| Ad Title: |
Do you have Schizophrenia and Diatebetes? |
| Study Title: |
A Randomized, Double-Blind, Placebo-Controlled Study to Demonstrate the Effects of Pralintide on Weight Reduction in Clozapine- and Olanzapine-Induced Weight Gain in Obese People Diagnosed with Schizophrenia |
| Protocol Number: |
092007-025 |
| Department(s) involved in the Study: |
Psychiatry
|
| Purpose of the Study: |
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. |
| Participant Eligibility: |
CRITERIA FOR INCLUSION OF SUBJECTS:
- Males or Females, 18-65 yrs of age.
- Diagnosis of schizophrenia or schizoaffective disorder with a history of weight gain on olanzapine or clozapine.
- Volunteers with a current BMI=>27 but equal to or less than 40.
- Volunteers will have been taking a stable dose of clozapine or olanzapine for at least two months.
- 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.
CRITERIA FOR EXCLUSION OF SUBJECTS:
- Any patient with current diabetes mellitus
- Patients with active liver disease requiring current treatment.
- Any patients with medical disorders that are not properly controlled by medications.
- Pregnant women or women who are breast feeding.
- Limited mental capacity.
- Subjects with a high risk of suicide.
- Known hypersensitivity to study medication or its components.
- Non-English speaking. |
| Disease/Condition Under Study: |
Schizophrenia and Diabetes |
| Cancer Related Study: |
No
|
| Study Drug(s): |
Symlin (Pramlintide)
|
| Study Device(s): |
|
| Study Doctor: |
Dr. Carol Tamminga |
| Location of Study: |
|
Sites
|
Recruiting at this Site
|
|
Parkland Memorial Hospital
|
Yes
|
|
UT Southwestern University Hospitals Zale Lipshy Building
|
Yes
|
|
Aston Ambulatory Care Center
|
Yes
|
|
Dallas County Mental Health, General Clinical Research Center, Dallas Veteran's Affairs Medical Center, UT Southwestern Medical Center
|
Yes
|
|
| Contact Phone: |
214-648-4653 |
| Email: |
Debra.Moore@utsouthwestern.edu |
| Other Information: |
|
| Website Keywords: |
Diabetes, Mental Health, Psychiatry
|
| Medical Keywords: |
obesity, schizoaffective, Schizophrenia, weight gain
|
