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Completed

NCT Number: NCT00627887

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

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

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Key information

Conditions

Depressive Disorder, Major Depressive Disorder Mental Disorders Mood Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Psychiatric Clinic, Säter, Dalarna County, Sweden

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Electroconvulsive therapy

Procedure

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

Other names: ECT

Venlafaxine

Drug

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

Other names: Efexor, Effexor

Lithium

Drug

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

Other names: Lithionit, Lithobid, Eskalith

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

Sponsors and collaborators

Lead sponsor

Örebro County Council

Other Gov

Collaborators

  • Uppsala-Örebro Regional Research Council

Registry information

Official study title

Randomised Controlled Trial of Electroconvulsive Therapy (ECT) With Pharmacotherapy or Pharmacotherapy Alone in Relapse Prevention of Depression

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Mar 4, 2008
Registry last updated
Jun 22, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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