Status:
COMPLETED
Study of a Neurocognition Enhancing Agent in Patients With Schizophrenia
Lead Sponsor:
National Research Foundation, Singapore
Collaborating Sponsors:
Duke University
National University of Singapore
Conditions:
Schizophrenia
Eligibility:
All Genders
21-65 years
Phase:
PHASE2
PHASE3
Brief 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.
Detailed Description
Aims: Schizophrenia is one of the most disabling disorders to afflict mankind. Despite the low lifetime prevalence of schizophrenia (1% world-wide), it has an enormous burden in both economic cost an...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00894842
Start Date
June 1 2009
End Date
September 1 2011
Last Update
October 6 2011
Active Locations (1)
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1
Institute of Mental Health
Singapore, Singapore, 539747