The VA augmentation and switching treatments for improving depression outcomes (VAST-D) study: Rationale and design considerations

Somaia Mohamed; Gary R Johnson; Julia E Vertrees; Peter D Guarino; Kimberly Weingart; Ilanit Tal Young; Jean Yoon; Theresa C Gleason; Katherine A Kirkwood; Amy M Kilbourne; Martha Gerrity; Stephen Marder; Kousick Biswas; Paul Hicks; Lori L Davis; Peijun Chen; AlexandraMary Kelada; Grant D Huang; David D Lawrence; Mary LeGwin; Sidney Zisook

doi:10.1016/j.psychres.2015.08.005

The VA augmentation and switching treatments for improving depression outcomes (VAST-D) study: Rationale and design considerations

Psychiatry Res. 2015 Oct 30;229(3):760-70. doi: 10.1016/j.psychres.2015.08.005. Epub 2015 Aug 6.

Authors

Somaia Mohamed¹, Gary R Johnson², Julia E Vertrees³, Peter D Guarino⁴, Kimberly Weingart⁵, Ilanit Tal Young⁵, Jean Yoon⁶, Theresa C Gleason⁷, Katherine A Kirkwood², Amy M Kilbourne⁸, Martha Gerrity⁹, Stephen Marder¹⁰, Kousick Biswas¹¹, Paul Hicks¹², Lori L Davis¹³, Peijun Chen¹⁴, AlexandraMary Kelada⁵, Grant D Huang¹⁵, David D Lawrence², Mary LeGwin², Sidney Zisook⁵

Affiliations

¹ VA VISN 1 New England Mental Illness Research,Education and Clinical Center, Veterans Health Administration, West Haven, CT and Yale University School of Medicine, 950 Campbell Ave., West Haven, CT 06516, USA. Electronic address: [email protected].
² VA Cooperative Studies Program Coordinating Center, VA Connecticut Healthcare System, West Haven, CT, USA.
³ VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, New Mexico VA Healthcare System, Albuquerque, NM, USA.
⁴ VA Cooperative Studies Program Coordinating Center, VA Connecticut Healthcare System, West Haven, CT, USA; Statistical Center for HIV/AIDS Research and Prevention, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
⁵ VA San Diego Healthcare System and University of California, San Diego, CA, USA.
⁶ Health Economics Resource Center (HERC), VA Palo Alto, Menlo Park, CA, USA.
⁷ Department of Veterans Affairs, Office of Research and Development, Washington, DC, USA.
⁸ Department of Veterans Affairs, Office of Research and Development, Washington, DC, USA; Department of Psychiatry, University of Michigan, Ann Arbor, MI, USA.
⁹ Portland VA Healthcare System, Portland, OR, USA.
¹⁰ VA Desert Pacific Mental Illness Research, Education, and Clinical Center and Semel Institute for Neuroscience at UCLA, Los Angeles, CA, USA.
¹¹ VA Cooperative Studies Program Coordinating Center, VA Maryland Healthcare Systems, Perry Point, MD, USA.
¹² Central Texas Veterans Healthcare System and Department of Psychiatry and Behavioral Science, Texas A&M Health Science Center College of Medicine, Temple, TX, USA.
¹³ Tuscaloosa VA Medical Center, Tuscaloosa, AL and University of Alabama School of Medicine, USA.
¹⁴ Louis Stokes VA Medical Center and Case Western Reserve University School of Medicine, Cleveland, OH, USA.
¹⁵ Cooperative Studies Program Central Office, Department of Veterans Affairs Office of Research & Development, Washington, DC, USA.

PMID: 26279130
DOI: 10.1016/j.psychres.2015.08.005

Abstract

Because two-thirds of patients with Major Depressive Disorder do not achieve remission with their first antidepressant, we designed a trial of three "next-step" strategies: switching to another antidepressant (bupropion-SR) or augmenting the current antidepressant with either another antidepressant (bupropion-SR) or with an atypical antipsychotic (aripiprazole). The study will compare 12-week remission rates and, among those who have at least a partial response, relapse rates for up to 6 months of additional treatment. We review seven key efficacy/effectiveness design decisions in this mixed "efficacy-effectiveness" trial.

Keywords: Antidepressants; Antipsychotics; Major depression; Methodology; Study design; Treatment resistance.

Publication types

Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Research Support, U.S. Gov't, Non-P.H.S.

MeSH terms

Antidepressive Agents / administration & dosage*
Antipsychotic Agents / administration & dosage*
Aripiprazole / administration & dosage
Bupropion / administration & dosage
Depressive Disorder, Major / drug therapy*
Drug Administration Schedule
Drug Substitution*
Drug Therapy, Combination
Female
Humans
Male
Remission Induction / methods*
Research Design*
Time Factors

Substances

Antidepressive Agents
Antipsychotic Agents
Bupropion
Aripiprazole