The purpose of this study is to determine if eltoprazine (as an adjunct to anti-psychotic medication) improves one or more aspects of cognitive impairment in adult schizophrenic patients.
Schizophrenia is a common and highly disabling psychiatric disorder with population prevalence around 1%. The manifestations of schizophrenia fall into three major domains: 1) "positive" symptoms, such as delusions, hallucinations, and disorganization of behavior; 2) "negative symptoms," including social withdrawal, lack of motivation, and reduced expression of affect; and 3) cognitive dysfunction. Cognitive deficits are seen in most patients with schizophrenia. Eltoprazine has agonist effects on both 5-HT1A and 5-HT1B receptors, which suggests that this drug may be useful for normalizing prefrontal cognitive abilities, reducing aggression and impulsivity, and improving cognitive function in schizophrenia. This study will compare the effects of Eltoprazine (as an adjunctive treatment to anti-psychotics) with Placebo in Adults with a DSM IV/DSM IV TR diagnosis of schizophrenia, in potentially improving one or more dimensions of cognitive impairment associated with schizophrenia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
31
Comparison of eltoprazine, dosed orally, for 8 weeks
Placebo to match eltoprazine
Veteran's Administration of Greater Los Angeles
Los Angeles, California, United States
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States
Maryland Psychiatric Research Center
Catonsville, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
MATRICS Consensus Cognitive Battery (MCCB)
Assessment of cognitive effects over time measured suing the MCCB battery
Time frame: At Baseline and every 4 weeks
Continuous Performance Test-AX Version (CPT-AX)
Assessment of Cognitive effects over time measured using the Continuous Performance Test (AX version)
Time frame: At Baseline and every 4 weeks
N-Back
Assessment of Cognitive effects over time measured using the N-Back Working Memory Test
Time frame: At Baseline and every 4 weeks
Brief Psychiatric Rating Scale (BPRS)
Time frame: At Baseline and every 2 weeks
Calgary Depression Scale (CDS)
Time frame: At Baseline and every 2 weeks
Scale for Assessment of Negative Symptoms (SANS)
Time frame: At Baseline and every 2 weeks
Simpson-Angus Extrapyramidal Symptom Rating Scale (SAS)
Time frame: At Baseline and every 2 weeks
Abnormal Involuntary Movement Scale (AIMS)
Time frame: At Baseline and every 2 weeks
Barnes Akathisia Scale (BAS)
Time frame: At Baseline and every 2 weeks
Columbia Suicide Severity Rating Scale (C-SSRS)
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Research Foundation for Mental Hygiene, Inc.
New York, New York, United States
Duke University School of Medicine
Durham, North Carolina, United States
Time frame: At baseline and end of study; every two weeks if there is a change in the CDRS suicidality rating to a score of 2 or 3