Status:

COMPLETED

COVID-19 Pandemic Burden in Severe Mental Disease Patients

Lead Sponsor:

Federico II University

Conditions:

Psychological Distress

COVID

Eligibility:

All Genders

18-70 years

Brief Summary

Despite being originated in Wuhan, in the China mainland region of the Hubei, Italy has been the hardest-hit country in the world by the COVID-19 pandemic during the month of March. Due to the uncont...

Eligibility Criteria

Inclusion

  • DSM-5 Diagnosis of Schizophrenia or Psychosis Spectrum; Bipolar Disorder; REcurrent Major Depressive Disorder
  • Linguistic and cognitive ability to complete the rating scales
  • Written informed consent
  • Psychopathological compensation at last clinical evaluation on January-February 2020

Exclusion

  • SARS-CoV-2 positive, suspected positive, or in recent close contact with positive ones
  • Not under strict quarantine, due to work reasons or to any other reason allowing to overcome quarantine
  • Current or recent hospitalization (i.e. on March-April), for any reason
  • Intellectual disability
  • Psychiatric disturbances secondary to general medical conditions or substances
  • Serious medical conditions with infaust prognosis or severely affecting the quality of life
  • Living in Northern Italy
  • Adjunctive Exclusion Criteria for the General Population and Caregivers:
  • Psychiatric Disorder, of any type
  • Adjunctive Exclusion Criteria for the General Population:
  • First degree relative or caregiver of a psychiatric patient

Key Trial Info

Start Date :

April 10 2020

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

April 25 2020

Estimated Enrollment :

400 Patients enrolled

Trial Details

Trial ID

NCT04357769

Start Date

April 10 2020

End Date

April 25 2020

Last Update

February 3 2021

Active Locations (1)

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1

University of Naples "Federico II"

Napoli, Italy, 80131