Clinical trial NCT01305707: Continuation Electroconvulsive Therapy (C-ECT) for Relapse Prevention in Major Depression
Official title: Continuation Electroconvulsive Therapy Associated With Pharmacotherapy Versus Pharmacotherapy Alone for Relapse Prevention in Major Depression. A Clinical, Controlled, Prospective and Randomized Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Depression
Keywords: Consolidation ECT
Pharmacotherapy
Efficacy
Depression
Prevention
Electroconvulsive therapy
Drug therapy
Lead sponsor: Hospital Universitari de Bellvitge
Sponsor class: OTHER
First posted: 2011-03-01
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed description: Major Depressive Disorder (MDD) is a severe psychiatric disorder that affects more than 6 million people in our country and has a life prevalence of 8.9% for men and 16. 5% for women (Haro et al, 2007). Besides, in recent decades, its incidence is increasing (Kessler et al, 2004). MDD has high recurrence rates and 25% of the cases develop chronification. Moreover it can occur at any age leading to severe disability. The majority of studies published in this field demonstrated the efficacy of antidepressant treatment in a short or medium-term basis, but there is a lack of long-term clinical trials regarding antidepressant efficacy and published ones present methodological problems. At present, a line of fundamental research in therapeutics includes pragmatic studies because they can answer crucial and specific questions in clinical practice. Therefore, the aim of this project is to conduct a pragmatic, parallel, randomized trial with 2 treatment arms to answer a key question of great interest to psychiatrists: Is it more effective to extend the use of ECT as maintenance therapy (together with drug therapy) rather than just using drug therapy in patients that previously required an acute ECT course for a depressive episode? This study is a controlled randomized clinical trial that starts after the remission of the acute depressive episode. Once patients have clinically remitted they will be randomized in two groups:

1. C-ECT together with pharmacotherapy (same treatment used in the acute episode).
2. Maintenance pharmacotherapy treatment (same treatment used in the acute episode).

Consolidation treatment with ECT will be considered finished after 9 months of being started, at which time patients will stay only on the pharmacological treatment they already had. The study will be completed within 15 months of patient inclusion (six months after the end of C-ECT). Patient assessment and follow-up will be conducted by participant researchers. Blind rater will conduct clinical and adverse effects ratings. A neuropsychologist will conduct neuropsychological assessments.

Eligibility 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.

Primary outcomes:
measure: Hamilton Depression Rating Scale 21 items (HDRS-21)
timeFrame: One year. HDRS will be assessed in each follow-up visit (weekly the first month, fortnightly the second and third month, monthly the following 6 months and quarterly at 12 and 15 months).
Secondary outcomes:
measure: Mini-Mental State Examination (MMSE 35)
timeFrame: Basal, at 8 months and 12 months
measure: UKU - Adverse effects rating scales
timeFrame: Every assessment (weekly, fortnightly, monthly and quarterly) till the month 15 of the follow-up.
measure: Demographical Data Memory (MEDABI-20)
timeFrame: Basal, at 8 months and 12 months
measure: Rey Figure
timeFrame: Basal, at 8 months and 12 months
measure: Trail Making Test A
timeFrame: Basal, at 8 months and 12 months
measure: Trail Making Test B
timeFrame: Basal, at 8 months and 12 months
measure: Stroop Test
timeFrame: Basal, at 8 months and 12 months
measure: Direct and inverse digits (WAIS, Weschler Adults Intelligence Sacle).
timeFrame: Basal
measure: Vocabulary WAIS (Weschler Adults Intelligence Scale)
timeFrame: Basal
measure: Frequency Hospitalization Quotient
timeFrame: One year
measure: Hospital Day Quotient (HDQ)
timeFrame: One year
Other outcomes:
Locations:
city: Hospitalet de Llobregat
country: Spain
facility: Hospital Universitari de Bellvitge
state: Barcelona
city: Sabadell
country: Spain
facility: Corporació Sanitària Parc Tauli
state: Barcelona
city: Barcelona
country: Spain
facility: Hospital Universitari de Bellvitge, IDIBELL
Study officials:
affiliation: Hospital Universitari de Bellvitge - IDIBELL
name: Mikel Urretavizcaya Sarachaga, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Corporacion Parc Tauli
name: Èrika Martínez Amorós, MD
role: PRINCIPAL_INVESTIGATOR
References: