Table E-1List of ongoing studies of first- and second-generation antipsychotics in children and young adults as of May 2011

Reg #TitlePIFunder
NCT010981106-Week Trial of the Efficacy and Safety of Asenapine Compared to Placebo in Subjects With an Acute Exacerbation of Schizophrenia (Study P06124)Multi-centerSchering-Plough
NCT01136772A Comparison of Long-Acting Injectable Medications for SchizophreniaScott Stroup, MD, MPH, Columbia University and Joseph P McEvoy, MD, Duke UniversityNational Institute of Mental Health (NIMH)
NCT01149655A Long-Term Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Aripiprazole (OPC 14597) as Maintenance Treatment in Adolescent PatientsEva Kohegyi, MD Otsuka Pharmaceutical Development and Commercialization, Inc.Otsuka Pharmaceutical Development & Commercialization, Inc.
JPRN-JapicCTI-101147A Long-Term, Extended Treatment Study of Aripiprazole in Pediatric Patients with SchizophreniaMulti-Center (Japan)Otsuka Pharmaceutical Co., Ltd.
7R34MH080791-04A Novel Mulitmodal Intervention for Children with ADHD and Impaired MoodJames Waxmonsky, Florida International UniversityNational Institute of Mental Health (NIMH)
JPRN-MIN000005355A randomized open label study of the effects of aripiprazole in overweight and obstructive sleep apnea subjects with schizophrenia or schizoaffective disorder switched from other antipsychotic drugs.Junichi Murakami, Biwako Hospital Department of PsychiatryBiwako Hospital
NCT01212575A Retrospective NIS to Evaluate the Use of Seroquel XR and IR in the Clinical Practice of Outpatients With SchizophreniaCharlotte Emborg, Skovager 2, Risskov, DenmarkAstraZeneca
JPRN-JapicCTI-101146A Short Treatment Study of Aripiprazole in Pediatric Patients with SchizophreniaMulti-CenterOtsuka Pharmaceutical Co., Ltd.
NCT01299389A Study of Paliperidone Palmitate in Patients With SchizophreniaNone namedJanssen Pharmaceutical K.K.
NCT01206517A Study to Evaluate the Safety and Tolerability of Sublingual Asenapine in a Pediatric Population With Schizophrenia or Bipolar I Disorder (Study P06522)None namedSchering-Plough
NCT01338298Adjunctive AripiprazoleDeanna L. Kelly Pharm.D., BCPP, Maryland Psychiatric Research CenterUniversity of Maryland
NCT01197404Affect Management for Early AdolescentsChristopher D. Houck, Rhode Island HospitalRhode Island Hospital
5R01MH075921-05Antimanic Use During PregnancyKatherine Wisner, University Of PittsburghNational Institute of Mental Health (NIMH)
NCT01082848ARIpiprazole in Anorexia NErvosaJaime Moyá, Hospital Clinic of BarcelonaHospital Clinic of Barcelona
5R01MH078576-05Behavioral Intervention to Reduce Novel Antipsychotic Medication Health RisksJeffrey Kelly, Medical College of WisconsinNational Institute of Mental Health (NIMH)
NCT01333072Biomarkers in Autism of Aripiprazole and Risperidone Treatment (BAART)C. Lindsay DeVane, PharmD, Medical University of South CarolinaMedical University of South Carolina
NCT01164059Clinical Effectiveness of Newer Antipsychotics in Comparison With Conventional Antipsychotics in SchizophreniaDr. Jürgen TimmUniversity of Bremen
5R01MH082839-03Collaboration to Advance Negative Symptom Assessment in SchizophreniaJack Blanchard, University of MarylandNational Institute of Mental Health (NIMH)
(From HSR Proj)Comparative Safety and Effectiveness of AntipsychoticsStephen Crystal, Institute for Health, Health Care Policy and Aging Research, Rutgers, The State University of New JerseyAgency for Healthcare Research and Quality
1R01HS018550-01A1Comparative Safety of Atypical Antipsychotics in High-Risk U.S. Children with ADHDDavid Rubin, Children’s Hospital of PhiladelphiaAgency for Healthcare Research and Quality
