Study to Demonstrate Cognitive Enhancing Effects of BF2.649

Completed · Phase 2 · Has a placebo group

Conditions studied: Schizophrenia

In brief

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.

Key facts

Study ID

NCT00690274

Run by

University of Texas Southwestern Medical Center

People needed

52

Starts

2008-06-01

Expected to finish

2011-10-01

Last updated by the study team

2019-04-23

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 may not qualify if…

• 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.

Where it is running

• The University of Texas Southwestern Medical Center — Dallas, Texas, United States
• UT Southwestern Medical Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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