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

Information source: ÷rebro 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: ÷rebro 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 Examination

ADAS-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

Page last updated: August 23, 2015

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