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

Depressive Disorder, Major Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00627887
• Other study ID #: ISRCTN40355220
• Secondary ID: ISRCTN40355220
• Status: Completed
• Phase: Phase 4
• First received: January 4, 2008
• Last updated: June 20, 2012
• Start date: January 2008
• Est. completion date: May 2012

Study information

• Verified date: June 2012
• Source: Örebro County Council
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: The National Board of Health and WelfareSweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major

Intervention

Procedure:
• Electroconvulsive therapy
unilateral briefpulse ECT weekly for the first 6 weeks thereafter every 2 weeks for a total of one year

Drug:
• venlafaxine
extended release target dose of 300mg/day duration of one year
• Lithium
serum concentration 0,5-0,8 mmol/L, one year duration

Locations

Country	Name	City	State
Sweden	Psychiatric clinic	Orebro
Sweden	Psychiatric Clinic	Sater	Dalarna
Sweden	Löwenströmska sjukhuset	Stockholm
Sweden	Psychiatric Clinic	Uppsala

Sponsors (2)

Lead Sponsor	Collaborator
Örebro County Council	Uppsala-Örebro Regional Research Council

Country where clinical trial is conducted

Sweden, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MADRS >20, psychiatric hospitalization or suicide		1 year, all patients assessed if MADRS-S > 20 and at 2,6 and 12 months	No
Secondary	Mini Mental State Examination		2,6 and 12 months	Yes
Secondary	ADAS-cog		2,6 and 12 months	Yes
Secondary	Autobiographical Memory Inventory -Short Form (AMI-SF)		2,6 and 12 months patients treated in Örebro	Yes
Secondary	Clinical Global Impression-Severity		2,6 and 12 months	No
Secondary	Udvalg for Kliniske Undersogelser (UKU)		2, 6 and 12 months	Yes
Secondary	MADRS-S Montgomery Asberg Depression Rating scale- self assessment		weekly for 6 weeks thereafter every 2 weeks for a total of one year	No