tDCS as an add-on Treatment for Resistant Major Depression in Uni- or Bipolar Patients (STICODEP)
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| ClinicalTrials.gov Identifier: NCT01644747 |
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Recruitment Status : Unknown
Verified August 2016 by Centre Hospitalier Universitaire de Besancon.
Recruitment status was: Recruiting
First Posted : July 19, 2012
Last Update Posted : August 23, 2016
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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)
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Resistant Depression Moods Disorders Unipolar Depression Bipolar Disorder | Device: transcranial Direct Current Stimulation (tDCS) (Eldith DC NeuroConn Stimulator) | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 120 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | tDCS as an add-on Treatment for Resistant Major Depression in Uni- or Bipolar Patients: a Randomized, Double-blind, Placebo Controlled Study |
| Study Start Date : | July 2012 |
| Estimated Primary Completion Date : | December 2017 |
| Estimated Study Completion Date : | December 2017 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: active tDCS
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.
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Device: transcranial Direct Current Stimulation (tDCS) (Eldith DC NeuroConn Stimulator)
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.
Other Name: EldithDC-NeuroConn Stimulator (NeuroConn Gmbh, Ilmenau, Germany) |
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Sham Comparator: sham tDCS
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.
|
Device: transcranial Direct Current Stimulation (tDCS) (Eldith DC NeuroConn Stimulator)
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.
Other Name: EldithDC-NeuroConn Stimulator (NeuroConn Gmbh, Ilmenau, Germany) |
- 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.
- Change from baseline in MADRS, BDI, HAMA, STAI, YMRS [ Time Frame: baseline, 1 wk, 2 wk, 4wk, 12 wk, 24 wk ]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
- Change from baseline in COT, TMT, IST and Cardebat fluency task [ Time Frame: baseline, 4wk ]Crossing of test (COT) Trail Making test (TMT) Isaacs Set Test (IST) Cardebat fluency task
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| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01644747
| Contact: Emmanuel HAFFEN, Prof | +33381218154 | emmanuel.haffen@univ-fcomte.fr | |
| Contact: Magali NICOLIER, PhD | +33381219007 | mnicolier@chu-besancon.fr |
| France | |
| CHRU Besancon - Service de Psychiatrie - Centre Investigation Clinique Innovation Technologique (CIC-IT808) | Recruiting |
| Besancon, France | |
| Contact: Emmanuel HAFFEN, Prof +33381218154 emmanuel.haffen@univ-fcomte.fr | |
| Contact: Magali NICOLIER, PhD +33381219007 mnicolier@chu-besancon.fr | |
| Principal Investigator: Emmanuel HAFFEN, MD PhD | |
| CHU Grenoble - Clinique de Psychiatrie de l'Adulte | Recruiting |
| Grenoble, France | |
| Contact: Mircea POLOSAN, MD | |
| Contact: David SZEKELY, MD DSzekely@chu-grenoble.fr | |
| Principal Investigator: David SZEKELY, MD | |
| CH Le Vinatier - Service de Psychiatrie | Recruiting |
| Lyon, France | |
| Contact: Emmanuel POULET, MD EMMANUEL.POULET@ch-le-vinatier.fr | |
| Principal Investigator: Emmanuel POULET, MD | |
| Centre Hospitalier Guillaume Régnier - Rennes - Service Hospitalo-Universitaire de Psychiatrie | Recruiting |
| Rennes, France | |
| Contact: Dominique DRAPIER, MD PhD d.drapier@ch-guillaumeregnier.fr | |
| Principal Investigator: Dominique DRAPIER, MD PhD | |
| Hôpital Civil de Strasbourg - Service de Psychiatrie | Recruiting |
| Strasbourg, France | |
| Contact: Gilles BERTSCHY, MD PhD gilles.bertschy@chru-strasbourg.fr | |
| Principal Investigator: Gilles BERTSCHY, MD PhD | |
| Etablissement Public de Santé Mentale - Unité de Recherche Clinique | Recruiting |
| Ville Evrard, France | |
| Contact: Dominique JANUEL, MD d.januel@eps-ville-evrard.fr | |
| Contact: Alexane STEPHAN a.stephan@epsve.fr | |
| Principal Investigator: Dominique JANUEL, MD | |
| Principal Investigator: | Emmanuel HAFFEN, MD PhD | Centre Hospitalier Universitaire de Besancon |
| Responsible Party: | Centre Hospitalier Universitaire de Besancon |
| ClinicalTrials.gov Identifier: | NCT01644747 |
| Other Study ID Numbers: |
N/2011/60 |
| First Posted: | July 19, 2012 Key Record Dates |
| Last Update Posted: | August 23, 2016 |
| Last Verified: | August 2016 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
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Resistant Depression Moods disorders Unipolar depression Bipolar disorder tDCS |
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Disease Depression Depressive Disorder Bipolar Disorder Mood Disorders |
Pathologic Processes Behavioral Symptoms Mental Disorders Bipolar and Related Disorders |