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

Abstract

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-Åsberg 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.

• Authors: Roger S McIntyre, Joseph R Calabrese, Andrew A Nierenberg, Khodayar Farahmand, Chuck Yonan, Scott Siegert, Joshua Burke
• Journal: Journal of affective disorders (J Affect Disord) Vol. 246 Pg. 217-223 (03 01 2019) ISSN: 1573-2517 [Electronic] Netherlands
• PMID: 30583148 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2018 The Authors. Published by Elsevier B.V. All rights reserved.

Chemical References

• Antipsychotic Agents
• valbenazine
• Valine
• Tetrabenazine

Topics

• Antipsychotic Agents (adverse effects, therapeutic use)
• Double-Blind Method
• Female
• Humans
• Male
• Middle Aged
• Mood Disorders (complications, drug therapy)
• Tardive Dyskinesia (chemically induced, complications, drug therapy)
• Tetrabenazine (adverse effects, analogs & derivatives, therapeutic use)
• Valine (adverse effects, analogs & derivatives, therapeutic use)