Study of a Neurocognition Enhancing Agent in Patients With Schizophrenia

NCT00894842 | Completed Phase 2 DMC

• 1 other identifier: TCR-NS-003
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia

Keywords

Schizophrenia; Pregnenolone; Neurocognition

Outcome Measures

Primary Outcomes (2)

• Improvement in composite score of the MATRICS Consensus Cognitive Battery (MCCB) and BACS.

  10 weeks

• Improvement of negative symptoms as assessed by the Scale for Assessment of Negative Symptoms (SANS).

  10 weeks

Secondary Outcomes (3)

• To provide additional safety data on pregnenolone in patients with schizophrenia via reported serious and non serious adverse events.

  10 weeks

• Improvement of functional outcome by the University of California Performance Based Skills Assessment (UPSA-B)at Week 2, 6 and 10.

  10 weeks

• Efficacy outcome variables will be evaluated by the Clinical Global Impression -Improvement (CGI-I) score at week 2 to week 10.

  10 weeks

Study Arms (2)

Pregnenolone

ACTIVE COMPARATOR

Drug: Pregnenolone

Sugar pill

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Pregnenolone DRUG

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)

Pregnenolone

Placebo DRUG

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)

Sugar pill

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• National Research Foundation, Singapore: lead
• Duke University: collaborator
• National University of Singapore: collaborator
• Singapore Clinical Research Institute: collaborator

Study Sites (1)

Institute of Mental Health

Singapore, 539747, Singapore

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Pregnenolone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progesterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones

Study Officials

• Siow Ann Chong

  Vice Chairman of Medical Board (Research)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 6, 2009
• First Posted: May 7, 2009
• Study Start: June 1, 2009
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: October 6, 2011

Record last verified: 2011-10

Locations

SG (1)