Study to Demonstrate Cognitive Enhancing Effects of BF2.649
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      We will recruit persons with schizophrenia or schizoaffective disorder who are not currently
      experiencing an acute exacerbation of psychotic symptoms, but still display cognitive
      symptoms and have consequent psychosocial dysfunction. The subjects recruited will be taking
      haloperidol, aripiprazole, risperidone or paliperidone. Each study subject will spend 4 weeks
      on a fixed dose of his or her APD with stable symptoms, during which time the baseline workup
      will be completed. At baseline (Week 0), each study subject will have a full symptom
      evaluation, side effects, and neuropsychological battery along with the full clinical
      laboratory and baseline safety study workup. Next, subjects, while remaining on their APD,
      will be randomized to BF2.649 or placebo. The dose of BF2.649 will be up to 20 mg/day.
      Assessment of safety parameters (vital signs, EKGs, clinical labs) and side effects (adverse
      events, BAS, SAS) will occur once weekly for the first 4 weeks (through study week 4) and
      then every other week for the next 4 weeks (to study week 8) including End of Study (week
      12). An EEG will be taken at Week 1 and then at Week 8. Symptomatic outcome measures (PANSS
      and CGI) will be measured every two weeks during the double blind phase and at end of study.
      The neuropsychological battery will be done first at baseline and repeated at the end of the
      8-week double blind phase. After 8 weeks of medication, the double-blinded drug will be
      stopped and the patient followed for a period 4 weeks with clinical and side effect measures
      recorded weekly with the exception of clinical laboratories, which will be recorded every
      other week. Each study participant will be seen weekly throughout the protocol for clinical
      assessment.

      Finally, persons with schizophrenia display severe deficits in neuropsychological, cognitive,
      and social functioning. Our primary outcome measure will be to determine if BF2.649 can
      produce a cognitive enhancing effect and repair some of the neuropsychological deficiencies
      seen in this population. Therefore, blood samples will be collected from study volunteers for
      DNA analysis, serology testing, and white cell immortalization during and only at the
      baseline phase of the study (Week 0). If a therapeutic effect is seen, it will be important
      to be able to identify the genetic characteristics of the responders to BF2.649.
    

Intervention name(s): BF2.649; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): up to 20mg per day; up to 20mg per day
Other intervention name(s): Study medication; cornstarch capsule
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: schizophrenia; cognitive deficients; cognitive enhancing; antipsychotics