Resistant DepressionPhase 2STICODEPNCT01644747
tDCS as an add-on Treatment for Resistant Major Depression in Uni- or Bipolar Patients
A Phase 2 study testing transcranial Direct Current Stimulation (tDCS) (Eldith DC NeuroConn Stimulator) in people with Resistant Depression and Moods Disorders, run by Centre Hospitalier Universitaire de Besancon at 6 sites in France.
Trial summary
The aim is to investigate the effect of transcranial Direct Current Stimulation (tDCS) applied at the anodal left CDLPF of patients with resistant depression compared to patients treated with conventional therapy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Resistant Depression, Moods Disorders, Unipolar Depression
- What is being tested?
- transcranial Direct Current Stimulation (tDCS) (Eldith DC NeuroConn Stimulator)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 87 participants
- Where
- 6 sitesFrance
- Study dates
- 19 Jul 2012to 1 Mar 2022
- 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 to 65 years
- 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 failed antidepressant treatments for the current depressive episode)
- HDRS-21 score ≥ 21
- drug treatment by SSRIs or SNRIs for unipolar patients or with Lithium for bipolar patients for at least 4 weeks
- right-handed patients
- without severe progressive somatic pathology (especially tumor diseases, degenerative diseases)
- without severe cognitive impairment making psychometric evaluation impossible
- excepted antidepressant or Lithium treatment, psychotropic following are tolerated during the course of the study : hydroxyzin; cyamemazin (up to 100 mg/day) ; hypnotics (imidazopyridin).
Who cannot join
- subject treated with antipsychotics or mood stabilizers or anticonvulsants or by ECT or rTMS for the current depressive episode
- subject resistant to SSRIs or SNRIs for unipolar patients or with Lithium for bipolar patients
- subject with mixed features
- pregnancy and/or lactation
- presence of a specific contraindication for tDCS (e.g., personal history of epilepsy, metallic head implant, cardiac pacemaker)
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
CHRU Besancon - Service de Psychiatrie - Centre Investigation Clinique Innovation Technologique (CIC-IT808)
Besançon
CHU Grenoble - Clinique de Psychiatrie de l'Adulte
Grenoble
CH Le Vinatier - Service de Psychiatrie
Lyon
Centre Hospitalier Guillaume Régnier - Rennes - Service Hospitalo-Universitaire de Psychiatrie
Rennes
Hôpital Civil de Strasbourg - Service de Psychiatrie
Strasbourg
Etablissement Public de Santé Mentale - Unité de Recherche Clinique
Ville Evrard
About this study
Official title: tDCS as an add-on Treatment for Resistant Major Depression in Uni- or Bipolar Patients: a Randomized, Double-blind, Placebo Controlled Study
The aim is to investigate the effect of transcranial Direct Current Stimulation (tDCS) applied at the anodal left CDLPF of patients with resistant depression compared to patients treated with conventional therapy. The tDCS is used in add-on drug treatment in resistant depression stabilized for 4 weeks (antidepressant as SSRIs (Selective Serotonin Reuptake Inhibitors) or SNRIs (Serotonine-Norepinephrine Reuptake Inhibitors) for unipolar patients and lithium for bipolar patients). The delay of 4 weeks 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.
This is a randomized 2-arm parallel, double blind study comparing 2 groups of 60 patients (48 unipolar plus 12 bipolar patients per group. Patients will be selected in the psychiatric department of the University Hospital of different centers and the two groups are matched for age (+/- 5 years), gender and depression diagnosis (unipolar vs bipolar).
Read more
After giving informed consent, patients will be evaluated by a psychiatrist using the Hamilton Depression Rating Scale (HDRS), Montgomery Asberg Depression Rating Scale (MADRS), the STAI and Beck Depression Inventory (BDI) and for bipolar patient only, by the Young Mania Rating Scale (YMRS). The complete assessment takes 50 minutes. A neuropsychologist assessment will be also realized during 20 minutes using the Crossing of Test (COT), the Trail Making Test (TMT), the Isaacs Set Test (IST) and the Cardebat fluency Task.
After locating the left DLPFC, treatment with active tDCS with a current of 2 mA or sham will be directed by 30-minute session. A psychometric assessment will be conducted again at the end of treatment week and 4, 12 and finally 24 weeks after stopping treatment. The neuropsychologist assessment will be conducted again 4 weeks after the end of treatment. Scales of comfort and acceptability will also be proposed to the patient to determine whether any gene is caused by this treatment.
These people will be recruited on a voluntary basis, after notification and consent in the 6 research centers. This study was conducted over a period of 36 months.
This study was supporting by a grant from the French Hospital Program of Clinical Reseach (PHRC N/2011-60-2011-A01074-37)
- Being tested
- transcranial Direct Current Stimulation (tDCS) (Eldith DC NeuroConn Stimulator)
- Keywords
- Resistant Depression, Moods disorders, Unipolar depression, Bipolar disorder, tDCS
- Medical subject headings
- Depressive Disorder, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial Direct Current Stimulation (tDCS) (Eldith DC NeuroConn Stimulator)Device
Also called EldithDC-NeuroConn Stimulator (NeuroConn Gmbh, Ilmenau, Germany)
After locating the left DLPFC, ttt with active anodal tDCS with a current of 2 mA or sham over the left DLPFC will be directed by 30-minute session. Treatment will occur 2 sessions per day during 5 days per week. Subjects will be monitored during tDCS for any side effects or adverse events.
| Study group | Role | What they receive |
|---|---|---|
| active tDCS | Active comparator | a group named G1 and treated by medication with SSRIs (Selective Serotonin Reuptake Inhibitors) or SNRIs (Serotonine-Norepinephrine Reuptake Inhibitors) for 48 unipolar patients or with Lithium for 12 bipolar patients stabilized for at least 4 months and 10 sessions of active anodal tDCS at 2 sessions per day (1 morning and 1 afternoon with a gap of 3h) for 5 days with an electric current 2 mA. Receives: Device: transcranial Direct Current Stimulation (tDCS) (Eldith DC NeuroConn Stimulator) |
| sham tDCS | Sham comparator | a group named G2 and treated by medication with SSRIs or SNRIs for 48 unipolar patients or with Lithium for 12 bipolar patients stabilized for at least 4 months and sham tDCS. Receives: Device: transcranial Direct Current Stimulation (tDCS) (Eldith DC NeuroConn Stimulator) |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline in HDRS-21 scale
The changes in HDRS-21 will constitute the major research outcome measure used to assess response to tDCS. Response to treatment is defined as a ≥ 50% reduction in the scores of the HDRS. Remission is defined as a HDRS score ≤ 8.
Measured: baseline, 1 wk, 2 wk, 4wk, 12 wk, 24 wk
Secondary outcomes (2)
Change from baseline in MADRS, BDI, HAMA, STAI, YMRS
Montgomery and Asberg Depression Rating Scale (MADRS) Beck Depression Inventory-13 (BDI) Subscores for anxiety depression scale from HDRS-21 State-Trait Anxiety Inventory (STAI) Young Mania Rating Scale (YMRS) : only for bipolar patient
Measured: baseline, 1 wk, 2 wk, 4wk, 12 wk, 24 wk
Change from baseline in COT, TMT, IST and Cardebat fluency task
Crossing of test (COT) Trail Making test (TMT) Isaacs Set Test (IST) Cardebat fluency task
Measured: baseline, 4wk
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2012 (estimated)
- Study start19 Jul 2012
- Primary completion1 Mar 2022
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resistant 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
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Collaborators
- Clinical Investigation Centre for Innovative Technology Network, University Hospital, Grenoble, CH Le Vinatier - Service de Psychiatrie (Dr Emmanuel POULET), Rennes University Hospital, EPS Ville-Evrard - Unité de Recherche Clinique (Dr Dominique JANUEL), Hôpital Civil de Strasbourg - Service de Psychiatrie (Pr G.Bertschy)
- Responsible party
- Sponsor
- Investigators
- Emmanuel HAFFEN, MD PhD, Principal investigator, Centre Hospitalier Universitaire de Besancon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01644747
- Sponsor's protocol ID
- N/2011/60
- Acronym
- STICODEP
- Status last verified
- Jun 2023
- First submitted
- 17 Jul 2012
- Last updated
- 6 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- tDCS as an add-on Treatment for Resistant Major Depression in Uni- or Bipolar Patients: a Randomized, Double-blind, Placebo Controlled Study
- ClinicalTrials.gov ID
- NCT01644747
- Acronym / sponsor ID
- STICODEP / N/2011/60
- Keywords
- Resistant Depression, Moods disorders, Unipolar depression, Bipolar disorder, tDCS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Collaborators
- Clinical Investigation Centre for Innovative Technology Network, University Hospital, Grenoble, CH Le Vinatier - Service de Psychiatrie (Dr Emmanuel POULET), Rennes University Hospital, EPS Ville-Evrard - Unité de Recherche Clinique (Dr Dominique JANUEL), Hôpital Civil de Strasbourg - Service de Psychiatrie (Pr G.Bertschy)
- Study start
- 19 Jul 2012 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 19 Jul 2012 (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 aim is to investigate the effect of transcranial Direct Current Stimulation (tDCS) applied at the anodal left CDLPF of patients with resistant depression compared to patients treated with conventional therapy. The tDCS is used in add-on drug treatment in resistant depression stabilized for 4 weeks (antidepressant as SSRIs (Selective Serotonin Reuptake Inhibitors) or SNRIs (Serotonine-Norepinephrine Reuptake Inhibitors) for unipolar patients and lithium for bipolar patients). The delay of 4 weeks 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.
