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

This study has been completed.
Sponsor:
Collaborator:
Regional Research Council in the Uppsala-Örebro region
Information provided by (Responsible Party):
prof Ingemar Engström, Örebro County Council
ClinicalTrials.gov Identifier:
NCT00627887
First received: January 4, 2008
Last updated: June 20, 2012
Last verified: June 2012
  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:


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:

  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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 July 24, 2014