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OpenTrials
Completed

NCT Number: NCT01746134

The Management of Schizophrenia in Clinical Practice (MOSAIC)

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.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Granada Hills, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Positive and Negative Symptoms of Schizophrenia (PANSS)

    Time frame: up to 5 years

  2. Clinical Global Impression Schizophrenia Scale (CGI-SCH)

    Time frame: up to 5 years

  3. Cognitive function (Fluency, Digit Symbol-Coding, Trail Making Test)

    Time frame: up to 5 years

Secondary outcomes

  1. Negative Symptom Assessment Scale (NSA4)

    Time frame: up to 5 years

  2. Pharmacologic/behavioural treatments used in usual care settings: intervention

    Time frame: up to 5 years

  3. Pharmacologic/behavioural treatments used in usual care settings: dose

    Time frame: up to 5 years

  4. Pharmacologic/behavioural treatments used in usual care settings: duration

    Time frame: up to 5 years

  5. Personal and Social Performance (PSP)

    Time frame: up to 5 years

  6. Schizophrenia Quality of Life Scale (SQLS)

    Time frame: up to 5 years

  7. Schizophrenia Caregiver Questionnaire

    Time frame: up to 5 years

  8. Maslach Burnout Inventory (MBI)

    Time frame: up to 5 years

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Dec 10, 2012
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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