Clinical trial NCT01746134: The Management of Schizophrenia in Clinical Practice (MOSAIC)
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2012-12-10
Enrollment: 557
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with schizophrenia, schizoaffective disorder, or schizophreniform across the disease spectrum treated in usual care settings

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.


Eligibility criteria: 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

Primary outcomes:
measure: Positive and Negative Symptoms of Schizophrenia (PANSS)
timeFrame: up to 5 years
measure: Clinical Global Impression Schizophrenia Scale (CGI-SCH)
timeFrame: up to 5 years
measure: Cognitive function (Fluency, Digit Symbol-Coding, Trail Making Test)
timeFrame: up to 5 years
Secondary outcomes:
measure: Negative Symptom Assessment Scale (NSA4)
timeFrame: up to 5 years
measure: Pharmacologic/behavioural treatments used in usual care settings: intervention
timeFrame: up to 5 years
measure: Pharmacologic/behavioural treatments used in usual care settings: dose
timeFrame: up to 5 years
measure: Pharmacologic/behavioural treatments used in usual care settings: duration
timeFrame: up to 5 years
measure: Personal and Social Performance (PSP)
timeFrame: up to 5 years
measure: Schizophrenia Quality of Life Scale (SQLS)
timeFrame: up to 5 years
measure: Schizophrenia Caregiver Questionnaire
timeFrame: up to 5 years
measure: Maslach Burnout Inventory (MBI)
timeFrame: up to 5 years
Other outcomes:
Locations:
city: Granada Hills
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Santa Monica
country: United States
state: California
city: Cedar Rapids
country: United States
state: Connecticut
city: New Haven
country: United States
state: Connecticut
city: Chicago
country: United States
state: Florida
city: Gainesville
country: United States
state: Florida
city: Gainesville
country: United States
state: Florida
city: Gainesville
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Lake City
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Chicago
country: United States
state: Illinois
city: Iowa City
country: United States
state: Iowa
city: Iowa City
country: United States
state: Iowa
city: Iowa City
country: United States
state: Iowa
city: Belmont
country: United States
state: Massachusetts
city: Minneapolis
country: United States
state: Minnesota
city: St. Paul
country: United States
state: Minnesota
city: St. Paul
country: United States
state: Minnesota
city: New York
country: United States
state: New York
city: New York
country: United States
state: New York
city: New York
country: United States
state: New York
city: New York
country: United States
state: New York
city: New York
country: United States
state: New York
city: New York
country: United States
state: New York
city: Orangeburg
country: United States
state: New York
city: Carrboro
country: United States
state: North Carolina
city: Cary
country: United States
state: North Carolina
city: Chapel Hill
country: United States
state: North Carolina
city: Durham
country: United States
state: North Carolina
city: Durham
country: United States
state: North Carolina
city: Durham
country: United States
state: North Carolina
city: Hillsborough
country: United States
state: North Carolina
city: Pinehurst
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Lytle
country: United States
state: Texas
city: Round Rock
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Taylor
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Tacoma
country: United States
state: Washington
Study officials:
affiliation: Genentech, Inc.
name: Clinical Trials
role: STUDY_DIRECTOR
References: