Study of a Neurocognition Enhancing Agent in Patients With Schizophrenia

• Status: Completed
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether pregnenolone will demonstrate significant improvements in cognitive functioning and negative symptoms compared to patients receiving placebo.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Research Foundation, Singapore
• Collaborators: Duke University; National University, Singapore; Singapore Clinical Research Institute

Criteria

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.