Effects of Eltoprazine on Cognitive Impairment Associated With Schizophrenia (CIAS) in Adults (NCT01266174) | Clinical Trial Compass
CompletedPhase 2
Effects of Eltoprazine on Cognitive Impairment Associated With Schizophrenia (CIAS) in Adults
United States31 participantsStarted 2011-08
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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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 trihexyphenid…