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This study evaluates transcranial Direct Current Stimulation (tDCS, mild electrical stimulation through the scalp) as an add-on treatment in unipolar or bipolar patients with treatment-resistant major depression. It included patients on medication who had failed at least one antidepressant. It was a Phase 2 study and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine 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)