Study to Demonstrate Cognitive Enhancing Effects of BF2.649
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|ClinicalTrials.gov Identifier: NCT00690274|
Recruitment Status : Completed
First Posted : June 4, 2008
Results First Posted : April 23, 2019
Last Update Posted : April 23, 2019
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia||Drug: BF2.649 Drug: Placebo||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||52 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Randomized, Double Blind, Placebo Controlled, Study to Demonstrate the Cognitive Enhancing Effects of BF2.649 in People With Schizophrenia and Schizoaffective Disorder|
|Study Start Date :||June 2008|
|Actual Primary Completion Date :||October 2011|
|Actual Study Completion Date :||October 2011|
Placebo Comparator: Placebo
Volunteers are given Placebo, up to 20mg per day
up to 20mg per day
Other Name: cornstarch capsule
Active Comparator: BF2.649
Volunteers are given BF2.649, up to 20mg per day
up to 20mg per day
Other Name: Study medication
- Changes in Delayed Recall From Baseline to 12 Weeks [ Time Frame: 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.
- To Evaluate the Effect of BF2.649 on Symptom Severity Between Baseline and Week 12 [ Time Frame: 12 weeks ]Montgomery-Asberg Depression Rating Scale (MADRS), a depression rating scale. The score can total from 0-60, with the higher score indicating more severe depressive symptoms. The scores indicate a change between baseline and 12 weeks.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00690274
|United States, Texas|
|UT Southwestern Medical Center|
|Dallas, Texas, United States, 75390-9127|
|The University of Texas Southwestern Medical Center|
|Dallas, Texas, United States, 75390|
|Principal Investigator:||Carol A Tamminga, MD||UT Southwestern Medical Center|