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

Randomised Controlled Trial of Electroconvulsive Therapy (ECT) With Pharmacotherapy or Pharmacotherapy Alone 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.

Study Overview

• Status: Completed
• Conditions: Depressive Disorder, Major
• Intervention / Treatment: Procedure: Electroconvulsive therapy; Drug: venlafaxine; Drug: Lithium

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.

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; unilateral briefpulse ECT weekly for the first 6 weeks thereafter every 2 weeks for a total of one year; Other Names: ECT; Drug: venlafaxine; extended release target dose of 300mg/day duration of one year; Other Names: Effexor; Efexor; Drug: Lithium; serum concentration 0,5-0,8 mmol/L, one year duration; Other Names: Lithobid; Eskalith; Lithionit
Active Comparator: pharmacotherapy; Venlafaxine target dose 300mg/day; Lithium 0,5-0,8 mmol/L.	Drug: venlafaxine; extended release target dose of 300mg/day duration of one year; Other Names: Effexor; Efexor; Drug: Lithium; serum concentration 0,5-0,8 mmol/L, one year duration; Other Names: Lithobid; Eskalith; Lithionit

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
MADRS >20, psychiatric hospitalization or suicide	1 year, all patients assessed if MADRS-S > 20 and at 2,6 and 12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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
MADRS-S Montgomery Asberg Depression Rating scale- self assessment	weekly for 6 weeks thereafter every 2 weeks for a total of one year

Collaborators and Investigators

• Sponsor: Örebro County Council
• Collaborators: Uppsala-Örebro Regional Research Council
• Investigators: Principal Investigator: Ingemar Engstrom, MD, PhD, County Council of Orebro, University of Orebro, Sweden; Study Director: Axel Nordenskjold, MD, County Council of Orebro,; Study Director: Lars von Knorring, PhD, MD, County Council of Uppsala, University of Uppsala Sweden

Publications and helpful links

General 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: January 4, 2008
• First Submitted That Met QC Criteria: February 25, 2008
• First Posted (Estimate): March 4, 2008

Study Record Updates

• Last Update Posted (Estimate): June 22, 2012
• Last Update Submitted That Met QC Criteria: June 20, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Keywords: Electroconvulsive Therapy; Depressive Disorder, Major; venlafaxine; Lithium Carbonate
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Antidepressive Agents; Antidepressive Agents, Second-Generation; Serotonin and Noradrenaline Reuptake Inhibitors; Venlafaxine Hydrochloride
• Other Study ID Numbers: ISRCTN40355220