| Ad Title: |
A New Cognitive Treatment for People with Schizophrenia |
| Study Title: |
A Randomized, Double Blind, Placebo Controlled Study to Demonstrate the Cognitive Enhancing Effects of BF2.649 in Schizophrenic and Schizoaffective Disorder Patients. |
| Protocol Number: |
022008-078 |
| Department(s) involved in the Study: |
Psychiatry
|
| Purpose of the Study: |
This research is being done because people with schizophrenia often have problems with thinking including learning, remembering, paying attention, and problem solving. During this study, we will test if a drug called BF2.649 can help with these kinds of problems. Another purpose of this study is to determine the safety, tolerability, and pharmacokinetics (how your body absorbs the drug) of BF2.649 compared with a placebo (inactive substance or sugar pill). |
| Participant Eligibility: |
CRITERIA FOR INCLUSION OF PATIENTS:
-Patients with schizophrenia and schizoaffective disorder.
-Stable antipsychotic drug treatment for at least 4 weeks of Abilify, Risperdal, Invega or Haldol.
-Able to execute written informed consent.
-Males and females, between the ages of 18-55 years old.
-All races and ethnicities fluent and literate in English.
CRITERIA FOR EXCLUSION OF PATIENTS:
-Diagnosis alcohol or substance abuse or dependence within the last 3 months.
-Any patient who has received any known hepatic or renal clearance altering agents.
-Patients taking any concurrent medications for a major medical illness.
-Any patients who test positive for HIV.
-Any patient testing positive for Hepatitis B or C.
-Any patient who has donated plasma or blood within 30 days before the first dose of study medication.
-Currently being treated with ECT.
-Pregnant women or women who are breast feeding.
-Limited mental capacity. |
| Disease/Condition Under Study: |
Schizophrenia |
| Cancer Related Study: |
No
|
| Study Drug(s): |
Abilify (Aripiprazole), BF2.649, Haldol (Haloperidol), Invega (Paliperidone), Risperdal (Risperidone)
|
| Study Device(s): |
|
| Study Doctor: |
Dr. Carol Tamminga |
| Location of Study: |
|
Sites
|
Recruiting at this Site
|
|
Dallas County Mental Health, UT Southwestern Medical Center
|
Yes
|
|
| Contact Phone: |
214-648-4653 |
| Email: |
Debra.Moore@utsouthwestern.edu |
| Other Information: |
|
| Website Keywords: |
Mental Health, Psychiatry
|
| Medical Keywords: |
schizoaffective, schizophrenia
|
