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Efficacy of Dose Increase Among Nonresponders to Low-Dose Aripiprazole Augmentation in Patients With Inadequate Response to Antidepressant Treatment
- Source :
- The Journal of Clinical Psychiatry. 73:353-357
- Publication Year :
- 2011
- Publisher :
- Physicians Postgraduate Press, Inc, 2011.
-
Abstract
- OBJECTIVE To examine the efficacy of a dose increase of aripiprazole to 5 mg/d in subjects with major depressive disorder (MDD) who did not respond to 4 weeks of treatment with aripiprazole 2 mg/d in a randomized, double-blind, placebo-controlled, parent study. METHOD 221 Subjects with Structured Clinical Interview for DSM-IV Axis I Disorders-Patient Edition-diagnosed DSM-IV-TR MDD (mean ± SD age, 45 ± 11 years; 64% women) with inadequate antidepressant response were recruited from September 2008-July 2009 and randomized to 60 days of double-blind augmentation with either aripiprazole or placebo in two 30-day phases. The study was performed across 8 academic hospital sites and 14 nonacademic (private clinic) sites throughout the United States. Randomization in a 2:3:3 ratio per sequential parallel comparison design was drug/drug (aripiprazole 2 mg/d in phase 1 and 5 mg/d in phase 2), placebo/placebo (placebo in both phases), and placebo/drug (placebo in phase 1 and aripiprazole 2 mg/d in phase 2). In phase 2, we examined efficacy of an aripiprazole dose increase to 5 mg/d in nonresponders to 2 mg/d by assessing response rates (≥ 50% reduction in Montgomery-Asberg Depression Rating Scale [MADRS] score [primary outcome measure]) and score changes in MADRS, Quick Inventory of Depressive Symptomatology-Self-Report, 9-item Patient Health Questionnaire (PHQ-9), the Clinical Global Impressions-Severity of Illness (CGI-S) and -Improvement (CGI-I) scales, and patient-rated versions of the CGI-I and CGI-S scales. RESULTS Response rate for aripiprazole 2 mg/d in phase 1 was 18.5% (n/n = 10/54). Among 39 nonresponders who increased their dose to 5 mg/d, response rate was 12.8% (95% CI, 4.30%-27.43%), with significant overall mean ± SD reductions in MADRS scores (-9.46 ± 7.83 [95% CI, -12.00 to -6.92]; P < .0001), Symptoms Questionnaire Distress scores (19.51 ± 17.73 [95% CI, 13.60 to 25.43]; P < .0001), PHQ-9 scores (-7.92 ± 5.92 [95% CI, -9.89 to -5.94]; P < .0001), and CGI-S scores (-0.86 ± 0.86 [95% CI, -1.15 to -0.58]; P < .0001). Differences in efficacy between drug and placebo groups were nonsignificant, however. Aripiprazole and placebo were well tolerated. CONCLUSIONS Augmentation with aripiprazole 5 mg/d may provide only a modest additional benefit in patients who do not benefit from lower doses. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00683852.
- Subjects :
- Male
medicine.medical_specialty
Randomization
Aripiprazole
Drug Resistance
Quinolones
Placebo
Piperazines
Double-Blind Method
Internal medicine
medicine
Humans
Psychiatry
Depression (differential diagnoses)
Psychiatric Status Rating Scales
Response rate (survey)
Depressive Disorder, Major
Dose-Response Relationship, Drug
business.industry
Middle Aged
medicine.disease
Antidepressive Agents
Patient Health Questionnaire
Psychiatry and Mental health
Major depressive disorder
Antidepressant
Female
business
medicine.drug
Subjects
Details
- ISSN :
- 01606689
- Volume :
- 73
- Database :
- OpenAIRE
- Journal :
- The Journal of Clinical Psychiatry
- Accession number :
- edsair.doi.dedup.....9ca6a365aec3cc6926456ee32a20981a