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  1 / 137 MEDLINE  
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[PMID]:28142338
[Au] Autor:Krishna G; Gopalakrishnan G; Goel S
[Ad] Endereço:a Supernus Pharmaceuticals Inc. , Rockville , MD , USA.
[Ti] Título:Toxicity assessment of molindone hydrochloride, a dopamine D2/D5 receptor antagonist in juvenile and adult rats.
[So] Source:Toxicol Mech Methods;27(5):352-362, 2017 Jun.
[Is] ISSN:1537-6524
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:Neuroleptic drug molindone hydrochloride is a dopamine D2/D5 receptor antagonist and it is in late stage development for the treatment of impulsive aggression in children and adolescents who have attention deficient/hyperactivity disorder (ADHD). This new indication for this drug would expand the target population to include younger patients, and therefore, toxicity assessments in juvenile animals were undertaken in order to determine susceptibility differences, if any, between this age group and the adult rats. Adult rats were administered molindone by oral gavage for 13 weeks at dose levels of 0, 5, 20, or 60 mg/kg-bw/day. Juvenile rats were dosed for 8 weeks by oral gavage at dose levels of 0, 5, 25, 50, or 75 mg/kg-bw/day. Standard toxicological assessments were made using relevant study designs in consultation with FDA. Treatment-related elevation in serum cholesterol and triglycerides and decreases in glucose levels were observed in both the age groups. Organ weight changes included increases in liver, adrenal gland and seminal vesicles/prostate weights. Decreases in uterine weights were also observed in adult females exposed to the top two doses with sufficient exposure. In juveniles, sexual maturity parameters secondary to decreased body weights were observed, but, were reversed. In conclusion, the adverse effects noted in reproductive tissues of adults were attributed to hyperprolactinemia and these changes were not considered to be relevant to humans due to species differences in hormonal regulation of reproduction. On the whole, there were no remarkable differences in the toxicity profile of the drug between the two age groups.
[Mh] Termos MeSH primário: Antipsicóticos/toxicidade
Antagonistas dos Receptores de Dopamina D2/toxicidade
Molindona/toxicidade
Receptores de Dopamina D3/antagonistas & inibidores
[Mh] Termos MeSH secundário: Administração Oral
Envelhecimento/sangue
Envelhecimento/metabolismo
Animais
Antipsicóticos/sangue
Peso Corporal/efeitos dos fármacos
Antagonistas dos Receptores de Dopamina D2/sangue
Feminino
Masculino
Molindona/sangue
Tamanho do Órgão/efeitos dos fármacos
Especificidade de Órgãos/efeitos dos fármacos
Prolactina/sangue
Ratos Sprague-Dawley
Ratos Wistar
Reprodução/efeitos dos fármacos
Toxicocinética
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Antipsychotic Agents); 0 (Dopamine D2 Receptor Antagonists); 0 (Receptors, Dopamine D3); 9002-62-4 (Prolactin); RT3Y3QMF8N (Molindone)
[Em] Mês de entrada:1707
[Cu] Atualização por classe:170724
[Lr] Data última revisão:
170724
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170202
[St] Status:MEDLINE
[do] DOI:10.1080/15376516.2017.1288768


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[PMID]:27040600
[Au] Autor:Krishna G; Gopalakrishnan G; Goel S
[Ad] Endereço:Supernus Pharmaceuticals Inc, Rockville, Maryland.
[Ti] Título:In vitro and in vivo genotoxicity assessment of the dopamine receptor antagonist molindone hydrochloride.
[So] Source:Environ Mol Mutagen;57(4):288-98, 2016 May.
