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

Outcome

Outcome not reported

Stopped (Enrollment): “Difficulties in recruiting”

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 —