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

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

Detailed Description
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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.

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

Conditions
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Depressive Disorder, Major

Intervention / Treatment
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* Procedure: Electroconvulsive therapy
* Drug: venlafaxine
* Drug: Lithium


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depressive Disorder, Major, Electroconvulsive Therapy, Lithium Carbonate, venlafaxine