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Completed

NCT Number: NCT01634542

An Non-Interventional Study of Patients With Persistent Symptoms of Schizophrenia

This multicenter, prospective, non-interventional study will evaluate the prevalence and characteristics of patients with persistent symptoms of schizophrenia and the course of their illness over 24 months.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients:

  • Adult patients, >/= 18 years of age
  • Diagnosis of schizophrenia according to Diagnostic and Statistical Manual for Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) or International Classification of Diseases, 10th revision (ICD-10)

Caregivers:

  • Age >/= 18 years
  • Family member or friend of the patient, who spends at least 4 hours a week with the patient

Exclusion criteria

  • Acute psychotic exacerbation in the 3 months prior to the baseline observation (e.g. hospitalization or increased psychiatric care in order to prevent hospitalization)
  • Enrolled in an interventional study at the baseline observation

Treatment and study plan

Primary outcomes

  1. Course of illness: Change in Positive and Negative Syndrome Scale for Schizophrenia (PANSS) scores

    Time frame: from baseline to Month 24

Secondary outcomes

  1. Frequency/characteristics (PANSS) of patients with diagnosis of schizophrenia of >/= 12 months duration before baseline

    Time frame: at screening (approximately 18 months)

  2. Duration/severity of symptoms of schizophrenia according to Personal Social Performance Scale (PSP) / Health Related Quality of Life (HRQoL) questionnaire

    Time frame: 24 months

  3. Medical resource utilization/costs

    Time frame: 24 months

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

A Non-Interventional Prospective Cohort Study of Patients With Persistent Symptoms of Schizophrenia to Describe The Course and Burden of Illness

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Jul 6, 2012
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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