OverweightPhase 4NCT00222833
The Effect of Switching to Aripiprazole on Heart Health in Overweight and Obese Patients With Schizophrenia
A Phase 4 study testing Aripiprazole in people with Overweight and Hyperlipidemia, run by University of Pittsburgh at 1 site in United States.
Trial summary
This is a 2-year study proposing to examine the effects of aripiprazole on heart health factors such as serum lipids, serum leptin, fasting blood sugar, body weight and blood pressure. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Overweight, Hyperlipidemia, Cardiovascular Diseases
- What is being tested?
- Aripiprazole
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2004to Dec 2005
- Phase
- Phase 4
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female subjects ages 18-65 years
- Outpatients and stable partial hospital patients
- Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) diagnosis of schizophrenia or schizoaffective disorder
- No psychiatric hospitalization in 30 days prior to study start
- Partially remitted patients with a PANSS score below 100 at screening
- Currently on a stable dose of only one antipsychotic for at least 30 days prior to study start
Show all 10Show fewer
- Currently receiving a stable dose of all other psychotropic medications for at least 30 days prior to study start
- BMI greater than 26
- Female patients of childbearing age must be using an acceptable method of birth control for at least 1 month prior to participation in the research study and continue for at least 4 weeks after the final study visit.
- Ability to provide informed consent.
Who cannot join
- Mental retardation
- Current treatment with clozapine
- Currently enrolled in a weight management program or receiving pharmacological treatment for weight reduction
- Serious or unstable medical illness
- Female patients who are pregnant, lactating, or plan to become pregnant during the study period
- Concurrently receiving treatment with ketoconazole, quinidine, carbamazepine.
Trial locations and contacts
1 site in 1 country.
United States1 site
Western Psychiatric Institute and Clinic of UPMC
Pittsburgh, Pennsylvania, 15213
About this study
Official title: The Effect of Switching to Aripiprazole on Indices of Cardiovascular Health in Overweight and Obese Patients With Schizophrenia
This is a 2-year study proposing to examine the effects of aripiprazole on heart health factors such as serum lipids, serum leptin, fasting blood sugar, body weight and blood pressure. This study also examines the safety of switching to aripiprazole with respect to changes in the clinical state, preexisting or emergent side-effects, how the brain processes information and changes in social functioning and quality of life.
Read the detailed description
This is a 2-yr study proposing to examine the effects of switching subjects from conventional and atypical antipsychotic agents to Aripiprazole on cardiovascular health indices in overweight and obese patients with Schizophrenia or Schizoaffective disorder. Thirty partially remitted patients with Positive and Negative Syndrome Scale (PANSS) score of less than 100, who have body mass index (BMI) of 26 or higher will be switched from their existing antipsychotic to aripiprazole over 2-3 weeks period using a clinician determined cross-tapering approach.The objective of the study is to examine cardiovascular health indices such as serum lipids, serum leptin, fasting blood sugar, body weight and blood pressure. This study also examines the safety of switching to Aripiprazole with respect to changes in clinical state, preexisting or emergent side-effects, how brain processes information and changes in social functioning and quality of life.
- Conditions
- Overweight, Hyperlipidemia, Cardiovascular Diseases
- Being tested
- Aripiprazole
- Keywords
- Schizophrenia, Schizoaffective disorder, Aripiprazole, Obese, Overweight, Heart Health, Antipsychotic, Heart Health Factors, Cardiovascular Health Indices, Cardiovascular health
- Medical subject headings
- Overweight, Hyperlipidemias, Cardiovascular Diseases, Schizophrenia, Psychotic Disorders, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AripiprazoleDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To examine heart health factors: serum lipids, serum leptin, fasting blood glucose, body weight, and blood pressure
Secondary outcomes (6)
Changes in clinical state
Pre-existing or emergent side effects
Cognition and insight
Attitude towards medication
Social functioning
Quality of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startOct 2004
- Primary completionDec 2005
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Investigators
- Rohan Ganguli, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00222833
- Sponsor's protocol ID
- 0312010
- Other IDs
- PITT#02 90599
- Status last verified
- Jan 2008
- First submitted
- 7 Sep 2005
- Last updated
- 15 Jan 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Switching to Aripiprazole on Indices of Cardiovascular Health in Overweight and Obese Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT00222833
- Acronym / sponsor ID
- 0312010
- Conditions
- Overweight, Hyperlipidemia, Cardiovascular Diseases
- Keywords
- Schizophrenia, Schizoaffective disorder, Aripiprazole, Obese, Overweight, Heart Health, Antipsychotic, Heart Health Factors
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- Oct 2004
- Primary completion
- Dec 2005 (actual)
- Study completion
- Dec 2005 (actual)
- First posted
- 22 Sep 2005 (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 is a 2-year study proposing to examine the effects of aripiprazole on heart health factors such as serum lipids, serum leptin, fasting blood sugar, body weight and blood pressure. This study also examines the safety of switching to aripiprazole with respect to changes in the clinical state, preexisting or emergent side-effects, how the brain processes information and changes in social functioning and quality of life.
Detailed description
This is a 2-yr study proposing to examine the effects of switching subjects from conventional and atypical antipsychotic agents to Aripiprazole on cardiovascular health indices in overweight and obese patients with Schizophrenia or Schizoaffective disorder. Thirty partially remitted patients with Positive and Negative Syndrome Scale (PANSS) score of less than 100, who have body mass index (BMI) of 26 or higher will be switched from their existing antipsychotic to aripiprazole over 2-3 weeks period using a clinician determined cross-tapering approach.The objective of the study is to examine cardiovascular health indices such as serum lipids, serum leptin, fasting blood sugar, body weight and blood pressure. This study also examines the safety of switching to Aripiprazole with respect to changes in clinical state, preexisting or emergent side-effects, how brain processes information and changes in social functioning and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male and female subjects ages 18-65 years
- Outpatients and stable partial hospital patients
- Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) diagnosis of schizophrenia or schizoaffective disorder
- No psychiatric hospitalization in 30 days prior to study start
- Partially remitted patients with a PANSS score below 100 at screening
Key exclusion criteria (6 listed)
- Mental retardation
- Current treatment with clozapine
- Currently enrolled in a weight management program or receiving pharmacological treatment for weight reduction
- Serious or unstable medical illness
- Female patients who are pregnant, lactating, or plan to become pregnant during the study period
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 |
|---|---|---|
| Aripiprazole | Drug | – |
Primary outcome
To examine heart health factors: serum lipids, serum leptin, fasting blood glucose, body weight, and blood pressure
6 secondary outcomes
Changes in clinical state
Pre-existing or emergent side effects
Cognition and insight
Attitude towards medication
Social functioning
Quality of life
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 15 Jan 2008.
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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.
Rohan Ganguli, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aripiprazole in people with Overweight and Hyperlipidemia, run by University of Pittsburgh at 1 site 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 10 inclusion and 6 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 15 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
To examine heart health factors: serum lipids, serum leptin, fasting blood glucose, body weight, and blood pressure. 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 15 Jan 2008.