Completed
A Randomized, Double Blind, Placebo Controlled, Study to Demonstrate the Cognitive Enhancing Effects of BF2.649 in People With Schizophrenia and Schizoaffective Disorder
Led by University of Texas Southwestern Medical Center · Updated on 2019-04-23
52
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Texas Southwestern Medical Center
Lead Sponsor
B
Bioprojet
Collaborating Sponsor
AI-Summary
What this Trial Is About
To evaluate the cognitive enhancing effect of BF2.649 and to evaluate the effect of BF2.649 on symptom severity in persons with schizophrenia or schizoaffective disorder.
CONDITIONS
Brief Title
Study to Demonstrate Cognitive Enhancing Effects of BF2.649
Who Can Participate
Eligibility Criteria
You may qualify if you...
- DSM-IV diagnosis of schizophrenia and schizoaffective disorder and not experiencing an acute exacerbation of severe psychosis
- Stable antipsychotic drug treatment for at least 4 weeks of Abilify or Haldol or willing to switch to either of these two APDs.
- Able to execute written informed consent.
- Males and females, between the ages of 18-55 years old, in good health (based on medical history, physical examination, electrocardiograms, and clinical laboratory tests)
- All races and ethnicities fluent and literate in English.
You will not qualify if you...
- Diagnosis of DSM-IV alcohol or substance abuse within the last month or DSM-IV alcohol or substance dependence within the last 3 months.
- Patients on a stable regimen of antipsychotic medication (other than Haldol or Abilify) for a minimum of 3 months who are not experiencing psychotic symptoms.
- Clinically significant abnormal pre-admission vital signs, EKGs, or clinical laboratory evaluations, in which the principle investigator deems the subject-volunteer ineligible for the study.
- Any patient scheduled to undergo any surgical procedure during the duration of the study
- Patients suffering an acute psychotic episode within the previous 30 days as determined by the attending physician or Principal Investigator.
- Patients on any antihistaminergic antipsychotic medications who are not willing to switch to either Haldol or Abilify.
- Any patient who has received any known hepatic or renal clearance altering agents (e.g., erythromycin, cimetidine, barbiturates, phenothiazines, etc.) for a period of 3 months before the first dose of study medication
- 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 whose liver panel (taken during clinical laboratories) reports clinically significant abnormalities of liver enzyme ranges suggesting a cirrhotic stage.
- Any patient who has donated plasma or blood within 30 days before the first dose of study medication
- Concurrent treatment with electroconvulsive therapy.
- Pregnant women, women in the child bearing age without an efficacious contraceptive device, or women who are breast feeding.
- Mental capacity is limited to the extent that the patient cannot provide legal consent or understand information regarding the side effects or tolerance of the study drug
- Any patient judged by the principal investigator to be inappropriate for the study.
Trial Site Locations
Total: 2 locations
1
UT Southwestern Medical Center
Dallas, Texas, United States, 75390-9127
Status Unknown
2
The University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Status Unknown
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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