SchizophreniaCRESSOBNCT00584519
Control of Metabolic and Cardiovascular Risk in Patients With Schizophrenia and Overweight
An observational study of Schizophrenia, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc..
Trial summary
To analyse the progress of modifiable metabolic risk factors (Blood pressure, cigarette smoking, waist perimeter, BMI, glycemia and lipidic profile) in schizophrenic patients with overweight for 12 months. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia
- What is being tested?
- non-interventional
- Type of treatment
- Injection or infusion
- How many people
- 430 participants
- Where
- No sites listed yet
- Study dates
- Jun 2007to Jun 2009
- 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: Community sample. Patients >17 years older with diagnosis of Schizophrenia (DSM-IV TR) and Overweight (BMI more or equal to 25 Kg/m2)
Who may be able to join
- Patients with diagnosis of schizophrenia, schizophreniform or schizoaffective disorder (DSM-IV TR)
- Patients with BMI (body mass index) more or equal to 25 Kg/m2
- Patients or their legal representative have provided written informed consent
Who cannot join
- Patients are unable to complete or to understand health questionnaires in Spanish language
- Patients are currently enrolled on clinical trials or other investigational studies
About this study
Official title: Control of Metabolic and Cardiovascular Risk in Patients With Schizophrenia and Overweight (CRESSOB)
To analyse the progress of modifiable metabolic risk factors (Blood pressure, cigarette smoking, waist perimeter, BMI, glycemia and lipidic profile) in schizophrenic patients with overweight for 12 months.
To analyse the perceived health status and the level of functioning and disability of patients with schizophrenia and overweight and their progress at 3, 6 and 12 months.
To assess the progress of the symptoms of the disease at 6 and 12 months.
Read the detailed description
Consecutive patient sampling. Any investigational site four consecutive patients with diagnosis of Schizophrenia (DSM-IV TR) and Overweight (BMI more or equal to 25 Kg/m2)
- Conditions
- Schizophrenia
- Being tested
- non-interventional
- Keywords
- Schizophrenia, Overweight, Cardiovascular Risk, Obesity
- Medical subject headings
- Schizophrenia, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-interventionalOther
non-interventional
| Study group | Role | What they receive |
|---|---|---|
| 500 patients | Patients with diagnosis of schizophrenia, schizophreniform or schizoaffective disorder (DSM-IV TR) with BMI (body mass index) more or equal to 25 Kg/m2 Receives: Other: non-interventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of modifiable metabolic risk factors (Blood pressure, cigarette smoking, waist perimeter, BMI, glycemia and lipidic profile) in schizophrenic patients with overweight for 12 months.
Measured: 12 months
Secondary outcomes (5)
Cardiovascular Risk
Measured: 12 months
To assess the progress of the symptoms and clinical evolution of the disease
Measured: 12 months
Patient Functional Impairment
Measured: 12 months
Patient Quality of Life
Measured: 12 months
Current Pattern of Treatment in this Population
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2008 (estimated)
- Study startJun 2007
- Primary completionJun 2009
- Study completionJun 2009
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.
- 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
- 430 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00584519
- Sponsor's protocol ID
- A1281162
- Acronym
- CRESSOB
- Status last verified
- Feb 2021
- First submitted
- 21 Dec 2007
- Last updated
- 21 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Control of Metabolic and Cardiovascular Risk in Patients With Schizophrenia and Overweight (CRESSOB)
- ClinicalTrials.gov ID
- NCT00584519
- Acronym / sponsor ID
- CRESSOB / A1281162
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Overweight, Cardiovascular Risk, Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 430 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2007
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 2 Jan 2008 (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.
To analyse the progress of modifiable metabolic risk factors (Blood pressure, cigarette smoking, waist perimeter, BMI, glycemia and lipidic profile) in schizophrenic patients with overweight for 12 months.
To analyse the perceived health status and the level of functioning and disability of patients with schizophrenia and overweight and their progress at 3, 6 and 12 months.
To assess the progress of the symptoms of the disease at 6 and 12 months.
Detailed description
Consecutive patient sampling. Any investigational site four consecutive patients with diagnosis of Schizophrenia (DSM-IV TR) and Overweight (BMI more or equal to 25 Kg/m2)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 500 patients | – | Other: non-interventionalPatients with diagnosis of schizophrenia, schizophreniform or schizoaffective disorder (DSM-IV TR) with BMI (body mass index) more or equal to 25 Kg/m2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Community sample. Patients >17 years older with diagnosis of Schizophrenia (DSM-IV TR) and Overweight (BMI more or equal to 25 Kg/m2)
Key inclusion criteria (3 listed)
- Patients with diagnosis of schizophrenia, schizophreniform or schizoaffective disorder (DSM-IV TR)
- Patients with BMI (body mass index) more or equal to 25 Kg/m2
- Patients or their legal representative have provided written informed consent
Key exclusion criteria (2 listed)
- Patients are unable to complete or to understand health questionnaires in Spanish language
- Patients are currently enrolled on clinical trials or other investigational studies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| non-interventionalnon-interventional | Other | 500 patients |
Primary outcome
Evolution of modifiable metabolic risk factors (Blood pressure, cigarette smoking, waist perimeter, BMI, glycemia and lipidic profile) in schizophrenic patients with overweight for 12 months.
Time frame: 12 months
5 secondary outcomes
Cardiovascular Risk
Time frame: 12 months
To assess the progress of the symptoms and clinical evolution of the disease
Time frame: 12 months
Patient Functional Impairment
Time frame: 12 months
Patient Quality of Life
Time frame: 12 months
Current Pattern of Treatment in this Population
Time frame: 12 months
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 21 Feb 2021.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc..
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 3 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 21 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Evolution of modifiable metabolic risk factors (Blood pressure, cigarette smoking, waist perimeter, BMI, glycemia and lipidic profile) in schizophrenic patients with overweight for 12 months. (time frame: 12 months). 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 21 Feb 2021.