Evaluation of Patient-Reported Outcomes in Tardive Dyskinesia Patients With Underlying Psychotic and Mood Disorders in the ARM-TD and AIM-TD Trials

December 15, 2017
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This poster was presented at the 30th annual  Psych Congress, held Sept. 16-19, 2017, in New Orleans, Louisiana.

Introduction: In tardive dyskinesia (TD), patients' perception of benefit can be assessed using the Patient Global Impression of Change (PGIC). The PGIC may not be optimal for patients with psychotic disorders due to commonly associated lack of awareness of their condition and cognitive impairment. However, it can still provide important information on the perception of benefit in TD patients with mood disorders.

Objective: To assess patients' impression of treatment benefit from deutetrabenazine for the treatment of TD from the pooled ARM-TD and AIM-TD (24 and 36 mg/day doses) data sets, as compared with the pooled placebo cohort.

Methods: Pooled results from two 12-week trials, ARM-TD and AIM-TD, are presented. PGIC ratings at each visit were analyzed using the Cochran-Mantel-Haenszel test. Results were stratified by baseline comorbidities: psychotic disorders (schizophrenia/schizoaffective disorder) and mood disorders (bipolar disorder/depression/other).

Results: Among 97 patients with a mood disorder, 47% of patients on deutetrabenazine considered themselves "Much Improved" or "Very Much Improved" on the PGIC compared with 26% of those on placebo (OR: 2.76; P=0.028). Among 161 patients with a psychotic disorder, 41% were considered "Much Improved" or "Very Much Improved" in the deutetrabenazine group, versus 32% in the placebo group (OR: 1.38; P=0.342). Deutetrabenazine was generally well tolerated in both studies.

Conclusions: TD patients with underlying mood disorders were more likely to perceive treatment benefit with deutetrabenazine than with placebo. The self-reported treatment benefit in TD patients with psychotic disorders may be underestimated due to their lack of awareness of their condition and cognitive impairment.

Authors: 
Hubert Fernandez, MD; Mat Davis, PhD; Stewart Factor, DO; Robert Hauser, MD, MBA; Lars Jarskog, MD; Joohi Jimenez-Shahed, MD; Rajeev Kumar, MD, FRCPC; Stanislaw Ochudlo, MD, PhD; William Ondo, MD; Karen Anderson, MD
Sponsoring Organization: 
Teva Pharmaceutical Industries
Year: 
2017
Tracks: 
Psychotic Disorders
Mood Disorders