An open-label study of aripiprazole: Pharmacokinetics, tolerability, and effectiveness in children and adolescents with conduct disorder

Journal of Child and Adolescent Psychopharmacology

Volumn 19, Issue 4, 2009, Pages 431-439

  Findling, Robert L ^a   Kauffman, Ralph ^b   Sallee, Floyd R ^c   Salazar, Daniel E ^d   Sahasrabudhe, Vaishali ^d   Kollia, Georgia ^d   Kornhauser, David M ^d   Vachharajani, Nimish N ^d   Assuncao Talbott, Sheila ^d   Mallikaarjun, Suresh ^e   Iwamoto, Taro ^f   McQuade, Robert D ^e   Boulton, David W ^d   Blumer, Jeffrey ^g  

^a UNIVERSITY HOSPITALS OF CLEVELAND   (United States)

^b UNIVERSITY OF MISSOURI KANSAS CITY   (United States)

^c CINCINNATI CHILDREN'S HOSPITAL MEDICAL CENTER   (United States)

^d BRISTOL MYERS SQUIBB   (United States)

^e OTSUKA PHARMACEUTICAL DEVELOPMENT AND COMMERCIALIZATION INC   (United States)

^f OTSUKA PHARMACEUTICAL CO LTD   (Japan)

^g CASE WESTERN RESERVE UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANTACID AGENT; ANTIBIOTIC AGENT; ANTIHISTAMINIC AGENT; ARIPIPRAZOLE; BUSPIRONE; CENTRAL STIMULANT AGENT; CIMETIDINE; OMEPRAZOLE; SALBUTAMOL; STEROID;

ADOLESCENT; AGGRESSION; ALANINE AMINOTRANSFERASE BLOOD LEVEL; AREA UNDER THE CURVE; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; BEHAVIOR THERAPY; CHILD; CHILD PSYCHIATRY; CLINICAL ARTICLE; CLINICAL GLOBAL IMPRESSION SCALE; CLINICAL TRIAL; COGNITIVE THERAPY; CONDUCT DISORDER; CONTROL GROUP; CONTROLLED STUDY; COUGHING; CREATINE KINASE BLOOD LEVEL; DECREASED APPETITE; DIAGNOSTIC AND STATISTICAL MANUAL OF MENTAL DISORDERS; DIARRHEA; DIZZINESS; DRUG BLOOD LEVEL; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DRUG TREATMENT FAILURE; DRUG WITHDRAWAL; DYSMENORRHEA; EXTRAPYRAMIDAL SYMPTOM; FEMALE; HEADACHE; HUMAN; HYPOKINESIA; INCREASED APPETITE; INFLUENZA; LACERATION; LIQUID CHROMATOGRAPHY; MALE; MASS SPECTROMETRY; MAXIMUM PLASMA CONCENTRATION; MORNING DOSAGE; MULTICENTER STUDY; NAUSEA; OPEN STUDY; PRESCHOOL CHILD; PROLACTIN BLOOD LEVEL; RHINOPHARYNGITIS; RIGIDITY; SCHOOL CHILD; SEDATION; SIDE EFFECT; SOMNOLENCE; SORE THROAT; STEADY STATE; TIME TO MAXIMUM PLASMA CONCENTRATION; TREATMENT DURATION; TREMOR; UPPER ABDOMINAL PAIN; VITAL SIGN; VOMITING; WEIGHT CHANGE;

ADOLESCENT; AGE FACTORS; ANTIPSYCHOTIC AGENTS; CHILD; CONDUCT DISORDER; FEMALE; FOLLOW-UP STUDIES; HUMANS; MALE; PIPERAZINES; PROSPECTIVE STUDIES; QUINOLONES; TREMOR; VOMITING;

EID: 69549133858     PISSN: 10445463     EISSN: None     Source Type: Journal    
DOI: 10.1089/cap.2008.0111     Document Type: Article

References (35)

