title: The risk of elevated prolactin levels in pediatric patients exposed to antipsychotics for the treatment of schizophrenia and schizophrenia spectrum disorders: protocol for a systematic review and meta-analysis.
abstract: BACKGROUND
  Antipsychotic medications, particularly second-generation antipsychotics, are increasingly being used to alleviate the symptoms of schizophrenia and other severe mental disorders in the pediatric population. While evidence-based approaches examining efficacy and safety outcomes have been reported, no review has evaluated prolactin-based adverse events for antipsychotic treatments in schizophrenia and schizophrenia spectrum disorders.
  
  
  METHODS
  Searches involving MEDLINE, EMBASE, CENTRAL, PsycINFO, and clinical trial registries (ClinicalTrials.gov, Drug Industry Document Archive [DIDA], International Clinical Trials Registry Platform [ICTRP]) will be used to identify relevant studies. Two reviewers will independently screen abstracts and relevant full-text articles of the papers identified by the initial search according to the prospectively defined eligibility criteria. Data extraction will be conducted in duplicate independently. Pairwise random effects meta-analyses and network meta-analyses will be conducted on individual drug and class effects where appropriate.
  
  
  CONCLUSIONS
  This systematic review will evaluate prolactin-based adverse events of first- and second-generation antipsychotics in the pediatric population with schizophrenia and schizophrenia spectrum disorders. It will also seek to strengthen the evidence base of the safety of antipsychotics by incorporating both randomized controlled trials and observational studies.
  
  
  BACKGROUND
  PROSPERO CRD42014009506.
authors.affiliation: Faculty of Health Sciences, University of Ottawa, 25 University Private, Ottawa, Ontario K1N 6N5, Canada. edruyts@uottawa.ca.
authors.forename: Eric
authors.initials: E
authors.lastname: Druyts
authors.forename: Shawn
authors.initials: S
authors.lastname: Eapen
authors.forename: Ping
authors.initials: P
authors.lastname: Wu
authors.forename: Kristian
authors.initials: K
authors.lastname: Thorlund
mesh_terms: D000293:Adolescent; D014150:Antipsychotic Agents / Q000009:adverse effects*; D002648:Child; D002675:Child, Preschool; D005260:Female; D005687:Galactorrhea / Q000097:blood / Q000139:chemically induced; D006177:Gynecomastia / Q000097:blood / Q000139:chemically induced; D006801:Humans; D008297:Male; D008599:Menstruation Disturbances / Q000097:blood / Q000139:chemically induced; D011388:Prolactin / Q000097:blood*; D012107:Research Design; D012559:Schizophrenia / Q000097:blood* / Q000188:drug therapy*; D012735:Sexual Dysfunction, Physiological / Q000097:blood / Q000139:chemically induced; D000078202:Systematic Reviews as Topic; D015201:Meta-Analysis as Topic
chemical_list: D014150:Antipsychotic Agents; D011388:Prolactin