A Multicenter, Randomized, Double-Blind Parallel Group Placebo-Controlled Phase III, Efficacy and Safety Study of 3 Fixed Dose Groups of TC-5214 (S-mecamylamine) as an Adjunct to an Antidepressants in Patients With Major Depressive Disorder Who Exhibit an Inadequate Response to Antidepressant Therapy

CompletadoFase 3ClinicalTrials.gov

ID: NCT01197508Tipo: INTERVENTIONALInicio: 1 de sept de 2010Fin estimado: 1 de ene de 2012

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to determine if TC-5214 or placebo (a tablet that looks like a medicine tablet or capsule, but contains no active medicine) is safe and effective when taken together with another antidepressant.

Descripción detallada

A Multicenter, Randomized, Double-Blind Parallel Group Placebo-Controlled Phase III, Efficacy and Safety Study of 3 Fixed Dose Groups of TC-5214 (S-mecamylamine) as an Adjunct to an Antidepressants in Patients with Major Depressive Disorder Who Exhibit an Inadequate Response to Antidepressant Therapy

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 65 YearsSexo: ALL

Criterios de inclusión

Provision of signed and dated informed consent before initiation of any study-related procedures.
The patient must have a clinical diagnosis of major depressive disorder (MDD) with inadequate response to no more than one antidepressant.
Outpatient status at enrollment and randomization.

Criterios de exclusión

Patients with a lifetime history of bipolar disorder, psychotic disorder or post-traumatic stress disorder.
Patients with a history of suicide attempts in the past year and/or seen by the investigator as having a significant history of risk of suicide or homicide.
History of renal insufficiency or impairment or conditions that could affect absorption or metabolism of investigational product.

Intervenciones

drug

TC-5214

Twice daily for 8 weeks.

drug

Placebo

Twice daily for 8 weeks.

Ubicaciones

Research Site

Buenos Aires, Buenos Aires F.D., Argentina

Research Site

Mendoza, Mendoza Province, Argentina

Research Site

Ciudad Autonoma Bs As, Cba, Argentina

Research Site

Dublin, Argentina

Patrocinadores

PrincipalAstraZeneca

ColaboradorTargacept Inc.

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