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

• ClinicalTrials.gov Identifier: NCT01305707
• Recruitment Status: Terminated
• First Posted: March 1, 2011
• Last Update Posted: August 31, 2015
• Sponsor: Hospital Universitari de Bellvitge
• Information provided by (Responsible Party): Mikel Urretavizcaya Sarachaga, Hospital Universitari de Bellvitge

Tracking Information

• First Submitted Date: February 28, 2011
• First Posted Date: March 1, 2011
• Last Update Posted Date: August 31, 2015
• Study Start Date: July 2009
• Actual Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 28, 2011)

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). ]

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.

• Original Primary Outcome Measures: Same as current
• Change History: Complete list of historical versions of study NCT01305707 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (submitted: August 28, 2015)

• Mini-Mental State Examination (MMSE 35) [ Time Frame: Basal, at 8 months and 12 months ]
  Assessment of general cognitive status.
• UKU - Adverse effects rating scales [ Time Frame: Every assessment (weekly, fortnightly, monthly and quarterly) till the month 15 of the follow-up. ]
  Qualitiative measure of side effects in each treatment group.
• Demographical Data Memory (MEDABI-20) [ Time Frame: Basal, at 8 months and 12 months ]
  Descriptive measure of cogntive status.
• Rey Figure [ Time Frame: Basal, at 8 months and 12 months ]
  Measure of visual perception, concentration and memory.
• Trail Making Test A [ Time Frame: Basal, at 8 months and 12 months ]
  Measure of attention and cognitive flexibility.
• Trail Making Test B [ Time Frame: Basal, at 8 months and 12 months ]
  Measure of attention and cognitive flexibility.
• Stroop Test [ Time Frame: Basal, at 8 months and 12 months ]
  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 ]
  Measure of general intelligence and attention
• Vocabulary WAIS (Weschler Adults Intelligence Scale) [ Time Frame: Basal ]
  Measure of general intelligence
• Frequency Hospitalization Quotient [ Time Frame: One year ]
  Measure of number of hospitalization per year.
• Hospital Day Quotient (HDQ) [ Time Frame: One year ]
  Number of days hospitalized per year.

Original Secondary Outcome Measures (submitted: February 28, 2011)

• Mini-Mental State Examination (MMSE 35) [ Time Frame: Basal, at 8 months and 12 months ]
  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. ]
  Qualitiative measure of side effects in each treatment group.
• Demographical Data Memory (MEDABI-20) [ Time Frame: Basal, at 8 months and 12 months ]
  Descriptive measure of cogntive status.
• Rey Figure [ Time Frame: Basal, at 8 months and 12 months ]
  Measure of visual perception, concentration and memory.
• Trail Making Test A [ Time Frame: Basal, at 8 months and 12 months ]
  Measure of attention and cognitive flexibility.
• Trail Making Test B [ Time Frame: Basal, at 8 months and 12 months ]
  Measure of attention and cognitive flexibility.
• Stroop Test [ Time Frame: Basal, at 8 months and 12 months ]
  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 ]
  Measure of general intelligence and attention
• Vocabulary WAIS (Weschler Adults Intelligence Scale) [ Time Frame: Basal ]
  Measure of general intelligence
• Frequency Hospitalization Quotient [ Time Frame: One year ]
  Measure of number of hospitalization per year.
• Hospital Day Quotient (HDQ) [ Time Frame: One year ]
  Number of days hospitalized per year.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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

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.

• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Prevention
• Condition: Depression

Intervention

• Device: 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.

  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
• 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

Study Arms

• Experimental: 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.
  Intervention: Device: C-ECT
• 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.
  Intervention: Drug: PHARMACOTHERAPY

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: February 28, 2011): 104
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: July 2014
• Actual Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Spain

Administrative Information

• NCT Number: NCT01305707
• Other Study ID Numbers: TECHUB2007
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Mikel Urretavizcaya Sarachaga, Hospital Universitari de Bellvitge
• Study Sponsor: Hospital Universitari de Bellvitge
• Collaborators: Not Provided

Investigators

• Principal Investigator: Mikel Urretavizcaya Sarachaga, MD, PhD; Hospital Universitari de Bellvitge, IDIBELL
• Principal Investigator: Èrika Martínez Amorós, MD; Corporacion Parc Tauli

• PRS Account: Hospital Universitari de Bellvitge
• Verification Date: August 2015