The Management of Schizophrenia in Clinical Practice (MOSAIC)

A Prospective, Non-Interventional Registry of Diverse Patients With Schizophrenia Across the Disease Spectrum in Usual Care Settings: Course of Disease, Treatments, and Burden of Illness

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia

• Study Type: Observational
• Enrollment (Actual): 557

Contacts and Locations

Study Locations

• United States
  • California
    • Granada Hills, California, United States, 91344
    • Los Angeles, California, United States, 90095-6968
    • Santa Monica, California, United States, 90403
  • Connecticut
    • Cedar Rapids, Connecticut, United States, 6514
    • New Haven, Connecticut, United States, 06519
  • Florida
    • Chicago, Florida, United States, 60653
    • Gainesville, Florida, United States, 32608
    • Gainesville, Florida, United States, 32601
    • Gainesville, Florida, United States, 32608-1197
    • Jacksonville, Florida, United States, 32209
    • Lake City, Florida, United States, 32025
    • Miami, Florida, United States, 33136
    • Miami, Florida, United States, 33125
  • Illinois
    • Chicago, Illinois, United States, 60611
  • Iowa
    • Iowa City, Iowa, United States, 52242
    • Iowa City, Iowa, United States, 52240
    • Iowa City, Iowa, United States, 52242-1000
  • Massachusetts
    • Belmont, Massachusetts, United States, 02478
  • Minnesota
    • Minneapolis, Minnesota, United States, 55454
    • St. Paul, Minnesota, United States, 55107
    • St. Paul, Minnesota, United States, 55114
  • New York
    • New York, New York, United States, 10032
    • New York, New York, United States, 11004
    • New York, New York, United States, 10029
    • New York, New York, United States, 10035
    • New York, New York, United States, 10018
    • New York, New York, United States, 10040
    • Orangeburg, New York, United States, 10962
  • North Carolina
    • Carrboro, North Carolina, United States, 27510
    • Cary, North Carolina, United States, 27513
    • Chapel Hill, North Carolina, United States, 27514
    • Durham, North Carolina, United States, 27707
    • Durham, North Carolina, United States, 27713
    • Durham, North Carolina, United States, 27704
    • Hillsborough, North Carolina, United States, 27278
    • Pinehurst, North Carolina, United States, 28374
  • Ohio
    • Cincinnati, Ohio, United States, 45219
  • Texas
    • Lytle, Texas, United States, 78052
    • Round Rock, Texas, United States, 78664
    • San Antonio, Texas, United States, 78202
    • San Antonio, Texas, United States, 78284-7792
    • Taylor, Texas, United States
  • Utah
    • Salt Lake City, Utah, United States, 84106
  • Washington
    • Tacoma, Washington, United States, 98493

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with schizophrenia, schizoaffective disorder, or schizophreniform across the disease spectrum treated in usual care settings

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Cohort

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Genentech, Inc.

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: December 4, 2012
• First Submitted That Met QC Criteria: December 6, 2012
• First Posted (Estimate): December 10, 2012

Study Record Updates

• Last Update Posted (Estimate): November 2, 2016
• Last Update Submitted That Met QC Criteria: November 1, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia
• Other Study ID Numbers: ML28264