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Pregnenolone for Cognitive and Negative Symptoms in Schizophrenia
This study is not yet open for participant recruitment.
Verified by Durham VA Medical Center, June 2008
Sponsored by: Durham VA Medical Center
Information provided by: Durham VA Medical Center
ClinicalTrials.gov Identifier: NCT00639886
  Purpose

This study will investigate adjunctive pregnenolone for cognitive symptoms and negative symptoms in patients with schizophrenia.


Condition Intervention Phase
Schizophrenia
Dietary Supplement: Pregnenolone or Placebo
Phase II

MedlinePlus related topics: Schizophrenia
Drug Information available for: Pregnenolone
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment
Official Title: Pregnenolone for Cognitive and Negative Symptoms in Schizophrenia

Further study details as provided by Durham VA Medical Center:

Primary Outcome Measures:
  • MATRICS,BACS,SANS [ Time Frame: Prospective ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • CDSS, PANSS, CGI [ Time Frame: Prospective ] [ Designated as safety issue: No ]

Estimated Enrollment: 88
Study Start Date: August 2008
Estimated Study Completion Date: August 2011
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Pregnenolone: Active Comparator
Pregnenolone
Dietary Supplement: Pregnenolone or Placebo
Pregnenolone 50 mg BID x 14 DAYS, followed by Pregnenolone 150 mg BID x 14 DAYS, followed by Pregnenolone 250 mg BID x thereafter for the remainder of the 8-week trial
Placebo: Placebo Comparator
Placebo
Dietary Supplement: Pregnenolone or Placebo
Pregnenolone 50 mg BID x 14 DAYS, followed by Pregnenolone 150 mg BID x 14 DAYS, followed by Pregnenolone 250 mg BID x thereafter for the remainder of the 8-week trial

Detailed Description:

See brief summary

  Eligibility

Ages Eligible for Study:   25 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis: DSM IV/DSM IV TR schizophrenia
  • Gender: Males and Females
  • Age: 25 - 60
  • Caucasian or Non Caucasian
  • Capable of providing informed consent
  • Duration of illness equal to or greater than one year
  • No change in antipsychotic in the previous eight weeks, no change in antipsychotic dose in the previous 4 weeks.
  • No benzodiazepine use in the past twelve hours prior to cognitive testing.
  • The patient cohort will be enriched for cognitive symptoms (Composite BACS scores = 0-3 standard deviations below the mean, assessed at the screening visit).

Exclusion Criteria:

  • Subjects with a DSM-IV/DSM IV TR diagnosis of alcohol or substance dependence (other than nicotine) within the last month.
  • Subjects with a history of significant head injury/trauma, as defined by one or more of the following:

    1. Loss of consciousness (LOC) for more than 1 hour
    2. Recurring seizures resulting from the head injury
    3. Clear cognitive sequelae of the injury
    4. Cognitive rehabilitation following the injury
  • Subjects with unstable medical illness or neurologic illness (seizures, CVA).
  • Patients with hormone-sensitive tumors (such as breast, uterine, or prostate cancer).
  • Clinically significant abnormalities in physical examination, ECG, or laboratory assessments
  • Pregnant women or women of child-bearing potential, who are either not surgically-sterile or not using appropriate methods of birth control (serum beta-HCG will be performed at baseline, 4 weeks, and 8 weeks 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 estrogen. Although early studies suggested no effects on menstrual cycle, alterations in downstream metabolites of pregnenolone (such as estradiol) could theoretically impact the efficacy of oral contraceptives and/or estrogen replacement]. Similarly, it is theoretically possible that pregnenolone could be metabolized to other steroids, resulting in hair, skin, or other steroid-related changes. Since we have determined in our prior study that pregnenolone administration does not result in downstream elevations in DHEA, DHEAS, estradiol, or testosterone, these possibilities may be unlikely.
  • Current active suicidal and/or homicidal ideation, intent, or plan.
  • Known allergy to study medication.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00639886

Contacts
Contact: Jennifer C Naylor, PhD 919 286-0411 ext 7722 naylorjc@duke.edu

Locations
United States, North Carolina
Durham VAMC
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Durham VA Medical Center
Investigators
Principal Investigator: Christine E Marx, MD MA Durham VAMC
  More Information

Responsible Party: Durham Veterans Affairs Medical Center ( Christine E. Marx, MD MA )
Study ID Numbers: Pending (not yet submitted)
Study First Received: March 14, 2008
Last Updated: June 9, 2008
ClinicalTrials.gov Identifier: NCT00639886  
Health Authority: United States: Food and Drug Administration;   United States: Institutional Review Board;   United States: Federal Government

Keywords provided by Durham VA Medical Center:
Schizophrenia
Pregnenolone
Cognition
Negative Symptoms

Study placed in the following topic categories:
Schizophrenia
Mental Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on January 16, 2009