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 impairment associated 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 has an 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.
Thesaurus Terms: 21+ Years Old;3,4-Dihydroxyphenethylamine;4-(2-Aminoethyl)-1,2-Benzenediol;5-Ht(1a) Receptor;5-Ht1a Receptor;5-Hydroxytryptamine 1a Receptor;Ad/Hd;Adhd;Abscission;Adult;Adult Human;Adverse Experience;Adverse Effects;Adverse Event;Affective Symptoms;Aggression;Aggressive Behavior;Agonist;Antipsychotic Agents;Antipsychotic Drugs;Antipsychotics;Attention;Attention Deficit Hyperactivity Disorder;Back;Brief Psychiatric Rating Scale;Clinical;Clinical Trials;Cognition;Cognitive;Cognitive Disturbance;Cognitive Impairment;Cognitive Decline;Cognitive Function Abnormal;Common Rat Strains;Consensus;D2 Receptor;Drd2 Receptor;Disease;Disorder;Disturbance In Cognition;Dopamine;Dopamine D2 Receptor;Dorsum;Dose;Double-Blind Method;Double-Blind Study;Double-Blinded;Double-Masked Method;Double-Masked Study;Drug Interactions;Drugs;Dysfunction;Ecg;Eeg;Ekg;Electrocardiogram;Electrocardiography;Electroencephalography;Excision;Extirpation;Functional Disorder;Gender;Heterogeneity;Hydroxytyramine;Hyperactivity Disorder Nos;Hyperkinetic Syndrome;Immediate Memory;Impaired Cognition;Impairment;Impulsivity;Investigators;Loinc Axis 2 Property;Laboratories;Lead;Major Tranquilizers;Major Tranquilizing Agents;Marketing;Measures;Medical;Medication;Mental Depression;Mental Disorders;Mental Health Disorders;Mice;Mice Mammals;Monitor;Murine;Mus;Neurocognitive;Neuroleptic Agents;Neuroleptic Drugs;Neuroleptics;Outcome Measure;Overall And Gorham Brief Psychiatric Rating Scale;Patients;Pb Element;Performance;Pharmaceutic Preparations;Pharmaceutical Preparations;Phase;Physiopathology;Placebo Control;Placebos;Population;Predominantly Hyperactive-Impulsive Type Attention-Deficit Disorder;Predominantly Hyperactive-Impulsive Type Hyperactivity Disorder;Prevalence;Property;Psychiatric Disease;Psychiatric Disorder;Race;Racial Group;Racial Stocks;Rat;Rats Mammals;Rattus;Receptor Protein;Receptor, Serotonin, 5-Ht1a;Recognition (Psychology);Removal;Research Personnel;Researchers;Safety;Schizophrenia;Schizophrenic Disorders;Serious Adverse Event;Serotonin 1a Receptor;Sham Treatment;Short-Term Memory;Shortterm Memory;Surgical Removal;Symptoms;Testing;Therapeutic Agents;Time;Treatment Side Effects;Work;Adult Human (21+);Adulthood;Attention Deficit Hyperactive Disorder;Blind;Clinical Investigation;Clinical Significance;Clinically Significant;Cognitive Dysfunction;Cognitive Loss;Cognitively Impaired;Dementia Praecox;Depression;Design;Designing;Disease/Disorder;Drug/Agent;Executive Control;Executive Function;Falls;Heavy Metal Pb;Heavy Metal Lead;Improved;Inattention;Inattentiveness;Memory Recognition;Mental Illness;Object Recognition;Pathophysiology;Performance Tests;Psychological Disorder;Receptor;Resection;Schizophrenic;Sham Therapy;Side Effect;Therapy Adverse Effect;Treatment Adverse Effect;Treatment Effect;Working Memory