This is a randomized 2-arm parallel, double blind study comparing 2 groups of 60 patients (48 unipolar plus 12 bipolar patients per group. Patients will be selected in the psychiatric department of the University Hospital of different centers and the two groups are matched for age (+/- 5 years), gender and depression diagnosis (unipolar vs bipolar).
After giving informed consent, patients will be evaluated by a psychiatrist using the Hamilton Depression Rating Scale (HDRS), Montgomery Asberg Depression Rating Scale (MADRS), the STAI and Beck Depression Inventory (BDI) and for bipolar patient only, by the Young Mania Rating Scale (YMRS). The complete assessment takes 50 minutes. A neuropsychologist assessment will be also realized during 20 minutes using the Crossing of Test (COT), the Trail Making Test (TMT), the Isaacs Set Test (IST) and the Cardebat fluency Task.
After locating the left DLPFC, treatment with active tDCS with a current of 2 mA or sham will be directed by 30-minute session. A psychometric assessment will be conducted again at the end of treatment week and 4, 12 and finally 24 weeks after stopping treatment. The neuropsychologist assessment will be conducted again 4 weeks after the end of treatment. Scales of comfort and acceptability will also be proposed to the patient to determine whether any gene is caused by this treatment.
These people will be recruited on a voluntary basis, after notification and consent in the 6 research centers. This study was conducted over a period of 36 months.
This study was supporting by a grant from the French Hospital Program of Clinical Reseach (PHRC N/2011-60-2011-A01074-37)
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) (Eldith DC NeuroConn Stimulator)a group named G1 and treated by medication with SSRIs (Selective Serotonin Reuptake Inhibitors) or SNRIs (Serotonine-Norepinephrine Reuptake Inhibitors) for 48 unipolar patients or with Lithium for 12 bipolar patients stabilized for at least 4 months and 10 sessions of active anodal tDCS at 2 sessions per day (1 morning and 1 afternoon with a gap of 3h) for 5 days with an electric current 2 mA. |
| sham tDCS | Sham comparator | Device: transcranial Direct Current Stimulation (tDCS) (Eldith DC NeuroConn Stimulator)a group named G2 and treated by medication with SSRIs or SNRIs for 48 unipolar patients or with Lithium for 12 bipolar patients stabilized for at least 4 months and sham tDCS. |
Who may qualify
- Ages
- 18 to 65 years
- 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 failed antidepressant treatments for the current depressive episode)
- HDRS-21 score ≥ 21
- drug treatment by SSRIs or SNRIs for unipolar patients or with Lithium for bipolar patients for at least 4 weeks
- right-handed patients
Key exclusion criteria (5 listed)
- subject treated with antipsychotics or mood stabilizers or anticonvulsants or by ECT or rTMS for the current depressive episode
- subject resistant to SSRIs or SNRIs for unipolar patients or with Lithium for bipolar patients
- subject with mixed features
- pregnancy and/or lactation
- presence of a specific contraindication for tDCS (e.g., personal history of epilepsy, metallic head implant, cardiac pacemaker)
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) (Eldith DC NeuroConn Stimulator)Also: EldithDC-NeuroConn Stimulator (NeuroConn Gmbh, Ilmenau, Germany)After locating the left DLPFC, ttt with active anodal tDCS with a current of 2 mA or sham over the left DLPFC will be directed by 30-minute session. Treatment will occur 2 sessions per day during 5 days per week. Subjects will be monitored during tDCS for any side effects or adverse events. | Device | active tDCS, sham tDCS |
Primary outcome
change from baseline in HDRS-21 scale
Time frame: baseline, 1 wk, 2 wk, 4wk, 12 wk, 24 wk
The changes in HDRS-21 will constitute the major research outcome measure used to assess response to tDCS. Response to treatment is defined as a ≥ 50% reduction in the scores of the HDRS. Remission is defined as a HDRS score ≤ 8.
2 secondary outcomes
Change from baseline in MADRS, BDI, HAMA, STAI, YMRS
Time frame: baseline, 1 wk, 2 wk, 4wk, 12 wk, 24 wk
Change from baseline in COT, TMT, IST and Cardebat fluency task
Time frame: baseline, 4wk
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 6 Jun 2023.
- 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.
Emmanuel HAFFEN, MD PhD principal investigator
Centre Hospitalier Universitaire de Besancon
6 sites 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) (Eldith DC NeuroConn Stimulator) in people with Resistant Depression and Moods Disorders, run by Centre Hospitalier Universitaire de Besancon at 6 sites 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 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: finished, as of the sponsor's last update on 6 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
change from baseline in HDRS-21 scale (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?
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 6 Jun 2023.