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

• Status: Terminated
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital Universitari de Bellvitge
• Treatments: Antidepressive Agents; Antipsychotic Agents; Aripiprazole; Citalopram; Clomipramine; Clorazepate Dipotassium; Dexetimide; Diazepam; Duloxetine Hydrochloride; Fluoxetine; Imipramine; Lithium Carbonate; Lorazepam; Mianserin; Mirtazapine; Nortriptyline; Olanzapine; Paroxetine; Quetiapine Fumarate; Risperidone; Sertraline; Venlafaxine Hydrochloride

Criteria

Inclusion Criteria:

• MDD diagnosis by DSM IV-TR.

• ECT requirement during acute episode. Therapeutic indication will be based on clinical criteria, following APA guidelines. During the acute episode, patients will be controlled by the usual clinical care team.

• Complete clinical remission (HDRS < or = 7 across two weeks).

• Appropriate intellectual level that allows adequate communication.

• Women of childbearing potential must use contraceptive methods.

• Signed Consent form.

• Other axis I or II diagnosis by DSM-IV-TR, except for nicotine dependence.

• To be in maintenance ECT program.

• To receive ECT during the previous three months of the acute episode.

• Pregnancy or breastfeeding.

Exclusion Criteria:

• Other axis I or II diagnosis by DSM-IV-TR, except for nicotine dependence.

• To be in maintenance ECT program.

• To receive ECT during the previous three months of the acute episode.

• Pregnancy or breastfeeding.