OBJECTIVES: Paliperidone is a relatively new atypical antipsychotic, offers a potential new treatment option for adolescents, with several advantages including single dosage per day and availability in hepatic problems. However, there is a lack of efficacy and safety data for the use of this medication in various psychiatric disorders among children and adolescents. In this study, we retrospectively investigated the use of paliperidone in various psychiatric disorders among a youth population.
METHODS: The children and adolescents treated with paliperidone for any psychiatric problem at the outpatient and inpatient Child and Adolescent Psychiatry clinics of Düzce University Medical Faculty Hospital and Bakırkoy Mental Health Hospital were evaluated for the study. Data were collected retrospectively from the patient records. Patients’ charts were reviewed to retrieve additional data on indications of the medications, adverse drug reactions (ADRs) and changes in the clinical condition. The clinical status of individual patients was assessed using the Clinical Global Index (CGI) score for severity and improvement.
RESULTS: The mean age of patients was 15.8 ± 1.3 years, and 59.6% (n = 31) of the group was male and 40.4% (n = 21) was female. Paliperidone was prescribed for median 150 days (quartiles 60 and 487 days). The median average daily dose was 7.6 mg/day (range 3–12 mg/day). The main indications for paliperidone prescription were psychotic disorders and bipolar disorders (BPDs) (17 patients, 32.6%; 16 patients, 30.7%, respectively). The other most common diagnostic group was disruptive behavior disorders (DBDs) associated with attention deficit hyperactivity disorder (ADHD), autism spectrum disorders, intellectual disability, conduct disorders, or oppositional defiant disorders (15 patients; 28.8%) tic/neurological disorder (4 patients; 7.9%). Thirty-five patients (67.4%) did not have a diagnosis of schizophrenia and were considered to have received these drugs off-label. Dosing was notably lower in the group of DBDs patients than for patients with BPD or psychotic disorders. Of the 52 patients receiving paliperidone, 53.9% of patients were concurrently treated at some point with one or more than one of a psychostimulant/ADHD medication, an other antipsychotics, an antidepressant, a mood stabilizer, and any other class of psychotropic drug (such as a sleep medication). Totally, ADRs were recorded in 26 (50%) patients: weight gain (n = 24); extra pyramidal symptoms (n = 8); gastrointestinal system symptoms (n = 4); insomnia (n = 2); hyperprolactinemia (n = 4); sedation (n = 2); and skin affection (n = 1).
CONCLUSIONS: In this study group, paliperidone has been commonly used for schizophrenia, but it has also been used for mood disorders, DBDs, and Tourette’s disorder in children and adolescents. Results showed clinically meaningful improvements in symptom measurements of different disorders. The drug is generally well tolerated and the most frequent adverse events include rigidity, akathisia, sedation, and increased appetite. Future prospective studies with large samples are needed for definite conclusions.