SchizophreniaPhase 4NCT00167817
Effect of Switch to Aripiprazole on Health and Smoking Parameters in Patients With Schizophrenia: A Pilot Study
A Phase 4 study testing Aripiprazole in people with Schizophrenia, run by Veterans Medical Research Foundation at 1 site in United States.
Trial summary
Patients with schizophrenia are much more likely to be engaged in smoking and other addictive behaviors, possibly related to biochemical abnormalities in the reward center of the brain. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Aripiprazole
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2003to Sep 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
- Schizophrenia, on stable antipsychotic dose for at least one month
- Ages 18-65 inclusive
- Overweight (body mass index of 25 kg/m2 or greater)
- Daily cigarette smoker (by self-report)
Who cannot join
- Inability to provide informed consent
- Treatment refractory schizophrenia
- Current treatment with clozapine
- Current antipsychotic polypharmacy which may preclude monotherapy with aripiprazole
- Documented poor compliance with oral antipsychotic medication
Trial locations and contacts
1 site in 1 country.
United States1 site
VA San Diego Healthcare System
San Diego, California, 92161
About this study
Patients with schizophrenia are much more likely to be engaged in smoking and other addictive behaviors, possibly related to biochemical abnormalities in the reward center of the brain. The primary purpose of the present study is to investigate whether switching patients with schizophrenia to a new atypical antipsychotic, aripiprazole, a drug with a novel mechanism of action, will have an impact on smoking behavior.
Read the detailed description
This is an 8 week open label trial being conducted in stable adult outpatients with schizophrenia who are smokers. The primary intervention is a switch in the subject's antipsychotic to aripiprazole, flexibly dosed between 15-30 mg/day. The outcome measures include a rating of smoking behavior using the Fagerstrom Test for Nicotine Dependence, and saliva cotinine obtained at baseline and endpoint. Secondary measures include weight, serum glucose and lipids, rating of symptom severity using the PANSS, and both ratings and instrumental measures of motor functioning. We anticipate enrolling up to 25 subjects to obtain the needed 15 completers at the week 8 endpoint.
- Conditions
- Schizophrenia
- Being tested
- Aripiprazole
- Keywords
- Schizophrenia, Smoking, Metabolic, Health, Glucose, Lipids
- Medical subject headings
- Schizophrenia, Smoking
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.
Saliva cotinine, Fagerstrom Test for Nicotine Dependence
Secondary outcomes (4)
Weight
Serum glucose and lipids
Rating of symptom severity using the PANSS
Ratings and instrumental measures of motor functioning
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startJul 2003
- Study completionSep 2005
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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants
Sponsor and investigators
- Lead sponsor
- Veterans Medical Research Foundation
- Sponsor type
- University, hospital or other
- Investigators
- Jonathan M Meyer, MD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00167817
- Sponsor's protocol ID
- 030762
- Status last verified
- Apr 2007
- First submitted
- 10 Sep 2005
- Last updated
- 19 Apr 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Switch to Aripiprazole on Health and Smoking Parameters in Patients With Schizophrenia: A Pilot Study
- ClinicalTrials.gov ID
- NCT00167817
- Acronym / sponsor ID
- 030762
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Smoking, Metabolic, Health, Glucose, Lipids
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants
- Lead sponsor
- Veterans Medical Research FoundationUniversity, hospital or other
- Study start
- Jul 2003
- Study completion
- Sep 2005 (actual)
- First posted
- 14 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.
Patients with schizophrenia are much more likely to be engaged in smoking and other addictive behaviors, possibly related to biochemical abnormalities in the reward center of the brain. The primary purpose of the present study is to investigate whether switching patients with schizophrenia to a new atypical antipsychotic, aripiprazole, a drug with a novel mechanism of action, will have an impact on smoking behavior.
Detailed description
This is an 8 week open label trial being conducted in stable adult outpatients with schizophrenia who are smokers. The primary intervention is a switch in the subject's antipsychotic to aripiprazole, flexibly dosed between 15-30 mg/day. The outcome measures include a rating of smoking behavior using the Fagerstrom Test for Nicotine Dependence, and saliva cotinine obtained at baseline and endpoint. Secondary measures include weight, serum glucose and lipids, rating of symptom severity using the PANSS, and both ratings and instrumental measures of motor functioning. We anticipate enrolling up to 25 subjects to obtain the needed 15 completers at the week 8 endpoint.
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 (4 listed)
- Schizophrenia, on stable antipsychotic dose for at least one month
- Ages 18-65 inclusive
- Overweight (body mass index of 25 kg/m2 or greater)
- Daily cigarette smoker (by self-report)
Key exclusion criteria (5 listed)
- Inability to provide informed consent
- Treatment refractory schizophrenia
- Current treatment with clozapine
- Current antipsychotic polypharmacy which may preclude monotherapy with aripiprazole
- Documented poor compliance with oral antipsychotic medication
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
Saliva cotinine, Fagerstrom Test for Nicotine Dependence
4 secondary outcomes
Weight
Serum glucose and lipids
Rating of symptom severity using the PANSS
Ratings and instrumental measures of motor functioning
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 19 Apr 2007.
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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.
Jonathan M Meyer, MD principal investigator
University of California, San Diego
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 Schizophrenia, run by Veterans Medical Research Foundation 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 4 inclusion and 5 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 19 Apr 2007. 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?
Saliva cotinine, Fagerstrom Test for Nicotine Dependence. 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 19 Apr 2007.