Resistant Major DepressionPhase 2DEPRESCONCT01428804
Study of Transcranial Direct Current Stimulation (tDCS) as add-on Treatment for Resistant Major Depression
A Phase 2 study testing transcranial Direct Current Stimulation (tDCS) in people with Resistant Major Depression, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
The purpose of the study is to investigate the effect of tDCS applied at the anodic left DLPFC of patients with resistant depression compared to patients treated with conventional therapy. The tDCS is used in add-on drug treatment with antidepressants of reference in resistant depression. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Resistant Major Depression
- What is being tested?
- transcranial Direct Current Stimulation (tDCS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2011to Jul 2013
- Phase
- Phase 2
- 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
- subject whose MDD are single or recurrent without psychotic features according to DSM-IV-TR
- subject with a diagnosis of resistant major depression (1 or 2 failed antidepressant treatments for the current depressive episode)
- MADRS score ≥ 25
- subjects with drug treatment by escitalopram (Seroplex®) for at least one month
- right-handed patients
- without severe progressive somatic pathology (especially tumor diseases, degenerative diseases)
- without severe cognitive impairment making psychometric evaluation impossible
- excepted antidepressant treatment, psychotropic following are tolerated during the course of the study : benzodiazepine anxiolytics (up to 20mg/day diazepam equivalent) ; hydroxyzine (up to 50 mg/day) ; cyamemazine (up to 50 mg/day) ; hypnotics (imidazopyridine up to 7.5 mg/day).
Who cannot join
- subject treated with antipsychotics or mood stabilizers
- subjects resistant to escitalopram (Seroplex®)
Trial locations and contacts
1 site in 1 country.
France1 site
CHU Besancon - Clinical Psychaitric Department
Besançon, France, 25000
About this study
Official title: Pilot Study of Feasibility of the Effect of Treatment With tDCS in Patients Suffering From Resistant Depression
The purpose of the study is to investigate the effect of tDCS applied at the anodic left DLPFC of patients with resistant depression compared to patients treated with conventional therapy. The tDCS is used in add-on drug treatment with antidepressants of reference in resistant depression.
Read the detailed description
The aim of our study is to investigate the effect of tDCS applied at the anodic left dorsolateral prefrontal cortex (DLPFC)of patients with resistant depression compared to patients treated with conventional therapy. The tDCS is used in add-on drug treatment with antidepressants of reference in resistant depression.
This is a randomized 2-arm parallel, double blind study comparing 2 groups of 12 patients: patients treated with sham tDCS and whose medication reference is stabilized for a month vs. patients treated by active tDCS 10 sessions over five days and whose medication reference is stabilized for a month. The 24 patients with resistant depression will be selected in the psychiatric department of the University Hospital of Besançon. After giving informed consent, patients will be evaluated by a psychiatrist using the Montgomery Asberg Depression Rating Scale (MADRS), the Hamilton Depression Rating Scale (HDRS), State-Trait Anxiety Inventory (STAI) and Beck Depression Inventory (BDI). The complete assessment takes 40 minutes.
After locating the left DLPFC, treatment with active tDCS with a current of 2 mA or sham will be directed by 20-minute session. A psychometric assessment will be conducted again at the end of treatment week and one month, three months and finally six months after stopping treatment. Scales of comfort and acceptability will also be proposed to the patient to determine whether any gene is caused by this treatment.
This study will include two parallel arms:
- a group named G1 and treated by medication with escitalopram (Seroplex®) stabilized for at least 1 month and 10 sessions of tDCS anode active at 2 sessions per day (1 morning and 1 afternoon) for 5 days with an electric current 2 mA;
- a group named G2 and treated by medication with escitalopram (Seroplex®) stabilized for at least 1 month and sham tDCS.
These two groups are matched for age (+/- 5 years) and gender. The population of this study will be comprised of patients over age 18 with unipolar depressive episode resistant episode characterized by the failure of two antidepressant treatments for depressive episode and treated by medication with escitalopram (Seroplex®) (20 mg/day), since at least 1 month. The delay of one month is a minimum to observe a non-response. Moreover, in term of ethical point of view, it's difficult to wait 6 to 8 weeks to observe the non-response to treatment.
These people will be recruited on a voluntary basis, after notification and consent in the research center, the Psychiatry Clinical Department of the University Hospital of Besançon. This study was conducted over a period of 15 months.
