SchizophreniaNCT01746134
The Management of Schizophrenia in Clinical Practice (MOSAIC)
An observational study of Schizophrenia, run by Genentech, Inc. at 44 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia
- How many people
- 557 participants
- Where
- 44 sitesUnited States
- Study dates
- Dec 2012to May 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with schizophrenia, schizoaffective disorder, or schizophreniform across the disease spectrum treated in usual care settings
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
44 sites in 1 country.
44 sites in 1 country
United States44 sites
Study site
Belmont, Massachusetts, 02478
Study site
Carrboro, North Carolina, 27510
Study site
Cary, North Carolina, 27513
Study site
Cedar Rapids, Connecticut, 6514
Study site
Chapel Hill, North Carolina, 27514
Study site
Chicago, Florida, 60653
Study site
Chicago, Illinois, 60611
Study site
Cincinnati, Ohio, 45219
Study site
Durham, North Carolina, 27704
Study site
Durham, North Carolina, 27707
Study site
Durham, North Carolina, 27713
Study site
Gainesville, Florida, 32601
Study site
Gainesville, Florida, 32608-1197
Study site
Gainesville, Florida, 32608
Study site
Granada Hills, California, 91344
Study site
Hillsborough, North Carolina, 27278
Study site
Iowa City, Iowa, 52240
Study site
Iowa City, Iowa, 52242-1000
Study site
Iowa City, Iowa, 52242
Study site
Jacksonville, Florida, 32209
Study site
Lake City, Florida, 32025
Study site
Los Angeles, California, 90095-6968
Study site
Lytle, Texas, 78052
Study site
Miami, Florida, 33125
Study site
Miami, Florida, 33136
Study site
Minneapolis, Minnesota, 55454
Study site
New Haven, Connecticut, 06519
Study site
New York, New York, 10018
Study site
New York, New York, 10029
Study site
New York, New York, 10032
Study site
New York, New York, 10035
Study site
New York, New York, 10040
Study site
New York, New York, 11004
Study site
Orangeburg, New York, 10962
Study site
Pinehurst, North Carolina, 28374
Study site
Round Rock, Texas, 78664
Study site
Saint Paul, Minnesota, 55107
Study site
Saint Paul, Minnesota, 55114
Study site
Salt Lake City, Utah, 84106
Study site
San Antonio, Texas, 78202
Study site
San Antonio, Texas, 78284-7792
Study site
Santa Monica, California, 90403
Study site
Tacoma, Washington, 98493
Study site
Taylor, Texas
About this study
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
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.
- Conditions
- Schizophrenia
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive and Negative Symptoms of Schizophrenia (PANSS)
Measured: up to 5 years
Clinical Global Impression Schizophrenia Scale (CGI-SCH)
Measured: up to 5 years
Cognitive function (Fluency, Digit Symbol-Coding, Trail Making Test)
Measured: up to 5 years
Secondary outcomes (8)
Negative Symptom Assessment Scale (NSA4)
Measured: up to 5 years
Pharmacologic/behavioural treatments used in usual care settings: intervention
Measured: up to 5 years
Pharmacologic/behavioural treatments used in usual care settings: dose
Measured: up to 5 years
Pharmacologic/behavioural treatments used in usual care settings: duration
Measured: up to 5 years
Personal and Social Performance (PSP)
Measured: up to 5 years
Schizophrenia Quality of Life Scale (SQLS)
Measured: up to 5 years
Schizophrenia Caregiver Questionnaire
Measured: up to 5 years
Maslach Burnout Inventory (MBI)
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Genentech, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 557 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Genentech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01746134
- Sponsor's protocol ID
- ML28264
- Status last verified
- Nov 2016
- First submitted
- 4 Dec 2012
- Last updated
- 2 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01746134
- Acronym / sponsor ID
- ML28264
- Conditions
- Schizophrenia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 557 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 10 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with schizophrenia, schizoaffective disorder, or schizophreniform across the disease spectrum treated in usual care settings
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
8 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2016.
Related trials for Schizophrenia
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Deep Brain Stimulation for Treatment-Resistant Schizophrenia
Treatment Resistant Disorders
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Genentech, Inc.
44 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia, run by Genentech, Inc. at 44 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive and Negative Symptoms of Schizophrenia (PANSS) (time frame: up to 5 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2016.