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Treatment moderators and predictors of outcome in the Treatment of Early Age Mania (TEAM) study.

ABSTRACT: OBJECTIVE:Both the diagnosis and treatment of bipolar disorder in youth remain the subject of debate. In the Treatment of Early Age Mania (TEAM) study, risperidone was more effective than lithium or divalproex in children diagnosed with bipolar mania and highly comorbid with attention-deficit/hyperactivity disorder (ADHD). We searched for treatment moderators and predictors of outcome. METHOD:TEAM was a multi-site, 8-week, randomized clinical trial of risperidone, lithium, or divalproex in 279 medication-naïve patients, aged 6 through 15 years, with a DSM-IV diagnosis of bipolar disorder currently in manic or mixed phase. Outcome measures included binary end-of-treatment responder status and change in the Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS) Mania Rating Scale (KMRS). Baseline demographics and clinical characteristics were tested as modifiers of treatment effect and as overall predictors of outcome. RESULTS:Moderator effects were detected for site, ADHD, and obesity. Across sites, the response ratio (RR) for risperidone versus lithium ranged from 1.2 (95% confidence interval [CI] = 0.8-1.7) to 8.3 (95% CI = 1.1-60.8), and for risperidone versus divalproex from 1.3 (95% CI = 0.8-2.2) to 10.5 (95% CI = 1.4-77.7). The RR for risperidone versus lithium was 2.1 for patients with ADHD, but 1.0 for those without ADHD, and 2.3 (95% CI = 1.6-3.3) for nonobese patients, but 1.1 (95% CI = 0.6-2.0) for obese ones. Older age and less severe ADHD symptoms were associated with greater improvement on the KMRS. CONCLUSIONS:Risperidone was more effective than lithium or divalproex across the demographics and clinical characteristics of the sample, but the magnitude of its effect was influenced by site-related characteristics and presence of ADHD. Clinical trial registration information--Treatment of Early Age Mania; http://clinicaltrials.gov/; NCT00057681.

SUBMITTER: Vitiello B

PROVIDER: S-EPMC3427533 | biostudies-literature | 2012 Sep

REPOSITORIES: biostudies-literature

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Treatment moderators and predictors of outcome in the Treatment of Early Age Mania (TEAM) study.

Vitiello Benedetto B Riddle Mark A MA Yenokyan Gayane G Axelson David A DA Wagner Karen D KD Joshi Paramjit P Walkup John T JT Luby Joan J Birmaher Boris B Ryan Neal D ND Emslie Graham G Robb Adelaide A Tillman Rebecca R

Journal of the American Academy of Child and Adolescent Psychiatry 20120731 9

<h4>Objective</h4>Both the diagnosis and treatment of bipolar disorder in youth remain the subject of debate. In the Treatment of Early Age Mania (TEAM) study, risperidone was more effective than lithium or divalproex in children diagnosed with bipolar mania and highly comorbid with attention-deficit/hyperactivity disorder (ADHD). We searched for treatment moderators and predictors of outcome.<h4>Method</h4>TEAM was a multi-site, 8-week, randomized clinical trial of risperidone, lithium, or diva ...[more]

PMID: 22917200

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Project description:BackgroundAntipsychotic-related weight gain is a common clinically relevant side effect when treating psychotic disorders in pediatric populations, yet few predictors and no moderators of antipsychotic-related weight gain are known.MethodsThe Treatment of Early-Onset Schizophrenia Spectrum Disorders (TEOSS) study randomized 119 youths (age 8-19 years) with schizophrenia or schizoaffective disorder to 8 weeks of antipsychotic treatment with molindone, risperidone, or olanzapine and assessed treatment response and side effects. In this secondary analysis, we used multivariable linear regression and receiver operating characteristic analysis to investigate predictors and moderators of weight change and percent weight change from baseline to week 8.ResultsTreatment assignment was the most discriminant predictor of weight change [F(2, 66) = 17.00, p < 0.001] and percent weight change [F(2, 66) = 16.85, p < 0.001]. Mean weight gain was 0.74 (standard deviation ±3.51) kg for molindone, 4.13 ± 3.79 kg for risperidone, and 7.29 ± 3.44 kg for olanzapine. After adjusting for treatment assignment, lower pretreatment hemoglobin A1C (HgbA1C) predicted more weight gain [F(1, 55) = 4.71, p = 0.03]. Diagnosis (schizoaffective vs. schizophrenia) moderated weight change [F(2, 63) = 6.02, p = 0.004] and percent weight change [F(2, 63) = 5.26, p = 0.008] such that schizoaffective diagnosis predicted larger weight gain for youths in the risperidone treatment arm. Age, sex, family income, baseline weight, and symptoms neither predicted nor moderated weight change or percent weight change.ConclusionWe identified prognostic subgroups and novel risk factors for antipsychotic-related weight gain. We confirmed that antipsychotic choice is extremely important for predicting future weight gain. We also found that younger age did not predict greater weight gain, in contrast to prior studies. Our findings require replication in an independent sample because we did not adjust for multiple comparisons to minimize false negatives. ClinicalTrials.gov Identifier: NCT00053703.

