The response in patients with bipolar depression to treatment with lurasidone at the 2-week mark is an important indicator of both short- and long-term improvements in patient treatment outcomes, according to data presented at the 2017 American Psychiatric Association Annual Meeting, held May 20 -24, in San Diego, California.
Because response to lurasidone treatment between baseline and week 2 has indicated later success in bipolar depression, Daisy S. Ng-Mak, PhD, a research scientist at Sunovion Pharmaceuticals in Marlborough, Massachusetts, and colleagues examined the relationship between early clinical improvement and functioning and health-related quality of life at 6, 12, and 24 weeks.
The researchers used a post hoc analysis of bipolar depression data from patients who entered and completed a 24-week open-label trial of lurasidone. They were divided into one of two 6-week randomized placebo-controlled clinical trials that assessed the effect of lurasidone as monotherapy (either 20 to 60 mg or 80 to 120 mg) or in conjunction with lithium or valproate (20 to 120 mg) vs placebo. They controlled age, gender, pooled study center, and baseline outcome score through covariance analyses.
Of 414 patients, 240 were classified as early responders, with no significant differences at baseline between early and late responders on clinical and patient health outcomes.
“By week 6, early responders reported significantly greater clinical (Montgomergy-Asberg Depression [MADRS] Score −19.8±8.6 vs −10.9±8.6; Clinical Global Impression-Bipolar Illness-Severity [CGI-BP-S] score −2.3±1.1 vs −1.0±1.0), and patient health outcomes improvements from baseline (Sheehan Disability Score [SDS] total −12±7.2 vs −8.1±6.8; Quality of Life Enjoyment and Satisfaction Questionnaire [Q-LES-Q SF] score 26.8±15.5 vs 18.3±14.8; all P <.001),” the researchers said. “At week 12, the observed clinical and patient health outcome levels (MADRS 7.8±7.2 vs 9.9±6.5; CGI-BP-S 1.9±1.0 vs 2.3±0.9; SDS total 6.2±5.95 vs 7.2±5.64; Q-LES-Q SF 49.9±9.25 vs 47.5±8.87) became more alike between early and late responders.”
“At week 24, the observed outcome levels were similar for both groups (MADRS 6.8±7.6 vs 7.5±6.0; CGI-BP-S 1.7±1.0 vs 2.3±0.9; SDS total 4.4±5.15 vs 6.0±5.17; Q-LES-Q SF 51.1±8.91 vs 49.6±8.35), and outcome improvements were sustained for the total sample and by treatment arm,” the researchers added.
Ng-Mak DS, Bacci ED, Poon JL, Rajagopalan K, Loebel A. Early vs. later treatment response in lurasidone treated patients with bipolar depression: association with patient-reported health outcomes. Presented at: 2017 American Psychiatric Association Annual Meeting, May 20-24, San Diego, California. Abstract #P5-35.