Study to Demonstrate Cognitive Enhancing Effects of BF2.649

NCT00690274 | Completed Phase 2 Results DMC

• 1 other identifier: BF2.649
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Schizophrenia

Keywords

schizophrenia; cognitive deficients; cognitive enhancing; antipsychotics

Outcome Measures

Primary Outcomes (1)

• Changes in Delayed Recall From Baseline to 12 Weeks

  The Brief Visuospatial Memory Test-Revised (Delayed Recall) is a neuropsychological test to assess one's ability to recall a previously exposed stimuli. The t-score range (as being reported) is from 35-81, with higher scores being better and indicating being able to recall more items after a 45-minute delay. (The t-score is a score calculated from the individual score and based on each individual's age group.) The t-scores are then grouped together and reported as a mean with the standard deviation.

  12 weeks

Secondary Outcomes (1)

• To Evaluate the Effect of BF2.649 on Symptom Severity Between Baseline and Week 12

  12 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Volunteers are given Placebo, up to 20mg per day

Drug: Placebo

BF2.649

ACTIVE COMPARATOR

Volunteers are given BF2.649, up to 20mg per day

Drug: BF2.649

Interventions

BF2.649 DRUG

up to 20mg per day

Also known as: Study medication

BF2.649

Placebo DRUG

up to 20mg per day

Also known as: cornstarch capsule

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• Bioprojet: collaborator
• Stanley Medical Research Institute: collaborator

Study Sites (2)

UT Southwestern Medical Center

Dallas, Texas, 75390-9127, United States

Location

The University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

pitolisant; Starch

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Carbohydrates; Polysaccharides

Results Point of Contact

• Title: Carol A. Tamminga, MD
• Organization: University of Texas Southwestern Medical Center

carol.tamminga@utsouthwestern.edu

214-645-2789

Study Officials

• Carol A Tamminga, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2008
• First Posted: June 4, 2008
• Study Start: June 1, 2008
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: April 23, 2019
• Results First Posted: April 23, 2019

Record last verified: 2019-03

Locations

US (2)