The effects of valbenazine on tardive dyskinesia in patients with a primary mood disorder

JOURNAL OF AFFECTIVE DISORDERS

卷:246

Article

McIntyre, Roger S.¹  Calabrese, Joseph R.²  Nierenberg, Andrew A.³  Farahmand, Khodayar⁴  Yonan, Chuck⁴  Siegert, Scott⁴  Burke, Joshua⁴ 

[1] Univ Toronto, Dept Psychiat, Toronto, ON, Canada

[2] Case Western Reserve Univ, Univ Hosp Cleveland, Sch Med, Dept Psychiat,Med Ctr, Cleveland, OH 44106 USA

[3] Massachusetts Gen Hosp, Dauten Family Ctr Bipolar Treatment Innovat, Boston, MA 02114 USA

[4] Neurocrine Biosci Inc, San Diego, CA USA

关键词: Bipolar depression;    Major depressive disorder;    Mood disorder;    Tardive dyskinesia;    Valbenazine;    VMAT2;   

DOI  :  10.1016/j.jad.2018.12.023

来源: Elsevier

【 摘 要 】

Background: Few studies have assessed the treatment of tardive dyskinesia (TD) in patients with primary mood disorders who are managed with antipsychotics. The effects of once-daily valbenazine on TD were evaluated in adults with a bipolar or depressive disorder. Methods: Data were pooled from two 6-week double-blind placebo-controlled trials (KINECT 2 and KINECT 3; 114 mood participants) and a long-term blinded extension study (KINECT 3 extension; 77 mood participants) of valbenazine in adults with TD. Efficacy assessments included Abnormal Involuntary Movement Scale (AIMS) total score (sum of items 1-7), Clinical Global Impression of Change-Tardive Dyskinesia (CGI-TD), and Patient Global Impression of Change (PGIC). Safety assessments included treatment-emergent adverse events (TEAEs), Young Mania Rating Scale, and Montgomery-Asberg Depression Rating Scale. Results: At Week 6, mean improvements in AIMS total score were significantly greater with valbenazine versus placebo (40 mg/day, -3.1 [P<0.01]; 80 mg/day, -3.5 [P<0.001]; placebo, -0.9). Significant differences between valbenazine (80 mg/day) and placebo were also found for Week 6 AIMS response (>= 50% total score improvement) and CGI-TD response (much improved or very much improved), but not PGIC response. Sustained improvements in AIMS, CGI-TD, and PGIC were found through 48 weeks. Valbenazine was generally well tolerated, with no unexpected TEAEs, worsening in psychiatric symptoms, or emergence of suicidality. Limitations: Pooled analyses were conducted post hoc, and neither study was designed to focus solely on mood disorder patients. Conclusions: In participants with primary mood disorders, once-daily treatment with valbenazine was generally well tolerated and resulted in 6-week and sustained TD improvements.

【 授权许可】

Free