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Study of a Neurocognition Enhancing Agent in Patients With Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00894842
Recruitment Status : Completed
First Posted : May 7, 2009
Last Update Posted : October 6, 2011
Duke University
National University, Singapore
Singapore Clinical Research Institute
Information provided by (Responsible Party):
Chong Siow Ann, National Research Foundation, Singapore

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.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Pregnenolone Drug: Placebo Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 10-week, Randomized, Double-Blind, Placebo-Controlled Trial of a Neurocognition Enhancing Agent(Pregnenolone) in Patients With Schizophrenia.
Study Start Date : June 2009
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Active Comparator: Pregnenolone Drug: Pregnenolone
Pregnenolone 50 mg BID x 14 days, followed by Pregnenolone 300 mg per day for 14 days (200 mg qAM and 100 mg qPM), followed by Pregnenolone 500 mg per day for the remainder of the 8-week trial (300 mg qAM and 200 mg qPM)

Placebo Comparator: Sugar pill Drug: Placebo
Placebo 50 mg BID x 14 days, followed by Placebo 300 mg per day for 14 days (200 mg qAM and 100 mg qPM), followed by Placebo 500 mg per day for the remainder of the 8-week trial (300 mg qAM and 200 mg qPM)

Primary Outcome Measures :
  1. Improvement in composite score of the MATRICS Consensus Cognitive Battery (MCCB) and BACS. [ Time Frame: 10 weeks ]
  2. Improvement of negative symptoms as assessed by the Scale for Assessment of Negative Symptoms (SANS). [ Time Frame: 10 weeks ]

Secondary Outcome Measures :
  1. To provide additional safety data on pregnenolone in patients with schizophrenia via reported serious and non serious adverse events. [ Time Frame: 10 weeks ]
  2. Improvement of functional outcome by the University of California Performance Based Skills Assessment (UPSA-B)at Week 2, 6 and 10. [ Time Frame: 10 weeks ]
  3. Efficacy outcome variables will be evaluated by the Clinical Global Impression -Improvement (CGI-I) score at week 2 to week 10. [ Time Frame: 10 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00894842

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Institute of Mental Health
Singapore, Singapore, 539747
Sponsors and Collaborators
National Research Foundation, Singapore
Duke University
National University, Singapore
Singapore Clinical Research Institute
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Principal Investigator: Siow Ann Chong Vice Chairman of Medical Board (Research)
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Responsible Party: Chong Siow Ann, Associate Professor, National Research Foundation, Singapore Identifier: NCT00894842    
Other Study ID Numbers: TCR-NS-003
First Posted: May 7, 2009    Key Record Dates
Last Update Posted: October 6, 2011
Last Verified: October 2011
Keywords provided by Chong Siow Ann, National Research Foundation, Singapore:
Additional relevant MeSH terms:
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Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders