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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01746134

Enrollment

557

Registered

2012-12-10

Start date

2012-12-31

Completion date

2014-05-31

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

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

Countries

United States

Outcome results