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

NCT ID: NCT00627887

Last Updated: 2012-06-22

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2012-05-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Depressive Disorder, Major

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

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.

Group Type EXPERIMENTAL

Electroconvulsive therapy

Intervention Type PROCEDURE

unilateral briefpulse ECT weekly for the first 6 weeks thereafter every 2 weeks for a total of one year

venlafaxine

Intervention Type DRUG

extended release target dose of 300mg/day duration of one year

Lithium

Intervention Type DRUG

serum concentration 0,5-0,8 mmol/L, one year duration

pharmacotherapy

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

Group Type ACTIVE_COMPARATOR

venlafaxine

Intervention Type DRUG

extended release target dose of 300mg/day duration of one year

Lithium

Intervention Type DRUG

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

Intervention Type PROCEDURE

venlafaxine

extended release target dose of 300mg/day duration of one year

Intervention Type DRUG

Lithium

serum concentration 0,5-0,8 mmol/L, one year duration

Intervention Type DRUG

Other Intervention Names

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ECT Efexor Effexor Lithionit Lithobid Eskalith

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Uppsala-Örebro Regional Research Council

OTHER

Sponsor Role collaborator

Örebro County Council

OTHER_GOV

Sponsor Role lead

Responsible Party

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prof Ingemar Engström

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Löwenströmska sjukhuset

Stockholm, Stockholm County, Sweden

Site Status

Psychiatric Clinic

Uppsala, Uppsala County, Sweden

Site Status

Psychiatric clinic

Örebro, Örebro County, Sweden

Site Status

Countries

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Sweden

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.

Reference Type BACKGROUND
PMID: 17146008 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11255384 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38232249 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23303421 (View on PubMed)

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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