SchizophreniaPhase 4NCT00690235
Demonstrate the Effects of Pramlintide on Weight Reduction in Schizophrenia
A Phase 4 study testing Pramlintide in people with Schizophrenia and Schizoaffective Disorder, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
Primary Objective: To test the effect of pramlintide on body weight in clozapine- and olanzapine-induced weight gain in persons with schizophrenia who are currently taking either drug; measures of the metabolic syndrome will be evaluated as well. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder, Diabetes
- What is being tested?
- Pramlintide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2007to Aug 2011
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Volunteers will be males or females 18-65 yrs of age with a diagnosis of schizophrenia or schizoaffective disorder who have a history of significant weight gain with olanzapine or clozapine administration.
- Volunteers will have a current BMI=>27 but equal to or less than 40.
- Volunteers will have been taking a stable dose (less than 10% dose change) of clozapine or olanzapine or at least two months prior to study start.
- Volunteers will be willing and able to participate in the subcutaneous administration training week prior to study start.
- Able and willing to give informed consent.
Who cannot join
- Clinically significant abnormal pre-admission vital signs, positive HIV, or clinical laboratory evaluations, in which the principal investigator deems the subject-volunteer ineligible for the study
- Positive results for infectious diseases and sexually-transmitted diseases will be reported according to the Texas Department of State Health and Texas Administrative Code rules and guidelines
- Any patient with current diabetes mellitus, even if caused by antipsychotic use .
- Patients with active liver disease requiring current treatment. Positive hepatitis C volunteers will only be excluded if they have active liver disease or they have enzyme values are two times the upper limit of normal.
- Any patients with medical disorders that are not properly controlled by medications.
- Pregnant women or women who are breast feeding.
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- Patients concomitantly treated with another conventional or second generation antipsychotic medication or with any other anti-obesity drug.
- Mental capacity is limited to the extent that the patient cannot understand the nature of the study along with its risks and benefits.
- Subjects with a high risk of suicide since there is a potential that the study medication will lower the subject's glucose levels.
- Any patient judged by the principal investigator to be inappropriate for the study.
- Known hypersensitivity to study medication or its components
- Non-English speaking
- The clinical assessments that will be used are not available in valid and reliable forms for non-English speaking populations.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Southwestern Medical Center
Dallas, Texas, 75390
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Demonstrate the Effects of Pramlintide on Weight Reduction in Clozapine- and Olanzapine-Induced Weight Gain in Obese People Diagnosed With Schizophrenia
Primary Objective:
To test the effect of pramlintide on body weight in clozapine- and olanzapine-induced weight gain in persons with schizophrenia who are currently taking either drug; measures of the metabolic syndrome will be evaluated as well.
Read the detailed description
This study is a sixteen week placebo-controlled, double-blind investigation of the effect of pramlintide on body weight in clozapine- and olanzapine-induced weight gain. We will recruit approximately 72 volunteers with the plan of having a final N = 25 in each of the 2 treatment groups. (This number is to allow for normal attrition in this patient population. If needed, we will recruit more than 72 volunteers in order to achieve the appropriate number of completed subjects.) Patients will be recruited from the local Dallas public and VA mental health systems as volunteers for this study. This study is anticipated to last 20 weeks (2 weeks lead-in [approximately 2-3 visits], 1 week training [4 visits], 16 weeks active drug/placebo [one visit per week for the first 4 weeks, then one visit every 2 weeks for the remainder], and one week follow-up [one visit]. Please see attached chart for more details about each visit.) Volunteers will have to have a history of significant weight gain accompanying olanzapine or clozapine treatment and have a BMI=>27 and =<40. Each volunteer will be maintained on their optimal dose of clozapine or olanzapine and be randomized blindly to pramlintide or placebo. Pramlintide will be administered by the patients in a self-injectable form and dosing will begin at 180 mcg bid for 2 weeks and then increase to 360 mcg bid for the remainder of the study. The randomization to pramlintide/placebo will be preceded by a week-long self-administration training program using placebo for pramlintide (with additional information regarding nutrition, exercise, general self-care, and risk factors for diabetes being provided to the patients during this training program).
- Conditions
- Schizophrenia, Schizoaffective Disorder, Diabetes, Weight Gain
- Being tested
- Pramlintide, Placebo
- Keywords
- Schizophrenia, Schizoaffective, Olanzapine, Zyprexa, Clozapine, Clozaril, Pramlintide, Diabetes, Weight Gain, Obesity, Metabolic Syndrome
- Medical subject headings
- Schizophrenia, Psychotic Disorders, Diabetes Mellitus, Weight Gain, Obesity, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PramlintideDrug
Also called Amylin
180mg subcutaneous injections, twice daily
PlaceboDrug
Also called sterile saline
180mg subcutaneous injections, twice daily
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Other | Patients will be given the Placebo for injection twice daily Receives: Drug: Placebo |
| Pramlintide | Other | volunteers are given 180mg of pramlintide, twice daily Receives: Drug: Pramlintide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight Loss With Pramlintide in Persons With Schizophrenia Who Have Gained Weight Taking Olanzapine or Clozapine
Mean Number of Pounds Lost on Pramlintide Over 16 Weeks
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2008 (estimated)
- Study startNov 2007
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Amylin Pharmaceuticals, LLC.
