The Management of Schizophrenia in Clinical Practice (MOSAIC)

Completed

• Conditions: Schizophrenia

• Registration Number: NCT01746134
• Lead Sponsor: Genentech, Inc.

Brief Summary

This study is a disease-based registry designed to follow patients with a DSM-IV-TR (Diagnostic and Statistic Manual of Mental Disorders, Text Revision) diagnosis of schizophrenia, schizoaffective disorder, or schizophreniform disorder treated in usual care settings for up to 5 years. The registry seeks to describe the course of disease in schizophrenia, including cognitive function and negative symptoms, its treatment, and its burden of disease for participants, caregivers, clinicians, and society as a whole.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2012-12-04
• Study First Submitted QC: 2012-12-06
• Study First Posted: 2012-12-10
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 557

Inclusion Criteria

• Adult patients, >/= 18 years of age
• DSM-IV-TR diagnosis of schizophrenia, schizoaffective disorder, or schizophreniform disorder
• Participants presenting with the normal course of care in usual treatment settings
• Able to read and speak English
• Able and willing to provide informed consent
• Able and willing to comply with the study protocol

Exclusion Criteria

• Participants enrolled as subjects in clinical trials at registry enrollment
• Participants anticipating they will be unable to participate in regularly scheduled assessments as per protocol

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Positive and Negative Symptoms of Schizophrenia (PANSS)	up to 5 years
Clinical Global Impression Schizophrenia Scale (CGI-SCH)	up to 5 years
Cognitive function (Fluency, Digit Symbol-Coding, Trail Making Test)	up to 5 years

Secondary Outcome Measures

Name	Time	Method
Negative Symptom Assessment Scale (NSA4)	up to 5 years
Pharmacologic/behavioural treatments used in usual care settings: intervention	up to 5 years
Pharmacologic/behavioural treatments used in usual care settings: dose	up to 5 years
Pharmacologic/behavioural treatments used in usual care settings: duration	up to 5 years
Personal and Social Performance (PSP)	up to 5 years
Schizophrenia Quality of Life Scale (SQLS)	up to 5 years
Schizophrenia Caregiver Questionnaire	up to 5 years
Maslach Burnout Inventory (MBI)	up to 5 years