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A Randomized, Double-Blind, Placebo-Controlled Trial of Vilazodone in Children and Adolescents with Major Depressive Disorder with Twenty-Six-Week Open-Label Follow-Up.
Findling, Robert L; McCusker, Emily; Strawn, Jeffrey R.
Afiliação
  • Findling RL; Department of Psychiatry, Virginia Commonwealth University, Richmond, Virginia, USA.
  • McCusker E; CNS, AbbVie, Irvine, California, USA.
  • Strawn JR; Anxiety Disorders Research Program, University of Cincinnati, Cincinnati, Ohio, USA.
J Child Adolesc Psychopharmacol ; 30(6): 355-365, 2020 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-32460523
ABSTRACT

Objective:

To evaluate the efficacy and long-term safety of vilazodone in children and adolescent outpatients with major depressive disorder (MDD).

Methods:

Children and adolescents aged 7-17 years of age with MDD were randomized 221 to 8 weeks of double-blind placebo, vilazodone 15 or 30 mg/day or fluoxetine 20 mg/day, respectively. The primary and secondary efficacy outcomes, respectively, were change from baseline to week 8 in Children's Depression Rating Scale-Revised (CDRS-R) score total score and Clinical Global Impressions-Severity (CGI-S) score analyzed using a mixed model for repeated measurement approach. Patients who completed the 8-week randomized controlled trial (RCT), as well as new (de novo) patients, could participate in a 26-week, vilazodone-only, open-label extension (OLE) study.

Results:

The RCT enrolled 473 patients (60% female) with an average age of 13 years. Change in CDRS-R and CGI-S scores from baseline to week 8 did not differ between patients who received vilazodone and those randomized to placebo. The least-squares mean change from baseline in CDRS-R scores was similar for vilazodone and placebo (-20.7 vs. -20.3, p = 0.77; least-squares mean difference [LSMD] = -0.40). For fluoxetine, the LSMD versus placebo was -2.3 (p = 0.14). The OLE enrolled 330 patients (60% female) with an average age of 13-14 years. Overall, no new safety concerns were identified compared to what is known in adults.

Conclusions:

Similar improvements in depressive symptoms were observed in all arms. This study does not support the efficacy of vilazodone 15 or 30 mg/day for pediatric patients with MDD. No new or unexpected safety concerns were detected during the RCT or OLE studies.
Texto completo: Disponível Coleções: Bases de dados internacionais Contexto em Saúde: Agenda de Saúde Sustentável para as Américas Tema em saúde: Objetivo 9: Redução de doenças não transmissíveis Base de dados: MEDLINE Tipo de estudo: Ensaio clínico controlado / Estudo prognóstico Idioma: Inglês Revista: J Child Adolesc Psychopharmacol Assunto da revista: Pediatria / Psicofarmacologia Ano de publicação: 2020 Tipo de documento: Artigo País de afiliação: Estados Unidos

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Texto completo: Disponível Coleções: Bases de dados internacionais Contexto em Saúde: Agenda de Saúde Sustentável para as Américas Tema em saúde: Objetivo 9: Redução de doenças não transmissíveis Base de dados: MEDLINE Tipo de estudo: Ensaio clínico controlado / Estudo prognóstico Idioma: Inglês Revista: J Child Adolesc Psychopharmacol Assunto da revista: Pediatria / Psicofarmacologia Ano de publicação: 2020 Tipo de documento: Artigo País de afiliação: Estados Unidos