Patients treated with antipsychotics. A follow-up study (Ícaro)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Drug utilisation

  Effectiveness study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (N05A) ANTIPSYCHOTICS

  ANTIPSYCHOTICS

Population studied

• Age groups:
  Adolescents (12 to < 18 years)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  425

Study design details

• Main study objective:
  To identify some of the genetic polymorphisms related to weight gain in patients treated with antipsychotics. Other objectives are, to further learn and characterize other adverse reactions, the effectiveness of these medications and the way they are being used in a real setting, finally, an intervention to optimize the use of this medication is foreseen.
• Outcomes:
  Weight gain > 7% of inicial weight at baseline
• Data analysis plan:
  Risk estimation

Documents

Study, other information

Autorizacion del Estudio EC11-395 por la AEMPS

DICTAMEN CEIC HCUV EPA-12-78