Phase 2
Completed N=52
Study to Demonstrate Cognitive Enhancing Effects of BF2.649
Source: ClinicalTrials.gov NCT00690274 ↗Enrolled (actual)
52
Serious AEs
2.6%
Results posted
Apr 2019
Primary outcomePrimary: Changes in Delayed Recall From Baseline to 12 Weeks — 40.2; 43.4 t-score
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in Delayed Recall From Baseline to 12 Weeks |
40.2; 43.4 | — |
| SECONDARY To Evaluate the Effect of BF2.649 on Symptom Severity Between Baseline and Week 12 |
0.5; -4.9 | — |
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.
Data sourced from ClinicalTrials.gov (NCT00690274). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.