Status:
COMPLETED
VA Augmentation and Switching Treatments for Improving Depression Outcomes
Lead Sponsor:
VA Office of Research and Development
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The overall purpose is to determine research based 'next-steps' for outpatients with major depressive disorder who have not had satisfactory outcomes to standard 'first-step' treatments. The primary o...
Detailed Description
The overall aim of VAST-D is to enhance treatment outcomes for representative outpatients diagnosed with nonpsychotic major depressive disorder (MDD) and treated in primary or psychiatric VA care sett...
Eligibility Criteria
Inclusion
- DSM-IV diagnosis of single or recurrent, non-psychotic, major depressive disorder
- Currently taking a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI) or mirtazapine for major depressive disorder
- Need for "next-step" treatment based on documented suboptimal outcome from current antidepressant treatment for major depressive episode (at least 6 weeks treatment with a QIDS-C16 \>= 16 or at least 8 weeks with a QIDS-C16 \>= 11; and at least 3 weeks at a stable "optimal" dose
- Age: 18 years of age or older
Exclusion
- Prior inadequate response after an adequate treatment trial or clear cut intolerance to either of the study medications (aripiprazole or bupropion)
- Current treatment with bupropion, aripiprazole or any other antipsychotic agent
- Lifetime history of bipolar disorder, schizophrenia, schizoaffective disorder, or psychosis not otherwise specified
- Current diagnosis of Dementia
- Current diagnosis of an eating disorder or a seizure disorder
- High suicide risk currently requiring acute intervention (other than outpatient treatment of depression)
- Unstable, serious medical condition or one requiring acute medical treatment, or anticipation of hospitalization for extended care
- Requiring immediate hospitalization for psychiatric disorders
- Physiologic substance dependence requiring detoxification (excluding nicotine) in the past 30 days (substance abuse is not an exclusion criteria)
- Taking any concomitant medication that contraindicates any of treatment options or augmenting agents known to have an antidepressant effect
- Concurrent or recent participation (within the last 30 days) in another conflicting clinical trial with a mental health, investigational drug, or medical device intervention
- Female - pregnant or lactating or planning to become pregnant
- Patient was not able or willing to provide informed consent; or changed mind about participating prior to randomization
- Patient was not referred to the study
Key Trial Info
Start Date :
December 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2016
Estimated Enrollment :
1522 Patients enrolled
Trial Details
Trial ID
NCT01421342
Start Date
December 1 2012
End Date
June 1 2016
Last Update
May 29 2018
Active Locations (35)
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1
Tuscaloosa VA Medical Center, Tuscaloosa, AL
Tuscaloosa, Alabama, United States, 35404
2
Phoenix VA Health Care System, Phoenix, AZ
Phoenix, Arizona, United States, 85012
3
Southern Arizona VA Health Care System, Tucson
Tucson, Arizona, United States, 85723
4
VA Loma Linda Healthcare System, Loma Linda, CA
Loma Linda, California, United States, 92357