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

Sponsors and Collaborators:	Örebro County Council Regional Research Council in the Uppsala-Örebro region
Information provided by:	Örebro County Council
ClinicalTrials.gov Identifier:	NCT00627887

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 IV

MedlinePlus related topics: Depression

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Randomised Controlled Trial of Electroconvulsive Therapy (ECT) With Pharmacotherapy or Pharmacotherapy Alone in Relapse Prevention of Depression

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 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 ]

Estimated Enrollment:	100
Study Start Date:	January 2008
Estimated Study Completion Date:	January 2011
Estimated Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
ECT+pharmacotherapy: Experimental 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 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
pharmacotherapy: Active Comparator 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 Drug: Lithium serum concentration 0,5-0,8 mmol/L, one year duration

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

Contacts

Contact: Ingemar Engström, MD, PhD	+4619602588	ingemar.engstrom@orebroll.se
Contact: Axel Nordenskjöld, MD	+46702777777	axel.nordenskjold@orebroll.se

Locations

Sweden
Psychiatric clinic	Recruiting
Orebro, Sweden, 70116
Contact: Axel Nordenskjold, MD +46702777777 axel.nordenskjold@orebroll.se
Contact: Ann-Charlotte Fridenberger +46196020590 ann-charlotte.fridenberger@orebroll.se
Principal Investigator: Axel Nordenskjold, MD
Löwenströmska sjukhuset	Recruiting
Stockholm, Sweden, 11000
Contact: Andreas Carlborg, MD
Psychiatric Clinic	Recruiting
Uppsala, Sweden, 75017
Contact: Petros Koulouris, MD +46196110000 petros.koulouris@akademiska.se
Principal Investigator: Ioannis Pantziaras, MD
Sweden, Dalarna
Psychiatric Clinic	Recruiting
Sater, Dalarna, Sweden, 78327
Contact: Tomas Ljung, MD +4623490000 tomas.ljung@ltdalarna.se
Principal Investigator: Tomas Ljung, MD

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:	County Council of Orebro ( Prof Ingemar Engstrom )
Study ID Numbers:	ISRCTN40355220, ISRCTN40355220
Study First Received:	January 4, 2008
Last Updated:	January 15, 2009
ClinicalTrials.gov Identifier:	NCT00627887
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

Study placed in the following topic categories:

Depression
Mental Disorders
Venlafaxine
Mood Disorders
Lithium Carbonate

Depressive Disorder, Major
Depressive Disorder
Serotonin
Lithium
Behavioral Symptoms

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Antipsychotic Agents

Antimanic Agents
Serotonin Uptake Inhibitors
Pharmacologic Actions
Serotonin Agents
Therapeutic Uses
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on January 16, 2009