The Management of Schizophrenia in Clinical Practice (MOSAIC)

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01746134
• Other study ID #: ML28264
• Status: Completed
• Phase: N/A
• First received: December 4, 2012
• Last updated: November 1, 2016
• Start date: December 2012
• Est. completion date: May 2014

Study information

• Verified date: November 2016
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 557
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Schizophrenia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Positive and Negative Symptoms of Schizophrenia (PANSS)		up to 5 years	No
Primary	Clinical Global Impression Schizophrenia Scale (CGI-SCH)		up to 5 years	No
Primary	Cognitive function (Fluency, Digit Symbol-Coding, Trail Making Test)		up to 5 years	No
Secondary	Negative Symptom Assessment Scale (NSA4)		up to 5 years	No
Secondary	Pharmacologic/behavioural treatments used in usual care settings: intervention		up to 5 years	No
Secondary	Pharmacologic/behavioural treatments used in usual care settings: dose		up to 5 years	No
Secondary	Pharmacologic/behavioural treatments used in usual care settings: duration		up to 5 years	No
Secondary	Personal and Social Performance (PSP)		up to 5 years	No
Secondary	Schizophrenia Quality of Life Scale (SQLS)		up to 5 years	No
Secondary	Schizophrenia Caregiver Questionnaire		up to 5 years	No
Secondary	Maslach Burnout Inventory (MBI)		up to 5 years	No