Biomedical subjects

Julie A Carbray

Publications and source records attributed to Julie A Carbray.

6 recordsLinked to original sources

PubMed2006

A one-year open-label trial of risperidone augmentation in lithium nonresponder youth with preschool-onset bipolar disorder.

OBJECTIVE: The aim of this study was to assess the safety and efficacy of risperidone augmentation of lithium in preschool-onset bipolar disorder (BD) among youth who insufficiently respond to lithium monotherapy. METHOD: Thirty-eight subjects between the ages of 4 and 17 years (mean age = 11.37 +/- 3.8 years) with onset of BD in preschool years (manic or mixed episode) entered this 12-month trial. All subjects received lithium monotherapy. Patients who failed to adequately respond to lithium monotherapy after 8 weeks and those who relapsed after an initial response were given risperidone augmentation for up to 11 months. The Young Mania Rating Scale (YMRS) was the primary outcome measure. Response was defined as a > or =50% decrease from baseline. Additional data were collected on diagnostic comorbidity, family history, number of hospitalizations, perinatal risk factors, history of physical or sexual abuse, Child Depression Rating Scale-Revised (CDRS-R), Clinical Global Impression (CGI) scale for BD (CGI-BP), Children's Global Assessment Scale (C-GAS), and adverse medication effects. RESULTS: Of the 38 subjects treated with lithium monotherapy, 17 responded, whereas 21 required augmentation with risperidone. Response rate in the youths treated with lithium + risperidone was 85.7% (n = 18/21). Significant predictors of inadequate response to lithium monotherapy requiring augmentation were: (1) attention-deficit/hyperactivity disorder (ADHD), (2) severity at baseline, (3) history of sexual or physical abuse, and (4) preschool age. Combination treatment of lithium and risperidone was found to be safe and well tolerated. CONCLUSIONS: A substantial proportion of youth with a history of preschool-onset BD treated with lithium were either nonresponders or partial responders. Subsequent augmentation of lithium with risperidone in these cases was well tolerated and efficacious. Potential predictors of lithium nonresponse identified in this study may guide the choice of medications earlier in the treatment process.

Adolescent↗

PubMed2006

Child mania rating scale: development, reliability, and validity.

OBJECTIVE: To develop a reliable and valid parent-report screening instrument for mania, based on DSM-IVsymptoms. METHOD: A 21-item Child Mania Rating Scale-Parent version (CMRS-P) was completed by parents of 150 children (42.3% female) ages 10.3 +/- 2.9 years (healthy controls = 50; bipolar disorder = 50; attention-deficit/hyperactivity disorder [ADHD] = 50). The Washington University Schedule for Affective Disorders and Schizophrenia was used to determine DSM-IV diagnosis. The Young Mania Rating Scale, Schedule for Affective Disorders and Schizophrenia Mania Rating Scale, Child Behavior Checklist, and Child Depression Inventory were completed to estimate the construct validity of the measure. RESULTS: Exploratory and confirmatory factor analysis of the CMRS-P indicated that the scale was unidimensional. The internal consistency and retest reliability were both 0.96. Convergence of the CMRS-P with the Washington University Schedule for Affective Disorders and Schizophrenia mania module, the Schedule for Affective Disorders and Schizophrenia Mania Rating Scale, and the Young Mania Rating Scale was excellent (.78-.83). The scale did not correlate as strongly with the Conners parent-rated ADHD scale, the Child Behavior Checklist -Attention Problems and Aggressive Behavior subscales, or the child self-report Child Depression Inventory (.29-.51). Criterion validity was demonstrated in analysis of receiver operating characteristics curves, which showed excellent sensitivity and specificity in differentiating children with mania from either healthy controls or children with ADHD (areas under the curve of.91 to.96). CONCLUSION: The CMRS-P is a promising parent-report scale that can be used in screening for pediatric mania.

Adolescent↗

PubMed2005

Divalproex sodium for pediatric mixed mania: a 6-month prospective trial.

OBJECTIVE: This prospective 6-month open trial examined the effectiveness and safety of divalproex sodium (DVPX) in pediatric mixed mania. METHOD: Thirty-four subjects with a mean age of 12.3 (SD = 3.7) years, DSM-IV diagnosis of a current mixed episode and a baseline Young Mania Rating Scale (YMRS) score >20 were treated with DVPX monotherapy. The primary outcome measures were the YMRS and the Child Depression Rating Scale-Revised. Secondary measures were the Clinical Global Impression Scale for Bipolar Disorder (CGI-BP) and the Children's Global Assessment of Functioning Scale (C-GAS). Measures of safety and tolerability were also administered. RESULTS: Effect size (Cohen's d) based on change scores from baseline was 2.9 for the YMRS and 1.23 for the CDRS-R. Response rate (> or =50% change from baseline YMRS score and < or =40 score on CDRS-R at the end of study) was 73.5%. The remission rate (> or =50% change from baseline on YMRS, < or =40 on CDRS-R, CGI-BP-Improvement subscale of < or =2, and > or =51 CGAS score) was 52.9%. Significant improvements (p < 0.001) from baseline were seen for mean scores on all outcome measures (i.e., YMRS, CGI-BP, CDRS-R, and C-GAS). DVPX was safe and well tolerated with no serious adverse events during the 6-month trial. CONCLUSION: This study provides evidence for the effectiveness and safety of DVPX in the treatment of pediatric mixed mania over a 6-month period. Placebo-controlled, randomized trials involving larger samples will ultimately shed light on the efficacy of this agent.

