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

NCT00627887 | Completed Phase 4

• 1 other identifier: ISRCTN40355220
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Depressive Disorder, Major

Keywords

Depressive Disorder, Major; Electroconvulsive Therapy; Lithium Carbonate; venlafaxine

Outcome Measures

Primary Outcomes (1)

• MADRS >20, psychiatric hospitalization or suicide

  1 year, all patients assessed if MADRS-S > 20 and at 2,6 and 12 months

Secondary Outcomes (6)

• Mini Mental State Examination

  2,6 and 12 months

• ADAS-cog

  2,6 and 12 months

• Autobiographical Memory Inventory -Short Form (AMI-SF)

  2,6 and 12 months patients treated in Örebro

• Clinical Global Impression-Severity

  2,6 and 12 months

• Udvalg for Kliniske Undersogelser (UKU)

  2, 6 and 12 months

Study Arms (2)

ECT+pharmacotherapy

EXPERIMENTAL

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

pharmacotherapy

ACTIVE COMPARATOR

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

Drug: venlafaxine; Drug: Lithium

Interventions

Electroconvulsive therapy PROCEDURE

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

Also known as: ECT

ECT+pharmacotherapy

venlafaxine DRUG

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

Also known as: Efexor, Effexor

ECT+pharmacotherapy; pharmacotherapy

Lithium DRUG

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

Also known as: Lithionit, Lithobid, Eskalith

ECT+pharmacotherapy; pharmacotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Örebro County Council: lead
• Uppsala-Örebro Regional Research Council: collaborator

Study Sites (4)

Psychiatric Clinic

Säter, Dalarna County, 78327, Sweden

Location

Löwenströmska sjukhuset

Stockholm, Stockholm County, 11000, Sweden

Location

Psychiatric Clinic

Uppsala, Uppsala County, 75017, Sweden

Location

Psychiatric clinic

Örebro, Örebro County, 70116, Sweden

Location

Related Publications (4)

• 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.

  PMID: 17146008 BACKGROUND

• 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.

  PMID: 11255384 BACKGROUND

• 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.

  PMID: 38232249 DERIVED

• 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.

  PMID: 23303421 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Electroconvulsive Therapy; Venlafaxine Hydrochloride; Lithium; Lithium Carbonate

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Phenethylamines; Ethylamines; Amines; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Lipids; Metals, Alkali; Elements; Inorganic Chemicals; Metals, Light; Metals; Carbonates; Alkalies; Carbonic Acid; Carbon Compounds, Inorganic; Lithium Compounds

Study Officials

• Ingemar Engstrom, MD, PhD

  County Council of Orebro, University of Orebro, Sweden

  PRINCIPAL INVESTIGATOR

• Axel Nordenskjold, MD

  County Council of Orebro,

  STUDY DIRECTOR

• Lars von Knorring, PhD, MD

  County Council of Uppsala, University of Uppsala Sweden

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 4, 2008
• First Posted: March 4, 2008
• Study Start: January 1, 2008
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: June 22, 2012

Record last verified: 2012-06

Locations

SE (4)