Project description:BackgroundWith few RCTs having compared active treatments for paediatric PTSD, little is known about whether or which baseline (i.e. pre-randomization) variables predict or moderate outcomes in the evaluated treatments.ObjectiveTo identify predictors and moderators of paediatric PTSD outcomes for Eye Movement Desensitization and Reprocessing Therapy (EMDR) and Cognitive Behavioural Writing Therapy (CBWT).MethodData were obtained as part of a multi-centre, randomized controlled trial of up to six sessions (up to 45 minutes each) of either EMDR therapy, CBWT, or wait-list, involving 101 youth (aged 8-18 years) with a PTSD diagnosis (full/subthreshold) tied to a single event. The predictive and moderating effects of the child's baseline sociodemographic and clinical characteristics, and parent's psychopathology were evaluated using linear mixed models (LMM) from pre- to post-treatment and from pre- to 3- and 12-month follow-ups.ResultsAt post-treatment and 3-month follow-up, youth with an index trauma of sexual abuse, severe symptoms of PTSD, anxiety, depression, more comorbid disorders, negative posttraumatic beliefs, and with a parent with more severe psychopathology fared worse in both treatments. For children with more severe self-reported PTSD symptoms at baseline, the (exploratory) moderator analysis showed that the EMDR group improved more than the CBWT group, with the opposite being true for children and parents with a less severe clinical profile.ConclusionsThe most consistent finding from the predictor analyses was that parental symptomatology predicted poorer outcomes, suggesting that parents should be assessed, supported and referred for their own treatment where indicated. The effect of the significant moderator variables was time-limited, and given the large response rate (>90%) and brevity (<4 hours) of both treatments, the present findings suggest a focus on implementation and dissemination, rather than tailoring, of evidence-based trauma-focused treatments for paediatric PTSD tied to a single event.

Project description:ImportanceThe application of precision medicine principles for the treatment of depressive disorders in adolescents requires an examination of the variables associated with depression outcomes in randomized clinical trials (RCTs).ObjectiveTo describe predictors, moderators, and mediators associated with outcomes in RCTs for the treatment of depressive disorders in adolescents.Evidence reviewA scoping review of RCTs for the treatment of depression in adolescents was conducted. Databases searched included MEDLINE, Embase, APA PsycInfo, and CINAHL. Included publications tested predictors, moderators, and/or mediators associated with depression symptom outcomes (eg, symptom reduction, response, remission) in RCTs pertaining to the treatment of adolescents, ages 13 to 17 years. Predictors were defined as variables that were associated with depression outcomes, independent of treatment group. Moderators were defined as baseline variables that were associated with differential outcomes between treatment groups. Mediators were defined by a formal mediation analysis. In duplicate, variables were extracted and coded with respect to analysis type (univariable or multivariable), statistical significance, direction of effect size, reporting of a priori hypotheses, and adjustment for multiple comparisons. Aggregated results were summarized by variable domain and RCT sample.FindingsEighty-one articles reporting on variables associated with outcomes across 33 RCTs were identified, including studies of biological (10 RCTs), psychosocial (18 RCTs), and combined (4 RCTs) treatments as well as a service delivery model (1 RCT). Fifty-three variable domains were tested as baseline predictors of depression outcome, 41 as moderators, 19 as postbaseline predictors, and 5 as mediators. Variable domains that were reported as significant in at least 3 RCTs included age, sex/gender, baseline depression severity, early response to treatment, sleep changes, parent-child conflict, overall psychopathology, suicidal ideation, hopelessness, functional impairment, attendance at therapy sessions, and history of trauma. Two publications reported a priori hypotheses and adjustment for multiple comparisons, both finding that baseline depression severity and family conflict were associated with poorer outcomes.Conclusions and relevanceThis review identified commonly researched variables requiring more scrutiny as well as underresearched variables to inform future study designs. Further efforts to discover predictors, moderators, and mediators associated with treatment response have great potential to optimize care for adolescents with depression.

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Treatment moderators and predictors of outcome in the Treatment of Early Age Mania (TEAM) study.

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Treatment moderators and predictors of outcome in the Treatment of Early Age Mania (TEAM) study.

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