KINECT 3: A phase 3 randomized, double-blind, placebo-controlled trial of valbenazine for tardive dyskinesia

American Journal of Psychiatry

Volumn 174, Issue 5, 2017, Pages 476-484

  Hauser, Robert A ^a,b,c,d,e,f   Factor, Stewart A ^a,b,c,d,e,f   Marder, Stephen R ^a,b,c,d,e,f   Knesevich, Mary Ann ^a,b,c,d,e,f   Ramirez, Paul M ^a,b,c,d,e,f   Jimenez, Roland ^a,b,c,d,e,f   Burke, Joshua ^a,b,c,d,e,f   Liang, Grace S ^a,b,c,d,e,f   O'Brien, Christopher F ^a,b,c,d,e,f  

^a UNIVERSITY OF SOUTH FLORIDA   (United States)

^b EMORY UNIVERSITY SCHOOL OF MEDICINE   (United States)

^c UNIVERSITY OF CALIFORNIA   (United States)

^d University Hills Clinical Research   (United States)

^e LONG ISLAND UNIVERSITY   (United States)

^f NEUROCRINE BIOSCIENCES INC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARIPIPRAZOLE; ATYPICAL ANTIPSYCHOTIC AGENT; BENZATROPINE; DOPAMINE RECEPTOR BLOCKING AGENT; FLUOXETINE; HALOPERIDOL; MIRTAZAPINE; NEUROLEPTIC AGENT; OLANZAPINE; PLACEBO; QUETIAPINE; RISPERIDONE; SERTRALINE; TRAZODONE; VALBENAZINE; ZIPRASIDONE; TETRABENAZINE; VALINE;

ABNORMAL INVOLUNTARY MOVEMENT SCALE; ADULT; AGED; AKATHISIA; CHRONIC OBSTRUCTIVE LUNG DISEASE; CONFERENCE PAPER; CONGESTIVE HEART FAILURE; CONTROLLED STUDY; DIABETES MELLITUS; DISEASE EXACERBATION; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG MONITORING; DRUG SAFETY; DRUG SCREENING; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSARTHRIA; ELECTROCARDIOGRAPHY; FEMALE; HUMAN; HYPERTENSION; LABORATORY TEST; MAJOR CLINICAL STUDY; MALE; MOOD DISORDER; MULTICENTER STUDY; PARALLEL DESIGN; PATIENT COMPLIANCE; PHASE 3 CLINICAL TRIAL; PSYCHOLOGIC ASSESSMENT; RANDOMIZED CONTROLLED TRIAL; SCHIZOAFFECTIVE PSYCHOSIS; SCHIZOPHRENIA; SCORING SYSTEM; SINGLE DRUG DOSE; SOMNOLENCE; SUICIDAL IDEATION; SUICIDE ATTEMPT; TARDIVE DYSKINESIA; TREATMENT DURATION; VIDEORECORDING; VIRUS HEPATITIS; XEROSTOMIA; ANALOGS AND DERIVATIVES; CLINICAL TRIAL; COMBINATION DRUG THERAPY; COMPARATIVE STUDY; DOSE RESPONSE; MIDDLE AGED; MOOD DISORDERS; PSYCHOTIC DISORDERS; TREATMENT OUTCOME;

ABNORMAL INVOLUNTARY MOVEMENT SCALE; ADULT; AGED; ANTIPSYCHOTIC AGENTS; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; DRUG THERAPY, COMBINATION; FEMALE; HUMANS; MALE; MIDDLE AGED; MOOD DISORDERS; PSYCHOTIC DISORDERS; SCHIZOPHRENIA; TARDIVE DYSKINESIA; TETRABENAZINE; TREATMENT OUTCOME; VALINE;

EID: 85018390919     PISSN: 0002953X     EISSN: 15357228     Source Type: Journal    
DOI: 10.1176/appi.ajp.2017.16091037     Document Type: Conference Paper

References (25)

