A phase 2a randomized, parallel group, dose-ranging study of molindone in children with attention-deficit/hyperactivity disorder and persistent, serious conduct problems

Journal of Child and Adolescent Psychopharmacology

Volumn 22, Issue 2, 2012, Pages 102-111

  Stocks, Jennifer Dugan ^a   Taneja, Baldeo K ^a   Baroldi, Paolo ^a   Findling, Robert L ^b  

^a Supernus Pharmaceuticals Inc   (United States)

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

Author keywords

[No Author keywords available]

Indexed keywords

MOLINDONE; PROLACTIN;

AGITATION; AKATHISIA; ARTICLE; ATTENTION DEFICIT DISORDER; BODY MASS; CHILD; CHILDHOOD DISEASE; CONDUCT DISORDER; CONTROLLED STUDY; DECREASED APPETITE; DISEASE SEVERITY; DRUG DOSE INCREASE; DRUG DOSE REDUCTION; DRUG DOSE TITRATION; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; ELECTROCARDIOGRAPHY; EXTRAPYRAMIDAL SYMPTOM; FATIGUE; FEMALE; FEVER; HUMAN; INSOMNIA; LABORATORY TEST; LIMB PAIN; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NEUROLOGIC DISEASE; OPEN STUDY; OUTCOME ASSESSMENT; PARALLEL DESIGN; PATIENT COMPLIANCE; PHASE 2 CLINICAL TRIAL; PHYSICAL EXAMINATION; PRESCHOOL CHILD; PROLACTIN BLOOD LEVEL; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; SCHOOL CHILD; SEDATION; SIDE EFFECT; SOMNOLENCE; UPPER ABDOMINAL PAIN; UPPER RESPIRATORY TRACT INFECTION; VIRUS INFECTION; VITAL SIGN; WEIGHT GAIN;

ANTIPSYCHOTIC AGENTS; ATTENTION DEFICIT DISORDER WITH HYPERACTIVITY; CHILD; CONDUCT DISORDER; DOSE-RESPONSE RELATIONSHIP, DRUG; HUMANS; MALE; MOLINDONE; PSYCHIATRIC STATUS RATING SCALES; SEVERITY OF ILLNESS INDEX; TREATMENT OUTCOME;

EID: 84859984483     PISSN: 10445463     EISSN: 15578992     Source Type: Journal    
DOI: 10.1089/cap.2011.0087     Document Type: Article

References (26)

