PMID- 24024534
OWN - NLM
STAT- MEDLINE
DCOM- 20141114
LR  - 20211021
IS  - 1557-8992 (Electronic)
IS  - 1044-5463 (Print)
IS  - 1044-5463 (Linking)
VI  - 23
IP  - 7
DP  - 2013 Sep
TI  - Safety, tolerability, and efficacy of quetiapine in youth with schizophrenia or 
      bipolar I disorder: a 26-week, open-label, continuation study.
PG  - 490-501
LID - 10.1089/cap.2012.0092 [doi]
AB  - OBJECTIVE: The purpose of this study was to describe the safety, tolerability, 
      and efficacy of quetiapine monotherapy continued for up to 26-weeks in youth with 
      schizophrenia or bipolar I disorder. METHODS: Medically healthy boys and girls 
      with a baseline Diagnostic and Statistical Manual of Mental Disorders, 4th ed. 
      (DSM-IV-TR) diagnosis of schizophrenia (ages 13-17 years) or a manic episode of 
      bipolar I disorder (ages 10-17 years) who participated in one of two acute, 
      double-blind, placebo-controlled studies of immediate-release quetiapine were 
      potentially eligible to enroll in a 26-week, open-label study. During the 
      open-label study, quetiapine was flexibly dosed at 400-800 mg/day, with options 
      to reduce dosing to 200 mg/day based on tolerability. Safety and tolerability 
      outcomes assessed from open-label baseline to week 26 included adverse events 
      (AEs), metabolic/laboratory parameters, extrapyramidal symptoms, suicidality, and 
      vital signs. RESULTS: Of 381 patients enrolled in the open-label study (n=176, 
      schizophrenia; n=205, bipolar disorder diagnosis), 237 patients (62.2%) completed 
      the 26-week study period (71.0%, schizophrenia; 54.6%, bipolar disorder). The 
      most common AEs reported during the study included somnolence, headache, 
      sedation, weight increase, and vomiting. A total of 14.9% of patients experienced 
      a shift to potentially clinically significant low levels of high-density 
      lipoprotein cholesterol and 10.2% of patients experienced a shift to potentially 
      clinically significant high triglyceride levels. Weight gain >/= 7% was reported in 
      35.6% of patients between open-label baseline and final visit. After adjustment 
      for normal growth, 18.3% of study participants experienced clinically significant 
      weight gain (i.e., increase in body mass index >/= 0.5 standard deviations from 
      baseline). CONCLUSIONS: In this 26-week study, quetiapine flexibly dosed at 
      400-800 mg/day, with options to reduce dosing based on tolerability, was 
      generally safe and well tolerated in youth. Clinicians should monitor lipid 
      profiles and weight gain in youth with schizophrenia or bipolar disorder during 
      treatment with quetiapine.
FAU - Findling, Robert L
AU  - Findling RL
AD  - 1 Johns Hopkins Medicine and the Kennedy Krieger Institute , Baltimore, Maryland.
FAU - Pathak, Sanjeev
AU  - Pathak S
FAU - Earley, Willie R
AU  - Earley WR
FAU - Liu, Sherry
AU  - Liu S
FAU - DelBello, Melissa
AU  - DelBello M
LA  - eng
SI  - ClinicalTrials.gov/NCT00227305
GR  - UL1 TR000077/TR/NCATS NIH HHS/United States
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20130911
PL  - United States
TA  - J Child Adolesc Psychopharmacol
JT  - Journal of child and adolescent psychopharmacology
JID - 9105358
RN  - 0 (Antipsychotic Agents)
RN  - 0 (Dibenzothiazepines)
RN  - 2S3PL1B6UJ (Quetiapine Fumarate)
SB  - IM
MH  - Adolescent
MH  - Antipsychotic Agents/*adverse effects/*therapeutic use
MH  - Bipolar Disorder/*drug therapy
MH  - Child
MH  - Dibenzothiazepines/*adverse effects/*therapeutic use
MH  - Female
MH  - Humans
MH  - Male
MH  - Quetiapine Fumarate
MH  - Schizophrenia/*drug therapy
PMC - PMC3778946
EDAT- 2013/09/13 06:00
MHDA- 2014/11/15 06:00
PMCR- 2014/09/01
CRDT- 2013/09/13 06:00
PHST- 2013/09/13 06:00 [entrez]
PHST- 2013/09/13 06:00 [pubmed]
PHST- 2014/11/15 06:00 [medline]
PHST- 2014/09/01 00:00 [pmc-release]
AID - 10.1089/cap.2012.0092 [pii]
AID - 10.1089/cap.2012.0092 [doi]
PST - ppublish
SO  - J Child Adolesc Psychopharmacol. 2013 Sep;23(7):490-501. doi: 
      10.1089/cap.2012.0092. Epub 2013 Sep 11.