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The Management of Schizophrenia in Clinical Practice (MOSAIC)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01746134
First Posted: December 10, 2012
Last Update Posted: November 2, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Genentech, Inc.
  Purpose
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.

Condition
Schizophrenia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Genentech, Inc.:

Primary Outcome Measures:
  • Positive and Negative Symptoms of Schizophrenia (PANSS) [ Time Frame: up to 5 years ]
  • Clinical Global Impression Schizophrenia Scale (CGI-SCH) [ Time Frame: up to 5 years ]
  • Cognitive function (Fluency, Digit Symbol-Coding, Trail Making Test) [ Time Frame: up to 5 years ]

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

Enrollment: 557
Study Start Date: December 2012
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with schizophrenia, schizoaffective disorder, or schizophreniform across the disease spectrum treated in usual care settings
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01746134


  Show 44 Study Locations
Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: Clinical Trials Genentech, Inc.
  More Information

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT01746134     History of Changes
Other Study ID Numbers: ML28264
First Submitted: December 4, 2012
First Posted: December 10, 2012
Last Update Posted: November 2, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders