VA Augmentation and Switching Treatments for Improving Depression Outcomes

• Status: Completed
• Trial end date: 2016-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: VA Office of Research and Development
• Treatments: Antidepressive Agents; Aripiprazole; Bupropion

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