NCT01644747: STICODEP

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

Completed Phase 2 Last updated 6 June 2023

What this trial tests

Phase 2 trial testing transcranial Direct Current Stimulation (tDCS) (Eldith DC NeuroConn Stimulator) in Resistant Depression in 87 participants. Completed in 1 March 2022.

Timeline

19 July 2012

Primary endpoint
1 March 2022

1 March 2022

Quick facts

Lead sponsor	Centre Hospitalier Universitaire de Besancon
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	87
Start date	19 July 2012
Primary completion	1 March 2022
Estimated completion	1 March 2022
Sites	6 locations across France

Drugs / interventions tested

• transcranial Direct Current Stimulation (tDCS) (Eldith DC NeuroConn Stimulator)

Conditions studied

• Resistant Depression — all drugs for Resistant Depression →
• Moods Disorders — all drugs for Moods Disorders →
• Unipolar Depression — all drugs for Unipolar Depression →
• Bipolar Disorder — all drugs for Bipolar Disorder →

Sponsor

Centre Hospitalier Universitaire de Besancon

Who can join

Adults 18 to 65, any sex, with Resistant Depression or Moods Disorders. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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)

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.