Study of a Neurocognition Enhancing Agent in Patients With Schizophrenia

Inclusion Criteria:

• Male and female subjects aged 21 to 65 years inclusively at screening.
• Current diagnosis of Schizophrenia established by Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for at least 1 year prior to screening.
• Subjects can be either inpatients or outpatients.
• Provision of written informed consent.
• Able to understand and comply with the requirements of the study, as judged by the investigator.
• Subjects have to be treated with a first generation and/or second generation antipsychotic for the previous 8 weeks or longer, with no change in dose in ≥ 4 weeks at screening.
• Women of childbearing potential (less than two years post-menopausal or not surgically sterile), must have a negative urine pregnancy test at screening - and must use a highly effective method of birth control for at least one month prior to screening such as barrier methods, implants, sexual abstinence or vasectomised partner.

Exclusion Criteria:

• Subjects with a DSM-IV diagnosis of alcohol or other substance dependence (other than nicotine) within the last month.
• Subjects with a history of significant head injury/trauma, with loss of consciousness (LOC) for more than 1 hour, recurring seizures resulting from the head injury, clear cognitive sequelae of the injury, or cognitive rehabilitation following the injury.

• Subjects with a history of clinically significant neurological, metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, and/or urological disorders (e.g., unstable angina, seizures, cerebrovascular accident, decompensate congestive heart failure, CNS infection, 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.

  • Active medical conditions that are minor or well-controlled are not exclusionary if they are not likely to affect risk to the patient or the study results.
  • Patients with hormone-sensitive tumours (such as breast, uterine, or prostate cancer) will be excluded.
• Clinically significant abnormalities in physical examination, ECG, or laboratory assessments.
• Pregnant women or sexually active women of child-bearing potential, who are either not surgically-sterile or not using appropriate methods of birth control (urine pregnancy test will be performed at baseline and week 10 of the study to exclude pregnancy).
• Women who are breast-feeding.
• ECT treatment within the last 3 months.
• Use of oral contraceptives or other hormonal supplementation such as oestrogen.
• Subjects who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others.
• Known allergy to study medication.
• Participation in another drug trial within 4 weeks of this study.