1. Aman M, Leone S, Lecavalier L, Park L, Buican B, Coury D: The Nisonger Child Behavior Rating Form: Typical IQ version. Int Clin Psychopharmacol 23:232-242, 2008.
2. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, 4th ed., Text Revision (DSM-IV-TR). Washington, DC: American Psychiatric Association; 2000.
3. Barnes TR: A rating scale for drug-induced akathisia. Br J Psychiatry 154:672-676, 1989. (Pubitemid 19154942)
4. Biederman J, Petty CR, Dolan C, Hughes S, Mick E, Monuteaux MC, Faraone SV: The long-term longitudinal course of oppositional defiant disorder and conduct disorder in ADHD boys: Findings from a controlled 10-year prospective longitudinal follow-up study. Psychol Med 38:1027-1036, 2008. (Pubitemid 351769224)
5. Blader JC, Pliszka SR, Jensen PS, Schooler NR, Kafantaris V: Stimulant-responsive and stimulant-refractory aggressive behavior among children with ADHD. Pediatrics 126:e796-e806, 2010.
6. Connor DF, Glatt SJ, Lopez ID, Jackson D, Melloni RH Jr.: Psychopharmacology and aggression. I: A meta-Analysis of stimulant effects on overt/covert aggression-related behaviors in ADHD. J Am Acad Child Adolesc Psychiatry 41:253-261, 2002. (Pubitemid 38338146)
7. Correll CU, Leucht S, Kane JM: Lower risk for tardive dyskinesia associated with second-generation antipsychotics: A systematic review of 1-year studies. Am J Psychiatry 161:414-425, 2004. (Pubitemid 38326094)
8. Findling RL: Atypical antipsychotic treatment of disruptive behavior disorders in children and adolescents. J Clin Psychiatry 69 Suppl 4:9-14, 2008.
9. Findling RL: Treatment of aggression in children. Prim Care Companion J Clin Psychiatry 5:5-9, 2003.
10. Greenhill LL, Solomon M, Pleak R, Ambrosini P: Molindone hydrochloride treatment of hospitalized children with conduct disorder. J Clin Psychiatry 46:20-25, 1985. (Pubitemid 16252195)
11. Guy W: ECDEU Assessment Manual for Psychopharmacology. Rockville, MD: U.S. Department of Health, Education, and Welfare, Alcohol, Drug Abuse and Mental Health Administration, NIMH Psychopharmacology Research Branch, Division of Extramural Research Programs, 1976.
12. Jensen PS, Youngstrom EA, Steiner H, Findling RL, Meyer RE, Malone RP, Carlson GA, Coccaro EF, Aman MG, Blair J, Dougherty D, Ferris C, Flynn L, Green E, Hoagwood K, Hutchinson J, Laughren T, Leve LD, Novins DK, Vitiello B: Consensus report on impulsive aggression as a symptom across diagnostic categories in child psychiatry: Implications for medication studies. J Am Acad Child Adolesc Psychiatry 46:309-322, 2007.
13. Kane JM, Correll CU: Pharmacologic treatment of schizophrenia. Dialogues Clin Neurosci 12:345-357, 2010.
14. 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)
15. Lahey BB, Loeber R, Burke J, Rathouz PJ: Adolescent outcomes of childhood conduct disorder among clinic-referred boys: Predictors of improvement. J Abnorm Child Psychol 30:333-348, 2002. (Pubitemid 38471284)
16. Mayberg HS, Silva JA, Brannan SK, Tekell JL, Mahurin RK, McGinnis S, Jerabek PA: The functional neuroanatomy of the placebo effect. Am J Psychiatry 159:728-737, 2002. (Pubitemid 34465045)
17. Moban-: (molindone hydrochloride tablets, USP) prescribing information. Updated: December, 2010. Available at www.endo.com/pdf/products/moban-pack- insert.pdf. Accessed: August 11, 2011.
18. Naugle RI, Chelune GI, Tucker GD: Validity of the Kaufman Brief Intelligence Test. Psychol Assess 52:182-186, 1993.
19. Pappadopulos E, Woolston S, Chait A, Perkins M, Connor DF, Jensen PS: Pharmacotherapy of aggression in children and adolescents efficacy and effect size. J Can Acad Child Adolesc Psychiatry 15:27-39, 2006.
20. Polymeropoulos MH, Licamele L, Volpi S, Mack K, Mitkus SN, Carstea ED, Getoor L, Thompson A, Lavedan C: Common effects of antipsychotics on the biosynthesis and regulation of fatty acids and cholesterol supports a key role of lipid homeostasis in schizophrenia. Schizophr Res 108:134-142, 2009.
21. Sikich L, Frazier JA, McClellan J, Findling RL, Vitiello B, Ritz L, Ambler D, Puglia M, Maloney AE, Michael E, De Jong S, Slifka K, Noyes N, Hlastala S, Pierson L, McNamara NK, Delporto-Bedoya D, Anderson R, Hamer RM, Lieberman JA: Double-blind comparison of first- and second-generation antipsychotics in early-onset schizophrenia and schizo-Affective disorder: Findings from the treatment of early-onset schizophrenia spectrum disorders (TEOSS) study. Am J Psychiatry 165:1420-1431, 2008.
22. Simpson GM, Angus JW: A rating scale for extrapyramidal side effects. Acta Psychiatr Scand Suppl 212:11-19, 1970.
23. Swanson JM, Kraemer HC, Hinshaw SP, Arnold LE, Conners CK, Abikoff HB, Clevenger W, Davies M, Elliott GR, Greenhill LL, Hechtman L, Hoza B, Jensen PS, March JS, Newcorn JH, Owens EB, Pelham WE, Schiller E, Severe JB, Simpson S, Vitiello B, Wells K, Wigal T, Wu M: Clinical relevance of the primary findings of the MTA: Success rates based on severity of ADHD and ODD symptoms at the end of treatment. J Am Acad Child Adolesc Psychiatry 40:168-179, 2001. (Pubitemid 32111020)
24. The MTA Cooperative Group: A 14-month randomized clinical trial of treatment strategies for attention-deficit/hyperactivity disorder. Multimodal Treatment Study of Children with ADHD. Arch Gen Psychiatry 56:1073-1086, 1999.
25. Wilens TE, Biederman J, Brown S, Tanguay S, Monuteaux MC, Blake C, Spencer TJ: Psychiatric comorbidity and functioning in clinically referred preschool children and school-Age youths with ADHD. J Am Acad Child Adolesc Psychiatry 41:262-268, 2002. (Pubitemid 38338147)
26. Woods SW, Morgenstern H, Saksa JR, Walsh BC, Sullivan MC, Money R, Hawkins KA, Gueorguieva RV, Glazer WM: Incidence of tardive dyskinesia with atypical versus conventional antipsychotic medications: A prospective cohort study. J Clin Psychiatry 71:463-474, 2010.