[Is] ISSN:1098-2280
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:Molindone hydrochloride is a dihydroindolone neuroleptic with dopamine D2 and D5 receptor antagonist activity. As an integral component of its preclinical safety evaluation, molindone hydrochloride was evaluated in a series of in vitro and in vivo genetic toxicology assays. In the bacterial reverse gene mutation assays employing four Salmonella tester strains (TA98, TA100, TA1535, and TA1537) and the E. coli tester strain WP2uvrA, molindone hydrochloride was negative in all strains, except TA100, in which it induced a positive response (up to 3-fold) in the presence of rat liver S9. With human S9, a small (2-fold), but nonreproducible, increase in revertants was observed in TA100 at the highest concentration of molindone tested (5,000 µg/plate). The mutagenicity was completely abrogated by the addition of glutathione and UDP-glucuronic acid to rat liver S9, suggesting detoxification of the mutagenic metabolite(s) by Phase II conjugation reactions, pathways commonly operational in humans. Molindone hydrochloride did not induce chromosomal aberrations in human lymphocyte cultures, did not elicit a positive response in a rat bone marrow micronucleus test for clastogencity/aneugenicity, and did not give a positive response in the rat liver comet assay for DNA damage. Collectively, the weight of evidence from these studies, combined with a large margin of safety and efficient detoxification through Phase II conjugation supports the interpretation that molindone hydrochloride does not pose a genotoxic risk to humans at the anticipated clinical dose levels.
[Mh] Termos MeSH primário: Antagonistas de Dopamina/toxicidade
Molindona/toxicidade
Mutagênicos/toxicidade
[Mh] Termos MeSH secundário: Adulto
Animais
Medula Óssea/efeitos dos fármacos
Medula Óssea/metabolismo
Linhagem Celular
Aberrações Cromossômicas/induzido quimicamente
Ensaio Cometa
Dano ao DNA/efeitos dos fármacos
Feminino
Seres Humanos
Fígado/efeitos dos fármacos
Fígado/metabolismo
Linfócitos/efeitos dos fármacos
Linfócitos/metabolismo
Masculino
Testes para Micronúcleos
Testes de Mutagenicidade
Ratos
Salmonella typhimurium/efeitos dos fármacos
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Dopamine Antagonists); 0 (Mutagens); RT3Y3QMF8N (Molindone)
[Em] Mês de entrada:1609
[Cu] Atualização por classe:160417
[Lr] Data última revisão:
160417
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:160405
[St] Status:MEDLINE
[do] DOI:10.1002/em.22007


  3 / 137 MEDLINE  
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[PMID]:26327279
[Au] Autor:Krishna G; Ganiger S; Kannan K; Gopalakrishnan G; Goel S
[Ad] Endereço:Supernus Pharmaceuticals Inc., Rockville, MD 20850, United States. Electronic address: gkrishna@supernus.com.
[Ti] Título:Reversibility of dopamine receptor antagonist-induced hyperprolactinemia and associated histological changes in Tg RasH2 wild-type mice.
[So] Source:Reprod Toxicol;58:73-8, 2015 Dec.
[Is] ISSN:1873-1708
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:The purpose of this study was to better understand the biological effects of increased prolactin levels induced in mice by dopamine D2 receptor antagonist molindone treatment. Toxicokinetics, prolactin levels, and reproductive tissue histology were evaluated in Tg rasH2 wild-type mice treated orally with molindone at 0, 5, 15, and 50mg/kg/day for 6 months, followed by a 2-month posttreatment recovery period. A greater than dose-proportional increase in molindone exposure ([AUC]0‒24) was observed on Day 180 for both sexes. Statistically significant (P<0.01) increases in prolactin levels were observed in most treatment groups compared with controls at 0.5h postdose on Days 1 and 180. Prolactin levels returned to baseline levels during the recovery period. Microscopic changes attributable to hyperprolactinemia, including corpora lutea enlargement and interstitial cell atrophy in the ovaries, and atrophy of the uterus and vagina were observed on Day 180. These changes were reversed during the recovery period in the 5- and 15-mg/kg/day treatment groups. Mice receiving molindone at 50mg/kg/day also showed signs of reversal on histologic examination.
[Mh] Termos MeSH primário: Antagonistas de Dopamina
Hiperprolactinemia/patologia
Molindona
Ovário/patologia
Útero/patologia
Vagina/patologia
[Mh] Termos MeSH secundário: Animais
Atrofia
Biomarcadores/sangue
Modelos Animais de Doenças
Feminino
Genes ras
Hiperprolactinemia/sangue
Hiperprolactinemia/induzido quimicamente
Hiperprolactinemia/genética
Masculino
Camundongos Endogâmicos C57BL
Camundongos Transgênicos
Prolactina/sangue
Fatores de Tempo
[Pt] Tipo de publicação:JOURNAL ARTICLE; RESEARCH SUPPORT, NON-U.S. GOV'T
[Nm] Nome de substância:
0 (Biomarkers); 0 (Dopamine Antagonists); 9002-62-4 (Prolactin); RT3Y3QMF8N (Molindone)
[Em] Mês de entrada:1609
[Cu] Atualização por classe:151224
[Lr] Data última revisão:
151224
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:150902
[St] Status:MEDLINE


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[PMID]:24129841
[Au] Autor:Kumar A; Datta SS; Wright SD; Furtado VA; Russell PS
[Ad] Endereço:Psychiatry, Leeds and York Partnership NHS Foundation Trust, Linden House, St Mary's Hospital, Green Hill Road, Leeds, UK, LS12 3QE.
[Ti] Título:Atypical antipsychotics for psychosis in adolescents.
[So] Source:Cochrane Database Syst Rev;(10):CD009582, 2013 Oct 15.
[Is] ISSN:1469-493X
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: Schizophrenia often presents in adolescence, but current treatment guidelines are based largely on studies of adults with psychosis. Over the past decade, the number of studies on treatment of adolescent-onset psychosis has increased. The current systematic review collates and critiques evidence obtained on the use of various atypical antipsychotic medications for adolescents with psychosis. OBJECTIVES: To investigate the effects of atypical antipsychotic medications in adolescents with psychosis. We reviewed in separate analyses various comparisons of atypical antipsychotic medications with placebo or a typical antipsychotic medication or another atypical antipsychotic medication or the same atypical antipsychotic medication but at a lower dose. SEARCH METHODS: We searched the Cochrane Schizophrenia Group Register (October 2011), which is based on regular searches of BIOSIS, CENTRAL, CINAHL, EMBASE, MEDLINE and PsycINFO. We inspected references of all identified studies and contacted study authors and relevant pharmaceutical companies to ask for more information. SELECTION CRITERIA: We included all relevant randomised controlled trials (RCTs) that compared atypical antipsychotic medication with placebo or another pharmacological intervention or with psychosocial interventions, standard psychiatric treatment or no intervention in children and young people aged 13 to 18 years with a diagnosis of schizophrenia, schizoaffective disorder, acute and transient psychoses or unspecified psychosis. We included studies published in English and in other languages that were available in standardised databases. DATA COLLECTION AND ANALYSIS: Review authors AK and SSD selected the studies, rated the quality of the studies and performed data extraction. For dichotomous data, we estimated risk ratios (RRs) with 95% confidence intervals (CIs) using a fixed-effect model. When possible, for binary data presented in the 'Summary of findings' table, we calculated illustrative comparative risks. We summated continuous data using the mean difference (MD). Risk of bias was assessed for included studies. MAIN RESULTS: We included 13 RCTs, with a total of 1112 participants. We found no data on service utilisation, economic outcomes, behaviour or cognitive response. Trials were classified into the following groups. 1. Atypical antipsychotics versus placebo: Only two studies compared one atypical antipsychotic medication with placebo. In one study, the number of non-responders treated with olanzapine was not different from the number treated with placebo (1 RCT, n = 107, RR 0.84, 95% CI 0.65 to 1.10); however, significantly more (57% vs 32%) people left the study early (1 RCT, n = 107, RR 0.56, 95% CI 0.36 to 0.87) from the placebo group compared with the olanzapine group. With regard to adverse effects, young people treated with aripiprazole had significantly lower serum cholesterol compared with those given placebo (1 RCT, n = 302, RR 3.77, 95% CI 1.88 to 7.58). 2. Atypical antipsychotics versus typical antipsychotics: When the findings of all five trials comparing atypical antipsychotic medications with a typical antipsychotic medication were collated, no difference in the mean end point Brief Psychiatric Rating Scale (BPRS) score was noted between the two arms (5 RCTs, n = 236, MD -1.08, 95% CI -3.08 to 0.93). With regard to adverse effects, the mean end point serum prolactin concentration was much higher than the reference range for treatment with risperidone, olanzapine and molindone in one of the studies. However, fewer adolescents who were receiving atypical antipsychotic medications left the study because of adverse effects (3 RCTs, n = 187, RR 0.65, 95% CI 0.36 to 1.15) or for any reason (3 RCTs, n = 187, RR 0.62, 95% CI 0.39 to 0.97).3. One atypical antipsychotic versus another atypical antipsychotic: The mean end point BPRS score was not significantly different for people who received risperidone compared with those who received olanzapine; however, the above data were highly skewed. Overall no difference was noted in the number of people leaving the studies early because of any adverse effects between each study arm in the three studies comparing olanzapine and risperidone (3 RCTs, n = 130, RR 1.15, 95% CI 0.44 to 3.04). Specific adverse events were not reported uniformly across the six different studies included in this section of the review; therefore it was difficult to do a head-to-head comparison of adverse events for different atypical antipsychotic medications.4. Lower-dose atypical antipsychotic versus standard/higher-dose atypical antipsychotic: Three studies reported comparisons of lower doses of the atypical antipsychotic medication with standard/higher doses of the same medication. One study reported better symptom reduction with a standard dose of risperidone as compared with a low dose (1 RCT, n = 257, RR -8.00, 95% CI -13.75 to -2.25). In another study, no difference was reported in the number of participants not achieving remission between the group receiving 10 mg/d and those who received 30 mg/d of aripiprazole (1 RCT, n = 196, RR 0.84, 95% CI 0.48 to 1.48). Similarly in the other study, authors reported no statistically significant difference in clinical response between the two groups receiving lower-dose (80 mg/d) and higher-dose (160 mg/d) ziprasidone, as reflected by the mean end point BPRS score (1 RCT, n = 17, MD -4.40, 95% CI -19.20 to 10.40). AUTHORS' CONCLUSIONS: No convincing evidence suggests that atypical antipsychotic medications are superior to typical medications for the treatment of adolescents with psychosis. However, atypical antipsychotic medications may be more acceptable to young people because fewer symptomatic adverse effects are seen in the short term. Little evidence is available to support the superiority of one atypical antipsychotic medication over another, but side effect profiles are different for different medications. Treatment with olanzapine, risperidone and clozapine is often associated with weight gain. Aripiprazole is not associated with increased prolactin or with dyslipidaemia. Adolescents may respond better to standard-dose as opposed to lower-dose risperidone, but for aripiprazole and ziprasidone, lower doses may be equally effective. Future trials should ensure uniform ways of reporting.
[Mh] Termos MeSH primário: Antipsicóticos/uso terapêutico
Transtornos Psicóticos/tratamento farmacológico
[Mh] Termos MeSH secundário: Adolescente
Antipsicóticos/efeitos adversos
Aripiprazol
Benzodiazepinas/efeitos adversos
Benzodiazepinas/uso terapêutico
Seres Humanos
Molindona/efeitos adversos
Molindona/uso terapêutico
Piperazinas/efeitos adversos
Piperazinas/uso terapêutico
Quinolonas/efeitos adversos
Quinolonas/uso terapêutico
Ensaios Clínicos Controlados Aleatórios como Assunto
Risperidona/efeitos adversos
Risperidona/uso terapêutico
Esquizofrenia/tratamento farmacológico
[Pt] Tipo de publicação:JOURNAL ARTICLE; META-ANALYSIS; RESEARCH SUPPORT, NON-U.S. GOV'T; REVIEW
[Nm] Nome de substância:
0 (Antipsychotic Agents); 0 (Piperazines); 0 (Quinolones); 12794-10-4 (Benzodiazepines); 82VFR53I78 (Aripiprazole); L6UH7ZF8HC (Risperidone); N7U69T4SZR (olanzapine); RT3Y3QMF8N (Molindone)
[Em] Mês de entrada:1404
[Cu] Atualização por classe:161125
[Lr] Data última revisão:
161125
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:131017
[St] Status:MEDLINE
[do] DOI:10.1002/14651858.CD009582.pub2


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[PMID]:22917209
[Au] Autor:Croarkin PE; Daskalakis ZJ
[Ti] Título:Could repetitive transcranial magnetic stimulation improve neurocognition in early-onset schizophrenia spectrum disorders?
[So] Source:J Am Acad Child Adolesc Psychiatry;51(9):949-51, 2012 Sep.
[Is] ISSN:1527-5418
[Cp] País de publicação:United States
[La] Idioma:eng
[Mh] Termos MeSH primário: Antipsicóticos/uso terapêutico
Benzodiazepinas/uso terapêutico
Transtornos Cognitivos/tratamento farmacológico
Molindona/uso terapêutico
Testes Neuropsicológicos
Transtornos Psicóticos/tratamento farmacológico
Risperidona/uso terapêutico
Esquizofrenia/tratamento farmacológico
Psicologia do Esquizofrênico
[Mh] Termos MeSH secundário: Feminino
Seres Humanos
Masculino
[Pt] Tipo de publicação:COMMENT; LETTER
[Nm] Nome de substância:
0 (Antipsychotic Agents); 12794-10-4 (Benzodiazepines); L6UH7ZF8HC (Risperidone); RT3Y3QMF8N (Molindone)
[Em] Mês de entrada:1301
[Cu] Atualização por classe:131121
[Lr] Data última revisão:
131121
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:120825
[St] Status:MEDLINE
[do] DOI:10.1016/j.jaac.2012.05.012


  6 / 137 MEDLINE  
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[PMID]:22525956
[Au] Autor:Frazier JA; Giuliano AJ; Johnson JL; Yakutis L; Youngstrom EA; Breiger D; Sikich L; Findling RL; McClellan J; Hamer RM; Vitiello B; Lieberman JA; Hooper SR
[Ad] Endereço:University of Massachusetts Medical School, Worcester, MA 01605, USA. Jean.Frazier@umassmed.edu
[Ti] Título:Neurocognitive outcomes in the Treatment of Early-Onset Schizophrenia Spectrum Disorders study.
[So] Source:J Am Acad Child Adolesc Psychiatry;51(5):496-505, 2012 May.
[Is] ISSN:1527-5418
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:OBJECTIVE: To assess neurocognitive outcomes following antipsychotic intervention in youth enrolled in the National Institute of Mental Health (NIMH)-funded Treatment of Early-Onset Schizophrenia Spectrum Disorders (TEOSS). METHOD: Neurocognitive functioning of youth (ages 8 to 19 years) with schizophrenia or schizoaffective disorder was evaluated in a four-site, randomized, double-blind clinical trial comparing molindone, olanzapine, and risperidone. The primary outcomes were overall group change from baseline in neurocognitive composite and six domain scores after 8 weeks and continued treatment up to 52 weeks. Age and sex were included as covariates in all analyses. RESULTS: Of 116 TEOSS participants, 77 (66%) had post-baseline neurocognitive data. No significant differences emerged in the neurocognitive outcomes of the three medication groups. Therefore, the three treatment groups were combined into one group to assess overall neurocognitive outcomes. Significant modest improvements were observed in the composite score and in three of six domain scores in the acute phase, and in four of six domain scores in the combined acute and maintenance phases. Partial correlation analyses revealed very few relationships among Positive and Negative Syndrome Scale (PANSS) baseline or change scores and neurocognition change scores. CONCLUSIONS: Antipsychotic intervention in youth with early-onset schizophrenia spectrum disorders (EOSS) led to modest improvement in measures of neurocognitive function. The changes in cognition were largely unrelated to baseline symptoms or symptom change. Small treatment effect sizes, easily accounted for by practice effects, highlight the critical need for the development of more efficacious interventions for the enduring neurocognitive deficits seen in EOSS. Clinical trial registry information-Treatment of Early-Onset Schizophrenia Spectrum Disorders (TEOSS); http://www.clinicaltrials.gov; NCT00053703.
[Mh] Termos MeSH primário: Antipsicóticos/uso terapêutico
Benzodiazepinas/uso terapêutico
Transtornos Cognitivos/tratamento farmacológico
Molindona/uso terapêutico
Testes Neuropsicológicos
Transtornos Psicóticos/tratamento farmacológico
Risperidona/uso terapêutico
Esquizofrenia/tratamento farmacológico
Psicologia do Esquizofrênico
[Mh] Termos MeSH secundário: Adolescente
Antipsicóticos/efeitos adversos
Benzodiazepinas/efeitos adversos
Criança
Transtornos Cognitivos/diagnóstico
Transtornos Cognitivos/psicologia
Método Duplo-Cego
Feminino
Seguimentos
Seres Humanos
Masculino
Molindona/efeitos adversos
Transtornos Psicóticos/diagnóstico
Transtornos Psicóticos/psicologia
Risperidona/efeitos adversos
Esquizofrenia/diagnóstico
[Pt] Tipo de publicação:COMPARATIVE STUDY; JOURNAL ARTICLE; MULTICENTER STUDY; RANDOMIZED CONTROLLED TRIAL; RESEARCH SUPPORT, N.I.H., EXTRAMURAL; RESEARCH SUPPORT, U.S. GOV'T, P.H.S.
[Nm] Nome de substância:
0 (Antipsychotic Agents); 12794-10-4 (Benzodiazepines); L6UH7ZF8HC (Risperidone); N7U69T4SZR (olanzapine); RT3Y3QMF8N (Molindone)
[Em] Mês de entrada:1208
[Cu] Atualização por classe:171121
[Lr] Data última revisão:
171121
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:120425
[Cl] Clinical Trial:ClinicalTrial
[St] Status:MEDLINE
[do] DOI:10.1016/j.jaac.2012.02.001


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[PMID]:22525952
[Au] Autor:Bachman P; Jalbrzikowski M; Bearden CE
[Ti] Título:The voices go, but the song remains the same: how can we rescue cognition in early-onset schizophrenia?
[So] Source:J Am Acad Child Adolesc Psychiatry;51(5):464-6, 2012 May.
[Is] ISSN:1527-5418
[Cp] País de publicação:United States
[La] Idioma:eng
[Mh] Termos MeSH primário: Antipsicóticos/uso terapêutico
Benzodiazepinas/uso terapêutico
Transtornos Cognitivos/tratamento farmacológico
Molindona/uso terapêutico
Testes Neuropsicológicos
Transtornos Psicóticos/tratamento farmacológico
Risperidona/uso terapêutico
Esquizofrenia/tratamento farmacológico
Psicologia do Esquizofrênico
[Mh] Termos MeSH secundário: Feminino
Seres Humanos
Masculino
[Pt] Tipo de publicação:EDITORIAL; COMMENT
[Nm] Nome de substância:
0 (Antipsychotic Agents); 12794-10-4 (Benzodiazepines); L6UH7ZF8HC (Risperidone); N7U69T4SZR (olanzapine); RT3Y3QMF8N (Molindone)
[Em] Mês de entrada:1208
[Cu] Atualização por classe:161125
[Lr] Data última revisão:
161125
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:120425
[St] Status:MEDLINE
[do] DOI:10.1016/j.jaac.2012.02.002


  8 / 137 MEDLINE  
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[PMID]:22372512
[Au] Autor:Stocks JD; Taneja BK; Baroldi P; Findling RL
[Ad] Endereço:Supernus Pharmaceuticals, Inc., Rockville, Maryland 20850, USA. jstocks@supernus.com
[Ti] Título:A phase 2a randomized, parallel group, dose-ranging study of molindone in children with attention-deficit/hyperactivity disorder and persistent, serious conduct problems.
[So] Source:J Child Adolesc Psychopharmacol;22(2):102-11, 2012 Apr.
[Is] ISSN:1557-8992
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:OBJECTIVE: To evaluate safety and tolerability of four doses of immediate-release molindone hydrochloride in children with attention-deficit/hyperactivity disorder (ADHD) and serious conduct problems. METHODS: This open-label, parallel-group, dose-ranging, multicenter trial randomized children, aged 6-12 years, with ADHD and persistent, serious conduct problems to receive oral molindone thrice daily for 9-12 weeks in four treatment groups: Group 1-10 mg (5 mg if weight <30 kg), group 2-20 mg (10 mg if <30 kg), group 3-30 mg (15 mg if <30 kg), and group 4-40 mg (20 mg if <30 kg). The primary outcome measure was to evaluate safety and tolerability of molindone in children with ADHD and serious conduct problems. Secondary outcome measures included change in Nisonger Child Behavior Rating Form-Typical Intelligence Quotient (NCBRF-TIQ) Conduct Problem subscale scores, change in Clinical Global Impressions-Severity (CGI-S) and -Improvement (CGI-I) subscale scores from baseline to end point, and Swanson, Nolan, and Pelham rating scale-revised (SNAP-IV) ADHD-related subscale scores. RESULTS: The study randomized 78 children; 55 completed the study. Treatment with molindone was generally well tolerated, with no clinically meaningful changes in laboratory or physical examination findings. The most common treatment-related adverse events (AEs) included somnolence (n=9), weight increase (n=8), akathisia (n=4), sedation (n=4), and abdominal pain (n=4). Mean weight increased by 0.54 kg, and mean body mass index by 0.24 kg/m(2). The incidence of AEs and treatment-related AEs increased with increasing dose. NCBRF-TIQ subscale scores improved in all four treatment groups, with 34%, 34%, 32%, and 55% decreases from baseline in groups 1, 2, 3, and 4, respectively. CGI-S and SNAP-IV scores improved over time in all treatment groups, and CGI-I scores improved to the greatest degree in group 4. CONCLUSIONS: Molindone at doses of 5-20 mg/day (children weighing <30 kg) and 20-40 mg (≥ 30 kg) was well tolerated, and preliminary efficacy results suggest that molindone produces dose-related behavioral improvements over 9-12 weeks. Additional double-blind, placebo-controlled trials are needed to further investigate molindone in this pediatric population.
[Mh] Termos MeSH primário: Antipsicóticos/uso terapêutico
Transtorno do Deficit de Atenção com Hiperatividade/tratamento farmacológico
Transtorno da Conduta/tratamento farmacológico
Molindona/uso terapêutico
[Mh] Termos MeSH secundário: Antipsicóticos/administração & dosagem
Antipsicóticos/efeitos adversos
Transtorno do Deficit de Atenção com Hiperatividade/complicações
Transtorno do Deficit de Atenção com Hiperatividade/fisiopatologia
Criança
Transtorno da Conduta/complicações
Relação Dose-Resposta a Droga
Seres Humanos
Masculino
Molindona/administração & dosagem
Molindona/efeitos adversos
Escalas de Graduação Psiquiátrica
Índice de Gravidade de Doença
Resultado do Tratamento
[Pt] Tipo de publicação:CLINICAL TRIAL, PHASE II; JOURNAL ARTICLE; MULTICENTER STUDY; RANDOMIZED CONTROLLED TRIAL; RESEARCH SUPPORT, NON-U.S. GOV'T
[Nm] Nome de substância:
0 (Antipsychotic Agents); RT3Y3QMF8N (Molindone)
[Em] Mês de entrada:1208
[Cu] Atualização por classe:131121
[Lr] Data última revisão:
131121
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:120301
[Cl] Clinical Trial:ClinicalTrial
[St] Status:MEDLINE
[do] DOI:10.1089/cap.2011.0087


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[PMID]:20494268
[Au] Autor:Findling RL; Johnson JL; McClellan J; Frazier JA; Vitiello B; Hamer RM; Lieberman JA; Ritz L; McNamara NK; Lingler J; Hlastala S; Pierson L; Puglia M; Maloney AE; Kaufman EM; Noyes N; Sikich L
[Ad] Endereço:Case Western Reserve University. robert.findling@uhhospitals.org
[Ti] Título:Double-blind maintenance safety and effectiveness findings from the Treatment of Early-Onset Schizophrenia Spectrum (TEOSS) study.
[So] Source:J Am Acad Child Adolesc Psychiatry;49(6):583-94; quiz 632, 2010 Jun.
[Is] ISSN:1527-5418
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:OBJECTIVE: To examine the long-term safety and efficacy of three antipsychotics in early-onset schizophrenia spectrum disorders. METHOD: Patients (8 to 19 years old) who had improved during an 8-week, randomized, double-blind acute trial of olanzapine, risperidone, or molindone (plus benztropine) were eligible to continue on the same medication for up to 44 additional weeks under double-blind conditions. Adjunctive medications were allowed according to defined algorithms. Standardized symptom, safety, and functional assessments were conducted every 4 weeks. RESULTS: Of the 116 youths randomized in the acute trial, 54 entered maintenance treatment (molindone, n = 20; olanzapine, n = 13; risperidone, n = 21). Fourteen (26%) completed 44 weeks of treatment. Adverse effects (n = 15), inadequate efficacy (n = 14), or study nonadherence (n = 8) were the most common reasons for discontinuation. The three treatment arms did not significantly differ in symptom decrease or time to discontinuation. Akathisia was more common with molindone and elevated prolactin concentrations more common with risperidone. Although weight gain and metabolic adverse events had occurred more often with olanzapine and risperidone during the acute trial, no significant between-drug differences emerged in most of these parameters during maintenance treatment. CONCLUSIONS: Only 12% of youths with early-onset schizophrenia spectrum disorders continued on their originally randomized treatment at 52 weeks. No agent demonstrated superior efficacy, and all were associated with side effects, including weight gain. Improved treatments are needed for early-onset schizophrenia spectrum disorders. Clinical trial registry information-Treatment of Schizophrenia and Related Disorders in Children and Adolescents; URL: http://www.clinicaltrials.gov, unique identifier: NCT00053703.
[Mh] Termos MeSH primário: Benzodiazepinas/uso terapêutico
Molindona/uso terapêutico
Transtornos Psicóticos/tratamento farmacológico
Psicotrópicos/uso terapêutico
Risperidona/uso terapêutico
Esquizofrenia/tratamento farmacológico
Psicologia do Esquizofrênico
[Mh] Termos MeSH secundário: Adolescente
Acatisia Induzida por Medicamentos/etiologia
Benzodiazepinas/efeitos adversos
Criança
Método Duplo-Cego
Feminino
Seres Humanos
Assistência de Longa Duração
Masculino
Molindona/efeitos adversos
Prolactina/sangue
Escalas de Graduação Psiquiátrica
Transtornos Psicóticos/diagnóstico
Transtornos Psicóticos/psicologia
Psicotrópicos/efeitos adversos
Fatores de Risco
Risperidona/efeitos adversos
Esquizofrenia/diagnóstico
Ganho de Peso/efeitos dos fármacos
Adulto Jovem
[Pt] Tipo de publicação:COMPARATIVE STUDY; JOURNAL ARTICLE; MULTICENTER STUDY; RANDOMIZED CONTROLLED TRIAL; RESEARCH SUPPORT, N.I.H., EXTRAMURAL
[Nm] Nome de substância:
0 (Psychotropic Drugs); 12794-10-4 (Benzodiazepines); 9002-62-4 (Prolactin); L6UH7ZF8HC (Risperidone); N7U69T4SZR (olanzapine); RT3Y3QMF8N (Molindone)
[Em] Mês de entrada:1012
[Cu] Atualização por classe:161215
[Lr] Data última revisão:
161215
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:100525
[Cl] Clinical Trial:ClinicalTrial
[St] Status:MEDLINE
[do] DOI:10.1016/j.jaac.2010.03.013


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[PMID]:20031106
[Au] Autor:McCue RE; Unuigbe FE; Charles RA; Orendain GC; Waheed R
[Ti] Título:Treatment of morbidly obese psychotic patients with molindone: three case reports.
[So] Source:J Clin Psychiatry;70(11):1606-7, 2009 Nov.
[Is] ISSN:1555-2101
[Cp] País de publicação:United States
[La] Idioma:eng
[Mh] Termos MeSH primário: Antipsicóticos/uso terapêutico
Molindona/uso terapêutico
Obesidade Mórbida/epidemiologia
Transtornos Psicóticos/tratamento farmacológico
[Mh] Termos MeSH secundário: Comorbidade
Transtorno Depressivo Maior/tratamento farmacológico
Transtorno Depressivo Maior/epidemiologia
Quimioterapia Combinada
Feminino
Seres Humanos
Masculino
Meia-Idade
Molindona/efeitos adversos
Transtornos Psicóticos/epidemiologia
Esquizofrenia/tratamento farmacológico
Esquizofrenia/epidemiologia
Resultado do Tratamento
[Pt] Tipo de publicação:CASE REPORTS; LETTER; REVIEW
[Nm] Nome de substância:
0 (Antipsychotic Agents); RT3Y3QMF8N (Molindone)
[Em] Mês de entrada:1001
[Cu] Atualização por classe:131121
[Lr] Data última revisão:
131121
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:091225
[St] Status:MEDLINE
[do] DOI:10.4088/JCP.09l05219yel



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