A Multicenter, Randomized, 8-Week Double-Blind Acute Phase Followed By a 6-Month Continuation Phase (Open-Label Or Double-Blind) Study to Evaluate the Efficacy, Safety, and Tolerability of DVS SR Versus Escitalopram in Postmenopausal Women With Major Depressive Disorder

CompletadoFase 3ClinicalTrials.gov

ID: NCT00406640Tipo: INTERVENTIONALInicio: 1 de dic de 2006Fin estimado: 1 de oct de 2008

Traducción no disponible, mostrando original

Resumen

Desvenlafaxine succinate (DVS) is a potent and selective serotonin and norepinephrine reuptake inhibitor (SNRI). This study will investigate the safety, efficacy, and tolerability of DVS SR versus escitalopram in women with major depressive disorder (MDD) who are postmenopausal.

Elegibilidad

Edad mínima: 40 YearsEdad máxima: 70 YearsSexo: FEMALE

Criterios de inclusión

Postmenopausal women between the ages of 40 and 70 years, inclusive.
A primary diagnosis of MDD, single or recurrent episode, without psychotic features using the modified MINI International Neuropsychiatric Interview (MINI).
Montgomery-Asberg Depression Rating Scale (MADRS) total score \> or = 22 at the screening and baseline visit.

Criterios de exclusión

Use of oral estrogen-, progestin-, androgen-, or Selective Estrogen Receptor Modulator (SERM)-containing drug products 8 weeks before baseline.
Current (within 12 months) psychoactive substance abuse or dependence (including alcohol), manic episode, post-traumatic stress disorder, obsessive-compulsive disorder, or a lifetime diagnosis of bipolar or psychotic disorder.
A history or active presence of clinically important medical disease.
Additional criteria apply.

Intervenciones

drug

Desvenlafaxine succinate sustained-release (DVS SR)

flexible dose of DVS 50-100 or 200 mg every day during 56 days. Extension until 6 months.

drug

Escitalopram

Flexible dose of Escitalopram 10 or 20 mg every day during 56 days. Extension until 6 months.

Ubicaciones

Buenos Aires, Argentina

La Plata, Argentina

Mendoza, Argentina

Patrocinadores

PrincipalWyeth is now a wholly owned subsidiary of Pfizer

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