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

Primary Purpose

Depressive Disorder, Major

Status
Completed
Phase
Phase 4
Locations
Sweden
Study Type
Interventional
Intervention
Electroconvulsive therapy
venlafaxine
Lithium
Sponsored by
Örebro County Council
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depressive Disorder, Major focused on measuring Depressive Disorder, Major, Electroconvulsive Therapy, Lithium Carbonate, venlafaxine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Psychiatric Clinic
  • Psychiatric clinic
  • Löwenströmska sjukhuset
  • Psychiatric Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ECT+pharmacotherapy

pharmacotherapy

Arm Description

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.

Venlafaxine target dose 300mg/day; Lithium 0,5-0,8 mmol/L.

Outcomes

Primary Outcome Measures

MADRS >20, psychiatric hospitalization or suicide

Secondary Outcome Measures

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

Full Information

First Posted
January 4, 2008
Last Updated
June 20, 2012
Sponsor
Örebro County Council
Collaborators
Uppsala-Örebro Regional Research Council
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1. Study Identification

Unique Protocol Identification Number
NCT00627887
Brief Title
Randomised Controlled Trial of Electroconvulsive Therapy (ECT) in Relapse Prevention of Depression
Official Title
Randomised Controlled Trial of Electroconvulsive Therapy (ECT) With Pharmacotherapy or Pharmacotherapy Alone in Relapse Prevention of Depression
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Örebro County Council
Collaborators
Uppsala-Örebro Regional Research Council

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder, Major
Keywords
Depressive Disorder, Major, Electroconvulsive Therapy, Lithium Carbonate, venlafaxine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ECT+pharmacotherapy
Arm Type
Experimental
Arm Description
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.
Arm Title
pharmacotherapy
Arm Type
Active Comparator
Arm Description
Venlafaxine target dose 300mg/day; Lithium 0,5-0,8 mmol/L.
Intervention Type
Procedure
Intervention Name(s)
Electroconvulsive therapy
Other Intervention Name(s)
ECT
Intervention Description
unilateral briefpulse ECT weekly for the first 6 weeks thereafter every 2 weeks for a total of one year
Intervention Type
Drug
Intervention Name(s)
venlafaxine
Other Intervention Name(s)
Efexor, Effexor
Intervention Description
extended release target dose of 300mg/day duration of one year
Intervention Type
Drug
Intervention Name(s)
Lithium
Other Intervention Name(s)
Lithionit, Lithobid, Eskalith
Intervention Description
serum concentration 0,5-0,8 mmol/L, one year duration
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Mini Mental State Examination
Time Frame
2,6 and 12 months
Title
ADAS-cog
Time Frame
2,6 and 12 months
Title
Autobiographical Memory Inventory -Short Form (AMI-SF)
Time Frame
2,6 and 12 months patients treated in Örebro
Title
Clinical Global Impression-Severity
Time Frame
2,6 and 12 months
Title
Udvalg for Kliniske Undersogelser (UKU)
Time Frame
2, 6 and 12 months
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ingemar Engstrom, MD, PhD
Organizational Affiliation
County Council of Orebro, University of Orebro, Sweden
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Axel Nordenskjold, MD
Organizational Affiliation
County Council of Orebro,
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Lars von Knorring, PhD, MD
Organizational Affiliation
County Council of Uppsala, University of Uppsala Sweden
Official's Role
Study Director
Facility Information:
Facility Name
Psychiatric Clinic
City
Sater
State/Province
Dalarna
ZIP/Postal Code
78327
Country
Sweden
Facility Name
Psychiatric clinic
City
Orebro
ZIP/Postal Code
70116
Country
Sweden
Facility Name
Löwenströmska sjukhuset
City
Stockholm
ZIP/Postal Code
11000
Country
Sweden
Facility Name
Psychiatric Clinic
City
Uppsala
ZIP/Postal Code
75017
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
17146008
Citation
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. doi: 10.1001/archpsyc.63.12.1337.
Results Reference
background
PubMed Identifier
11255384
Citation
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. doi: 10.1001/jama.285.10.1299.
Results Reference
background
PubMed Identifier
23303421
Citation
Nordenskjold A, von Knorring L, Ljung T, Carlborg A, Brus O, Engstrom I. Continuation electroconvulsive therapy with pharmacotherapy versus pharmacotherapy alone for prevention of relapse of depression: a randomized controlled trial. J ECT. 2013 Jun;29(2):86-92. doi: 10.1097/YCT.0b013e318276591f.
Results Reference
derived

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

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