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

NCT01266174 | Completed Phase 2 DMC

• 1 other identifier: PGI12004
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Cognitive Impairment; Schizophrenia

Keywords

CIAS; Cognition; Schizophrenia; Eltoprazine

Outcome Measures

Primary Outcomes (1)

• MATRICS Consensus Cognitive Battery (MCCB)

  Assessment of cognitive effects over time measured suing the MCCB battery

  At Baseline and every 4 weeks

Secondary Outcomes (9)

• Continuous Performance Test-AX Version (CPT-AX)

  At Baseline and every 4 weeks

• N-Back

  At Baseline and every 4 weeks

• Brief Psychiatric Rating Scale (BPRS)

  At Baseline and every 2 weeks

• Calgary Depression Scale (CDS)

  At Baseline and every 2 weeks

• Scale for Assessment of Negative Symptoms (SANS)

  At Baseline and every 2 weeks

Study Arms (2)

Eltoprazine

EXPERIMENTAL

eltoprazine pill 2.5mg bid, eltoprazine pill 5mg bid, eltoprazine 7.5mg bid

Drug: Eltoprazine

Placebo

PLACEBO COMPARATOR

placebo pill 2.5mg bid, placebo pill 5mg bid, placebo 7.5mg bid

Drug: Placebo

Interventions

Eltoprazine DRUG

Comparison of eltoprazine, dosed orally, for 8 weeks

Also known as: eltropazine hydrochloride

Eltoprazine

Placebo DRUG

Placebo to match eltoprazine

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Amarantus BioScience Holdings, Inc.: lead

Study Sites (6)

Veteran's Administration of Greater Los Angeles

Los Angeles, California, 90073, United States

Location

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

Maryland Psychiatric Research Center

Catonsville, Maryland, 21228, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Research Foundation for Mental Hygiene, Inc.

New York, New York, 10032, United States

Location

Duke University School of Medicine

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Schizophrenia

Interventions

eltoprazine

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders

Study Officials

• John G Csernansky, MD

  NortWestern University Feinberg School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2010
• First Posted: December 24, 2010
• Study Start: August 1, 2011
• Primary Completion: September 1, 2012
• Study Completion: November 1, 2012
• Last Updated: April 14, 2015

Record last verified: 2015-04

Locations

US (6)