Study to Demonstrate Cognitive Enhancing Effects of BF2.649
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: BF2.649; Placebo
Intervention description: up to 20mg per day; up to 20mg per day
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 52.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: schizophrenia; cognitive deficients; cognitive enhancing; antipsychotics

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.
    

Eligibility 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.