DepressionNCT02886858
tDCS in the Prevention of Relapse After Electroconvulsive Therapy
A study testing Device : Transcranial direct current stimulation in people with Depression, run by Hôpital le Vinatier at 1 site in France.
Trial summary
While electroconvulsive therapy (ECT) in major depression is effective, high relapse rates and cognitive side effects limit its long-term use. There is no consensus about optimal continuation pharmacological treatments after a ECT course. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Depression
- What is being tested?
- Device : Transcranial direct current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 1 siteFrance
- Study dates
- 13 Feb 2017to 19 Apr 2019
- Phase
- Interventional
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-75 ans
- Remission (MADRS <10) of a major depressive episode after acute treatment with ECT + venlafaxine
- Lithium adjunction 48h after the last ECT session
- No comorbid psychiatric disorder, excluding personality disorder or nicotine dependance.
- Capacity to consent
- Sufficient comprehension of the French language
Who cannot join
- Contra-indications to tDCS
- Neurologic conditions
- Severe medical conditions.
- Pregnancy/breast-feeding.
- Current use of benzodiazepines or antipsychotics
Trial locations and contacts
1 site in 1 country.
About this study
Official title: tDCS as Continuation Treatment to Sustain Remission After Electroconvulsive Therapy in Depression
While electroconvulsive therapy (ECT) in major depression is effective, high relapse rates and cognitive side effects limit its long-term use. There is no consensus about optimal continuation pharmacological treatments after a ECT course.
Adjunction of tDCS to pharmacological continuation treatment after ECT may decrease relapse rates.
Read the detailed description
In a prospective, randomized, double blind, controlled, long-term study, investigators assign 40 depressed patients, in remission after ECT course associated to venlafaxine, with lithium adjunction after ECT course, either to tDCS or sham tDCS. Depressive symptoms and cognition were assessed after acute ECT after six months of continuation therapy.
- Conditions
- Depression
- Being tested
- Device : Transcranial direct current stimulation, Device : sham Transcranial direct current stimulation
- Keywords
- Depression, Moods disorders, electroconvulsive therapy
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Device : Transcranial direct current stimulationDevice
The anode will be applied over the F3 area and the cathode over the F4 area. The current dose is 2mA. Electrodes will be 7x5cm in size. The investigators will apply 2 daily, tDCS sessions of 30 minutes, weekly the first month, fortnightly the second and third month, monthly the following 3 months.
Device : sham Transcranial direct current stimulationDevice
The anode will be applied over the F3 area and the cathode over the F4 area. Electrodes will be 7x5cm in size. The investigators will apply 2 daily, tDCS sessions of 30 minutes, weekly the first month, fortnightly the second and third month, monthly the following 3 months.
| Study group | Role | What they receive |
|---|---|---|
| tDCS | Experimental | The anode will be applied over the F3 area and the cathode over the F4 area. The current dose is 2mA. Electrodes will be 7x5cm in size. The investigators will apply 2 daily, tDCS sessions of 30 minutes, weekly the first month, fortnightly the second and third month, monthly the following 3 months. Receives: Device: Device : Transcranial direct current stimulation |
| Sham tDCS | Sham comparator | The anode will be applied over the F3 area and the cathode over the F4 area. Electrodes will be 7x5cm in size. The investigators will apply 2 daily, tDCS sessions of 30 minutes, weekly the first month, fortnightly the second and third month, monthly the following 3 months. Receives: Device: Device : sham Transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse rate 6 months after remission, defined as the reappearance of a depressive syndrome, measured by a scoring MADRS >15.
MADRS will be assessed in each follow-up visit (weekly the first month, fortnightly the second and third month, monthly the following 3 months).
Measured: 6 months
Secondary outcomes (3)
Montreal Cognitive Assesment (MoCA)
Measured: basal and at 6 months
Scores on Clinical Global Impression (CGI)
Measured: after remission basal and at 6 months
Time to relapse
Measured: during 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2016 (estimated)
- Study start13 Feb 2017
- Primary completion19 Apr 2019
- Study completion19 Apr 2019
Why it stopped: investigator and sponsor decided by mutual agreement to stop study prematurely
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.