NCT01213836Compare the Effect on Cognitive Functioning of Two Formulations of Seroquel, Seroquel XR and IR in Patients With Stable SchizophreniaEva Dencker VansvikAstraZeneca
(From HSR Proj)Comparison of Long-Acting Injectable Medications for Schizophrenia-- ACLAIMSTS Stroup, NY Psychiatric InstituteNational Institute of Mental Health (NIMH)
5K23MH085005-03Counteracting Risperidone-Induced Hyperprolactinemia in YouthsChadi Calarge, University of IowaNational Institute of Mental Health (NIMH)
(From HSR Proj)DNA Diagnostics for Minimizing Metabolic Side-Effects of AntipsychoticsGualberto Ruano, Genomas Inc.National Institute of Mental Health (NIMH)
5R01HS018577-02Drug Cost Containment Changes and Quality of Care for Mentally Ill Dual EnrolleesSteven Soumerai, Harvard Pilgrim Health CareAgency for Healthcare Research and Quality
NCT01160679Effectiveness of Atypical Antipsychotics on Anhedonic Features in Patients With SchizophreniaSang-Woo Han, M.D., Ph.D., Department of PsychiatryAstra-Zeneca
NCT01222793Effects of Antipsychotics on Eating and Food Craving in People With SchizophreniaKimberly Warren, Ph.D., University of Maryland, BaltimoreNational Institute on Drug Abuse (NIDA)
NCT01244815Efficacy and Safety of Asenapine Treatment for Pediatric Bipolar Disorder (P06107)None namedSchering-Plough
NCT01157559Efficacy and Safety With Ziprasidone in First-Episode PsychosisYoung Chul Chung, Professor of Psychiatry, Chonbuk National University Hospital, Jeonju, KoreaChonbuk National University Hospital
NCT01291511Efficacy in Prevention of Relapse of Schizophrenia in Subjects Taking Either Placebo or Iloperidone.None namedNovartis Pharmaceuticals
NCT01256177Evaluate the Efficacy and Safety of Quetiapine Fumarate (SEROQUEL) Extended Release as Monotherapy in the Treatment of Patients With Bipolar DepressionNone namedAstraZeneca
NCT01184443Evaluation of the Efficacy and Safety of Olanzapine for Anorexia Nervosa in Children and AdolescentsWendy J Spettigue, MD, FRCPC, Children’s Hospital of Eastern OntarioChildren’s Hospital of Eastern Ontario
NCT01349907Extension Study of Asenapine for Pediatric Bipolar Disorder (P05898 AM1)None namedSchering-Plough
NCT01190254Fixed Dose Efficacy and Safety Study of Asenapine for the Treatment of Schizophrenia in Adolescents (Study P05896)None namedSchering-Plough
NCT01190267Flexible Dose, Long-Term Safety Study of Asenapine for the Treatment of Schizophrenia in Adolescents (Study P05897)None namedSchering-Plough
1R03HS019024-01A1Identifying Treatment-Resistant Depression in Automated DatabasesDarren Toh, Harvard Pilgrim Health Care Inc.Agency for Healthcare Research and Quality
5R01MH080325-03Improving Metabolic Parameters of Antipsychotics Child TreatmentLinmarie Sikich, University North Carolina–Chapel HillNIMH
NCT01155544Improving Outcomes in Psychosis Associated With Substance Use Using AripiprazoleSerge Sevy, M.D., M.B.A., Feinstein Institute for Medical ResearchNIMH
1R15MH094955-01Long-Term Effects of Early-Life Antipsychotic Drug TreatmentMark E. Bardgett, NorthernNational Institute of Mental Health (NIMH)
NCT01142596Long-Term Extension Trial of Asenapine in Subjects With Schizophrenia (Study P06125)None namedSchering-Plough
3R21MH080968-02S1Long-Term Safety and Genetic Risk Factors of Risperidone Treatment in YouthChadi Calarge, University of IowaNational Institute of Mental Health (NIMH)
5R01MH045404-19Maximizing Treatment Outcome in OCDEdna Foa, University of PennsylvaniaNational Institute of Mental Health (NIMH)
NCT01184235Multidimensional Measurement of Psychopharmacological Treatment ResponseBill J Duke, M.A., Ph.D., Child Psychopharmacology InstituteChild Psychopharmacology Institute
