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

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01634542
• Other study ID #: MN28151
• Status: Completed
• Phase: N/A
• First received: July 3, 2012
• Last updated: November 1, 2016
• Start date: February 2011
• Est. completion date: December 2014

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1433
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Schizophrenia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

Argentina,  Brazil,  Canada,  France,  Germany,  Italy,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Course of illness: Change in Positive and Negative Syndrome Scale for Schizophrenia (PANSS) scores		from baseline to Month 24	No
Secondary	Frequency/characteristics (PANSS) of patients with diagnosis of schizophrenia of >/= 12 months duration before baseline		at screening (approximately 18 months)	No
Secondary	Duration/severity of symptoms of schizophrenia according to Personal Social Performance Scale (PSP) / Health Related Quality of Life (HRQoL) questionnaire		24 months	No
Secondary	Medical resource utilization/costs		24 months	No