Randomised Controlled Trial of Electroconvulsive Therapy (ECT) in Relapse Prevention of Depression
NCT ID: NCT00627887
Last Updated: 2012-06-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
56 participants
INTERVENTIONAL
2008-01-31
2012-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Electroconvulsive therapy
unilateral briefpulse ECT weekly for the first 6 weeks thereafter every 2 weeks for a total of one year
venlafaxine
extended release target dose of 300mg/day duration of one year
Lithium
serum concentration 0,5-0,8 mmol/L, one year duration
pharmacotherapy
Venlafaxine target dose 300mg/day; Lithium 0,5-0,8 mmol/L.
venlafaxine
extended release target dose of 300mg/day duration of one year
Lithium
serum concentration 0,5-0,8 mmol/L, one year duration
Interventions
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Electroconvulsive therapy
unilateral briefpulse ECT weekly for the first 6 weeks thereafter every 2 weeks for a total of one year
venlafaxine
extended release target dose of 300mg/day duration of one year
Lithium
serum concentration 0,5-0,8 mmol/L, one year duration
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Uppsala-Örebro Regional Research Council
OTHER
Örebro County Council
OTHER_GOV
Responsible Party
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prof Ingemar Engström
Professor
Principal Investigators
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Ingemar Engstrom, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
County Council of Orebro, University of Orebro, Sweden
Axel Nordenskjold, MD
Role: STUDY_DIRECTOR
County Council of Orebro,
Lars von Knorring, PhD, MD
Role: STUDY_DIRECTOR
County Council of Uppsala, University of Uppsala Sweden
Locations
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Psychiatric Clinic
Säter, Dalarna County, Sweden
Löwenströmska sjukhuset
Stockholm, Stockholm County, Sweden
Psychiatric Clinic
Uppsala, Uppsala County, Sweden
Psychiatric clinic
Örebro, Örebro County, Sweden
Countries
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References
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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.
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.
Brus O, Cao Y, Carlborg A, Engstrom I, von Knorring L, Nordenskjold A. Long-Term Effect of Maintenance Electroconvulsive Therapy in Patients With Depression-Data From a Small Randomized Controlled Trial. J ECT. 2024 Sep 1;40(3):169-172. doi: 10.1097/YCT.0000000000000983. Epub 2023 Dec 28.
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.
Other Identifiers
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ISRCTN40355220
Identifier Type: -
Identifier Source: secondary_id
ISRCTN40355220
Identifier Type: -
Identifier Source: org_study_id
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