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

NCT ID: NCT01305707

Last Updated: 2015-08-31

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2014-07-31

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.

Conditions

Depression

Keywords

Consolidation ECT; Pharmacotherapy; Efficacy; Depression; Prevention; Electroconvulsive therapy; Drug therapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

C-ECT and Pharmacotherapy

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.

Group Type: EXPERIMENTAL

C-ECT

Intervention Type: DEVICE

C-ECT will be administered through a Thrymatron System IV device (Somatics, LLC, ISO 13485:2003). Electrode placement will be bilateral and energy administered during consolidation treatment will be same used in the acute episode. C-ECT will be given weekly for the first month, fortnightly for the following two months and monthly during the next 6 months. A total of 14 C-ECT sessions will be given over 9 months of treatment.

Pharmacotherapy will remain unchanged since the acute episode to the end of the study. Drugs will be obtained as usually from the National Health System and will be prescribed according to data sheet and it will have a duration of 15 months.

Pharmacotherapy

Pharmacotherapy will remain unchanged since the acute episode to the end of the study. Psychotropics will be obtained as usually from the National Health System and will be prescribed according to data sheet.

Group Type: ACTIVE_COMPARATOR

PHARMACOTHERAPY

Intervention Type: DRUG

Pharmacotherapy will remain unchanged since the acute episode to the end of the study. Psychotropics will be obtained as usually from the National Health System and will be prescribed according to data sheet and will have a 15 month duration.

Interventions

C-ECT

C-ECT will be administered through a Thrymatron System IV device (Somatics, LLC, ISO 13485:2003). Electrode placement will be bilateral and energy administered during consolidation treatment will be same used in the acute episode. C-ECT will be given weekly for the first month, fortnightly for the following two months and monthly during the next 6 months. A total of 14 C-ECT sessions will be given over 9 months of treatment.

Pharmacotherapy will remain unchanged since the acute episode to the end of the study. Drugs will be obtained as usually from the National Health System and will be prescribed according to data sheet and it will have a duration of 15 months.

Intervention Type: DEVICE

PHARMACOTHERAPY

Pharmacotherapy will remain unchanged since the acute episode to the end of the study. Psychotropics will be obtained as usually from the National Health System and will be prescribed according to data sheet and will have a 15 month duration.

Intervention Type: DRUG

Other Intervention Names

Thrymatron System IV device (Somatics, LLC, ISO 13485:2003).; Pharmacotherapy: Antidepressants: - Venlafaxine 75-225 mg/d. N06AX16; - Duloxetine 60-120 mg/d. N06AX21; - Imipramine 100-300 mg/d. N06AA02; - Clomipramine 75-225 mg/d. N06AA04; - Nortriptyline 75-200 mg/d. 906AA10; - Sertraline 50-200 mg/d. N06AB06; -Fluoxetine 20-40 mg/d. N06AB03; - Citalopram 20-60 mg/d. N06AB04; - Paroxetine 20-40 mg/d. N06AB05; - Escitalopram 10-20 mg/d. N06AB10; - Mirtazapine 15-45 mg/d. N06AX11; - Mianserin 10-60 mg/d. 906AX03; - Trazadone 50-200 mg/d. 906AX05; - Reboxetin 2-12 mg/d. N06AX18; Antipsychotic drugs; - Olanzapine 2'5-20 mg/d. N05AH03; - Risperidone 0'5-9 mg/d. N05AX08; - Quetiapine 50-600 mg/d. N05AH04; - Aripiprazole 5-30 mg/d. N05AX12; Lithium: 200-1200 mg/d. 905AN01; Anxyiolitics: - Diazepam 2'5-50 mg/d. N05BA01; - Clorazepate 5-50 mg/d. N05BA05; - Lorazepam 1-10 mg/d. N05BA06; Pharmacotherapy: Antidepressants: - Venlafaxine 75-225 mg/d. N06AX16; - Duloxetine 60-120 mg/d. N06AX21; - Imipramine 100-300 mg/d. N06AA02; - Clomipramine 75-225 mg/d. N06AA04; - Nortriptyline 75-200 mg/d. 906AA10; - Sertraline 50-200 mg/d. N06AB06; -Fluoxetine 20-40 mg/d. N06AB03; - Citalopram 20-60 mg/d. N06AB04; - Paroxetine 20-40 mg/d. N06AB05; - Escitalopram 10-20 mg/d. N06AB10; - Mirtazapine 15-45 mg/d. N06AX11; - Mianserin 10-60 mg/d. 906AX03; - Trazadone 50-200 mg/d. 906AX05; - Reboxetin 2-12 mg/d. N06AX18; Antipsychotic drugs; - Olanzapine 2'5-20 mg/d. N05AH03; - Risperidone 0'5-9 mg/d. N05AX08; - Quetiapine 50-600 mg/d. N05AH04; - Aripiprazole 5-30 mg/d. N05AX12; Lithium: 200-1200 mg/d. 905AN01; Anxyiolitics: - Diazepam 2'5-50 mg/d. N05BA01; - Clorazepate 5-50 mg/d. N05BA05; - Lorazepam 1-10 mg/d. N05BA06

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Universitari de Bellvitge

OTHER

Sponsor Role: lead

Responsible Party

Mikel Urretavizcaya Sarachaga

Psychiatrist, MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mikel Urretavizcaya Sarachaga, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitari de Bellvitge - IDIBELL

Èrika Martínez Amorós, MD

Role: PRINCIPAL_INVESTIGATOR

Corporacion Parc Tauli

Locations

Hospital Universitari de Bellvitge, IDIBELL

Barcelona, Barcelona, Spain

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain

Corporació Sanitària Parc Tauli

Sabadell, Barcelona, Spain

Countries

Spain

Other Identifiers

TECHUB2007

Identifier Type: -

Identifier Source: org_study_id