VA Augmentation and Switching Treatments for Improving Depression Outcomes

Completed · Phase 3

Conditions studied: Major Depressive Disorder

In brief

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.

Key facts

Study ID

NCT01421342

Run by

VA Office of Research and Development

People needed

1522

Starts

2012-12-01

Expected to finish

2016-06-01

Last updated by the study team

2018-05-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Tuscaloosa VA Medical Center, Tuscaloosa, AL — Tuscaloosa, Alabama, United States
• Phoenix VA Health Care System, Phoenix, AZ — Phoenix, Arizona, United States
• Southern Arizona VA Health Care System, Tucson — Tucson, Arizona, United States
• VA Loma Linda Healthcare System, Loma Linda, CA — Loma Linda, California, United States
• VA Long Beach Healthcare System, Long Beach, CA — Long Beach, California, United States
• VA Palo Alto Health Care System, Palo Alto, CA — Palo Alto, California, United States
• VA San Diego Healthcare System, San Diego, CA — San Diego, California, United States
• San Francisco VA Medical Center, San Francisco, CA — San Francisco, California, United States
• VA Eastern Colorado Health Care System, Denver, CO — Denver, Colorado, United States
• VA Connecticut Healthcare System West Haven Campus, West Haven, CT — West Haven, Connecticut, United States
• Washington DC VA Medical Center, Washington, DC — Washington D.C., District of Columbia, United States
• Miami VA Healthcare System, Miami, FL — Miami, Florida, United States
• James A. Haley Veterans' Hospital, Tampa, FL — Tampa, Florida, United States
• Atlanta VA Medical and Rehab Center, Decatur, GA — Decatur, Georgia, United States
• Edward Hines Jr. VA Hospital, Hines, IL — Hines, Illinois, United States
• Richard L. Roudebush VA Medical Center, Indianapolis, IN — Indianapolis, Indiana, United States
• Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD — Baltimore, Maryland, United States
• Minneapolis VA Health Care System, Minneapolis, MN — Minneapolis, Minnesota, United States
• Kansas City VA Medical Center, Kansas City, MO — Kansas City, Missouri, United States
• St. Louis VA Medical Center John Cochran Division, St. Louis, MO — St Louis, Missouri, United States
• Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE — Omaha, Nebraska, United States
• New Mexico VA Health Care System, Albuquerque, NM — Albuquerque, New Mexico, United States
• Asheville VA Medical Center, Asheville, NC — Asheville, North Carolina, United States
• Salisbury W.G. (Bill) Hefner VA Medical Center, Salisbury, NC — Salisbury, North Carolina, United States
• Cincinnati VA Medical Center, Cincinnati, OH — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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