Randomised Controlled Trial of Electroconvulsive Therapy (ECT) in Relapse Prevention of Depression - Full Text View

Purpose

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

Condition	Intervention	Phase
Depressive Disorder, Major	Procedure: Electroconvulsive therapy Drug: venlafaxine Drug: Lithium	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Randomised Controlled Trial of Electroconvulsive Therapy (ECT) With Pharmacotherapy or Pharmacotherapy Alone in Relapse Prevention of Depression

Resource links provided by NLM:

MedlinePlus related topics: Depression

Drug Information available for: Lithium carbonate Lithium citrate Venlafaxine Venlafaxine hydrochloride

U.S. FDA Resources

Further study details as provided by Örebro County Council:

Primary Outcome Measures:

MADRS >20, psychiatric hospitalization or suicide [ Time Frame: 1 year, all patients assessed if MADRS-S > 20 and at 2,6 and 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Mini Mental State Examination [ Time Frame: 2,6 and 12 months ] [ Designated as safety issue: Yes ]
ADAS-cog [ Time Frame: 2,6 and 12 months ] [ Designated as safety issue: Yes ]
Autobiographical Memory Inventory -Short Form (AMI-SF) [ Time Frame: 2,6 and 12 months patients treated in Örebro ] [ Designated as safety issue: Yes ]
Clinical Global Impression-Severity [ Time Frame: 2,6 and 12 months ] [ Designated as safety issue: No ]
Udvalg for Kliniske Undersogelser (UKU) [ Time Frame: 2, 6 and 12 months ] [ Designated as 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 ] [ Designated as safety issue: No ]

Enrollment:	56
Study Start Date:	January 2008
Study Completion Date:	May 2012
Primary Completion Date:	May 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.	Procedure: Electroconvulsive therapy unilateral briefpulse ECT weekly for the first 6 weeks thereafter every 2 weeks for a total of one year Other Name: ECT Drug: venlafaxine extended release target dose of 300mg/day duration of one year Other Names: Efexor Effexor Drug: Lithium serum concentration 0,5-0,8 mmol/L, one year duration Other Names: Lithionit Lithobid Eskalith
Active Comparator: pharmacotherapy Venlafaxine target dose 300mg/day; Lithium 0,5-0,8 mmol/L.	Drug: venlafaxine extended release target dose of 300mg/day duration of one year Other Names: Efexor Effexor Drug: Lithium serum concentration 0,5-0,8 mmol/L, one year duration Other Names: Lithionit Lithobid Eskalith

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

MINI-PLUS verified major depressive episode (unipolar or bipolar).
ECT within the last 3 weeks.
Either Remission defined as MADRS < 10 or
Response defined as MADRS < 15 combined with patient assessed CGI-I of at least much improved

Exclusion Criteria:

Schizophrenia or Schizoaffective disorder
Addiction or Dependence
Kidney disease that contraindicates lithium treatment
Vascular or heart disease that contraindicates venlafaxine treatment
Uncontrolled Epilepsia
Age less that 18
Pregnancy or Lactation

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00627887

Locations

Sweden
Psychiatric Clinic
Sater, Dalarna, Sweden, 78327
Psychiatric clinic
Orebro, Sweden, 70116
Löwenströmska sjukhuset
Stockholm, Sweden, 11000
Psychiatric Clinic
Uppsala, Sweden, 75017

Sponsors and Collaborators

Örebro County Council

Regional Research Council in the Uppsala-Örebro region

Investigators

Principal Investigator:	Ingemar Engstrom, MD, PhD	County Council of Orebro, University of Orebro, Sweden
Study Director:	Axel Nordenskjold, MD	County Council of Orebro,
Study Director:	Lars von Knorring, PhD, MD	County Council of Uppsala, University of Uppsala Sweden

More Information

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.

Responsible Party:	prof Ingemar Engström, Professor, Örebro County Council
ClinicalTrials.gov Identifier:	NCT00627887 History of Changes
Other Study ID Numbers:	ISRCTN40355220, ISRCTN40355220
Study First Received:	January 4, 2008
Last Updated:	June 20, 2012
Health Authority:	Sweden: The National Board of Health and Welfare Sweden: Regional Ethical Review Board

Keywords provided by Örebro County Council:

Depressive Disorder, Major
Electroconvulsive Therapy
Lithium Carbonate
venlafaxine

Additional relevant MeSH terms:

Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Lithium
Lithium Carbonate
Venlafaxine
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs

Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Antimanic Agents
Antidepressive Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Serotonin Agents
Antidepressive Agents, Second-Generation

ClinicalTrials.gov processed this record on May 16, 2013