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Study of a Neurocognition Enhancing Agent in Patients With Schizophrenia

This study has been completed.
Sponsor:
Collaborators:
Duke University
National University, Singapore
Singapore Clinical Research Institute
Information provided by (Responsible Party):
Chong Siow Ann, National Research Foundation, Singapore
ClinicalTrials.gov Identifier:
NCT00894842
First received: May 6, 2009
Last updated: October 4, 2011
Last verified: October 2011
  Purpose

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 Intervention Phase
Schizophrenia
Drug: Pregnenolone
Drug: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.

Resource links provided by NLM:


Further study details as provided by National Research Foundation, Singapore:

Primary Outcome Measures:
  • Improvement in composite score of the MATRICS Consensus Cognitive Battery (MCCB) and BACS. [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
  • Improvement of negative symptoms as assessed by the Scale for Assessment of Negative Symptoms (SANS). [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To provide additional safety data on pregnenolone in patients with schizophrenia via reported serious and non serious adverse events. [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 120
Study Start Date: June 2009
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00894842

Locations
Singapore
Institute of Mental Health
Singapore, Singapore, 539747
Sponsors and Collaborators
National Research Foundation, Singapore
Duke University
National University, Singapore
Singapore Clinical Research Institute
Investigators
Principal Investigator: Siow Ann Chong Vice Chairman of Medical Board (Research)
  More Information

No publications provided

Responsible Party: Chong Siow Ann, Associate Professor, National Research Foundation, Singapore
ClinicalTrials.gov Identifier: NCT00894842     History of Changes
Other Study ID Numbers: TCR-NS-003
Study First Received: May 6, 2009
Last Updated: October 4, 2011
Health Authority: Singapore: Domain Specific Review Boards
Singapore: Health Sciences Authority

Keywords provided by National Research Foundation, Singapore:
Schizophrenia
Pregnenolone
Neurocognition

Additional relevant MeSH terms:
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on November 24, 2014