Dataset Information

RE-KINECT: A Prospective Study of the Presence and Healthcare Burden of Tardive Dyskinesia in Clinical Practice Settings.

ABSTRACT:

Purpose/background

RE-KINECT (NCT03062033) was designed to assess the presence and impact of possible tardive dyskinesia (TD) in antipsychotic-treated outpatients.

Methods/procedures

The study included adults with 3 or more months of lifetime antipsychotic exposure and 1 or more psychiatric disorder. Based on clinician observation and assessment, patients were assigned to cohort 1 (without involuntary movements or with non-TD involuntary movements) or cohort 2 (with involuntary movements confirmed by clinician as possible TD). Baseline assessments included the following: patient characteristics; location/severity of involuntary movements; and impact of possible TD on health-related quality of life, including the EuroQoL 5-Dimensions 5-Level questionnaire.

Findings/results

Of 739 eligible patients, 204 (27.6%) had clinician-confirmed possible TD (cohort 2). Compared with cohort 1, patients in cohort 2 were significantly older (P < 0.0001), more likely to have schizophrenia or schizoaffective disorder (P < 0.0001) and longer lifetime exposure to antipsychotics (P < 0.0001), and less likely to be working or studying, based on clinician perception (P = 0.0010). Clinician- and patient-rated severity of possible TD movements was significantly correlated in each of 4 body regions (head/face, neck/trunk, upper extremities, lower extremities), for maximum severity in any region, and for total number of affected regions (P < 0.001 for all correlations). For the patient-rated EuroQoL 5-Dimensions 5-Level, the health state visual analog scale score was significantly lower (worse) in cohort 2 versus cohort 1 (66.8 vs 69.7; P = 0.0002), as was the utility index score (0.71 vs 0.76; P < 0.0175).

Implications/conclusions

Results from this real-world population indicate that TD occurs frequently and can significantly reduce quality of life in patients with a psychiatric disorder.

SUBMITTER: Caroff SN

PROVIDER: S-EPMC7190052 | biostudies-literature | 2020 May/Jun

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

RE-KINECT: A Prospective Study of the Presence and Healthcare Burden of Tardive Dyskinesia in Clinical Practice Settings.

Caroff Stanley N SN Yeomans Karen K Lenderking William R WR Cutler Andrew J AJ Tanner Caroline M CM Shalhoub Huda H Pagé Véronique V Chen Jun J Franey Ericha E Yonan Chuck C

Journal of clinical psychopharmacology 20200501 3

<h4>Purpose/background</h4>RE-KINECT (NCT03062033) was designed to assess the presence and impact of possible tardive dyskinesia (TD) in antipsychotic-treated outpatients.<h4>Methods/procedures</h4>The study included adults with 3 or more months of lifetime antipsychotic exposure and 1 or more psychiatric disorder. Based on clinician observation and assessment, patients were assigned to cohort 1 (without involuntary movements or with non-TD involuntary movements) or cohort 2 (with involuntary mo ...[more]

PMID: 32332461

Similar Datasets

Project description:Abstract Background: Valbenazine is a novel and highly selective vesicular monoamine transporter 2 (VMAT2) inhibitor that is being evaluated for the treatment of tardive dyskinesia (TD), a persistent movement disorder resulting from exposure to antipsychotics or other dopamine receptor blocking agents (DRBAs). The efficacy of valbenazine in treating TD was demonstrated in a Phase 3 clinical trial (KINECT 3; NCT02274558), which included subjects with underlying schizophrenia/schizoaffective disorder or mood disorder. Further analyses of data from that trial were conducted to explore the efficacy of valbenazine across diagnostic subgroups. Methods: Subjects in this 6-week, double-blind, placebo-controlled trial were randomized 1:1:1 to once-daily valbenazine 80?mg, valbenazine 40?mg, or placebo. The primary endpoint was change from baseline to Week 6 on the Abnormal Involuntary Movement Scale (AIMS) total score (items 1–7) for valbenazine 80?mg vs placebo in the intent-to-treat (ITT) population. AIMs were videotaped and ratings were conducted by central raters blind to study visit and group. Additional outcomes included AIMS total score change (40?mg vs placebo) and Clinical Global Impression of Change-Tardive Dyskinesia (CGI TD) score (80 and 40?mg vs placebo) at Week 6. In addition to being evaluated in the ITT population, these outcomes were analyzed in subgroups categorized by underlying psychiatric diagnosis (schizophrenia/schizoaffective disorder or mood disorder). Results: At Week 6 in the ITT population (N = 225), AIMS score improvement was significantly greater with valbenazine 80?mg than placebo (least squares [LS] mean change from baseline: 80?mg, 3.2; placebo, ?0.1; P < .0001). AIMS score change at Week 6 for valbenazine 40?mg (1.9) was also greater than placebo (P = .0021). Statistical testing was not conducted in the subgroups, but the magnitude of AIMS improvement in these patients was comparable to results in the overall ITT population: schizophrenia/schizoaffective disorder (n = 148; mean change from baseline: 80?mg, ?3.1; 40?mg, ?1.5; placebo, +0.4); mood disorder (n = 77; 80?mg, 3.6; 40?mg, ?2.5; placebo, ?0.7). CGI-TD scores at Week 6 in the ITT population indicated greater global improvement with valbenazine than placebo, but between-group differences were not statistically significant (LS mean scores: 80?mg, 2.9; 40?mg, 2.9; placebo, 3.2). CGI-TD outcomes in the subgroups were as follows: schizophrenia/schizoaffective disorder (mean scores: 80?mg, 3.0; 40?mg, 2.9; placebo, 3.1); mood disorder (80?mg, 2.7; 40?mg, 2.9; placebo, 3.2). Psychiatric status remained stable during the 6-week double-blind treatment period. Conclusion: Once-daily treatment with valbenazine improved TD regardless of underlying psychiatric diagnosis.

