The VA augmentation and switching treatments for improving depression outcomes (VAST-D) study: Rationale and design considerations.
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.
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: Somaia.Mohamed@va.gov.
Somaia
S
Mohamed
VA Cooperative Studies Program Coordinating Center, VA Connecticut Healthcare System, West Haven, CT, USA.
Gary R
GR
Johnson
VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, New Mexico VA Healthcare System, Albuquerque, NM, USA.
Julia E
JE
Vertrees
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.
Peter D
PD
Guarino
VA San Diego Healthcare System and University of California, San Diego, CA, USA.
Kimberly
K
Weingart
VA San Diego Healthcare System and University of California, San Diego, CA, USA.
Ilanit Tal
IT
Young
Health Economics Resource Center (HERC), VA Palo Alto, Menlo Park, CA, USA.
Jean
J
Yoon
Department of Veterans Affairs, Office of Research and Development, Washington, DC, USA.
Theresa C
TC
Gleason
VA Cooperative Studies Program Coordinating Center, VA Connecticut Healthcare System, West Haven, CT, USA.
Katherine A
KA
Kirkwood
Department of Veterans Affairs, Office of Research and Development, Washington, DC, USA; Department of Psychiatry, University of Michigan, Ann Arbor, MI, USA.
Amy M
AM
Kilbourne
Portland VA Healthcare System, Portland, OR, USA.
Martha
M
Gerrity
VA Desert Pacific Mental Illness Research, Education, and Clinical Center and Semel Institute for Neuroscience at UCLA, Los Angeles, CA, USA.
Stephen
S
Marder
VA Cooperative Studies Program Coordinating Center, VA Maryland Healthcare Systems, Perry Point, MD, USA.
Kousick
K
Biswas
Central Texas Veterans Healthcare System and Department of Psychiatry and Behavioral Science, Texas A&M Health Science Center College of Medicine, Temple, TX, USA.
Paul
P
Hicks
Tuscaloosa VA Medical Center, Tuscaloosa, AL and University of Alabama School of Medicine, USA.
Lori L
LL
Davis
Louis Stokes VA Medical Center and Case Western Reserve University School of Medicine, Cleveland, OH, USA.
Peijun
P
Chen
VA San Diego Healthcare System and University of California, San Diego, CA, USA.
AlexandraMary
A
Kelada
Cooperative Studies Program Central Office, Department of Veterans Affairs Office of Research & Development, Washington, DC, USA.
Grant D
GD
Huang
VA Cooperative Studies Program Coordinating Center, VA Connecticut Healthcare System, West Haven, CT, USA.
David D
DD
Lawrence
VA Cooperative Studies Program Coordinating Center, VA Connecticut Healthcare System, West Haven, CT, USA.
Mary
M
LeGwin
VA San Diego Healthcare System and University of California, San Diego, CA, USA.
Sidney
S
Zisook
D000928:Antidepressive Agents / Q000008:administration & dosage*; D014150:Antipsychotic Agents / Q000008:administration & dosage*; D000068180:Aripiprazole / Q000008:administration & dosage; D016642:Bupropion / Q000008:administration & dosage; D003865:Major Depressive Disorder / Q000188:drug therapy*; D004334:Drug Administration Schedule; D057915:Drug Substitution; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D008297:Male; D012074:Remission Induction / Q000379:methods*; D012107:Research Design; D013997:Time Factors
D000928:Antidepressive Agents; D014150:Antipsychotic Agents; D016642:Bupropion; D000068180:Aripiprazole
Antidepressants; Antipsychotics; Major depression; Methodology; Study design; Treatment resistance