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Effects of Eltoprazine on Cognitive Impairment Associated With Schizophrenia (CIAS) in Adults
This study has been completed.
Sponsor:
Amarantus BioScience Holdings, Inc.
Information provided by (Responsible Party):
Amarantus BioScience Holdings, Inc.
ClinicalTrials.gov Identifier:
NCT01266174
First received: December 21, 2010
Last updated: April 13, 2015
Last verified: April 2015
History of Changes
Full Text View Tabular ViewNo Study Results PostedDisclaimerHow to Read a Study Record
Purpose
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.
Condition Intervention Phase
Cognitive Impairment
Schizophrenia
Drug: Eltoprazine
Drug: Placebo
Phase 2
Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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
Resource links provided by NLM:
MedlinePlus related topics: Schizophrenia
U.S. FDA Resources
Further study details as provided by Amarantus BioScience Holdings, Inc.:
Primary Outcome Measures:
MATRICS Consensus Cognitive Battery (MCCB) [ Time Frame: At Baseline and every 4 weeks ] [ Designated as safety issue: No ]
Assessment of cognitive effects over time measured suing the MCCB battery
Secondary Outcome Measures:
Continuous Performance Test-AX Version (CPT-AX) [ Time Frame: At Baseline and every 4 weeks ] [ Designated as safety issue: No ]
Assessment of Cognitive effects over time measured using the Continuous Performance Test (AX version)
N-Back [ Time Frame: At Baseline and every 4 weeks ] [ Designated as safety issue: No ]
Assessment of Cognitive effects over time measured using the N-Back Working Memory Test
Brief Psychiatric Rating Scale (BPRS) [ Time Frame: At Baseline and every 2 weeks ] [ Designated as safety issue: No ]
Calgary Depression Scale (CDS) [ Time Frame: At Baseline and every 2 weeks ] [ Designated as safety issue: No ]
Scale for Assessment of Negative Symptoms (SANS) [ Time Frame: At Baseline and every 2 weeks ] [ Designated as safety issue: No ]
Simpson-Angus Extrapyramidal Symptom Rating Scale (SAS) [ Time Frame: At Baseline and every 2 weeks ] [ Designated as safety issue: Yes ]
Abnormal Involuntary Movement Scale (AIMS) [ Time Frame: At Baseline and every 2 weeks ] [ Designated as safety issue: Yes ]
Barnes Akathisia Scale (BAS) [ Time Frame: At Baseline and every 2 weeks ] [ Designated as safety issue: Yes ]
Columbia Suicide Severity Rating Scale (C-SSRS) [ 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 ] [ Designated as safety issue: Yes ]
Enrollment: 31
Study Start Date: August 2011
Study Completion Date: November 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Eltoprazine
eltoprazine pill 2.5mg bid, eltoprazine pill 5mg bid, eltoprazine 7.5mg bid
Drug: Eltoprazine
Comparison of eltoprazine, dosed orally, for 8 weeks
Other Name: eltropazine hydrochloride
Placebo Comparator: Placebo
placebo pill 2.5mg bid, placebo pill 5mg bid, placebo 7.5mg bid
Drug: Placebo
Placebo to match eltoprazine
Other Name: placebo
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
Ages Eligible for Study: 18 Years to 65 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Criteria
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.
Must have an ECG with QTc measurement performed at Screening that is not clinically significant.
Must have a negative drug screen.
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.
Have any medical condition that would increase sympathetic nervous system activity markedly.Patients who are taking a medication on a daily basis (for example, albuterol, inhalation aerosols, pseudoephedrine), that has sympathomimetic activity can be enrolled.
Used MAOIs during the 2 weeks (14 days) prior to Baseline. Have used any SSRI, a 5HT1A agonist or other serotonin-mediated treatment for any reason during the 4 weeks prior to Baseline.
Have current hypertension despite treatment. Have received treatment within the last 60 days with a drug that has not received regulatory approval for any indication at the time of study entry.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01266174
Locations
United States, California
Veteran's Administration of Greater Los Angeles
Los Angeles, California, United States, 90073
United States, Illinois
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States, 60611
United States, Maryland
Maryland Psychiatric Research Center
Catonsville, Maryland, United States, 21228
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, New York
Research Foundation for Mental Hygiene, Inc.
New York, New York, United States, 10032
United States, North Carolina
Duke University School of Medicine
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Amarantus BioScience Holdings, Inc.
Investigators
Principal Investigator: John G Csernansky, MD NortWestern University Feinberg School of Medicine
More Information
No publications provided
Responsible Party: Amarantus BioScience Holdings, Inc.
ClinicalTrials.gov Identifier: NCT01266174 History of Changes
Other Study ID Numbers: PGI12004
Study First Received: December 21, 2010
Last Updated: April 13, 2015
Health Authority: United States: Food and Drug Administration
Keywords provided by Amarantus BioScience Holdings, Inc.:
CIAS
Cognition
Schizophrenia
Eltoprazine
Additional relevant MeSH terms:
Cognition Disorders
Schizophrenia
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Eltoprazine
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Serotonin Agents
Serotonin Receptor Agonists
ClinicalTrials.gov processed this record on April 14, 2015
TO TOP
For Patients & Families For Researchers For Study Record Managers
Submit Studies »
Resources »
About This Site »
Text Size
HomeFind StudiesStudy Record Detail
Effects of Eltoprazine on Cognitive Impairment Associated With Schizophrenia (CIAS) in Adults
This study has been completed.
