Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2018 Aug;20(4):353-363.
doi: 10.1007/s40272-018-0290-4.

A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of Vilazodone in Adolescents with Major Depressive Disorder

Suresh Durgam  1 , Changzheng Chen  2 , Raffaele Migliore  2 , Chandran Prakash  2 , John Edwards  2 , Robert L Findling  3
Affiliations
Randomized Controlled Trial

A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of Vilazodone in Adolescents with Major Depressive Disorder

Suresh Durgam et al. Paediatr Drugs. 2018 Aug.

Abstract

Background: Major depressive disorder (MDD) is a serious illness in children and adolescents. Vilazodone is a selective serotonin reuptake inhibitor approved for MDD in adults. This study evaluated the efficacy, safety, and tolerability of vilazodone in adolescent patients, ages 12-17 years, with MDD (NCT01878292).

Methods: This double-blind, randomized, placebo-controlled, parallel-group, fixed-dose study was conducted at 56 study centers in the United States and was 10 weeks in duration (a 1-week screening period, an 8-week double-blind treatment period, and a 1-week double-blind down-taper period). Outpatients with an MDD diagnosis based on Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision criteria were included in the study. Clinical inclusion criteria required a Children's Depression Rating Scale-Revised (CDRS-R) total score of ≥ 40 and Clinical Global Impressions-Severity (CGI-S) score of ≥ 4. Patients were randomized 1:1:1 to 8 weeks of double-blind treatment with placebo (n = 174), vilazodone 15 mg/day (n = 175), or vilazodone 30 mg/day (n = 180). The primary and secondary efficacy parameters were change from baseline to week 8 in CDRS-R total score and CGI-S score, respectively. Safety parameters included adverse events (AEs); clinical laboratory, vital sign, and electrocardiogram parameters; and the Columbia-Suicide Severity Rating Scale.

Results: Approximately 86% of patients completed double-blind treatment. There was no statistically significant difference between vilazodone 15 mg/day or 30 mg/day and placebo in change from baseline in CDRS-R score. Change in CGI-S score was not significant after adjustment for multiple comparisons. The most common treatment-emergent AEs were nausea, upper abdominal pain, vomiting, diarrhea, nasopharyngitis, headache, and dizziness. Reports of suicidal ideation (placebo, 33.3%; vilazodone 15 mg/day, 36.0%; vilazodone 30 mg/day, 31.1%) and suicidal behavior (placebo, 1.8%; vilazodone 15 mg/day, 1.1%; vilazodone 30 mg/day, 1.1%) were similar between treatment groups. There were no deaths in the study.

Conclusions: The efficacy of vilazodone for the treatment of MDD in adolescent patients could not be confirmed in this study. Vilazodone was generally safe and well tolerated, with treatment-emergent AEs similar to those in adult patients.

Clinical trial registration: NCT01878292.

PubMed Disclaimer

Conflict of interest statement

Funding

The analyses and studies presented in this report were sponsored by Forest Research Institute, an Allergan affiliate. The sponsor was involved in conducting the analyses, interpreting the results, and the decision to submit this manuscript for publication.

Conflict of interest

R. Findling receives or has received research support, has acted as a consultant and/or served on a speaker’s bureau for Aevi, Akili, Alcobra, Amerex, American Academy of Child & Adolescent Psychiatry, American Psychiatric Press, Bracket, Epharma Solutions, Forest, Genentech, Guilford Press, Ironshore, Johns Hopkins University Press, KemPharm, Lundbeck, Merck, NIH, Neurim, Nuvelution, Otsuka, PCORI, Pfizer, Physicians Postgraduate Press, Purdue, Roche, Sage, Shire, Sunovion, Supernus Pharmaceuticals, Syneurx, Teva, Tris, TouchPoint, Validus, and WebMD. S. Durgam, C. Chen, R. Migliore, C. Prakash, and J. Edwards are full-time employees of Allergan.

Ethical approval

The study was approved by an institutional review board at each study center involved in the study (n = 56) and conducted in compliance with the Declaration of Helsinki and ICH Guidances on General Considerations for Clinical Trials and Good Clinical Practice.

Informed consent

Informed consent was obtained from all individual participants included in the study. Written permission was obtained from parents or legal guardians in accordance with appropriate local laws, where applicable.

Figures

Fig. 1
Fig. 1
Patient disposition
Fig. 2
Fig. 2
Change from baseline in CDRS-R total score (ITT Population, MMRM). CDRS-R Children’s Depression Rating Scale–Revised, ITT intent-to-treat, LS least squares, MMRM mixed-effect model for repeated measures
See this image and copyright information in PMC

References

    1. Kessler RC, Petukhova M, Sampson NA, Zaslavsky AM, Wittchen HU. Twelve-month and lifetime prevalence and lifetime morbid risk of anxiety and mood disorders in the United States. Int J Methods Psychiatr Res. 2012;21:169–184. doi: 10.1002/mpr.1359. - DOI - PMC - PubMed
    1. Zalsman G, Brent DA, Weersing VR. Depressive disorders in childhood and adolescence: an overview: epidemiology, clinical manifestation and risk factors. Child Adolesc Psychiatr Clin N Am. 2006;15:827–841. doi: 10.1016/j.chc.2006.05.002. - DOI - PubMed
    1. Fergusson DM, Woodward LJ. Mental health, educational, and social role outcomes of adolescents with depression. Arch Gen Psychiatry. 2002;59:225–231. doi: 10.1001/archpsyc.59.3.225. - DOI - PubMed
    1. Birmaher B, Brent D, Issues AWGOQ, Bernet W, Bukstein O, Walter H, et al. Practice parameter for the assessment and treatment of children and adolescents with depressive disorders. J Am Acad Child Adolesc Psychiatry. 2007;46:1503–1526. doi: 10.1097/chi.0b013e318145ae1c. - DOI - PubMed
    1. Thapar A, Collishaw S, Pine DS, Thapar AK. Depression in adolescence. Lancet. 2012;379:1056–1067. doi: 10.1016/S0140-6736(11)60871-4. - DOI - PMC - PubMed

Publication types

Substances

Associated data