welfare