A Multicenter, Randomized, Double-Blind, Active Controlled, Comparative, Fixed-Dose, Dose Response Study of the Efficacy and Safety of BMS-820836 in Patients With Treatment Resistant Major Depression (TRD).

CompletadoFase 2ClinicalTrials.gov

ID: NCT01369095Tipo: INTERVENTIONALInicio: 1 de jul de 2011Fin estimado: 1 de may de 2013

Traducción no disponible, mostrando original

Resumen

The purpose of the study is to evaluate the efficacy of study drug (BMS-820836) as compared with continued Duloxetine/Escitalopram in the treatment of patients with treatment resistant depression (TRD).

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 65 YearsSexo: ALL

Criterios de inclusión

In the current Major depressive disorder (MDD) episode, patients should report a history of inadequate response to 1-3 adequate trials of antidepressant treatment.
Men and women of age 18-65 years (Argentina minimum age will be 24 years of age)
Patients must be able to understand the nature of the study, agree to comply with the prescribed dosage regimens, report for regularly scheduled office visits, and communicate to study personnel about adverse events and concomitant medication use.
Patients with a diagnosis of Major Depressive Disorder, currently experiencing a Major Depressive Episode, as defined by Diagnostic and Statistical Manual of Mental Disorders- Fourth Edition (Text Revision)\[DSM IV TR\] criteria. The current depressive episode must be \> 8 weeks in duration and \< 3 years duration.
Patients must have a 17-item Hamilton Depression Rating Scale (HAM-D17) total score ≥ 18 at Screening and Baseline.

Criterios de exclusión

Patients who report an inadequate response (less than 50% reduction in depressive symptom severity) to more than three adequate trials of antidepressant treatments during the current depressive episode.
Patients who have failed Duloxetine and Escitalopram at an adequate dose and for an adequate duration in their current episode.

Intervenciones

drug

Escitalopram

Capsule, Oral, 10-20 mg/day, once daily, 7 weeks (Phase B), 7 weeks (Phase C\&D)

drug

BMS-820836 Placebo

Tablet, Oral, 0.0mg, once daily, 13 weeks (Phase B\&C)

drug

BMS-820836

Tablet, Oral, 0.25mg, once daily, 6 weeks (Phase C)

drug

BMS-820836

Tablet, Oral, 0.5 mg, once daily, 6 weeks (Phase C)

drug

BMS-820836

Tablet, Oral, 1.0 mg, once daily, 6 weeks (Phase C)

drug

Duloxetine

Capsule, Oral, 30-60mg/day, once daily, 7 weeks (Phase B), 7weeks (Phase C\&D)

drug

BMS-820836

Tablet, Oral, 2.0 mg, once daily, 6 weeks (Phase C)

Ubicaciones

Local Institution

Caba, Buenos Aires, Argentina

Local Institution

Caba, Buenos Aires, Argentina

Local Institution

La Plata, Buenos Aires, Argentina

Local Institution

Córdoba, Córdoba Province, Argentina

Local Institution

Córdoba, Córdoba Province, Argentina

Local Institution

Mendoza, Mendoza Province, Argentina

Patrocinadores

PrincipalBristol-Myers Squibb

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