Randomised Controlled Trial of Electroconvulsive Therapy (ECT) in Relapse Prevention of Depression
Information source: Örebro County Council
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Depressive Disorder, Major
Intervention: Electroconvulsive therapy (Procedure); venlafaxine (Drug); Lithium (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Örebro County Council Official(s) and/or principal investigator(s): Ingemar Engstrom, MD, PhD, Principal Investigator, Affiliation: County Council of Orebro, University of Orebro, Sweden Axel Nordenskjold, MD, Study Director, Affiliation: County Council of Orebro, Lars von Knorring, PhD, MD, Study Director, Affiliation: County Council of Uppsala, University of Uppsala Sweden
Summary
The purpose of the study is to determine if continuation electroconvulsive therapy (ECT) is
safe and effective in relapse prevention of depression.
Clinical Details
Official title: Randomised Controlled Trial of Electroconvulsive Therapy (ECT) With Pharmacotherapy or Pharmacotherapy Alone in Relapse Prevention of Depression
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: MADRS >20, psychiatric hospitalization or suicide
Secondary outcome: Mini Mental State ExaminationADAS-cog Autobiographical Memory Inventory -Short Form (AMI-SF) Clinical Global Impression-Severity Udvalg for Kliniske Undersogelser (UKU) MADRS-S Montgomery Asberg Depression Rating scale- self assessment
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Psychiatric clinic, Orebro 70116, Sweden
Löwenströmska sjukhuset, Stockholm 11000, Sweden
Psychiatric Clinic, Uppsala 75017, Sweden
Psychiatric Clinic, Sater, Dalarna 78327, Sweden
Additional Information
Related publications: Kellner CH, Knapp RG, Petrides G, Rummans TA, Husain MM, Rasmussen K, Mueller M, Bernstein HJ, O'Connor K, Smith G, Biggs M, Bailine SH, Malur C, Yim E, McClintock S, Sampson S, Fink M. Continuation electroconvulsive therapy vs pharmacotherapy for relapse prevention in major depression: a multisite study from the Consortium for Research in Electroconvulsive Therapy (CORE). Arch Gen Psychiatry. 2006 Dec;63(12):1337-44. Sackeim HA, Haskett RF, Mulsant BH, Thase ME, Mann JJ, Pettinati HM, Greenberg RM, Crowe RR, Cooper TB, Prudic J. Continuation pharmacotherapy in the prevention of relapse following electroconvulsive therapy: a randomized controlled trial. JAMA. 2001 Mar 14;285(10):1299-307.
Starting date: January 2008
Last updated: June 20, 2012
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