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Valbenazine Improved Tardive Dyskinesia in People with Schizophrenia

Am J Psychiatry; ePub 2017 Mar 21; Hauser, et al

Once-daily valbenazine significantly improved tardive dyskinesia in participants with underlying schizophrenia, schizoaffective disorder, or mood disorder, a recent study found. Valbenazine was generally well tolerated, and psychiatric status remained stable. Researchers conducted a 6-week, randomized, double-blind, placebo-controlled trial including patients with schizophrenia, schizoaffective disorder, or a mood disorder who had moderate or severe tardive dyskinesia. The intent-to-treat population included 225 participants, of whom 205 completed the study. Participants were randomly assigned in a 1:1:1 ratio to once-daily placebo, valbenazine at 40 mg/day, or valbenazine at 80 mg/day. The primary efficacy endpoint was change from baseline to week 6 in the 80 mg/day group compared with the placebo group on the Abnormal Involuntary Movement Scale (AIMS) dyskinesia score. They found:

  • Approximately 65% of participants had schizophrenia or schizoaffective disorder, and 85.5% were receiving concomitant antipsychotics.
  • Least squares mean change from baseline to week 6 in AIMS dyskinesia score was −3.2 for the 80 mg/day group, compared with −0.1 for the placebo group, a significant difference.
  • AIMS dyskinesia score was also reduced in the 40 mg/day group (−1.9 compared with −0.1).

Citation:

Hauser RA, Factor SA, Marder SR, et al. KINECT 3: A phase 3 randomized, double-blind, placebo-controlled trial of valbenazine for tardive dyskinesia. [Published online ahead of print March 21, 2017]. Am J Psychiatry. doi:10.1176/appi.ajp.2017.16091037.