Adolescent↗

PubMed2004

Open-label prospective trial of risperidone in combination with lithium or divalproex sodium in pediatric mania.

OBJECTIVE: This prospective 6-month open trial examined the safety and efficacy of two combination therapies for manic or mixed episodes of pediatric bipolar disorder: (1) divalproex sodium plus risperidone (DVPX+Risp), or (2) lithium plus risperidone (Li+Risp). METHODS: Thirty-seven (37) subjects aged 5 and 18 (age=12.1+/-3.5 years) with DSM IV current mixed or manic episode and Young Mania Rating Scale (YMRS) score >20 were sequentially assigned to either DVPX+Risp or Li+Risp in a 6-month, prospective open-label trial. Outcome measures included the YMRS, Clinical Global Impression Scale for Bipolar Disorder (CGI-BP), Child Depression Rating Scale-Revised (CDRS-R) as well as measures of safety and tolerability. RESULTS: Effect sizes (Cohen's d) based on change of YMRS scores from baseline were 4.36 for DVPX+Risp and 2.82 for Li+Risp. Response rates (>or=50% change from baseline YMRS score at the end of study) were 80% for DVPX+Risp and 82.4% for Li+Risp. Both combination treatments were well tolerated. Significant improvements (p<0.001) from baseline were seen for mean scores on all efficacy measures, i.e., YMRS, CGI-BP, and CDRS-R. There were no significant group differences in safety or tolerability, and no serious adverse events during the 6-month trial. CONCLUSION: Both DVPX+Risp and Li+Risp show strong effects coupled with safety and tolerability in treating children and adolescents with manic or mixed episodes associated with type I bipolar disorder.

Adolescent↗

PubMed2004

Child- and family-focused cognitive-behavioral therapy for pediatric bipolar disorder: development and preliminary results.

OBJECTIVE: To describe child- and family-focused cognitive-behavioral therapy (CFF-CBT), a new developmentally sensitive psychosocial intervention for pediatric bipolar disorder (PBD) that is intended for use along with medication. CFF-CBT integrates principles of family-focused therapy with those of CBT. The theoretical framework is based on (1). the specific problems of children and families coping with bipolar disorder, (2). a biological theory of excessive reactivity, and (3). the role of environmental stressors in outcome. CFF-CBT actively engages parents and children over 12 hour-long sessions. METHOD: An exploratory investigation was conducted to determine the feasibility of CFF-CBT. Participants included 34 patients with PBD (mean age 11.33 years, SD = 3.06) who were treated with CFF-CBT plus medication in a specialty clinic. Treatment integrity, adherence, and parent satisfaction were assessed. Symptom severity and functioning were evaluated before and after treatment using the severity scales of the Clinical Global Impression Scales for Bipolar Disorder (CGI-BP) and the Children's Global Assessment Scale (CGAS) respectively. RESULTS: On completion of therapy, patients with PBD showed significant reductions in severity scores on all CGI-BP scales and significantly higher CGAS scores compared to pretreatment results. High levels of treatment integrity, adherence, and satisfaction were achieved. CONCLUSIONS: CFF-CBT has a strong theoretical and conceptual foundation and represents a promising approach to the treatment of PBD. Preliminary results support the potential feasibility of the intervention.

Adaptation, Psychological↗

PubMed2004

A pharmacotherapy algorithm for stabilization and maintenance of pediatric bipolar disorder.

OBJECTIVE: To assess the feasibility and effectiveness of an evidence-based pharmacotherapy algorithm in the treatment of pediatric bipolar disorder. METHOD: The study reports the results of a study of 64 bipolar type I subjects who were treated according to an algorithm developed in our specialty clinic. All subjects had been diagnosed using the Washington University in St. Louis Schedule for Affective Disorders and Schizophrenia. Subjects scored an average of 28 (+/- 4) on the baseline Young Mania Rating Scale. All subjects were assessed over an 18-month period. In addition, we were able to match 17 of the 64 subjects in the algorithm sample for gender, age, ethnicity, socioeconomic status, and diagnosis with an equal number of subjects in a psychopharmacology clinic who received treatment as usual. RESULTS: Prescribing clinicians were able to implement primary and secondary strategies, including detailed tactics of medication choices in the algorithm group. Growth curve analysis of the total algorithm group showed strong and significant improvement in symptoms. Analyses of the matched groups also showed strong effects for the treatment algorithm over treatment as usual. Treatment adherence and family satisfaction were higher in the algorithm group. CONCLUSION: An evidence-based, problem-solving pharmacotherapy algorithm is feasible and may be associated with better outcomes in the treatment of pediatric bipolar disorder. Randomized trials will be necessary to gather additional support for the algorithm's effectiveness.

Algorithms↗