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CompletedNCT00627887Updated Jun 22, 2012

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

A Phase 4 interventional study of Electroconvulsive therapy and venlafaxine in Depressive Disorder, Major, sponsored by Örebro County Council. Completed at 4 sites in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-06-22.

Sponsored by Örebro County Council · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
56
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

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Conditions studied

  • Depressive Disorder, Major

Keywords

  • Depressive Disorder, Major
  • Electroconvulsive Therapy
  • Lithium Carbonate
  • venlafaxine
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In context

Depression

8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.

This study's enrollment of 56 is below the median of 84 across 6,720 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

Örebro County Council is the lead sponsor of 22 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
56 participants (actual)

Study arms

  • 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 · Drug: venlafaxine · Drug: Lithium

  • Active comparator
    pharmacotherapy

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

    Drug: venlafaxine · Drug: Lithium

Interventions

  • ProcedureElectroconvulsive therapy

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

    Also known as: ECT

  • Drugvenlafaxine

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

    Also known as: Efexor, Effexor

  • DrugLithium

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

    Also known as: Lithionit, Lithobid, Eskalith

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What researchers measure

Primary outcomes

  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 outcomes

  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

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Study locations

4 sites
  • Psychiatric Clinic
    Sater, Dalarna 78327, Sweden
  • Psychiatric clinic
    Orebro, 70116, Sweden
  • Löwenströmska sjukhuset
    Stockholm, 11000, Sweden
  • Psychiatric Clinic
    Uppsala, 75017, Sweden
08

References and documents

Publications

  • 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. PubMed 17146008 ↗
  • 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. PubMed 11255384 ↗
  • 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. PubMed 23303421 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 22, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00627887
Lead sponsor
Örebro County Council
Collaborators
Uppsala-Örebro Regional Research Council
Responsible party
prof Ingemar Engström (Professor, Örebro County Council) — Principal investigator
First posted
Mar 4, 2008
Start date
Jan 2008
Primary completion
May 2012
Completion
May 2012
Last update
Jun 22, 2012

Study contacts

Ingemar Engstrom, MD, PhD
principal investigator · County Council of Orebro, University of Orebro, Sweden
Axel Nordenskjold, MD
study director · County Council of Orebro,
Lars von Knorring, PhD, MD
study director · County Council of Uppsala, University of Uppsala Sweden

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2012. You cannot join it, but the record below documents what was studied.

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