1. Waln O, Jankovic J: An update on tardive dyskinesia: from phenomenology to treatment. Tremor Other Hyperkinet Mov (N Y) 2013; 3:tre-03-161-4138-1 (doi: 10.7916/D7988P7915Z7971)
2. Cloud LJ, Zutshi D, Factor SA: Tardive dyskinesia: therapeutic options for an increasingly common disorder. Neurotherapeutics 2014; 11:166-176
3. Zutshi D, Cloud LJ, Factor SA: Tardive syndromes are rarely reversible after discontinuing dopamine receptor blocking agents: experience from a university-based movement disorder clinic. Tremor Other Hyperkinet Mov (N Y) 2014; 4:266
4. Rana AQ, Chaudry ZM, Blanchet PJ: New and emerging treatments for symptomatic tardive dyskinesia. Drug Des Devel Ther 2013; 7: 1329-1340
5. de Leon J: The effect of atypical versus typical antipsychotics on tardive dyskinesia: A naturalistic study. Eur Arch Psychiatry Clin Neurosci 2007; 257:169-172
6. Woods SW, Morgenstern H, Saksa JR, et al: Incidence of tardive dyskinesia with atypical versus conventional antipsychotic medications: A prospective cohort study. J Clin Psychiatry 2010; 71:463-474
7. Caroff SN, Hurford I, Lybrand J, et al: Movement disorders induced by antipsychotic drugs: implications of the CATIE schizophrenia trial. Neurol Clin 2011; 29:127-148
8. Bhidayasiri R, Fahn S, Weiner WJ, et al: Evidence-based guideline: treatment of tardive syndromes: report of the Guideline Development Subcommittee of the American Academy of Neurology. Neurology 2013; 81:463-469
9. Jankovic J: Dopamine depleters in the treatment of hyperkinetic movement disorders. Expert Opin Pharmacother 2016; 17: 2461-2470
10. Müller T: Valbenazine granted breakthrough drug status for treating tardive dyskinesia. Expert Opin Investig Drugs 2015; 24:737-742
11. Jankovic J, Beach J: Long-term effects of tetrabenazine in hyperkinetic movement disorders. Neurology 1997; 48:358-362
12. GuyW(ed): ECDEU Assessment Manual for Psychopharmacology: Publication ADM 76-338. Washington, DC, US Department of Health, Education, and Welfare, 1976, pp 534-537
13. O'Brien CF, Jimenez R, Hauser RA, et al: NBI-98854, a selective monoamine transport inhibitor for the treatment of tardive dyskinesia: A randomized, double-blind, placebo-controlled study. Mov Disord 2015; 30:1681-1687
14. Jeste DV, Palmer BW, Appelbaum PS, et al: A new brief instrument for assessing decisional capacity for clinical research. Arch Gen Psychiatry 2007; 64:966-974
15. Kay SR, Fiszbein A, Opler LA: The Positive and Negative Syndrome Scale (PANSS) for schizophrenia. Schizophr Bull 1987; 13: 261-276
16. Young RC, Biggs JT, Ziegler VE, et al: A rating scale for mania: reliability, validity and sensitivity. Br J Psychiatry 1978; 133: 429-435
17. Montgomery SA, Asberg M: A new depression scale designed to be sensitive to change. Br J Psychiatry 1979; 134:382-389
18. Simpson GM, Angus JWS: A rating scale for extrapyramidal side effects. Acta Psychiatr Scand Suppl 1970; 212:11-19
19. Barnes TRE: A rating scale for drug-induced akathisia. Br J Psychiatry 1989; 154:672-676
20. Posner K,BrownGK,Stanley B, et al:TheColumbia-Suicide Severity Rating Scale: initial validity and internal consistency findings from three multisite studies with adolescents and adults.Am J Psychiatry 2011; 168:1266-1277
21. Stewart RM, Rollins J, Beckham B, et al: Baclofen in tardive dyskinesia patients maintained on neuroleptics. Clin Neuropharmacol 1982; 5:365-373
22. Zhang WF, Tan YL, Zhang XY, et al: Extract of Ginkgo biloba treatment for tardive dyskinesia in schizophrenia: A randomized, double-blind, placebo-controlled trial. J Clin Psychiatry 2011; 72: 615-621
23. Grigoriadis D, ComellaC, Remington G, et al: Efficacy of valbenazine (NBI-98854) in subjects with tardive dyskinesia: results of a longterm extension study (KINECT 3 Extension) (poster M151) Neuropsychopharmacol 2016; 41:S213
24. Emsley R, Niehaus DJ, Oosthuizen PP, et al: Subjective awareness of tardive dyskinesia and insight in schizophrenia. Eur Psychiatry 2011; 26:293-296
25. Citrome L: Compelling or irrelevant? Using number needed to treat can help decide. Acta Psychiatr Scand 2008; 117:412-419