tDCS as an add-on Treatment for Resistant Major Depression in Uni- or Bipolar Patients

Bipolar Disorder Clinical Trial

— STICODEP  

Official title:

tDCS as an add-on Treatment for Resistant Major Depression in Uni- or Bipolar Patients: a Randomized, Double-blind, Placebo Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01644747
• Other study ID #: N/2011/60
• Status: Completed
• Phase: Phase 2
• Start date: July 19, 2012
• Est. completion date: March 1, 2022

Study information

• Verified date: June 2023
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: March 1, 2022
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Bipolar Disorder
• Depression
• Depressive Disorder
• Mood Disorders
• Moods Disorders
• Resistant Depression
• Unipolar Depression

Intervention

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.

Locations

Country	Name	City	State
France	CHRU Besancon - Service de Psychiatrie - Centre Investigation Clinique Innovation Technologique (CIC-IT808)	Besancon
France	CHU Grenoble - Clinique de Psychiatrie de l'Adulte	Grenoble
France	CH Le Vinatier - Service de Psychiatrie	Lyon
France	Centre Hospitalier Guillaume Régnier - Rennes - Service Hospitalo-Universitaire de Psychiatrie	Rennes
France	Hôpital Civil de Strasbourg - Service de Psychiatrie	Strasbourg
France	Etablissement Public de Santé Mentale - Unité de Recherche Clinique	Ville Evrard

Sponsors (7)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon	CH Le Vinatier - Service de Psychiatrie (Dr Emmanuel POULET), Clinical Investigation Centre for Innovative Technology Network, EPS Ville-Evrard - Unité de Recherche Clinique (Dr Dominique JANUEL), Hôpital Civil de Strasbourg - Service de Psychiatrie (Pr G.Bertschy), Rennes University Hospital, University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline, 1 wk, 2 wk, 4wk, 12 wk, 24 wk
Secondary	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	baseline, 1 wk, 2 wk, 4wk, 12 wk, 24 wk
Secondary	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	baseline, 4wk