We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00627887
Recruitment Status : Completed
First Posted : March 4, 2008
Last Update Posted : June 22, 2012
Sponsor:
Collaborator:
Uppsala-Örebro Regional Research Council
Information provided by (Responsible Party):
prof Ingemar Engström, Örebro County Council

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The purpose of the study is to determine if continuation electroconvulsive therapy (ECT) is safe and effective in relapse prevention of depression.

Condition or disease Intervention/treatment Phase
Depressive Disorder, Major Procedure: Electroconvulsive therapy Drug: venlafaxine Drug: Lithium Phase 4

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.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomised Controlled Trial of Electroconvulsive Therapy (ECT) With Pharmacotherapy or Pharmacotherapy Alone in Relapse Prevention of Depression
Study Start Date : January 2008
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. MADRS >20, psychiatric hospitalization or suicide [ Time Frame: 1 year, all patients assessed if MADRS-S > 20 and at 2,6 and 12 months ]

Secondary Outcome Measures :
  1. Mini Mental State Examination [ Time Frame: 2,6 and 12 months ]
  2. ADAS-cog [ Time Frame: 2,6 and 12 months ]
  3. Autobiographical Memory Inventory -Short Form (AMI-SF) [ Time Frame: 2,6 and 12 months patients treated in Örebro ]
  4. Clinical Global Impression-Severity [ Time Frame: 2,6 and 12 months ]
  5. Udvalg for Kliniske Undersogelser (UKU) [ Time Frame: 2, 6 and 12 months ]
  6. 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 ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00627887


Locations
Layout table for location information
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
Uppsala-Örebro Regional Research Council
Investigators
Layout table for investigator information
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: prof Ingemar Engström, Professor, Örebro County Council
ClinicalTrials.gov Identifier: NCT00627887    
Other Study ID Numbers: ISRCTN40355220
ISRCTN40355220
First Posted: March 4, 2008    Key Record Dates
Last Update Posted: June 22, 2012
Last Verified: June 2012
Keywords provided by prof Ingemar Engström, Örebro County Council:
Depressive Disorder, Major
Electroconvulsive Therapy
Lithium Carbonate
venlafaxine
Additional relevant MeSH terms:
Layout table for MeSH terms
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Venlafaxine Hydrochloride
Antidepressive Agents
 Psychotropic Drugs
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Neurotransmitter Agents
Antidepressive Agents, Second-Generation