Sponsor:
Amarantus BioScience Holdings, Inc.
Information provided by (Responsible Party):
Amarantus BioScience Holdings, Inc.
ClinicalTrials.gov Identifier:
NCT01266174
First received: December 21, 2010
Last updated: April 13, 2015
Last verified: April 2015
History of Changes
Full Text View Tabular ViewNo Study Results PostedDisclaimerHow to Read a Study Record
Purpose
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.
Condition Intervention Phase
Cognitive Impairment
Schizophrenia
Drug: Eltoprazine
Drug: Placebo
Phase 2
Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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
Resource links provided by NLM:
MedlinePlus related topics: Schizophrenia
U.S. FDA Resources
Further study details as provided by Amarantus BioScience Holdings, Inc.:
Primary Outcome Measures:
MATRICS Consensus Cognitive Battery (MCCB) [ Time Frame: At Baseline and every 4 weeks ] [ Designated as safety issue: No ]
Assessment of cognitive effects over time measured suing the MCCB battery
Secondary Outcome Measures:
Continuous Performance Test-AX Version (CPT-AX) [ Time Frame: At Baseline and every 4 weeks ] [ Designated as safety issue: No ]
Assessment of Cognitive effects over time measured using the Continuous Performance Test (AX version)
N-Back [ Time Frame: At Baseline and every 4 weeks ] [ Designated as safety issue: No ]
Assessment of Cognitive effects over time measured using the N-Back Working Memory Test
Brief Psychiatric Rating Scale (BPRS) [ Time Frame: At Baseline and every 2 weeks ] [ Designated as safety issue: No ]
Calgary Depression Scale (CDS) [ Time Frame: At Baseline and every 2 weeks ] [ Designated as safety issue: No ]
Scale for Assessment of Negative Symptoms (SANS) [ Time Frame: At Baseline and every 2 weeks ] [ Designated as safety issue: No ]
Simpson-Angus Extrapyramidal Symptom Rating Scale (SAS) [ Time Frame: At Baseline and every 2 weeks ] [ Designated as safety issue: Yes ]
Abnormal Involuntary Movement Scale (AIMS) [ Time Frame: At Baseline and every 2 weeks ] [ Designated as safety issue: Yes ]
Barnes Akathisia Scale (BAS) [ Time Frame: At Baseline and every 2 weeks ] [ Designated as safety issue: Yes ]
Columbia Suicide Severity Rating Scale (C-SSRS) [ 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 ] [ Designated as safety issue: Yes ]
Enrollment: 31
Study Start Date: August 2011
Study Completion Date: November 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Eltoprazine
eltoprazine pill 2.5mg bid, eltoprazine pill 5mg bid, eltoprazine 7.5mg bid
Drug: Eltoprazine
Comparison of eltoprazine, dosed orally, for 8 weeks
Other Name: eltropazine hydrochloride
Placebo Comparator: Placebo
placebo pill 2.5mg bid, placebo pill 5mg bid, placebo 7.5mg bid
Drug: Placebo
Placebo to match eltoprazine
Other Name: placebo
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
Ages Eligible for Study: 18 Years to 65 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Criteria
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.
Must have an ECG with QTc measurement performed at Screening that is not clinically significant.
Must have a negative drug screen.
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.
Have any medical condition that would increase sympathetic nervous system activity markedly.Patients who are taking a medication on a daily basis (for example, albuterol, inhalation aerosols, pseudoephedrine), that has sympathomimetic activity can be enrolled.
Used MAOIs during the 2 weeks (14 days) prior to Baseline. Have used any SSRI, a 5HT1A agonist or other serotonin-mediated treatment for any reason during the 4 weeks prior to Baseline.
Have current hypertension despite treatment. Have received treatment within the last 60 days with a drug that has not received regulatory approval for any indication at the time of study entry.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01266174
Locations
United States, California
Veteran's Administration of Greater Los Angeles
Los Angeles, California, United States, 90073
United States, Illinois
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States, 60611
United States, Maryland
Maryland Psychiatric Research Center
Catonsville, Maryland, United States, 21228
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, New York
Research Foundation for Mental Hygiene, Inc.
New York, New York, United States, 10032
United States, North Carolina
Duke University School of Medicine
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Amarantus BioScience Holdings, Inc.
Investigators
Principal Investigator: John G Csernansky, MD NortWestern University Feinberg School of Medicine
More Information
No publications provided
Responsible Party: Amarantus BioScience Holdings, Inc.
ClinicalTrials.gov Identifier: NCT01266174 History of Changes
Other Study ID Numbers: PGI12004
Study First Received: December 21, 2010
Last Updated: April 13, 2015
Health Authority: United States: Food and Drug Administration
Keywords provided by Amarantus BioScience Holdings, Inc.:
CIAS
Cognition
Schizophrenia
Eltoprazine
Additional relevant MeSH terms:
Cognition Disorders
Schizophrenia
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Eltoprazine
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Serotonin Agents
Serotonin Receptor Agonists
ClinicalTrials.gov processed this record on April 14, 2015
TO TOP
For Patients & Families For Researchers For Study Record Managers
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