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Psych Congress  
2018

Assessment of Functional Recovery After Long-term Aripiprazole Once-Monthly Maintenance Treatment of Bipolar I Disorder

Authors  

Jessica Madera, MD – Otsuka Pharmaceutical Development & Commercialization, Inc.; Pedro Such, MD – H. Lundbeck A/S; Peter Zhang, PhD – Otsuka Pharmaceutical Development and Commercialization, Inc.; Ross Baker, PhD, MBA – Otsuka Pharmaceutical Development & Commercialization, Inc.; Mauricio Tohen, MD, DrPH, MBA – University of New Mexico; Mauricio Tohen, MD, DrPH, MBA – University of New Mexico; Mauricio Tohen, MD, DrPH, MBA – University of New Mexico; Jessica Madera, MD – Otsuka Pharmaceutical Development & Commercialization, Inc.; Mauricio Tohen, MD, DrPH, MBA – University of New Mexico; Thomas Brown, PhD – Brown Clinic for Attention & Related Disorders; Craig Surman, MD – Harvard Medical School

Sponsor  
Otsuka Pharmaceutical Development and Commercialization, Inc.

Background: Functional assessment is complex and often overlooked in patients with bipolar I disorder. The Functioning Assessment Short Test (FAST) assesses optimal functioning in these patients.

Method: Functioning was assessed in two long-term (52-week) studies using FAST, a 24-item questionnaire where higher total scores reflect more impaired functioning. Patient functional recovery was defined as a FAST total score of ≤11 (out of 72) for 8 consecutive weeks.

Results: In the long-term efficacy study (NCT01567527), 116 patients received aripiprazole once-monthly 400 mg (AOM 400) and 113 received placebo for 52 weeks and had ≥1 post-baseline FAST assessment. After 52 weeks, 30.2% (n=35) of AOM 400 patients and 24.8% (n=28) of placebo patients were functionally recovered. The mean FAST total score in the recovered patients in the AOM 400 group was 3.6 (SD=3.6, n=35).In the open-label, long-term safety study (NCT01710709), 402 patients received AOM 400 for 52 weeks and had ≥1 post-baseline FAST assessment. After 52 weeks of AOM 400, 36% (n=116/321) of the de novo patients and 43% (n=35/81) of the rollover patients had functionally recovered. The mean FAST total score in the functionally recovered patients was 3.7 (SD=3.4, n=116) and 3.5 (SD=3.4, n=35) in the de novo and rollover patients, respectively.

Conclusion: Both studies show a trend that approximately 30-43% of patients achieved functional recovery after 52 weeks long-term treatment with AOM 400. A high proportion (57%) of the patients who were functionally recovered on AOM 400 remained functionally recovered after up to 52 weeks of long-term treatment.

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