Clinical trial NCT00505765 (phase 2, status: completed)
Conditions: schizophrenia
ICD codes: F20.0, F20.1, F20.2, F20.3, F20.5, F20.89, F20.9
Drugs: al-108, al-108, placebo, placebo
SMILES: CC[C@H](C)[C@H](NC(=O)[C@H](CO)NC(=O)[C@@H](NC(=O)[C@@H]1CCCN1C(=O)[C@H](C)NC(=O)[C@@H](N)CC(N)=O)C(C)C)C(=O)N1CCC[C@H]1C(=O)N[C@@H](CCC(N)=O)C(O)=O, CC[C@H](C)[C@H](NC(=O)[C@H](CO)NC(=O)[C@@H](NC(=O)[C@@H]1CCCN1C(=O)[C@H](C)NC(=O)[C@@H](N)CC(N)=O)C(C)C)C(=O)N1CCC[C@H]1C(=O)N[C@@H](CCC(N)=O)C(O)=O, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
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.