At a glance
ClinicalIndex Comparison Record- ✓Age 18-70 years, male or female outpatients
- ✓DSM-IV diagnosis of Major Depressive Disorder, unipolar, nonpsychotic type
- ✓Baseline Hamilton Depression Scale score ≥14 on 17-item scale
- ✓Prior treatment with an SSRI at adequate dose for minimum 6 weeks
- ✕DSM-IV diagnoses of Bipolar Disorder, cyclothymia, Schizophrenia, Delusional Disorders, other Psychotic Disorders, Severe Borderline Personality Disorder, Anorexia Nervosa, or Bulimia
- ✕Abuse or dependence on any substance (including alcohol) within past 6 months
- ✕Pregnant or nursing women
- ✕High suicide risk: specific plan for suicide, Hamilton Depression Scale item #3 score ≥3, or suicide attempt within 6 months requiring medical attention
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Abilify (Aripiprazole) as an Adjunctive Treatment for Refractory Unipolar Depression
In Brief
A Phase 4 clinical trial evaluating Aripiprazole for Depressive Disorder, Major. Completed, enrolled 15 participants across 1 site.
Detailed Summary
This is a study of the effectiveness of adding Abilify (aripiprazole), an atypical antipsychotic medication, to ongoing selective serotonin reuptake inhibitor (SSRI) antidepressant treatment for depressed outpatients who are not responding fully to SSRI treatment alone. It is hypothesized that patients' functioning will improve after 12 weeks of treatment with Aripiprazole and SSRI medication.
Study Details
Timeline
Interventions
Aripiprazole dose ranging from 5 to 30 mg/day, augmenting antidepressant treatment. Aripiprazole is used as an augmenting medication on an open label basis for patients on antidepressant medication who continue to have depressive symptoms. This is an open label case series in which all subjects receive aripiprazole augmentation. There is no comparator group.