5K23MH079498-02Neuroprotective/Neurodevelopmental Effects-Antipsychotics in Adolescent PsychosesKarin Borgmann-Winter, Children’s Hospital of PhiladelphiaNational Institute of Mental Health (NIMH)
NCT01170117Olanzapine Versus Placebo for Outpatients With Anorexia NervosaEvelyn Attia, MD, Columbia University Medical CenterNational Institute of Mental Health (NIMH)
NCT01227668OPT - Phase IV Long Term Maintenance Study of Aripiprazole for the Treatment of Irritability Associated With Autistic DisorderNone namedBristol-Myers Squibb
NCT01154829Pan European Collaboration on Antipsychotic Naive Schizophrenia (PECANS)Birte Y Glenthoj, professor, University of Copenhagen, Psychiatric Center GlostrupUniversity of Copenhagen
NCT01075295Prevention of Weight Gain in Early PsychosesRohan Ganguli, MD, Centre for Addiction and Mental HealthCentre for Addiction and Mental Health
NCT01282281Prospective Metabolic Monitoring of Youth and Adults With Bipolar DisorderAyal Schaffer, MD and Benjamin Goldstein, MD, Sunnybrook Health Sciences CentreSunnybrook Health Sciences Centre
NCT01171937Risperidone Treatment in Children With Autism Spectrum Disorder and High Levels of Repetitive BehaviorJames T. McCracken, M.D., UCLAUniversity of California, Los Angeles; National Institutes of Health
NCT01117220Safety and Efficacy of Ziprasidone In Children and Adolescents With Bipolar I Disorder (Manic Or Mixed) (Protocol A1281196)None namedPfizer
NCT01122927Safety and Tolerability of Aripiprazole in Adolescents With Schizophrenia or Children and Adolescents With Bipolar I Disorder, Manic or Mixed Episode With or Without Psychotic Features.None namedOtsuka Pharmaceutical Development & Commercialization, Inc.
NCT01124877Safety and Tolerability of Flexible Doses of Oral Ziprasidone In Children and Adolescents With Bipolar I Disorder (Manic or Mixed)None namedPfizer
NCT01269710Second-Generation Antipsychotic Treatment Indication Effectiveness and Tolerability in Youth (Satiety) StudyLinmarie Sikich, MD, UNC- Chapel HillUniversity of North Carolina, Chapel Hill; Foundation of Hope, North Carolina
5R01MH080050-04Stepped Pharmacotherapy for Aggressive Youth with ADHDJoseph Blader, State University New York StonybrookNational Institute of Mental Health (NIMH)
5R01MH077750-03Stimulant and Risperidone for Youth with Severe Physical AggressionRobert Findling, Case Western Reserve UniversityNational Institute of Mental Health (NIMH)
2U01MH062565-06A2Sustaining Remission of Psychotic DepressionEllen White, University of PittsburgNational Institute of Mental Health (NIMH)
NCT01119014Tolerance and Effect of Antipsychotics in Children and Adolescents With PsychosisKatrine Pagsberg, Bispebjerg Centre for Child and Adolescent Psychiatry, University of CopenhagenUniversity of Copenhagen
5R01MH081235-04Ziprasidone Augmentation of SSRIs for Treatment-Resistant Depression (TRD)Richard C. Shelton, Vanderbilt UniversityNational Institute of Mental Health (NIMH)
NCT01172652Ziprasidone in Bipolar Disorder With Comorbid Lifetime Panic or Generalized Anxiety Disorder(GAD)Trisha Suppes, MD, PhD, VA Palo Alto Health Care System & Stanford School of MedicineVA Palo Alto Health Care System

From: Appendix E, Searches for Ongoing Research May 23, 2011/June 6, 2011; and List of Relevant Ongoing Studies

Cover of Future Research Needs for First- and Second-Generation Antipsychotics for Children and Young Adults
Future Research Needs for First- and Second-Generation Antipsychotics for Children and Young Adults [Internet].
Future Research Needs Papers, No. 13.
Christian R, Saavedra L, Gaynes BN, et al.

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