- Conditions
- Resistant Major Depression
- Being tested
- transcranial Direct Current Stimulation (tDCS)
- Keywords
- Resistant Major Depression, Mood disorders, tDCS
- Medical subject headings
- Mood Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial Direct Current Stimulation (tDCS)Device
Also called Eldith DC - Stimulator (neuroConn GmbH, Ilmenau, Germany)
Device: Eldith DC-Stimulator real or sham tDCS for 20 minutes at 2mA intensity over the left DLPFC (F3 according to the 10-20 system) Other Name: Eldith DC - Stimulator (neuroConn GmbH, Ilmenau, Germany)
| Study group | Role | What they receive |
|---|---|---|
| active tDCS | Active comparator | a group named G1 and treated by medication with escitalopram (Seroplex®) stabilized for at least 1 month and 10 sessions of tDCS anode active at 2 sessions per day (1 morning and 1 afternoon) for 5 days with an electric current 2 mA Receives: Device: transcranial Direct Current Stimulation (tDCS) |
| sham tDCS | Sham comparator | a group named G2 and treated by medication with escitalopram (Seroplex®) stabilized for at least 1 month and sham tDCS. Receives: Device: transcranial Direct Current Stimulation (tDCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
MADRS [time frame: baseline, 1 wk, 2 wk, 4wk, 12 wk, 24 wk]
The changes in MADRS will constitute the major research outcome measure used to assess response to tDCS
Measured: [time frame: baseline, 1 wk, 2 wk, 4wk, 12 wk, 24 wk]
Secondary outcomes (4)
HDRS-21
Measured: [time frame: baseline, 1 wk, 2 wk, 4wk, 12 wk, 24 wk]
BDI-13
Measured: [time frame: baseline, 1 wk, 2 wk, 4wk, 12 wk, 24 wk]
subscores for anxiety depression scale from HRDS-21
Measured: [time frame: baseline, 1 wk, 2 wk, 4wk, 12 wk, 24 wk]
STAI
Measured: [time frame: baseline, 1 wk, 2 wk, 4wk, 12 wk, 24 wk]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2011 (estimated)
- Study startJun 2011
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Resistant Major DepressionStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Collaborators
- H. Lundbeck A/S
- Responsible party
- Sponsor
- Investigators
- Emmanuel HAFFEN, Prof., Principal investigator, CHU Besancon - Clinical Psychiatric Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01428804
- Sponsor's protocol ID
- DEPRESCO
- Acronym
- DEPRESCO
- Status last verified
- Aug 2016
- First submitted
- 2 Sep 2011
- Last updated
- 23 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Bennabi D, Nicolier M, Monnin J, Tio G, Pazart L, Vandel P, Haffen E. Pilot study of feasibility of the effect of treatment with tDCS in patients suffering from treatment-resistant depression treated with escitalopram. Clin Neurophysiol. 2015 Jun;126(6):1185-1189. doi: 10.1016/j.clinph.2014.09.026. Epub 2014 Oct 5.
PubMed 25454337
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Feasibility of the Effect of Treatment With tDCS in Patients Suffering From Resistant Depression
- ClinicalTrials.gov ID
- NCT01428804
- Acronym / sponsor ID
- DEPRESCO / DEPRESCO
- Conditions
- Resistant Major Depression
- Keywords
- Resistant Major Depression, Mood disorders, tDCS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Collaborators
- H. Lundbeck A/S
- Study start
- Jun 2011
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 5 Sep 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.
The purpose of the study is to investigate the effect of tDCS applied at the anodic left DLPFC of patients with resistant depression compared to patients treated with conventional therapy. The tDCS is used in add-on drug treatment with antidepressants of reference in resistant depression.
Detailed description
The aim of our study is to investigate the effect of tDCS applied at the anodic left dorsolateral prefrontal cortex (DLPFC)of patients with resistant depression compared to patients treated with conventional therapy. The tDCS is used in add-on drug treatment with antidepressants of reference in resistant depression.
This is a randomized 2-arm parallel, double blind study comparing 2 groups of 12 patients: patients treated with sham tDCS and whose medication reference is stabilized for a month vs. patients treated by active tDCS 10 sessions over five days and whose medication reference is stabilized for a month. The 24 patients with resistant depression will be selected in the psychiatric department of the University Hospital of Besançon. After giving informed consent, patients will be evaluated by a psychiatrist using the Montgomery Asberg Depression Rating Scale (MADRS), the Hamilton Depression Rating Scale (HDRS), State-Trait Anxiety Inventory (STAI) and Beck Depression Inventory (BDI). The complete assessment takes 40 minutes.
After locating the left DLPFC, treatment with active tDCS with a current of 2 mA or sham will be directed by 20-minute session. A psychometric assessment will be conducted again at the end of treatment week and one month, three months and finally six months after stopping treatment. Scales of comfort and acceptability will also be proposed to the patient to determine whether any gene is caused by this treatment.
This study will include two parallel arms:
- a group named G1 and treated by medication with escitalopram (Seroplex®) stabilized for at least 1 month and 10 sessions of tDCS anode active at 2 sessions per day (1 morning and 1 afternoon) for 5 days with an electric current 2 mA;
- a group named G2 and treated by medication with escitalopram (Seroplex®) stabilized for at least 1 month and sham tDCS.
