Objective: To assess the effect of deutetrabenazine (DTB) on quality of life (QoL) of patients with tardive dyskinesia (TD) as measured by the modified Craniocervical Dystonia Questionnaire (mCDQ-24).

Background: TD is a movement disorder that can be debilitating, add to the stigma of a psychiatric disorder, and negatively impact QoL for patients already stigmatized by mental illness. The CDQ-24 is a QoL questionnaire developed and validated for use in patients with craniocervical dystonia. Some of the domains evaluated in the CDQ-24, including Activities of Daily Living (ADL), Pain, Emotional Well-Being, Social/Family Life and Stigma, are relevant to TD. In the AIM-TD study, 11 items of the CDQ-24 relevant to the impact of TD were assessed. Response options for each item on the questionnaire include: never, occasionally, sometimes, often, or always; a reduction in score indicates improvement.

Methods: Patients with moderate to severe TD were randomized 1:1:1:1 to receive one of three fixed-dose regimens of DTB (12 mg/day, 24 mg/day, or 36 mg/day) or placebo (PBO). Change in mCDQ-24 score from baseline to Week 12 was analyzed using an analysis of covariance model adjusted for treatment, concomitant dopamine-receptor antagonist use, and baseline mCDQ-24 score.

Results: At baseline, the mean (standard error) mCDQ-24 scores were similar between patients taking 36 mg/day [n=55; 36.4 (2.46)], 24 mg/day [n=49; 36.5 (2.89)], 12 mg/day [n=60; 38.6 (2.71)], and PBO [n=58; 41.2 (2.59)]. At Week 12, there was a clinically meaningful least-squares mean treatment difference comparing 36 mg/day (–4.4, P=0.123) and 24 mg/day (–3.5, P=0.242) with PBO. The 12 mg/day dose did not show improvements over PBO. Four of five mCDQ-24 subdomains evaluated improved with DTB 36 mg/day compared with PBO at Week 12 (ADL: –11.8 vs –6.8; Pain: –15.5 vs –6.1; Social: –10.5 vs –3.6; Stigma: –13.3 vs –9.9). DTB 24 mg/day also improved the Pain (–15.2 vs. –6.1) and Stigma (–17.8 vs. –9.9) subdomains compared with PBO. Emotional well-being did not improve with treatment. DTB was generally well tolerated.

Conclusions: The mCDQ-24 was used to evaluate QoL in patients with TD. Treatment with DTB 36 mg/day improved most mCDQ-24 subdomains. Improvements in key subdomains such as Pain and Stigma were seen with both 24 and 36 mg/day doses.

Presented at: APA annual meeting; May 20–24, 2017; San Diego, CA, USA

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MDS Abstracts - https://www.mdsabstracts.org/abstract/effect-of-deutetrabenazine-on-quality-of-life-in-patients-with-tardive-dyskinesia-in-aim-td-a-12-week-double-blind-placebo-controlled-study/