Cognitive ImpairmentPhase 2NCT01266174
Effects of Eltoprazine on Cognitive Impairment Associated With Schizophrenia (CIAS) in Adults
A Phase 2 study testing Eltoprazine in people with Cognitive Impairment and Schizophrenia, run by Amarantus BioScience Holdings, Inc. at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cognitive Impairment, Schizophrenia
- What is being tested?
- Eltoprazine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 6 sitesUnited States
- Study dates
- Aug 2011to Nov 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Maryland Psychiatric Research Center
Catonsville, Maryland, 21228
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611
Duke University School of Medicine
Durham, North Carolina, 27705
Veteran's Administration of Greater Los Angeles
Los Angeles, California, 90073
Research Foundation for Mental Hygiene, Inc.
New York, New York, 10032
About this study
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
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.
Read the 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.
- Conditions
- Cognitive Impairment, Schizophrenia
- Being tested
- Eltoprazine, Placebo
- Keywords
- CIAS, Cognition, Schizophrenia, Eltoprazine
- Medical subject headings
- Cognitive Dysfunction, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EltoprazineDrug
Also called eltropazine hydrochloride
Comparison of eltoprazine, dosed orally, for 8 weeks
PlaceboDrug
Placebo to match eltoprazine
| Study group | Role | What they receive |
|---|---|---|
| Eltoprazine | Experimental | eltoprazine pill 2.5mg bid, eltoprazine pill 5mg bid, eltoprazine 7.5mg bid Receives: Drug: Eltoprazine |
| Placebo | Placebo comparator | placebo pill 2.5mg bid, placebo pill 5mg bid, placebo 7.5mg bid Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
MATRICS Consensus Cognitive Battery (MCCB)
Assessment of cognitive effects over time measured suing the MCCB battery
Measured: At Baseline and every 4 weeks
Secondary outcomes (9)
Continuous Performance Test-AX Version (CPT-AX)
Assessment of Cognitive effects over time measured using the Continuous Performance Test (AX version)
Measured: At Baseline and every 4 weeks
N-Back
Assessment of Cognitive effects over time measured using the N-Back Working Memory Test
Measured: At Baseline and every 4 weeks
Brief Psychiatric Rating Scale (BPRS)
Measured: At Baseline and every 2 weeks
Calgary Depression Scale (CDS)
Measured: At Baseline and every 2 weeks
Scale for Assessment of Negative Symptoms (SANS)
Measured: At Baseline and every 2 weeks
Simpson-Angus Extrapyramidal Symptom Rating Scale (SAS)
Measured: At Baseline and every 2 weeks
Abnormal Involuntary Movement Scale (AIMS)
Measured: At Baseline and every 2 weeks
Barnes Akathisia Scale (BAS)
Measured: At Baseline and every 2 weeks
Columbia Suicide Severity Rating Scale (C-SSRS)
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2010 (estimated)
- Study startAug 2011
- Primary completionSep 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amarantus BioScience Holdings, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John G Csernansky, MD, Principal investigator, NortWestern University Feinberg School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01266174
- Sponsor's protocol ID
- PGI12004
- Status last verified
- Apr 2015
- First submitted
- 21 Dec 2010
- Last updated
- 14 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01266174
- Acronym / sponsor ID
- PGI12004
- Conditions
- Cognitive Impairment, Schizophrenia
- Keywords
- CIAS, Cognition, Schizophrenia, Eltoprazine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Amarantus BioScience Holdings, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 24 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eltoprazine | Experimental | Drug: Eltoprazineeltoprazine pill 2.5mg bid, eltoprazine pill 5mg bid, eltoprazine 7.5mg bid |
| Placebo | Placebo comparator | Drug: Placeboplacebo pill 2.5mg bid, placebo pill 5mg bid, placebo 7.5mg bid |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EltoprazineAlso: eltropazine hydrochlorideComparison of eltoprazine, dosed orally, for 8 weeks | Drug | Eltoprazine |
| PlaceboPlacebo to match eltoprazine | Drug | Placebo |
Primary outcome
MATRICS Consensus Cognitive Battery (MCCB)
Time frame: At Baseline and every 4 weeks
Assessment of cognitive effects over time measured suing the MCCB battery
9 secondary outcomes
Continuous Performance Test-AX Version (CPT-AX)
Time frame: At Baseline and every 4 weeks
N-Back
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)
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John G Csernansky, MD principal investigator
NortWestern University Feinberg School of Medicine
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Eltoprazine in people with Cognitive Impairment and Schizophrenia, run by Amarantus BioScience Holdings, Inc. at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MATRICS Consensus Cognitive Battery (MCCB) (time frame: At Baseline and every 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2015.