Project description:Tardive dyskinesia (TD), a movement disorder associated with antipsychotics, most frequently affects the lower face and jaw muscles, but can also affect walking, breathing and use of the hands and limbs. Knowledge of TD among physicians may be limited, and the pathophysiology of TD is poorly understood. We conducted this review to summarise the current knowledge surrounding the pathophysiology of TD and present recommendations for prevention and treatment based on a literature search and roundtable discussion attended by psychiatrists in Japan. It has been suggested that dopamine hypersensitivity, damaged gamma-aminobutyric acidergic neurons and/or increased production of reactive oxygen species may contribute to development of TD. Symptoms can profoundly affect everyday life; patients who develop TD have poorer prognoses, worse health-related quality of life, greater social withdrawal and higher mortality than patients without TD. Traditional treatment options include dietary supplements, although evidence for their effectiveness is low. Among pharmaceutical interventions, there is moderate evidence that switching to the second-generation antipsychotic clozapine, which has a lower affinity for dopamine D2 receptors than other antipsychotics, may improve symptoms. Vesicular monoamine transporter 2 (VMAT-2) inhibitors, which oppose the increased dopaminergic activity associated with prolonged antipsychotic use by interfering with dopamine uptake and storage, have the strongest evidence for efficacy. VMAT-2 inhibitors are approved in the United States for the treatment of TD, and the first VMAT-2 inhibitor was approved in Japan for this indication in March 2022. Most guidelines recommend treating TD by first reducing the dose of antipsychotics or switching to clozapine or other second-generation antipsychotics, which have a lower association with TD than first-generation antipsychotics. We recommend focusing on prevention and monitoring for TD when prescribing antipsychotics, given that TD is often irreversible. Physicians should treat with antipsychotics only when necessary and at the lowest effective dose, and frequently monitor for TD symptoms.Plain language summaryPlain Language Summary (In Japanese).Visual summaryVisual Summary (In Japanese).

Project description:Tardive dyskinesia (TD) is a movement disorder that can arise as a side effect of treatment with dopamine receptor-blocking agents (DRBAs), including antipsychotic drugs (APDs) used to manage psychotic illnesses. Second-generation APDs (SGAs) are often preferred to first-generation drugs due to their lower propensity to cause TD, however many SGAs-treated patients still develop the condition. Although TD is a global health concern, evidence regarding the occurrence of TD and how it is managed in Asian countries is currently limited. This article reports the results of a systematic review of the published literature on TD focusing on its prevalence, types of patients, knowledge of the condition, causative factors, and usual treatment pathways in clinical practice in Asian countries. Epidemiological data suggest that the prevalence of TD is increasing globally due to an overall rise in APD use, contributing factors being polypharmacy with multiple APDs, the use of higher than necessary doses, and off-label use for non-psychotic indications. Although exact prevalence figures for TD in Asian countries are difficult to define, there is a similar pattern of rising APD use which will result in increasing numbers of TD patients in this region. These issues need to be addressed and strategies developed to minimize TD risk and manage this disabling condition which impacts patients' quality of life and daily functioning. To date, both research into TD has been predominantly psychiatry focused and the perspectives from neurologists regarding the clinical management of this challenging condition are scarce. However, neurologists have an essential role in managing the movement disorders manifestations that characterize TD. Optimum management of TD, therefore, should ideally involve collaboration between psychiatrists and neurologists in joint care pathways, wherever practical. Collaborative pathways are proposed in this article, and the challenges that will need to be addressed in Asian countries to improve the care of people with TD are highlighted, with a focus on the neurologist's viewpoint and the implications for the management of TD globally.

Dataset Information

RE-KINECT: A Prospective Study of the Presence and Healthcare Burden of Tardive Dyskinesia in Clinical Practice Settings.

Purpose/background

Methods/procedures

Findings/results

Implications/conclusions

Publications

RE-KINECT: A Prospective Study of the Presence and Healthcare Burden of Tardive Dyskinesia in Clinical Practice Settings.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets