Abstract:
OBJECTIVE:The purpose of this study was to evaluate the short- and long-term efficacy and safety of ziprasidone in children and adolescents with bipolar I disorder. METHODS:Subjects 10-17 years of age with a manic or mixed episode associated with bipolar I disorder participated in a 4 week, randomized, double-blind, placebo-controlled multicenter trial (RCT) followed by a 26 week open-label extension study (OLE). Subjects were randomized 2:1 to initially receive flexible-dose ziprasidone (40-160 mg/day, based on weight) or placebo. Primary outcome was the change in Young Mania Rating Scale (YMRS) scores from baseline. Safety assessments included weight and body mass index (BMI), adverse events (AEs), vital signs, laboratory measures, electrocardiograms, and movement disorder ratings. RESULTS:In the RCT, 237 subjects were treated with ziprasidone (n=149; mean age, 13.6 years) or placebo (n=88; mean age, 13.7 years). The estimated least squares mean changes in YMRS total (intent-to-treat population) were -13.83 (ziprasidone) and -8.61 (placebo; p=0.0005) at RCT endpoint. The most common AEs in the ziprasidone group were sedation (32.9%), somnolence (24.8%), headache (22.1%), fatigue (15.4%), and nausea (14.1%). In the OLE, 162 subjects were enrolled, and the median duration of treatment was 98 days. The mean change in YMRS score from the end of the RCT to the end of the OLE (last observation carried forward) was -3.3 (95% confidence interval, -5.0 to -1.6). The most common AEs were sedation (26.5%), somnolence (23.5%), headache (22.2%), and insomnia (13.6%). For both the RCT and the OLE, no clinically significant mean changes in movement disorder scales, BMI z-scores, liver enzymes, or fasting lipids and glucose were observed. One subject on ziprasidone in the RCT and none during the OLE had Fridericia-corrected QT interval (QTcF) ≥ 460 ms. CONCLUSION:These results demonstrate that ziprasidone is efficacious for treating children and adolescents with bipolar disorder. Ziprasidone was generally well tolerated with a neutral metabolic profile. CLINICAL TRIALS REGISTRY:NCT00257166 and NCT00265330 at ClinicalTrials.gov.
journal_name
J Child Adolesc Psychopharmacoljournal_title
Journal of child and adolescent psychopharmacologyauthors
Findling RL,Cavuş I,Pappadopulos E,Vanderburg DG,Schwartz JH,Gundapaneni BK,DelBello MPdoi
10.1089/cap.2012.0029subject
Has Abstractpub_date
2013-10-01 00:00:00pages
545-57issue
8eissn
1044-5463issn
1557-8992journal_volume
23pub_type
杂志文章,多中心研究,随机对照试验abstract:OBJECTIVE:Little is known about the pattern of service receipt and outcomes from clinics implementing best practice guidelines in child mental health. This study aimed to determine these variables for a clinic that implemented an attention-deficit/hyperactivity disorder (ADHD) treatment guideline proposed by the Childr...
journal_title:Journal of child and adolescent psychopharmacology
pub_type: 杂志文章
doi:10.1089/cap.2014.0014
更新日期:2014-11-01 00:00:00
abstract:OBJECTIVE:Different methylphenidate (MPH) formulations, immediate release (IR) or extended release (ER), have been developed to treat Attention-Deficit/Hyperactivity Disorder (ADHD). A better use of these formulations, with a proper choice of their timing, dosage, and combination, can help to attain optimal therapeutic...
journal_title:Journal of child and adolescent psychopharmacology
pub_type: 杂志文章
doi:10.1089/cap.2018.0093
更新日期:2019-04-01 00:00:00
abstract:: Objective: To guide clinicians in selecting the "next line" selective serotonin reuptake inhibitor (SSRI) for adolescents with treatment-resistant major depressive disorder, we sought to compare response rates among SSRIs in the Treatment of SSRI-Resistant Depression in Ad...
journal_title:Journal of child and adolescent psychopharmacology
pub_type: 杂志文章
doi:10.1089/cap.2018.0145
更新日期:2019-05-01 00:00:00
abstract:BACKGROUND AND PURPOSE:Hyperkinetic conduct disorder (HCD) has been identified as a common psychiatric diagnosis among children and adolescents. This disorder affects many life aspects of both child and family. The aim of this study was to examine the efficacy of the selective norepinephrine reuptake inhibitor (SNRI), ...
journal_title:Journal of child and adolescent psychopharmacology
pub_type: 临床试验,杂志文章
doi:10.1089/cap.2005.15.259
更新日期:2005-04-01 00:00:00
abstract:OBJECTIVE:To compare fast versus slow switching from stimulants to atomoxetine (ATX) in children and adolescents with attention-deficit/hyperactivity disorder (ADHD). METHODS:This was a randomized, controlled, open-label study in 6-16-year-old ADHD patients, previously treated with stimulants and cross-titrated (fast ...
journal_title:Journal of child and adolescent psychopharmacology
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1089/cap.2012.0027
更新日期:2013-05-01 00:00:00
abstract:BACKGROUND:Despite the increased recognition of attention deficit hyperactivity disorder (ADHD) in adolescents, few controlled studies have assessed treatments for this age group. Adolescent issues, such as embarrassment at receiving medication at school and experimentation with abusable substances, have accelerated ef...
journal_title:Journal of child and adolescent psychopharmacology
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1089/10445460050167313
更新日期:2000-10-01 00:00:00
abstract::In clinical samples, juvenile bipolar disorder (JBPD) is frequently accompanied by co-morbid attention-deficit/hyperactivity disorder (ADHD). Clinical trials assessing combined psychopharmacological interventions in this population are scarce, and methylphenidate (MPH) may worsen manic symptoms. We conducted a randomi...
journal_title:Journal of child and adolescent psychopharmacology
pub_type: 杂志文章,随机对照试验
doi:10.1089/cap.2009.0037
更新日期:2009-10-01 00:00:00
abstract:OBJECTIVE:Methylphenidate (MPH) is commonly used to treat attention-deficit/hyperactivity disorder (ADHD) in all children, including those with velocardiofacial syndrome (VCFS). Yet concerns have been raised regarding its safety and efficacy in VCFS. The goal of this study was to examine the safety and efficacy of MPH ...
journal_title:Journal of child and adolescent psychopharmacology
pub_type: 杂志文章,随机对照试验
doi:10.1089/cap.2011.0042
更新日期:2011-12-01 00:00:00
abstract:OBJECTIVE:Abnormal prefrontal and subcortical activity during cognitive control tasks is identified in non-depressed adolescents with bipolar disorder (BD); however, little is known about the neural correlates of bipolar adolescents in a depressed state (BDd). We aimed to investigate baseline versus after-treatment pat...
journal_title:Journal of child and adolescent psychopharmacology
pub_type: 杂志文章
doi:10.1089/cap.2012.0054
更新日期:2013-04-01 00:00:00
abstract:OBJECTIVE:The purpose of this study was to evaluate the efficacy and safety of acute quetiapine monotherapy in adolescents with schizophrenia. METHODS:Patients ages 13-17 years with an American Psychiatric Association, Diagnostic and Statistical Manual of Mental Disorders, 4th ed., Text Revision (DSM-IV-TR) diagnosis ...
journal_title:Journal of child and adolescent psychopharmacology
pub_type: 杂志文章,随机对照试验
doi:10.1089/cap.2011.0092
更新日期:2012-10-01 00:00:00
abstract::The potential for the induction of mania, increased cycle frequency, and other behavioral adverse events associated with antidepressant exposure in patients with bipolar disorder is becoming an increasingly important area of research study, as this diagnosis receives wider recognition in youth. While the majority of s...
journal_title:Journal of child and adolescent psychopharmacology
pub_type: 杂志文章,评审
doi:10.1089/104454603322163880
更新日期:2003-07-01 00:00:00
abstract::This single case reports an open trial of lamotrigine in the treatment of self-injurious behavior (SIB) and epilepsy in an 18-year-old female diagnosed with generalized seizure disorder, stereotypic movement disorder, and compulsive SIB in the context of profound mental retardation. Animal models of SIB suggest that t...
journal_title:Journal of child and adolescent psychopharmacology
pub_type: 杂志文章
doi:10.1089/cap.1996.6.273
更新日期:1996-01-01 00:00:00
abstract:INTRODUCTION:This study compared two atomoxetine titration dosing schedules and two atomoxetine maintenance doses for treating adolescent attention-deficit/hyperactivity disorder (ADHD) inattention and hyperactivity/impulsivity. METHODS:Adolescents (N = 267) were randomized to a slow or fast titration schedule. Patien...
journal_title:Journal of child and adolescent psychopharmacology
pub_type: 杂志文章,随机对照试验
doi:10.1089/cap.2008.074
更新日期:2009-12-01 00:00:00
abstract::Current estimates suggest that between 0.4% and 8.3% of children and adolescents are affected by major depression. We report a favorable response to treatment with citalopram by a 15-year-old boy with major depression who exhibited palpebral twitching during his first 2 weeks of treatment. This may have been a side ef...
journal_title:Journal of child and adolescent psychopharmacology
pub_type: 杂志文章
doi:10.1089/10445460152595621
更新日期:2001-10-01 00:00:00
abstract:: Objectives: The objective of this research was to understand physician, patient, and parent perspectives on barriers to second-generation antipsychotic (SGA) medication adherence in youth with bipolar spectrum disorders, and attitudes toward treatment of SGA-related weight...
journal_title:Journal of child and adolescent psychopharmacology
pub_type: 杂志文章
doi:10.1089/cap.2019.0184
更新日期:2020-07-01 00:00:00
abstract:OBJECTIVE:This study evaluates pediatric antidepressant prescribing practices of Nebraska clinicians. METHODS:Surveys were sent in July, 2005, to 1,521 prescribing clinicians throughout Nebraska to assess pediatric antidepressant use along with any practice changes following the U.S. Food and Drug Administration (FDA)...
journal_title:Journal of child and adolescent psychopharmacology
pub_type: 杂志文章
doi:10.1089/cap.2007.0049
更新日期:2008-02-01 00:00:00
abstract:OBJECTIVE:The purpose of this study was to investigate the course of autistic symptoms, using a quantitative measure of core autistic traits, among risperidone-treated children who participated in a 10 year life course longitudinal study. METHODS:Parents completed surveys of intervention history, as well as serial sym...
journal_title:Journal of child and adolescent psychopharmacology
pub_type: 杂志文章
doi:10.1089/cap.2014.0055
更新日期:2014-11-01 00:00:00
abstract:OBJECTIVE:This article identifies and describes key considerations toward the development of a clinical guideline intended to optimize telemental healthcare (TMH) of children and adolescents. METHODS:The literature was searched with key terms and title words. Of 2824 articles that met primary or secondary key word sea...
journal_title:Journal of child and adolescent psychopharmacology
pub_type: 杂志文章,评审
doi:10.1089/cap.2015.0129
更新日期:2016-04-01 00:00:00
abstract::The selective serotonin reuptake inhibitors (SSRIs) are becoming widely used in children and adolescents, with possible unexpected side effects being observed over time. SSRIs have been associated with bleeding in adults who have unremarkable routine hematologic laboratory results except abnormal bleeding time or plat...
journal_title:Journal of child and adolescent psychopharmacology
pub_type: 杂志文章
doi:10.1089/cap.2000.10.35
更新日期:2000-04-01 00:00:00
abstract::The study assessed competencies and practices of a large group of healthcare providers in childhood attention-deficit/hyperactivity disorder (ADHD), and identified barriers to improving care. Methods were self-assessment using an Internet questionnaire with a standardized patient case; analysis compared with professio...
journal_title:Journal of child and adolescent psychopharmacology
pub_type: 杂志文章
doi:10.1089/cap.2010.0029
更新日期:2011-02-01 00:00:00
abstract:OBJECTIVE:Edivoxetine (LY2216684) is a selective and potent norepinephrine reuptake inhibitor (NERI). The pharmacokinetics (PK) and pharmacodynamics (PD) of edivoxetine were assessed in children and adolescent patients with attention-deficit/hyperactivity disorder (ADHD) following single and once-daily oral doses of ed...
journal_title:Journal of child and adolescent psychopharmacology
pub_type: 杂志文章
doi:10.1089/cap.2011.0151
更新日期:2012-08-01 00:00:00
abstract:OBJECTIVE:The expanded use of antidepressants in youth has been the subject of numerous studies and some concerns in recent years. This study describes prescription patterns of antidepressants (ATD) for youths in Germany for the years 2000-2003 and includes prescription use of St. John's Wort. METHODS:Prescription dat...
journal_title:Journal of child and adolescent psychopharmacology
pub_type: 杂志文章
doi:10.1089/cap.2006.16.197
更新日期:2006-02-01 00:00:00
abstract:OBJECTIVE:The aim of this study was to retrospectively review a large sample of children and adolescents with pervasive developmental disorders (PDDs) treated with open-label guanfacine in order to gather preliminary data as to its effectiveness and safety. METHOD:Eighty (80) subjects with PDDs (10 females, 70 males) ...
journal_title:Journal of child and adolescent psychopharmacology
pub_type: 杂志文章
doi:10.1089/1044546041649084
更新日期:2004-07-01 00:00:00
abstract::The autism spectrum disorders (ASDs) can present with symptoms commonly found in mood and anxiety disorders. The Social Communication Questionnaire (SCQ), Children's Communication Checklist (CCC-2), and the Social Reciprocity Scale (SRS) were used to screen children in a mood disorders research clinic setting for symp...
journal_title:Journal of child and adolescent psychopharmacology
pub_type: 杂志文章
doi:10.1089/cap.2005.15.452
更新日期:2005-06-01 00:00:00
abstract:OBJECTIVES:To evaluate the 52-week safety/tolerability of oral olanzapine for adolescents with schizophrenia or bipolar mania and compare effectiveness of a standard versus intense behavioral weight intervention in mitigating risk of weight gain. METHODS:Patients 13-17 years old with schizophrenia (Brief Psychiatric R...
journal_title:Journal of child and adolescent psychopharmacology
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1089/cap.2016.0010
更新日期:2016-12-01 00:00:00
abstract:OBJECTIVE:The aim of this study was to assess the efficacy and safety of the once-daily atomoxetine compared with placebo in pediatric patients with attention-deficit/hyperactivity disorder (ADHD) in Taiwan. METHOD:The study sample included 106 patients aged 6-16 years who met the Diagnostic and Statistical Manual of ...
journal_title:Journal of child and adolescent psychopharmacology
pub_type: 杂志文章,随机对照试验
doi:10.1089/cap.2006.0091
更新日期:2007-08-01 00:00:00
abstract:BACKGROUND:Weight gain due to the use of second-generation antipsychotics is a major health care issue for adult and paediatric psychiatric patients. Little is known about long-term weight gain effects of aripiprazole compared to risperidone in children and adolescents. OBJECTIVE:The primary aim of this study is to as...
journal_title:Journal of child and adolescent psychopharmacology
pub_type: 杂志文章
doi:10.1089/cap.2018.0111
更新日期:2019-04-01 00:00:00
abstract:OBJECTIVE:The purpose of this article was to examine whether injuries in early childhood and gender predict prescriptions of stimulant medication in three groups of children: With attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder (ASD), and other psychiatric disorders (OPD). METHODS:This was a ...
journal_title:Journal of child and adolescent psychopharmacology
pub_type: 杂志文章
doi:10.1089/cap.2013.0101
更新日期:2014-06-01 00:00:00
abstract:BACKGROUND:Recent evidence indicates that atypical antipsychotics represent a promising option for the treatment of autistic disorder. In particular, risperidone appears to be effective in treating aggressiveness, hyperactivity, irritability, stereotypies, social withdrawal, and lack of interests. OBJECTIVE:The aim of...
journal_title:Journal of child and adolescent psychopharmacology
pub_type: 临床试验,杂志文章
doi:10.1089/104454604773840472
更新日期:2004-04-01 00:00:00
abstract:OBJECTIVE:The purpose of this study was to investigate the preliminary effectiveness and safety of lamotrigine for the treatment of depressive episodes in adolescents. METHODS:This was a 12 week retrospective chart review of lamotrigine treatment among 37 adolescents (mean age 16.3±1.3 years) with depressive episodes ...
journal_title:Journal of child and adolescent psychopharmacology
pub_type: 杂志文章
doi:10.1089/cap.2013.0121
更新日期:2014-06-01 00:00:00