A Multicenter Study of NAP (AL-108) in Schizophrenia (AL-108)
Schizophrenia
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Cognition, Schizophrenia
Eligibility Criteria
Inclusion Criteria:
- DSM IV/DSM IV TR diagnosis of schizophrenia
- Capable of providing informed consent
- Males and Females
- Age: 18 and 60
- Caucasian or Non Caucasian
- Subjects will be treated with one of the following second generation antipsychotics: risperidone, olanzapine, quetiapine, ziprasidone, or aripiprazole for the previous two months, with no change in dose in the last month, and/or with injectable depot antipsychotics (fluphenazine or haloperidol decanoate) with no change in last 3 months.
Subjects will meet the following symptom criteria:
- Average Brief Psychiatric Rating Scale (BPRS) item score >3 (mild)
- Simpson-Angus Scale total score less than or equal to 6
- Calgary Depression Scale total score less than or equal to 10
Subjects will meet the following cognitive performance criteria:
Performance less than the maximum cutoff (in parentheses) for ONE of the following MCCB tests:
- Letter-number span (20);
- HVLT total (31); and
- CPT d-prime (3.47)
- Able to complete the baseline MCCB validly as assessed by Chief Neuropsychologist or NP tester
- Raw score of 6 or greater on the WTAR
Exclusion Criteria:
- Current treatment with oral conventional antipsychotics (e.g. fluphenazine, haloperidol) or clozapine.
- Subjects with a DSM-IV diagnosis of alcohol or substance abuse (other than nicotine) within the last month or a DSM-IV diagnosis of alcohol or substance dependence (other than nicotine) within the last 6 months
Subjects with a history of significant head injury/trauma, as defined by one or more of the following:
- Loss of consciousness (LOC) for more than 1 hour
- Recurring seizures resulting from the head injury
- Clear cognitive sequellae of the injury
- Cognitive rehabilitation following the injury
- Subjects with a clinically significant neurological, metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, and/or urological disorder (e.g. unstable angina, decompensated congestive heart failure, CNS infection or history of HIV seropositivity), which would pose a risk to the patient if they were to participate in the study or that might confound the results of the study.
- Clinically significant abnormalities in physical examination, ECG, or laboratory assessments.
- Clinically significant renal disease.
- Women who are pregnant or of child-bearing potential, either not surgically-sterile nor using appropriate methods of birth control
- Women who are breast-feeding
- Prior participation in a clinical trial of investigational medication within 60 days.
Sites / Locations
- UCLA
- Maryland Psychiatric Research Center
- Massachusetts General Hospital
- Harvard Medical School
- Washington University School of Medicine
- Columbia University Medical Center
- Nathan Kline Institute
- Duke University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Placebo Comparator
Placebo Comparator
AL-108, 30 mg/day
AL-108, 5 mg/day
Placebo, 3 sprays BID
Placebo, 1 Spray Daily
AL-108, 30 mg/day- 3 sprays in each nostril, twice per day
AL-108, 5 mg/day- one spray in each nostril once per day
Placebo- 3 sprays in each nostril, twice per day
Placebo- one spray in each nostril, once per day