Study to Demonstrate Cognitive Enhancing Effects of BF2.649

• Status: Completed
• Trial end date: 2011-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Texas Southwestern Medical Center
• Collaborators: Bioprojet; Stanley Medical Research Institute

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.