Psychosis and psychotic disorders” and “Depression and suicide/self-injury” following exposure to Hydroxychloroquine and chloroquine

Study type

• Study topic:
  Human medicinal product

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

  Drug utilisation
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  HYDROXYCHLOROQUINE

  CHLOROQUINE
• Medical condition to be studied:
  Reactive psychosis

  Psychotic behaviour

  Depression

  Suicide attempt

  Intentional self-injury
• Additional medical condition(s):
  Suicidality, Self-endangering behaviour, Psychotic disorders, Non-psychotic depression and other emotional disorders

Population studied

• Short description of the study population:
  The population eligible for the study consists of all patients in IMS ® Disease Analyzer Germany with an observation period of one-year or more at the time of their first prescription for HCQ or CQ. Patients are followed until their last consultation, or, in case of interruptions in consultation lasting 366 days or longer, follow-up will end on day 365 after the consultation immediately prior to the interruption. The study subjects are followed from the first use of Hydroxychloroquine and Chloroquine on the database (1992 onwards) to most recent data available (December 2019). In any case data do not cover data collected from the ongoing COVID19 pandemic.
• Age groups:
  Infants and toddlers (28 days – 23 months)

  Children (2 to < 12 years)

  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:
  55000

Study design details

• Main study objective:
  The study has the following objectives :1. To describe the pattern of use of HCQ and CQ.2. To estimate the incidence rate of recorded events as coded in primary care records whilst exposed and at any time following exposure to HCQ and CQ.a. Suicidalityb. Self-endangering behaviour (including self-harm)c. Affective, Psychosis and psychotic disordersd. Non-psychotic depression
• Outcomes:
  To describe the pattern of use of HCQ and CQ. To estimate the incidence rate of recorded events as coded in primary care records whilst exposed and at any time following exposure to HCQ and CQ.a. Suicidalityb. Self-endangering behaviour (including self-harm)c. Affective, Psychosis and psychotic disordersd. Non-psychotic depression
• Data analysis plan:
  All of the descriptive analyses in the study were performed by the authors based on data available in IMS® Disease Analyzer Germany and THIN IMRD UK. Incidence rates were calculated as the number of events occurring during follow-up divided by the person years of follow-up with 95% confidence intervals.

Documents

Study results

HCQ-CQ- Psychiatric events - EMA report on results - Germany