Transcranial Direct Current Stimulation as an add-on Treatment for Resistant Major Depression in Uni- or Bipolar Patients (STICODEP)
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Purpose
The aim of our study 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 (antidepressant for unipolar patients and lithium for bipolar patients).
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 treated with sham tDCS and whose medication reference is stabilized for 4 weeks vs. patients treated by active tDCS 10 sessions over five days and whose medication reference is stabilized for 4 weeks. The 120 patients with resistant depression will be selected in the psychiatric department of the University Hospital of different centers (Besançon, Grenoble, Lyon-Le Vinatier, Rennes, Strasbourg and Ville-Evrard). 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 weeks, 12 weeks 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.
This study will include two parallel arms:
- a group named G1 and treated by medication with SSRIs (Selective Serotonin Reuptake Inhibitors) or SNRIs (Serotonine-Norepinephrine Reuptake Inhibitors) for unipolar patients or with Lithium for 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 ;
- a group named G2 and treated by medication with with SSRIs or SNRIs for unipolar patients or with Lithium for bipolar patients stabilized for at least 4 months and sham tDCS.
These two groups are matched for age (+/- 5 years), gender and depression diagnosis (unipolar vs bipolar).
The population of this study will be comprised of patients over age 18 with unipolar or bipolar depressive episode resistant episode characterized by the failure of one antidepressant treatment for depressive episode and treated by medication with SSRIs or SNRIs for unipolar patients or with Lithium for bipolar patients, since at least 4 weeks. 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.
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 | Intervention | Phase |
|---|---|---|
|
Resistant Major Depression Moods Disorders Unipolar Disorder Bipolar Disorder |
Device: transcranial Direct Current Stimulation (tDCS) (Eldith DC NeuroConn Stimulator) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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 |
- change from baseline in HDRS-21 scale [ Time Frame: baseline, 1 wk, 2 wk, 4wk, 12 wk, 24 wk ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Crossing of test (COT) Trail Making test (TMT) Isaacs Set Test (IST) Cardebat fluency task
| Estimated Enrollment: | 120 |
| Study Start Date: | July 2012 |
| Estimated Study Completion Date: | July 2016 |
| Estimated Primary Completion Date: | December 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
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)
|
|
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)
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| 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)
Contacts and Locations| 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 |
More Information
No publications provided
| Responsible Party: | Emmanuel Haffen, MD PhD, Centre Hospitalier Universitaire de Besancon |
| ClinicalTrials.gov Identifier: | NCT01644747 History of Changes |
| Other Study ID Numbers: | STICODEP |
| Study First Received: | July 17, 2012 |
| Last Updated: | July 18, 2012 |
| Health Authority: | France: Direction Générale de la Santé France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by Centre Hospitalier Universitaire de Besancon:
|
Resistant Major Depression Moods disorders Unipolar disorder Bipolar disorder tDCS |
Additional relevant MeSH terms:
|
Bipolar Disorder Depression Depressive Disorder Depressive Disorder, Major Mood Disorders Affective Disorders, Psychotic Mental Disorders Behavioral Symptoms |
Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Serotonin Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 23, 2013