1. Abilify: Bristol-Myers Squibb/Otsuka America Pharmaceutical Inc., Aripiprazole (Abilify) Prescribing Information. Bristol-Myers Squibb & Otsuka America Pharmaceutical Inc. Princeton (New Jersey), 2007.
2. American Psychiatric Association: Diagnostic and Statistical Manual of Mental Disorders (DSM-IV). Washington (DC): American Psychiatric Association, 1994.
3. Andrezina R, Josiassen R, Marcus R, Oren D, Manos G, Stock E, Carson W, Iwamoto T: Intramuscular aripiprazole for the treatment of acute agitation in patients with schizophrenia or schizoaffective disorder: A double-blind, placebo-controlled comparison with IM haloperidol. Psychopharmacology 188:281-292, 2006. (Pubitemid 44387456)
4. Berg EA: A simple objective technique for measuring flexibility in thinking. J Gen Psychol 39:15-22, 1948.
5. Berman RM, Marcus RN, Swanink R, McQuade RD, Carson WH, Corey-Lisle PK, Khan A: The efficacy and safety of aripiprazole as adjunctive therapy in major depressive disorder: A multicenter, randomized, double-blind, placebocontrolled study. J Clin Psychiatry 68:843-853, 2007. (Pubitemid 47015482)
6. Burris KD, Molski TF, Xu C, Ryan E, Tottori K, Kikuchi T, Yocca FD, Molinoff PB: Aripiprazole, a novel antipsychotic, is a high-affinity partial agonist at human dopamine D2 receptors. J Pharmacol Exp Ther 302:381-389, 2002. (Pubitemid 34680462)
7. Bryden KE, Carrey NJ, Kutcher SP: Update and recommendations for the use of antipsychotics in early-onset psychoses. J Child Adolesc Psychopharmacol 11:113-130, 2001.
8. Correll CU: Clinical psychopharmacology of pediatric mood stabilizer and antipsychotic treatment, part 1: Challenges and developments. J Clin Psychiatry 68:1301-1302, 2007. (Pubitemid 47398782)
9. Findling R: Pharmacologic treatment of behavioral symptoms in autism and pervasive developmental disorders. J Clin Psychiatry 66:26-31, 2005. (Pubitemid 43133211)
10. Findling RL, Kauffman RE, Sallee FR, Carson WH, Nyilas M, Mallikaarjun S, Shoaf SE, Forbes RA, Boulton DW, Pikalov A: Tolerability and pharmacokinetics of aripiprazole in children and adolescents with psychiatric disorders:An open-label, dose-escalation study. J Clin Psychopharmacol 28:441-446, 2008.
11. Findling RL, Kauffman RE, Sallee FR, Carson WH, Nyilas M, Mallikaarjun S, Shoaf SE, Forbes RA, Boulton DW, Pikalov A: Tolerability and pharmacokinetics of aripiprazole in children and adolescents with psychiatric disorders: an open-label, dose-escalation study. J Clin Psychopharmacol 28:441-446, 2008.
12. Guy W: Clinical Global Impressions (CGI). In: ECDEU Assessment Manual for Psychopharmacology. US Department of Health, Education, and Welfare Publication (ADM) 76-338. Rockville (Maryland): National Institute of Mental Health, 1976, pp 218-222.
13. Jordan S, Koprivica V, Chen R, Tottori K, Kikuchi T, Altar CA: The antipsychotic aripiprazole is a potent, partial agonist at the human 5-HT(1A) receptor. Eur J Pharmacol 441:137-140, 2002. (Pubitemid 34626163)
14. Kane JM, Carson WH, Saha AR, McQuade RD, Ingenito GG, Zimbroff DL, Ali MW: Efficacy and safety of aripiprazole and haloperidol versus placebo in patients with schizophrenia and schizoaffective disorder. J Clin Psychiatry 63:763-771, 2002.
15. Kasper S, Lerman MN, McQuade RD, Saha A, Carson WH, Ali M, Archibald D, Ingenito G, Marcus R, Pigott T: Efficacy and safety of aripiprazole vs. haloperidol for long-term maintenance treatment following acute relapse of schizophrenia. Int J Neuropsychopharmacol 6:325-337, 2003. (Pubitemid 38146250)
16. Kaufman J, Birmaher B, Brent D, Rao U, Flynn C, Moreci P, Williamson D, Ryan N: Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL): initial reliability and validity data. J Am Acad Child Adolesc Psychiatry 36:980-988, 1997. (Pubitemid 27272932)
17. Keck PE, Marcus R, Tourkodimitris S, Ali M, Liebeskind A, Saha A, Ingenito G: A placebo-controlled, double-blind study of the efficacy and safety of aripiprazole in patients with acute bipolar mania. Am J Psychiatry 160:1651-1658, 2003. (Pubitemid 41079552)