- Responsible party
- Principal investigator, Carol A. Tamminga, University of Texas Southwestern Medical Center
- Investigators
- Carol A Tamminga, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00690235
- Sponsor's protocol ID
- 092007-025
- Status last verified
- Nov 2018
- First submitted
- 27 Jan 2008
- Last updated
- 16 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Study to Demonstrate the Effects of Pramlintide on Weight Reduction in Clozapine- and Olanzapine-Induced Weight Gain in Obese People Diagnosed With Schizophrenia
- ClinicalTrials.gov ID
- NCT00690235
- Acronym / sponsor ID
- 092007-025
- Conditions
- Schizophrenia, Schizoaffective Disorder, Diabetes, Weight Gain
- Keywords
- Schizophrenia, Schizoaffective, Olanzapine, Zyprexa, Clozapine, Clozaril, Pramlintide, Diabetes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- Amylin Pharmaceuticals, LLC.
- Study start
- Nov 2007
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 4 Jun 2008 (estimated)
- Results
- Posted 16 Nov 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary Objective:
To test the effect of pramlintide on body weight in clozapine- and olanzapine-induced weight gain in persons with schizophrenia who are currently taking either drug; measures of the metabolic syndrome will be evaluated as well.
Detailed description
This study is a sixteen week placebo-controlled, double-blind investigation of the effect of pramlintide on body weight in clozapine- and olanzapine-induced weight gain. We will recruit approximately 72 volunteers with the plan of having a final N = 25 in each of the 2 treatment groups. (This number is to allow for normal attrition in this patient population. If needed, we will recruit more than 72 volunteers in order to achieve the appropriate number of completed subjects.) Patients will be recruited from the local Dallas public and VA mental health systems as volunteers for this study. This study is anticipated to last 20 weeks (2 weeks lead-in [approximately 2-3 visits], 1 week training [4 visits], 16 weeks active drug/placebo [one visit per week for the first 4 weeks, then one visit every 2 weeks for the remainder], and one week follow-up [one visit]. Please see attached chart for more details about each visit.) Volunteers will have to have a history of significant weight gain accompanying olanzapine or clozapine treatment and have a BMI=>27 and =<40. Each volunteer will be maintained on their optimal dose of clozapine or olanzapine and be randomized blindly to pramlintide or placebo. Pramlintide will be administered by the patients in a self-injectable form and dosing will begin at 180 mcg bid for 2 weeks and then increase to 360 mcg bid for the remainder of the study. The randomization to pramlintide/placebo will be preceded by a week-long self-administration training program using placebo for pramlintide (with additional information regarding nutrition, exercise, general self-care, and risk factors for diabetes being provided to the patients during this training program).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Other | Drug: PlaceboPatients will be given the Placebo for injection twice daily |
| Pramlintide | Other | Drug: Pramlintidevolunteers are given 180mg of pramlintide, twice daily |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Volunteers will be males or females 18-65 yrs of age with a diagnosis of schizophrenia or schizoaffective disorder who have a history of significant weight gain with olanzapine or clozapine administration.
- Volunteers will have a current BMI=>27 but equal to or less than 40.
- Volunteers will have been taking a stable dose (less than 10% dose change) of clozapine or olanzapine or at least two months prior to study start.
- Volunteers will be willing and able to participate in the subcutaneous administration training week prior to study start.
- Able and willing to give informed consent.
Key exclusion criteria (13 listed)
- Clinically significant abnormal pre-admission vital signs, positive HIV, or clinical laboratory evaluations, in which the principal investigator deems the subject-volunteer ineligible for the study
- Any patient with current diabetes mellitus, even if caused by antipsychotic use .
- Patients with active liver disease requiring current treatment. Positive hepatitis C volunteers will only be excluded if they have active liver disease or they have enzyme values are two times the upper limit of normal.
- Any patients with medical disorders that are not properly controlled by medications.
- Pregnant women or women who are breast feeding.
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 |
|---|---|---|
| PramlintideAlso: Amylin180mg subcutaneous injections, twice daily | Drug | Pramlintide |
| PlaceboAlso: sterile saline180mg subcutaneous injections, twice daily | Drug | Placebo |
Primary outcome
Weight Loss With Pramlintide in Persons With Schizophrenia Who Have Gained Weight Taking Olanzapine or Clozapine
Time frame: 16 weeks
Mean Number of Pounds Lost on Pramlintide Over 16 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Carol A Tamminga, MD principal investigator
University of Texas Southwestern Medical Center
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 Pramlintide in people with Schizophrenia and Schizoaffective Disorder, run by University of Texas Southwestern Medical Center 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 5 inclusion and 13 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 16 Nov 2018. 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?
Yes. Results are posted in the registry (first posted 16 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Weight Loss With Pramlintide in Persons With Schizophrenia Who Have Gained Weight Taking Olanzapine or Clozapine (time frame: 16 weeks). 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 16 Nov 2018.