DepressionPhase 4NCT01305707
Continuation Electroconvulsive Therapy (C-ECT) for Relapse Prevention in Major Depression
A Phase 4 study testing C-ECT and PHARMACOTHERAPY in people with Depression, run by Hospital Universitari de Bellvitge at 3 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression
- What is being tested?
- C-ECT and PHARMACOTHERAPY
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 3 sitesSpain
- Study dates
- Jul 2009to Jul 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 10Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
Spain3 sites
Hospital Universitari de Bellvitge, IDIBELL
Barcelona, Barcelona, 08907
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907
Corporació Sanitària Parc Tauli
Sabadell, Barcelona, 08208
About this study
Official title: Continuation Electroconvulsive Therapy Associated With Pharmacotherapy Versus Pharmacotherapy Alone for Relapse Prevention in Major Depression. A Clinical, Controlled, Prospective and Randomized Trial
OBJECTIVES:
To evaluate the comparative efficacy and security of Continuation Electroconvulsive Therapy associated with pharmacotherapy versus pharmacotherapy alone in the prevention of depressive relapse.
Read more
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.
Read the 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:
- C-ECT together with pharmacotherapy (same treatment used in the acute episode).
- 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
- Being tested
- C-ECT, PHARMACOTHERAPY
- Keywords
- Consolidation ECT, Pharmacotherapy, Efficacy, Depression, Prevention, Electroconvulsive therapy, Drug therapy
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C-ECTDevice
Also called Thrymatron System IV device (Somatics, LLC, ISO 13485:2003)., Pharmacotherapy:, Antidepressants:, - Venlafaxine 75-225 mg/d. N06AX16
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.
PHARMACOTHERAPYDrug
Also called Pharmacotherapy:, Antidepressants:, - Venlafaxine 75-225 mg/d. N06AX16, - Duloxetine 60-120 mg/d. N06AX21
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: PHARMACOTHERAPY |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Assessment of general cognitive status.
Measured: Basal, at 8 months and 12 months
UKU - Adverse effects rating scales
Qualitiative measure of side effects in each treatment group.
Measured: Every assessment (weekly, fortnightly, monthly and quarterly) till the month 15 of the follow-up.
Demographical Data Memory (MEDABI-20)
Descriptive measure of cogntive status.
Measured: Basal, at 8 months and 12 months
Rey Figure
Measure of visual perception, concentration and memory.
Measured: Basal, at 8 months and 12 months
Trail Making Test A
Measure of attention and cognitive flexibility.
Measured: Basal, at 8 months and 12 months
Trail Making Test B
Measure of attention and cognitive flexibility.
Measured: Basal, at 8 months and 12 months
Stroop Test
Measure of selective attention, cognitive flexibility and processing speed as well as executive function.
Measured: Basal, at 8 months and 12 months
Direct and inverse digits (WAIS, Weschler Adults Intelligence Sacle).
Measure of general intelligence and attention
Measured: Basal
Vocabulary WAIS (Weschler Adults Intelligence Scale)
Measure of general intelligence
Measured: Basal
Frequency Hospitalization Quotient
Measure of number of hospitalization per year.
Measured: One year
Hospital Day Quotient (HDQ)
Number of days hospitalized per year.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2011 (estimated)
- Study startJul 2009
- Primary completionJul 2014
- Study completionJul 2014
Why it stopped: Difficulties in recruiting
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitari de Bellvitge
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mikel Urretavizcaya Sarachaga, Hospital Universitari de Bellvitge
- Investigators
- Mikel Urretavizcaya Sarachaga, MD, PhD, Principal investigator, Hospital Universitari de BellvitgeÈrika Martínez Amorós, MD, Principal investigator, Corporacion Parc Tauli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01305707
- Sponsor's protocol ID
- TECHUB2007
- Status last verified
- Aug 2015
- First submitted
- 28 Feb 2011
- Last updated
- 31 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuation Electroconvulsive Therapy Associated With Pharmacotherapy Versus Pharmacotherapy Alone for Relapse Prevention in Major Depression. A Clinical, Controlled, Prospective and Randomized Trial
- ClinicalTrials.gov ID
- NCT01305707
- Acronym / sponsor ID
- TECHUB2007
- Conditions
- Depression
- Keywords
- Consolidation ECT, Pharmacotherapy, Efficacy, Depression, Prevention, Electroconvulsive therapy, Drug therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulties in recruiting
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Hospital Universitari de BellvitgeUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 1 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- C-ECT together with pharmacotherapy (same treatment used in the acute episode).
- 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| C-ECT and Pharmacotherapy | Experimental | Device: C-ECTConsolidation 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. |
| Pharmacotherapy | Active comparator | Drug: PHARMACOTHERAPYPharmacotherapy 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| C-ECTAlso: Thrymatron System IV device (Somatics, LLC, ISO 13485:2003)., Pharmacotherapy:, Antidepressants:, - Venlafaxine 75-225 mg/d. N06AX16C-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. | Device | C-ECT and Pharmacotherapy |
| PHARMACOTHERAPYAlso: Pharmacotherapy:, Antidepressants:, - Venlafaxine 75-225 mg/d. N06AX16, - Duloxetine 60-120 mg/d. N06AX21Pharmacotherapy 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. | Drug | Pharmacotherapy |
Primary outcome
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.
11 secondary outcomes
Mini-Mental State Examination (MMSE 35)
Time frame: Basal, at 8 months and 12 months
UKU - Adverse effects rating scales
Time frame: Every assessment (weekly, fortnightly, monthly and quarterly) till the month 15 of the follow-up.
Demographical Data Memory (MEDABI-20)
Time frame: Basal, at 8 months and 12 months
Rey Figure
Time frame: Basal, at 8 months and 12 months
Trail Making Test A
Time frame: Basal, at 8 months and 12 months
Trail Making Test B
Time frame: Basal, at 8 months and 12 months
Stroop Test
Time frame: Basal, at 8 months and 12 months
Direct and inverse digits (WAIS, Weschler Adults Intelligence Sacle).
Time frame: Basal
Vocabulary WAIS (Weschler Adults Intelligence Scale)
Time frame: Basal
Frequency Hospitalization Quotient
Time frame: One year
Hospital Day Quotient (HDQ)
Time frame: One year
Results and safety
The study was stopped early (reason given: Difficulties in recruiting). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mikel Urretavizcaya Sarachaga, MD, PhD principal investigator
Hospital Universitari de Bellvitge
Èrika Martínez Amorós, MD principal investigator
Corporacion Parc Tauli
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing C-ECT and PHARMACOTHERAPY in people with Depression, run by Hospital Universitari de Bellvitge at 3 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 31 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Difficulties in recruiting). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2015.