Eltoprazine for the Treatment of Cognitive Dysfunction Assoc. With Schizophrenia

Award Information
Agency: Department of Health and Human Services
Branch: N/A
Contract: 1R43MH088096-01A1
Agency Tracking Number: R43MH088096
Amount: $700,000.00
Phase: Phase I
Program: SBIR
Awards Year: 2011
Solicitation Year: 2011
Solicitation Topic Code: NIMH
Solicitation Number: PA08-142
Small Business Information
PSYCHOGENICS, INC.
765 OLD SAW MILL RIVER RD, TARRYTOWN, NY, 10591-
DUNS: 004812744
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 EMER LEAHY
 (914) 593-0640
 emer.leahy@psychogenics.com
Business Contact
 BILL FASNACHT
Phone: (914) 593-0640
Email: bill.fasnacht@psychogenics.com
Research Institution
 Stub
Abstract
DESCRIPTION (provided by applicant): Schizophrenia is a common and highly disabling psychiatric disorder with a population prevalence around 1%. The manifestations of schizophrenia fall into three major domains: 1) positive symptoms; 2) negative symptoms: and 3) cognitive dysfunction. All marketed therapies for the treatment of Schizophrenia are antagonists or partial agonists of the D2 dopamine receptor which exert their effects primarily on the positive symptoms with little or no effect on negative symptoms or cognitive dysfunction. PsychoGenics proposes to study the effects of a selective 5-HT1A/1B receptor partial agonist, eltoprazine, as an adjunctive treatment for cognitive impairment associated with prefrontal dysfunction in a double-blind, placebo-controlled, parallel study comparing the effects of eltoprazine at 5mg BID to placebo as an adjunct to standard antipsychotic treatment over an eight week period. The aims of this study are: 1. Assess whether eltoprazine can improve cognitive impairmentassociated with schizophrenia on a summary score across all 7 cognitive domains from the MATRICS test battery administered at baseline, 4 weeks and 8 weeks, CPT-AX and 2-Back measures of attention and working memory. 2. Determine whether eltoprazine hasan effect on positive, negative or affective symptoms by administering the Brief Psychiatric Rating Scale (BPRS) for positive symptoms, Calgary Depression Scale (CDS) for depression, Scale for Assessment of Negative Symptoms (SANS) for negative symptoms. 3. Assess the safety of eltoprazine in a schizophrenic population and determine if there are any drug interaction effects by administering the Simpson-Angus Extrapyramidal Rating Scale (SAS), vital signs including 12 lead EEG and other laboratory measures. PUBLIC HEALTH RELEVANCE: Schizophrenia is a common and highly disabling psychiatric disorder with a population prevalence around 1%. The manifestations of schizophrenia fall into three major domains: 1) positive symptoms; 2) negative symptoms: and 3) cognitive dysfunction. All marketed therapies for the treatment of Schizophrenia are antagonists or partial agonists of the D2 dopamine receptor which exert their effects primarily on the positive symptoms with little or no effect on negative symptoms or cognitive dysfunction. PsychoGenics proposes to study the effects of a selective 5-HT1A/1B receptor partial agonist, eltoprazine, as an adjunctive treatment for cognitive impairment associated with prefrontal dysfunction in a double-blind, placebo-controlled, parallel study comparing the effects of eltoprazine at 5mg BID to placebo as an adjunct to standard antipsychotic treatment over an eight week period.

* information listed above is at the time of submission.

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