drugset / Trial / NCT01305707

Continuation Electroconvulsive Therapy (C-ECT) for Relapse Prevention in Major Depression

NCT01305707

Phase 4 Terminated 104 enrolled Hospital Universitari de Bellvitge
RandomizedParallel-groupSingle-blindPrevention

Summary

OBJECTIVES: To evaluate the comparative efficacy and security of Continuation Electroconvulsive Therapy associated with pharmacotherapy versus pharmacotherapy alone in the prevention of depressive relapse. METHODS: Demographic and clinical variables will be collected and side effects scales and neurocognitive battery will be performed. Variables of efficacy: relapse percentage in both groups in one year (primary variable); time without relapse. Main variable of security: occurrence of side effects and neurocognitive performance. DESIGN: Randomized controlled clinical trial. SAMPLE: 104 outpatients diagnosed with unipolar depression (DSM-IV-R criteria) who had remitted with a course of bilateral ECT. They will be randomized to two groups of treatment. SETTING: Psychiatry Department at Bellvitge University Hospital. ANALYSIS: Descriptive analysis of clinical variables; survive analysis and Cox model of regression.

Timeline

Start
2009-07
Primary completion
2014-07
Completion
2014-07

Drugs

EvaluationDrugModalityDoseRoute
Comparator Aripiprazole Other / unclassified 5 mg
Comparator Aripiprazole Other / unclassified 30 mg
Comparator Citalopram Small molecule 20 mg
Comparator Citalopram Small molecule 60 mg
Comparator Clomipramine Small molecule 75 mg
Comparator Clomipramine Small molecule 225 mg
Comparator Clorazepate Small molecule 5 mg
Comparator Clorazepate Small molecule 50 mg
Comparator Diazepam Small molecule 2.5 mg
Comparator Diazepam Small molecule 50 mg
Comparator Duloxetine Small molecule 60 mg
Comparator Duloxetine Small molecule 120 mg
Comparator Escitalopram Small molecule 10 mg
Comparator Escitalopram Small molecule 20 mg
Comparator Fluoxetine Small molecule 20 mg
Comparator Fluoxetine Small molecule 40 mg
Comparator Imipramine Small molecule 100 mg
Comparator Imipramine Small molecule 300 mg
Comparator Lithium Unknown 200 mg
Comparator Lithium Unknown 1200 mg
Comparator Lorazepam Small molecule 1 mg
Comparator Lorazepam Small molecule 10 mg
Comparator Mianserin Small molecule 10 mg
Comparator Mianserin Small molecule 60 mg
Comparator Mirtazapine Other / unclassified 15 mg
Comparator Mirtazapine Other / unclassified 45 mg
Comparator Nortriptyline Small molecule 75 mg
Comparator Nortriptyline Small molecule 200 mg
Comparator Olanzapine Small molecule 2.5 mg
Comparator Olanzapine Small molecule 20 mg
Comparator Paroxetine Small molecule 20 mg
Comparator Paroxetine Small molecule 40 mg
Comparator Quetiapine Small molecule 50 mg
Comparator Quetiapine Small molecule 600 mg
Comparator Reboxetin Unknown 2 mg
Comparator Reboxetin Unknown 12 mg
Comparator Risperidone Other / unclassified 0.5 mg
Comparator Risperidone Other / unclassified 9 mg
Comparator Sertraline Small molecule 50 mg
Comparator Sertraline Small molecule 200 mg
Comparator Trazadone Unknown 50 mg
Comparator Trazadone Unknown 200 mg
Comparator Venlafaxine Small molecule 75 mg
Comparator Venlafaxine Small molecule 225 mg