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Effects of Eltoprazine on Cognitive Impairment Associated With Schizophrenia (CIAS) in Adults | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Effects of Eltoprazine on Cognitive Impairment Associated With Schizophrenia (CIAS) in Adults

Randomized, Double-blind, Parallel Trial Comparing the Effects of Eltoprazine (Adjunct to Anti-psychotics) With Placebo in Adults With Schizophrenia, in Improving One or More Dimensions of Cognitive Impairment Associated With Schizophrenia

NCT01266174•Amarantus BioScience Holdings, Inc.

View on ClinicalTrials.gov

Summary

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.

Detailed Description

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.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Males and Females, 18-65 years of age, who meet the DSM-IV-TR for schizophrenia.
•Must test negative for pregnancy at the time of enrollment based on a pregnancy test \& agrees to use birth control during study.
•Performance less than the max cutoff (in parentheses) for ONE of the following MCCB tests: i) Letter-number span (20); ii) HVLT total (31); and iii) CPT d-prime (3.47) BPRS Hallucinatory Behavior or Unusual Thought Content item scores ≤ 5
•BPRS Conceptual Disorganization item score ≤ 4
•Simpson-Angus Scale total score ≤ 6
•CDRS total score ≤ 10
•Able to complete the baseline MCCB validly as assessed by tester
•WTAR raw score ≥ 6
•Be treated with one of the following second generation antipsychotics: risperidone, olanzapine, quetiapine, asenapine, iloperidone or paliperidone for the previous two months, with no change in dose in the last month, or with injectable depot antipsychotics (fluphenazine, haloperidol decanoate, risperdal Consta or paliperidone sustenna) with no change in last 3 months
•Laboratory results must show no clinically significant abnormalities.
+2 more criteria

Exclusion Criteria

•Current treatment with one of the following antipsychotics: clozapine, aripiprazole, lurasidone or ziprasidone.
•Current treatment with any anti-cholinergic drug in doses above 2 mg daily for benztropine, 5 mg per day for trihexyphenidyl, and 50 mg day for diphenhydramine.
•Current treatment with benzodiazepines in doses above 10 mg of diazepam (or the equivalent of another drug).
•Patients with a DSM-IV diagnosis of alcohol or substance abuse within the last month or a DSM-IV diagnosis of alcohol or substance dependence within the last 6 months.
•Have a significant suicide attempt within one year of Visit 1, answered yes to question 3, 4 or 5 on the C-SSRS at Visit 1,or are currently at risk of suicide in the opinion of the Investigator.
•Patients with a hx of significant head injury/trauma. Patients with a clinically significant neurological, metabolic,hepatic, hematological, pulmonary, cardiovascular, gastrointestinal, and/or urological disorder. Insulin-dependent diabetics who are clinically stable and whose baseline fasting glucose is 200 or less may be included.
•Clinically significant abnormalities in PE, ECG, or lab assessments. Clinically significant renal disease (e.g. chronic renal insufficiency with GFR \<60, inflammatory disease requiring medication, acute renal failure).
•Pregnant women or women of child-bearing potential, who are either not surgically-sterile or using appropriate methods of birth control.
•Women who are breast-feeding Have a TSH level consistent with hyperthyroidism or hypothyroidism. Patients previously diagnosed with hyperthyroidism or hypothyroidism, who have been treated on a stable dose of thyroid supplement for at least the past 3 months, and who are clinically and chemically euthyroid will be allowed to participate in the study.
•Have significant prior or current medical conditions that, in the judgment of the investigator, could be exacerbated by or compromised by study drug.
+3 more criteria

Locations (6)

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

Research Foundation for Mental Hygiene, Inc.

New York, New York, United States

Duke University School of Medicine

Durham, North Carolina, United States

Key Dates

Start Date

August 1, 2011

Primary Completion Date

September 1, 2012

Completion Date

November 1, 2012

Last Updated

April 14, 2015

Enrollment

ACTUAL participants

Conditions

Cognitive ImpairmentSchizophrenia

Interventions

Eltoprazine

DRUG

Placebo

DRUG

Sense4Safety Intervention

NCT07220668

Mild Cognitive Impairment

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RECRUITINGNA

Choline to Improve Malnutrition and Enhance Cognition

NCT06154174

Severe Acute MalnutritionCognitive Impairment+2 more

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RECRUITINGEARLY_PHASE1

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 14, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Effects of Eltoprazine on Cognitive Impairment Associated With Schizophrenia (CIAS) in Adults

Inclusion Criteria

Exclusion Criteria

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