18. Keck PE, Calabrese JR, McQuade RD, Carson WH, Carlson BX, Rollin LM, Marcus RN, Sanchez R: A randomized, double-blind, placebo-controlled 26-week trial of aripiprazole in recently manic patients with bipolar I disorder. J Clin Psychiatry 67:626-637, 2006. (Pubitemid 43764240)
19. Keck PE, Calabrese JR, McIntyre RS, McQuade RD, Carson WH, Eudicone JM, Carlson BX, Marcus RN, Sanchez R: Aripiprazole monotherapy for maintenance therapy in bipolar I disorder: A 100-week, double-blind study versus placebo. J Clin Psychiatry 68:1480-1491, 2007.
20. Kemph JP, DeVane CL, Levin GM, Jarecke R, Miller RL: Treatment of aggressive children with clonidine: Results of an open pilot study. J Am Acad Child Adolesc Psychiatry 32:577-581, 1993. (Pubitemid 23149034)
21. Kubo M, Mizooku Y, Hirao Y, Osumi T: Development and validation of an LC-MS/MS method for the quantitative determination of aripiprazole and its main metabolite, OPC-14857, in human plasma. J Chromatogr B Analyt Technol Biomed Life Sci 822:294-299, 2005. (Pubitemid 40994064)
22. Lezak MD. Neuro-psychological Assessment. Oxford: Oxford University Press, 1995.
23. Mallikaarjun S, Salazar DE, Bramer SL: Pharmacokinetics, tolerability, and safety of aripiprazole following multiple oral dosing in normal healthy volunteers. J Clin Pharmacol 44:179-187, 2004. (Pubitemid 38114317)
24. Marcus RN, McQuade RD, Carson WH, Hennicken D, Fava M, Simon JS, TrivediMH, ThaseME, Berman RM: The efficacy and safety of aripiprazole as adjunctive therapy in major depressive disorder: A second multicenter, randomized, double-blind, placebo-controlled study. J Clin Psychopharmacol 28:156-165, 2008.
25. Marder SR, McQuade RD, Stock E, Kaplita S, Marcus R, Safferman AZ, Saha A, Ali M, Iwamoto T: Aripiprazole in the treatment of schizophrenia: Safety and tolerability in short-term, placebo-controlled trials. Schizophr Res 61:123-136, 2003. (Pubitemid 36513927)
26. Pigott TA, Carson WH, Saha AR, Torbeyns AF, Stock EG, Ingenito GG: Aripiprazole for the prevention of relapse in stabilized patients with chronic schizophrenia: A placebo-controlled 26-week study. J Clin Psychiatry 64:1048-1056, 2003.
27. Potkin SG, Saha AR, Kujawa MJ, Carson WH, Ali M, Stock E, Stringfellow J, Ingenito G, Marder SR: Aripiprazole, an anti-psychotic with a novel mechanism of action, and risperidone vs placebo in patients with schizophrenia and schizoaffective disorder. Arch Gen Psychiatry 60:681-690, 2003. (Pubitemid 36818630)
28. Shapiro DA, Renock S, Arrington E, Chiodo LA, Liu LX, Sibley DR, Roth BL, Mailman R: Aripiprazole, a novel atypical antipsychotic drug with a unique and robust pharmacology. Neuropsychopharmacology 28:1400-1411, 2003. (Pubitemid 41070874)
29. Stark AD, Jordan S, Allers KA, Bertekap RL, Chen R, Mistry Kannan T, Molski TF, Yocca FD, Sharp T, Kikuchi T, Burris KD: Interaction of the novel antipsychotic aripiprazole with 5-HT(1A) and 5-HT (2A) receptors: functional receptor-binding and in vivo electrophysiological studies. Psychopharmacology (Berl) 190:373-382, 2007. (Pubitemid 46155646)
30. Steiner H, Saxena K, Chang K: Psychopharmacologic strategies for the treatment of aggression in juveniles. CNS Spectr 8:298-308, 2008. (Pubitemid 36765031)
31. Tetelbaum M, Finkelstein Y, Nava-Ocampo AA, Koren G. Back to basics: understanding drugs in children: Pharmacokinetic maturation. Pediatr Rev 26:321-328, 2005. (Pubitemid 41232658)
32. Volavka J, Czobor P, Citrome L, McQuade RD, Carson WH, Kostic D, Hardy S, Marcus R: Efficacy of aripiprazole against hostility in schizophrenia and schizoaffective disorder: Data from 5 double-blind studies. J Clin Psychiatry 66:1362-1366, 2005. (Pubitemid 41779532)
33. Wechsler D: Wechsler Intelligence Scale for Children, 3rd Edition. San Antonio (Texas):Psychological Corporation, 1991.
34. Wiznitzer M, Findling RL: Why do psychiatric drug research in children? Lancet 361:1147-1148, 2003.
35. Zimbroff DL, Marcus RN, Manos G, Stock E, McQuade RD, Auby P, Oren DA: Management of acute agitation in patients with bipolar disorder: Efficacy and safety of intramuscular aripiprazole. J Clin Psychopharmacol 27:171-176, 2007. (Pubitemid 46594934)