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The effects of valbenazine on tardive dyskinesia in patients with a primary mood disorder.
J Affect Disord. 2019 03 01; 246:217-223.JA

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+Show Affiliations

Department of Psychiatry, University of Toronto, Toronto, ON, Canada. Electronic address: roger.mcintyre@uhn.ca.Department of Psychiatry, Case Western Reserve University School of Medicine, University Hospitals Cleveland Medical Center, Cleveland, OH, United States.Dauten Family Center for Bipolar Treatment Innovation, Massachusetts General Hospital, Boston, MA, United States.Neurocrine Biosciences, Inc., San Diego, CA, United States.Neurocrine Biosciences, Inc., San Diego, CA, United States.Neurocrine Biosciences, Inc., San Diego, CA, United States.Neurocrine Biosciences, Inc., San Diego, CA, United States.

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

30583148

Citation

McIntyre, Roger S., et al. "The Effects of Valbenazine On Tardive Dyskinesia in Patients With a Primary Mood Disorder." Journal of Affective Disorders, vol. 246, 2019, pp. 217-223.
McIntyre RS, Calabrese JR, Nierenberg AA, et al. The effects of valbenazine on tardive dyskinesia in patients with a primary mood disorder. J Affect Disord. 2019;246:217-223.
McIntyre, R. S., Calabrese, J. R., Nierenberg, A. A., Farahmand, K., Yonan, C., Siegert, S., & Burke, J. (2019). The effects of valbenazine on tardive dyskinesia in patients with a primary mood disorder. Journal of Affective Disorders, 246, 217-223. https://doi.org/10.1016/j.jad.2018.12.023
McIntyre RS, et al. The Effects of Valbenazine On Tardive Dyskinesia in Patients With a Primary Mood Disorder. J Affect Disord. 2019 03 1;246:217-223. PubMed PMID: 30583148.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The effects of valbenazine on tardive dyskinesia in patients with a primary mood disorder. AU - McIntyre,Roger S, AU - Calabrese,Joseph R, AU - Nierenberg,Andrew A, AU - Farahmand,Khodayar, AU - Yonan,Chuck, AU - Siegert,Scott, AU - Burke,Joshua, Y1 - 2018/12/17/ PY - 2018/06/13/received PY - 2018/10/23/revised PY - 2018/12/15/accepted PY - 2018/12/26/pubmed PY - 2019/4/13/medline PY - 2018/12/25/entrez KW - Bipolar depression KW - Major depressive disorder KW - Mood disorder KW - Tardive dyskinesia KW - VMAT2 KW - Valbenazine SP - 217 EP - 223 JF - Journal of affective disorders JO - J Affect Disord VL - 246 N2 - 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. SN - 1573-2517 UR - https://www.unboundmedicine.com/medline/citation/30583148/The_effects_of_valbenazine_on_tardive_dyskinesia_in_patients_with_a_primary_mood_disorder_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0165-0327(18)31286-2 DB - PRIME DP - Unbound Medicine ER -