Phase 3
Completed N=1,522
VA Augmentation and Switching Treatments for Improving Depression Outcomes
Source: ClinicalTrials.gov NCT01421342 ↗Enrolled (actual)
1,522
Serious AEs
10.8%
Results posted
May 2018
Primary outcomePrimary: Rate of Protocol Remission of Symptoms of Major Depressive Disorder — 114; 136; 146 Participants — p=0.076
◆ Published Evidence
Highly cited
150citations · ~17 / year
Effect of Antidepressant Switching vs Augmentation on Remission Among Patients With Major Depressive Disorder Unresponsive to Antidepressant Treatment: The VAST-D Randomized Clinical Trial.
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 objective is to compare the acute (up to 12 weeks) treatment effectiveness of augmenting an antidepressant with aripiprazole or with bupropion-slow release (SR) vs. switching treatment to bupropion-SR monotherapy on symptom remission in Veterans with Major Depressive Disorder (MDD) who have not achieved optimal response after an adequate trial on antidepressant (a selective serotonin reuptake inhibitor [SSRI] or serotonin and norepinephrine reuptake inhibitor [SNRI] or mirtazapine) monotherapy. The secondary objectives are to compare the acute (up to 12 weeks) and long term (up to 36 weeks) efficacy, safety, effects on functioning, suicidality, quality of life, anxiety and other associated symptoms, costs and cost-effectiveness of each of the three treatments.
Linked Publications (5)
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Effect of Antidepressant Switching vs Augmentation on Remission Among Patients With Major Depressive Disorder Unresponsive to Antidepressant Treatment: The VAST-D Randomized Clinical Trial.
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Characteristics of U.S. Veteran Patients with Major Depressive Disorder who require "next-step" treatments: A VAST-D report.
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Childhood adversity and adulthood major depressive disorder.
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Continuation phase treatment outcomes for switching, combining, or augmenting strategies for treatment-resistant major depressive disorder: A VAST-D report.
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How Does Positive Mental Health Affect Next-Step Treatment Outcomes in Treatment-Resistant Depression? A VAST-D Report.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Protocol Remission of Symptoms of Major Depressive Disorder |
114; 136; 146 | 0.076 |
| SECONDARY Rate of Protocol Relapse of Symptoms of Major Depression After Achieving Remission in the Acute Phase |
26; 35; 37 | 0.70 |
| SECONDARY Rate of Protocol Response as Reduction in Symptoms of Major Depression (>= 50% Reduction in QIDS-C) |
319; 332; 375 | 0.28 |
| SECONDARY Rate of Protocol Response Measured as a Change in Clinical Global Impression (CGI) - Improvement Scale |
356; 376; 400 | 0.11 |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01421342) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.