A Double-Blind, Randomized, Placebo-Controlled Study of the Dopamine D3 Receptor Antagonist ABT-925 in Patients With Acute Schizophrenia

• DOI: 10.1097/jcp.0b013e31820e4818
• Publication Date: 2011-02-23T08:21:14Z
• Authors: Laura Redden; Beatrice Rendenba...; Walid M. Abi-Saab; David A. Katz; Armen Goenjian; Weining Z. Robieson; Yaqin Wang; Sandra L. Goss; Nicholas Greco; Mario D. Saltarelli
• Keywords: Dopamine antagonist

There is substantial preclinical and clinical evidence to suggest a potential role for the dopamine D₃ receptor in treatment of schizophrenia. ABT-925 selective antagonist with an approximately 100-fold higher vitro affinity versus D₂ receptors. This double-blind, randomized, placebo-controlled, escalating-dose, parallel-group study assessed efficacy safety patients acute exacerbation One hundred fifty-five were over 6-week double-blind period (placebo: n = 48; 50 mg once daily [QD]: 53; 150 QD: 54). The primary measure was mean change from baseline final evaluation on Positive Negative Syndrome Scale total score. Secondary measures pharmacokinetic parameters also assessed. Safety assessments included adverse event monitoring, laboratory tests, vital signs, movement rating scales, electrocardiogram measures. No statistically significant effect observed QD or compared placebo secondary end points. Pharmacokinetic parameter estimates increased dose linear fashion. generally well tolerated, profiles similar that placebo. Findings concurrent positron emission tomography among healthy volunteers doses used this may not have been sufficient adequately occupy receptors, thereby underscoring importance pharmacodynamic markers, such as PET, determining appropriate compound before embarking studies target population.