COLT1 Questionnaire Dataset in Pediatric Pharmacokinetic and Tolerability Study of Lithium for the Treatment of Pediatric Mania followed by an Open Label Long Term Safety Period, Discontinuation Phase, and Restabilization Period

Timing and results of the Abnormal Involuntary Movement Scale (AIMS), ADHD Rating Scale-IV (ARS-IV), Autism Screening Questionnaire (ASQ), Behaviorally Anchored Rating Scale (BARS), Brief Psychiatric Rating Scale for Children (BPRS-C), Children Depression Rating Scale - Revised (CDRS-R), Child Mania Rating Scale - Parent Version (CMRS-P), Caregiver Strain Questionnaire (CSQ), Family Environment Scale (FES), Irritability, Depression, Anxiety Scale (IDA), Kiddie-Schedule for the Assessment of Affective Disorders and Schizophrenia Past and Lifetime (K-SADS-PL), Nisonger Child Behavior Rating Form (NCBRF-TIQ), Pediatric Anxiety Rating Scale (PARS), General Behavior Inventory - Parent Report (P-GBI), Social Adjustment Inventory for Children and Adolescents (SAICA), Wechsler Abbreviated Scale of Intelligence (WASI), and Young Mania Rating Scale (YMRS)
Study Description
A multi-phase, multi-center trial that examined lithium in the treatment of pediatric patients (ages 7-17 years) with bipolar I disorder. There were four phases: 1) the Pharmacokinetic Phase included 8 weeks of open label treatment to determine empirically based dosing strategies for children and adolescents with bipolar disorder; 2) after completing the Pharmacokinetic Phase, eligible participants continued in the Long-Term Effectiveness Phase for a maximum of 16 weeks of lithium treatment; 3) participants meeting response criteria during the Long-Term Effectiveness Phase were eligible to continue in the Discontinuation Phase, when they were randomized to either placebo or lithium treatment for up to 28 weeks; and 4) participants who experienced a mood relapse during the Discontinuation Phase were enrolled in an open label Restabilization Phase and treated with lithium for up to 8 weeks.
Physically healthy male and female outpatients (7-17 years) with DSM-IV diagnosis of bipolar I (mania, mixed mania) without active psychotic symptoms as determined by a child and adolescent psychiatrist