Clinical trial NCT01137799 (phase 1, status: terminated)
Conditions: schizophrenia, alzheimer's disease, cognition disorders
ICD codes: F20.0, F20.1, F20.2, F20.3, F20.5, F20.89, F20.9, G30.8, G30.9, G30.0, G30.1, F20.81, F21, F34.0, F34.1, F42.3, F45.0, F51.5
Drugs: jnj-39393406, placebo, jnj-39393406, jnj-39393406, jnj-39393406, jnj-39393406
SMILES: CN(C)C(=O)CCN1N=C(NC2=CC=C3OC(F)(F)OC3=C2)N=C1C1=CC=NC=C1, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O, CN(C)C(=O)CCN1N=C(NC2=CC=C3OC(F)(F)OC3=C2)N=C1C1=CC=NC=C1, CN(C)C(=O)CCN1N=C(NC2=CC=C3OC(F)(F)OC3=C2)N=C1C1=CC=NC=C1, CN(C)C(=O)CCN1N=C(NC2=CC=C3OC(F)(F)OC3=C2)N=C1C1=CC=NC=C1, CN(C)C(=O)CCN1N=C(NC2=CC=C3OC(F)(F)OC3=C2)N=C1C1=CC=NC=C1
Reason stopped: 
    efficacy signals were insufficiently strong to justify recruitment of additional patients.
  
Eligibility criteria:

        Inclusion Criteria:

          -  Male between 18 and 55 years of age, inclusive

          -  A known history of schizophrenia of at least 12 months by the referring psychiatrist

          -  DSM-IV criteria for Schizophrenia (including all subtypes)

          -  Stable treatment for at least 3 months (minor changes are acceptable upon confirmation
             by the sponsor representative)

          -  Medically stable on the basis of physical examination, medical history, vital signs,
             and 12-lead ECG performed at screening. If there are abnormalities, they must be
             consistent with the underlying illness in the study population

          -  Medically stable on the basis of clinical laboratory tests performed at screening. If
             the results of the serum chemistry panel, hematology, or urinalysis are outside the
             normal reference ranges, the subject may be included only if the investigator judges
             the abnormalities or deviations from normal to be not clinically significant or to be
             appropriate and reasonable for the population under study. This determination must be
             recorded in the subject source documents and initialed by the investigator

          -  BMI between 18 and 35 kg/m² inclusive (BMI = weight/height²)

          -  For the pharmacogenomic component of this study subjects must have signed a separate
             written informed consent indicating willingness to participate in Part 1 genetic
             testing (mandatory), and indicate either consent or refusal for Part 2 DNA storage.
             Subject participation in the genetic testing component of the study (Part 1) is
             mandatory. Participation in the DNA storage component (Part 2) is voluntary and
             refusal to participate will not result in ineligibility for the main part of the study

        Exclusion Criteria:

          -  A DSM-IV axis I diagnosis other than schizophrenia

          -  Clinically significant abnormal values for clinical chemistry, hematology or
             urinalysis at screening or admission. It is expected that laboratory values will
             generally be within the normal range for the laboratory, though minor deviations,
             which are not considered to be of clinical significance to the investigator, are
             acceptable. Values of ALT/AST < 2 fold the upper limit of normal will be allowed

          -  Clinically significant abnormal physical examination, vital signs or 12 lead ECG at
             screening. Minor deviations in ECG, which are not considered to be of clinical
             significance to the investigator, are acceptable

          -  QTcb >470ms

          -  A DSM-IV diagnosis of substance dependence within 6 months prior to screening
             evaluation (caffeine dependence is not exclusionary. Patients with a positive drug
             screen at screening may be included provided use does not lead to a DSM-IV diagnosis
             of substance dependence and patients consents to abstain from illegal drugs within 3
             days prior to Day -1 and at any time during the study)

          -  Treatment-resistant subjects (failure to respond to two different antipsychotic drugs
             in the past)

          -  PANSS scores > 70

          -  Suicidal risk (assessed by the investigator such as, prior attempts to suicide,
             command hallucinations and / or hopelessness)

          -  Use of clozapine within 3 months before screening until follow-up

          -  Use of more than two antipsychotic drugs within 3 months before dosing until follow up