- More trials run by Hôpital le VinatierThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital le Vinatier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- GALVAO FILIPE, PH, Principal investigator, CH LE VINATIER
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02886858
- Sponsor's protocol ID
- 2016-A00824-47
- Status last verified
- Apr 2019
- First submitted
- 29 Aug 2016
- Last updated
- 22 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- tDCS as Continuation Treatment to Sustain Remission After Electroconvulsive Therapy in Depression
- ClinicalTrials.gov ID
- NCT02886858
- Acronym / sponsor ID
- 2016-A00824-47
- Conditions
- Depression
- Keywords
- Depression, Moods disorders, electroconvulsive therapy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: investigator and sponsor decided by mutual agreement to stop study prematurely
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Hôpital le VinatierUniversity, hospital or other
- Study start
- 13 Feb 2017 (actual)
- Primary completion
- 19 Apr 2019 (actual)
- Study completion
- 19 Apr 2019 (actual)
- First posted
- 1 Sep 2016 (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.
While electroconvulsive therapy (ECT) in major depression is effective, high relapse rates and cognitive side effects limit its long-term use. There is no consensus about optimal continuation pharmacological treatments after a ECT course.
Adjunction of tDCS to pharmacological continuation treatment after ECT may decrease relapse rates.
Detailed description
In a prospective, randomized, double blind, controlled, long-term study, investigators assign 40 depressed patients, in remission after ECT course associated to venlafaxine, with lithium adjunction after ECT course, either to tDCS or sham tDCS. Depressive symptoms and cognition were assessed after acute ECT after six months of continuation therapy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tDCS | Experimental | Device: Device : Transcranial direct current stimulationThe anode will be applied over the F3 area and the cathode over the F4 area. The current dose is 2mA. Electrodes will be 7x5cm in size. The investigators will apply 2 daily, tDCS sessions of 30 minutes, weekly the first month, fortnightly the second and third month, monthly the following 3 months. |
| Sham tDCS | Sham comparator | Device: Device : sham Transcranial direct current stimulationThe anode will be applied over the F3 area and the cathode over the F4 area. Electrodes will be 7x5cm in size. The investigators will apply 2 daily, tDCS sessions of 30 minutes, weekly the first month, fortnightly the second and third month, monthly the following 3 months. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18-75 ans
- Remission (MADRS <10) of a major depressive episode after acute treatment with ECT + venlafaxine
- Lithium adjunction 48h after the last ECT session
- No comorbid psychiatric disorder, excluding personality disorder or nicotine dependance.
- Capacity to consent
Key exclusion criteria (5 listed)
- Contra-indications to tDCS
- Neurologic conditions
- Severe medical conditions.
- Pregnancy/breast-feeding.
- Current use of benzodiazepines or antipsychotics
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 |
|---|---|---|
| Device : Transcranial direct current stimulationThe anode will be applied over the F3 area and the cathode over the F4 area. The current dose is 2mA. Electrodes will be 7x5cm in size. The investigators will apply 2 daily, tDCS sessions of 30 minutes, weekly the first month, fortnightly the second and third month, monthly the following 3 months. | Device | tDCS |
| Device : sham Transcranial direct current stimulationThe anode will be applied over the F3 area and the cathode over the F4 area. Electrodes will be 7x5cm in size. The investigators will apply 2 daily, tDCS sessions of 30 minutes, weekly the first month, fortnightly the second and third month, monthly the following 3 months. | Device | Sham tDCS |
Primary outcome
Relapse rate 6 months after remission, defined as the reappearance of a depressive syndrome, measured by a scoring MADRS >15.
Time frame: 6 months
MADRS will be assessed in each follow-up visit (weekly the first month, fortnightly the second and third month, monthly the following 3 months).
3 secondary outcomes
Montreal Cognitive Assesment (MoCA)
Time frame: basal and at 6 months
Scores on Clinical Global Impression (CGI)
Time frame: after remission basal and at 6 months
Time to relapse
Time frame: during 6 months
Results and safety
The study was stopped early (reason given: investigator and sponsor decided by mutual agreement to stop study prematurely). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2019.
- Individual participant dataSharing planned: No
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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.
GALVAO FILIPE, PH principal investigator
CH LE VINATIER
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Device : Transcranial direct current stimulation in people with Depression, run by Hôpital le Vinatier at 1 site in France.
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 6 inclusion and 5 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 22 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: investigator and sponsor decided by mutual agreement to stop study prematurely). 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?
Relapse rate 6 months after remission, defined as the reappearance of a depressive syndrome, measured by a scoring MADRS >15. (time frame: 6 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 22 Apr 2019.