These two groups are matched for age (+/- 5 years) and gender. The population of this study will be comprised of patients over age 18 with unipolar depressive episode resistant episode characterized by the failure of two antidepressant treatments for depressive episode and treated by medication with escitalopram (Seroplex®) (20 mg/day), since at least 1 month. The delay of one month is a minimum to observe a non-response. Moreover, in term of ethical point of view, it's difficult to wait 6 to 8 weeks to observe the non-response to treatment.
These people will be recruited on a voluntary basis, after notification and consent in the research center, the Psychiatry Clinical Department of the University Hospital of Besançon. This study was conducted over a period of 15 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| active tDCS | Active comparator | Device: transcranial Direct Current Stimulation (tDCS)a group named G1 and treated by medication with escitalopram (Seroplex®) stabilized for at least 1 month and 10 sessions of tDCS anode active at 2 sessions per day (1 morning and 1 afternoon) for 5 days with an electric current 2 mA |
| sham tDCS | Sham comparator | Device: transcranial Direct Current Stimulation (tDCS)a group named G2 and treated by medication with escitalopram (Seroplex®) stabilized for at least 1 month and sham tDCS. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- subject whose MDD are single or recurrent without psychotic features according to DSM-IV-TR
- subject with a diagnosis of resistant major depression (1 or 2 failed antidepressant treatments for the current depressive episode)
- MADRS score ≥ 25
- subjects with drug treatment by escitalopram (Seroplex®) for at least one month
- right-handed patients
Key exclusion criteria (2 listed)
- subject treated with antipsychotics or mood stabilizers
- subjects resistant to escitalopram (Seroplex®)
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 |
|---|---|---|
| transcranial Direct Current Stimulation (tDCS)Also: Eldith DC - Stimulator (neuroConn GmbH, Ilmenau, Germany)Device: Eldith DC-Stimulator real or sham tDCS for 20 minutes at 2mA intensity over the left DLPFC (F3 according to the 10-20 system) Other Name: Eldith DC - Stimulator (neuroConn GmbH, Ilmenau, Germany) | Device | active tDCS, sham tDCS |
Primary outcome
MADRS [time frame: baseline, 1 wk, 2 wk, 4wk, 12 wk, 24 wk]
Time frame: [time frame: baseline, 1 wk, 2 wk, 4wk, 12 wk, 24 wk]
The changes in MADRS will constitute the major research outcome measure used to assess response to tDCS
4 secondary outcomes
HDRS-21
Time frame: [time frame: baseline, 1 wk, 2 wk, 4wk, 12 wk, 24 wk]
BDI-13
Time frame: [time frame: baseline, 1 wk, 2 wk, 4wk, 12 wk, 24 wk]
subscores for anxiety depression scale from HRDS-21
Time frame: [time frame: baseline, 1 wk, 2 wk, 4wk, 12 wk, 24 wk]
STAI
Time frame: [time frame: baseline, 1 wk, 2 wk, 4wk, 12 wk, 24 wk]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2016.
- Results publication: PubMed 25454337Bennabi D, Nicolier M, Monnin J, Tio G, Pazart L, Vandel P, Haffen E. Pilot study of feasibility of the effect of treatment with tDCS in patients suffering from treatment-resistant depression treated with escitalopram. Clin Neurophysiol. 2015 Jun;126(6):1185-1189. doi: 10.1016/j.clinph.2014.09.026. Epub 2014 Oct 5.
- Individual participant dataSharing planned: No
Related trials for Resistant Major Depression
RecruitingPhase 2
ACP-211 Monotherapy for Major Depressive Disorder With Inadequate Antidepressant Response
Major Depressive Disorder (MDD), Depressive Disorder, Treatment-Resistant
Active, not recruiting
rTMS to Target Neural Connectivity and Rumination in Treatment-Resistant Depression
Depression, Treatment Resistant
RecruitingObservational study
Natural History of Depression, Bipolar Disorder and Suicide Risk
Behavioral Symptoms, Suicide
Recruiting
EEG-Guided Transcranial Magnetic Stimulation for Adults With Depression
Major Depressive Disorder (MDD), Treatment Resistant Depression
Recruiting
Regulated Stimulation for Optimized Network Activity and Therapeutic Equilibrium
Major Depressive Disorder
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.
Emmanuel HAFFEN, Prof. principal investigator
CHU Besancon - Clinical Psychiatric Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing transcranial Direct Current Stimulation (tDCS) in people with Resistant Major Depression, run by Centre Hospitalier Universitaire de Besancon 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 8 inclusion and 2 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: finished, as of the sponsor's last update on 23 Aug 2016. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
MADRS [time frame: baseline, 1 wk, 2 wk, 4wk, 12 wk, 24 wk] (time frame: [time frame: baseline, 1 wk, 2 wk, 4wk, 12 wk, 24 wk]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01428804, which also lists 1 linked publication.
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 23 Aug 2016.