Holland C Detke1, Melissa P DelBello2, John Landry3, Vicki Poole Hoffmann1, Alexandra Heinloth4, Ralf W Dittmann5. 1. 1 Lilly Research Laboratories , Indianapolis, Indiana. 2. 2 Department of Psychiatry, University of Cincinnati College of Medicine , Cincinnati, Ohio. 3. 3 Eli Lilly Canada , Danforth, Ontario, Canada . 4. 4 inVentiv Health Clinical, LLC , Ann Arbor, Michigan. 5. 5 Paediatric Psychopharmacology, Department of Child and Adolescent Psychiatry and Psychotherapy, Central Institute of Mental Health, Medical Faculty Mannheim, University of Heidelberg , Mannheim, Germany .
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 Rating Scale for Children [BPRS-C] total score >30; item score ≥3 for hallucinations, delusions, or peculiar fantasies) or bipolarI disorder (manic or mixed episode; Young Mania Rating Scale [YMRS] total score ≥15) receivedopen-label olanzapine (2.5-20 mg/day) and were randomized to standard (n = 102; a single weight counseling session) or intense (n = 101; weight counseling at each study visit) weight intervention. The primary outcome measure was mean change in body mass index (BMI) from baseline to 52 weeks using mixed-model repeated measures. Symptomatology was also assessed. RESULTS:No statistically significant differences between groups were observed in mean baseline-to-52-week change in BMI (standard: +3.6 kg/m2; intense: +2.8 kg/m2; p = 0.150) or weight (standard: +12.1 kg; intense: +9.6 kg; p = 0.148). Percentage of patients at endpoint who had gained ≥15% of their baseline weight was 40% for the standard group and 31% for the intense group (p = 0.187). Safety/tolerability results were generally consistent with those of previous olanzapine studies in adolescents, with the most notable exception being the finding of a mean decrease in prolactin. On symptomatology measures, patients with schizophrenia had a mean baseline-to-52-week change in BPRS-C of -32.5 (standard deviation [SD] = 10.8), and patients with bipolar disorder had a mean change in YMRS of -16.7 (SD = 8.9), with clinically and statistically significant improvement starting at 3-4 days for each. CONCLUSIONS:Long-term weight gain was high in both groups, with no statistically significant differences between the standard or intense behavioral weight interventions in BMI or weight. Safety, tolerability, and effectiveness findings were generally consistent with the known profile of olanzapine in adolescents.
RCT Entities:
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 Rating Scale for Children [BPRS-C] total score >30; item score ≥3 for hallucinations, delusions, or peculiar fantasies) or bipolar I disorder (manic or mixed episode; Young Mania Rating Scale [YMRS] total score ≥15) received open-label olanzapine (2.5-20 mg/day) and were randomized to standard (n = 102; a single weight counseling session) or intense (n = 101; weight counseling at each study visit) weight intervention. The primary outcome measure was mean change in body mass index (BMI) from baseline to 52 weeks using mixed-model repeated measures. Symptomatology was also assessed. RESULTS: No statistically significant differences between groups were observed in mean baseline-to-52-week change in BMI (standard: +3.6 kg/m2; intense: +2.8 kg/m2; p = 0.150) or weight (standard: +12.1 kg; intense: +9.6 kg; p = 0.148). Percentage of patients at endpoint who had gained ≥15% of their baseline weight was 40% for the standard group and 31% for the intense group (p = 0.187). Safety/tolerability results were generally consistent with those of previous olanzapine studies in adolescents, with the most notable exception being the finding of a mean decrease in prolactin. On symptomatology measures, patients with schizophrenia had a mean baseline-to-52-week change in BPRS-C of -32.5 (standard deviation [SD] = 10.8), and patients with bipolar disorder had a mean change in YMRS of -16.7 (SD = 8.9), with clinically and statistically significant improvement starting at 3-4 days for each. CONCLUSIONS: Long-term weight gain was high in both groups, with no statistically significant differences between the standard or intense behavioral weight interventions in BMI or weight. Safety, tolerability, and effectiveness findings were generally consistent with the known profile of olanzapine in adolescents.
Authors: Ginger E Nicol; Rachel Kolko; Eric J Lenze; Michael D Yingling; J Philip Miller; Amanda R Ricchio; Julia A Schweiger; Robert L Findling; Denise Wilfley; John W Newcomer Journal: J Child Adolesc Psychopharmacol Date: 2019-04-17 Impact factor: 2.576
Authors: Christoph U Correll; Linmarie Sikich; Gloria Reeves; Jacqueline Johnson; Courtney Keeton; Marina Spanos; Sandeep Kapoor; Kristin Bussell; Leslie Miller; Tara Chandrasekhar; Eva M Sheridan; Sara Pirmohamed; Shauna P Reinblatt; Cheryl Alderman; Abigail Scheer; Irmgard Borner; Terrence C Bethea; Sarah Edwards; Robert M Hamer; Mark A Riddle Journal: World Psychiatry Date: 2020-02 Impact factor: 49.548