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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Hospital Universitari de Bellvitge.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Hospital Universitari de Bellvitge
ClinicalTrials.gov Identifier:
NCT01305707
First received: February 28, 2011
Last updated: NA
Last verified: February 2011
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Depression
Device: Thrymatron System IV device (CONSOLIDATION ELECTROCONVUsLIVE THERAPY) plus PHARMACOTHERAPY
Drug: PHARMACOTHERAPY
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Continuation Electroconvulsive Therapy Associated With Pharmacotherapy Versus Pharmacotherapy Alone for Relapse Prevention in Major Depression. A Clinical, Controlled, Prospective and Randomized Trial

Resource links provided by NLM:


Further study details as provided by Hospital Universitari de Bellvitge:

Primary Outcome Measures:
  • Hamilton Depression Rating Scale 21 items (HDRS-21) [ Time Frame: 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). ] [ Designated as safety issue: No ]
    HDRS-21 will measure the relapse year in each group. Relapse will be defined as the reappearance of relevant symptoms after resolutin of the acute episode, measured by a scoring in HDRS-21 between 15-17 over two following measures or a HDRS>18 score in a single measure.


Secondary Outcome Measures:
  • Mini-Mental State Examination (MMSE 35) [ Time Frame: Basal, at 8 months and 12 months ] [ Designated as safety issue: Yes ]
    Assessment of general cognitive status.

  • UKU - Adverse effects rating scales [ Time Frame: Every assessment (weekly, fortnightly, monthly and quarterly) till the end of follow-up. ] [ Designated as safety issue: Yes ]
    Qualitiative measure of side effects in each treatment group.

  • Demographical Data Memory (MEDABI-20) [ Time Frame: Basal, at 8 months and 12 months ] [ Designated as safety issue: Yes ]
    Descriptive measure of cogntive status.

  • Rey Figure [ Time Frame: Basal, at 8 months and 12 months ] [ Designated as safety issue: Yes ]
    Measure of visual perception, concentration and memory.

  • Trail Making Test A [ Time Frame: Basal, at 8 months and 12 months ] [ Designated as safety issue: Yes ]
    Measure of attention and cognitive flexibility.

  • Trail Making Test B [ Time Frame: Basal, at 8 months and 12 months ] [ Designated as safety issue: Yes ]
    Measure of attention and cognitive flexibility.

  • Stroop Test [ Time Frame: Basal, at 8 months and 12 months ] [ Designated as safety issue: Yes ]
    Measure of selective attention, cognitive flexibility and processing speed as well as executive function.

  • Direct and inverse digits (WAIS, Weschler Adults Intelligence Sacle). [ Time Frame: Basal ] [ Designated as safety issue: No ]
    Measure of general intelligence and attention

  • Vocabulary WAIS (Weschler Adults Intelligence Scale) [ Time Frame: Basal ] [ Designated as safety issue: No ]
    Measure of general intelligence

  • Frequency Hospitalization Quotient [ Time Frame: One year ] [ Designated as safety issue: No ]
    Measure of number of hospitalization per year.

  • Hospital Day Quotient (HDQ) [ Time Frame: One year ] [ Designated as safety issue: No ]
    Number of days hospitalized per year.


Estimated Enrollment: 104
Study Start Date: July 2009
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: C-ECT together with 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.
Device: Thrymatron System IV device (CONSOLIDATION ELECTROCONVUsLIVE THERAPY) plus PHARMACOTHERAPY

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.

Other 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
Active Comparator: 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.
Drug: 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.
Other Names:
  • 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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01305707

Contacts
Contact: Mikel Urretavizcaya Sarachaga, MD, PhD 0034932607661 murretavizcaya@bellvitgehospital.cat

Locations
Spain
Hospital Universitari de Bellvitge, IDIBELL Recruiting
L'Hospitalet de Llobregat, Barcelona, Spain, 08907
Contact: Veronica Galvez Ortiz, MD    0034932607922    vgalvez@bellvitgehospital.cat   
Sub-Investigator: Veronica Gálvez Ortiz, MD         
Sub-Investigator: Eva Real Barrero, MD         
Sub-Investigator: Nuria Custal Teixido, MD         
Sub-Investigator: Virginia Soria Tomas, MD, PhD         
Principal Investigator: Mikel Urretavizcaya Sarachaga, MD, PhD         
Corporació Sanitària Parc Tauli Not yet recruiting
Sabadell, Barcelona, Spain, 08208
Contact: Erika Martinez Amoros, MD    0034937231010    akirema22@hotmail.com   
Principal Investigator: Erika Martinez Amoros, MD         
Sub-Investigator: Juan D Barbero Valverde, MD         
Sub-Investigator: Gemma Garcia Pares, MD, PhD         
Sponsors and Collaborators
Hospital Universitari de Bellvitge
Investigators
Principal Investigator: Mikel Urretavizcaya Sarachaga, MD, PhD Hospital Universitari de Bellvitge, IDIBELL
Principal Investigator: Èrika Martínez Amorós, MD Corporacion Parc Tauli
  More Information

No publications provided

Responsible Party: Mikel Urretavizcaya Sarachaga, Hospital Universitari de Bellvitge, IDIBELL
ClinicalTrials.gov Identifier: NCT01305707     History of Changes
Other Study ID Numbers: TECHUB2007
Study First Received: February 28, 2011
Last Updated: February 28, 2011
Health Authority: Agency of Medicines and Sanitary Products: Spain
European Medicines Agency: Europe

Keywords provided by Hospital Universitari de Bellvitge:
Consolidation ECT
Pharmacotherapy
Efficacy
Depression
Prevention
Electroconvulsive therapy
Drug therapy

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Clomipramine
Imipramine
Nortriptyline
Mirtazapine
Citalopram
Fluoxetine
Paroxetine
Sertraline
Venlafaxine
Olanzapine
Duloxetine
Antidepressive Agents
Mianserin
Dexetimide
Clorazepate Dipotassium
Diazepam
Lorazepam
Risperidone
Quetiapine
Aripiprazole
Antipsychotic Agents
Antidepressive Agents, Tricyclic
Psychotropic Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 17, 2014