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

NCT01305707 | Terminated Phase 4

• 1 other identifier: TECHUB2007
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 3

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.

Conditions

Depression

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Hamilton Depression Rating Scale 21 items (HDRS-21)

  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.

  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 (11)

• Mini-Mental State Examination (MMSE 35)

  Basal, at 8 months and 12 months

• UKU - Adverse effects rating scales

  Every assessment (weekly, fortnightly, monthly and quarterly) till the month 15 of the follow-up.

• Demographical Data Memory (MEDABI-20)

  Basal, at 8 months and 12 months

• Rey Figure

  Basal, at 8 months and 12 months

• Trail Making Test A

  Basal, at 8 months and 12 months

Study Arms (2)

C-ECT and Pharmacotherapy

EXPERIMENTAL

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: C-ECT

Pharmacotherapy

ACTIVE COMPARATOR

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

Interventions

C-ECT 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.

Also known as: 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

C-ECT and Pharmacotherapy

PHARMACOTHERAPY 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.

Also known as: 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitari de Bellvitge: lead

Study Sites (3)

Hospital Universitari de Bellvitge, IDIBELL

Barcelona, Barcelona, 08907, Spain

Location

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Corporació Sanitària Parc Tauli

Sabadell, Barcelona, 08208, Spain

Location

MeSH Terms

Conditions

Depression

Interventions

Drug Therapy; Antidepressive Agents; Venlafaxine Hydrochloride; Duloxetine Hydrochloride; Imipramine; Clomipramine; Nortriptyline; Sertraline; Fluoxetine; Citalopram; Paroxetine; Escitalopram; Mirtazapine; Mianserin; Antipsychotic Agents; Quetiapine Fumarate; Aripiprazole; Lithium; Clorazepate Dipotassium; Lorazepam

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Therapeutics; Psychotropic Drugs; Central Nervous System Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Phenethylamines; Ethylamines; Amines; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Lipids; Thiophenes; Sulfur Compounds; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Dibenzocycloheptenes; Benzocycloheptenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; 1-Naphthylamine; Naphthalenes; Propylamines; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Piperidines; Tranquilizing Agents; Central Nervous System Depressants; Physiological Effects of Drugs; Dibenzothiazepines; Thiazepines; Thiepins; Piperazines; Quinolones; Quinolines; Metals, Alkali; Elements; Inorganic Chemicals; Metals, Light; Metals; Benzodiazepines; Benzazepines; Benzodiazepinones

Study Officials

• Mikel Urretavizcaya Sarachaga, MD, PhD

  Hospital Universitari de Bellvitge - IDIBELL

  PRINCIPAL INVESTIGATOR

• Èrika Martínez Amorós, MD

  Corporacion Parc Tauli

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Psychiatrist, MD, PhD

Study Record Dates

• First Submitted: February 28, 2011
• First Posted: March 1, 2011
• Study Start: July 1, 2009
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: August 31, 2015

Record last verified: 2015-08

Locations

ES (3)