A Multicenter, Double-Blind, 58 Week Rollover Study to Assess the Safety and Tolerability of BMS-820836 in Patients With Treatment Resistant Major Depression

TerminadoFase 2ClinicalTrials.gov

ID: NCT01361555Tipo: INTERVENTIONALInicio: 1 de ago de 2011Fin estimado: 1 de oct de 2013

Traducción no disponible, mostrando original

Resumen

The purpose of this study it to evaluate the long-term safety and tolerability of BMS-820836 in patients with depression.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 65 YearsSexo: ALL

Criterios de inclusión

Men and women of age 18-65 years (Argentina the minimum age will be 24 years of age)
Patients randomized in parent study who complete CN162-006 and CN162-007 who consent to enter the rollover study.
Patient not randomized in parent study that meet inadequate response criteria

Criterios de exclusión

Patients who represent a significant risk of committing suicide based on the clinical judgment of the investigator, history or routine psychiatric status exam.
Patients with a Cardiovascular System Organ Class adverse event(s) occurring in parent study (CN162-006 or CN162-007), that in the investigators judgment is clinically significant and would impact safety of the subject in the current study \[including but not limited to left bundle branch block, or prolonged QT interval corrected (QTc)\].
In addition, patients should be excluded if they have any laboratory test, vital sign, electrocardiogram (ECG) or clinical findings that in the investigator's judgment is clinically significantly abnormal and could impact the safety of the patient or the interpretation of study assessments in the current study.

Intervenciones

drug

Placebo matching with BMS-820836

Tablet, Oral, 0.0 mg, Once daily, 54 weeks

drug

BMS-820836

Tablet, Oral, 0.5 mg, Once daily, 54 weeks

drug

BMS-820836

Tablet, Oral, 1.0 mg, Once daily, 54 weeks

drug

BMS-820836

Tablet, Oral, 2.0 mg, Once daily, 54 weeks

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

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

A Multicenter, Double-Blind, 58 Week Rollover Study to As... | EligiMed