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

• Register: ClinicalTrials.gov
• Last refreshed on: 20 June 2023
• Main ID: NCT01644747
• Date of registration: 17/07/2012
• Prospective Registration: Yes
• Primary sponsor: Centre Hospitalier Universitaire de Besancon
• Public title: tDCS as an add-on Treatment for Resistant Major Depression in Uni- or Bipolar Patients STICODEP
• Scientific title: tDCS as an add-on Treatment for Resistant Major Depression in Uni- or Bipolar Patients: a Randomized, Double-blind, Placebo Controlled Study
• Date of first enrolment: July 19, 2012
• Target sample size: 87
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01644747
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

France

Contacts

• Name: Emmanuel HAFFEN, MD PhD
• Affiliation: Centre Hospitalier Universitaire de Besancon

Key inclusion & exclusion criteria

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)



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Bipolar Disorder

Moods Disorders

Resistant Depression

Unipolar Depression

Intervention(s)

Device: transcranial Direct Current Stimulation (tDCS) (Eldith DC NeuroConn Stimulator)

Primary Outcome(s)

change from baseline in HDRS-21 scale [Time Frame: baseline, 1 wk, 2 wk, 4wk, 12 wk, 24 wk]

Secondary Outcome(s)

Change from baseline in COT, TMT, IST and Cardebat fluency task [Time Frame: baseline, 4wk]

Change from baseline in MADRS, BDI, HAMA, STAI, YMRS [Time Frame: baseline, 1 wk, 2 wk, 4wk, 12 wk, 24 wk]

Secondary ID(s)

N/2011/60

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

EPS Ville-Evrard - Unité de Recherche Clinique (Dr Dominique JANUEL)

Clinical Investigation Centre for Innovative Technology Network

Hôpital Civil de Strasbourg - Service de Psychiatrie (Pr G.Bertschy)

University Hospital, Grenoble

CH Le Vinatier - Service de Psychiatrie (Dr Emmanuel POULET)

Rennes University Hospital