Pregnenolone for Cognitive and Negative Symptoms in Schizophrenia

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
VA Office of Research and Development Identifier:
First received: August 1, 2008
Last updated: October 6, 2015
Last verified: October 2015

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

Condition Intervention Phase
Schizoaffective Disorder
Drug: Dietary Supplement: Pregnenolone
Dietary Supplement: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pregnenolone for Cognitive and Negative Symptoms in Schizophrenia

Resource links provided by NLM:

Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • MATRICS Consensus Cognitive Battery (MCCB), University of California Performance-based Skills Assessment (UPSA), Brief Assessment of Cognition in Schizophrenia (BACS), Scale for the Assessment of Negative Symptoms(SANS) [ Time Frame: Prospective, outcome measures collected over 10 week trial period. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary Outcome Measure: (CDSS), Positive and Negative Syndrome Scale (PANSS),Clinical Global Impressions (CGI) Scale [ Time Frame: Prospective, outcome measures collected over 10 week trial period. ] [ Designated as safety issue: No ]

Estimated Enrollment: 88
Study Start Date: December 2009
Estimated Study Completion Date: December 2015
Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm 1
Drug: Dietary Supplement: Pregnenolone
Pregnenolone 50mg BID x 14 days, followed by Pregnenolone 150 x 14 days, followed by Pregnenolone 250 mg BID x thereafter for the remainder of the 8-week trial.
Placebo Comparator: Arm 2
Dietary Supplement: Placebo


Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diagnosis: DSM-IV/DSM-IV TR schizophrenia or schizoaffective disorder;
  • Gender: Males and Females;
  • Age: 21-65;
  • Caucasian or Non Caucasian;
  • Capable of providing informed consent;
  • Duration of illness equal to or greater than one year;
  • No change in antipsychotic medication in the previous eight weeks, no change in antipsychotic dose in the previous four 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:

    • Loss of consciousness (LOC) for more than 1 hour,
    • Recurring seizures resulting from the head injury,
    • Clear cognitive sequelae of the injury,
    • Cognitive rehabilitation following the injury;
  • Subjects with unstable medical illness or neurological 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-human chorionic gonadotropin [HCG] will be performed at baseline, 4 weeks, and 8 weeks to exclude pregnancy);
  • Women who are breast-feeding;
  • Electroconvulsive therapy (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
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 identifier: NCT00728728

United States, North Carolina
Durham VA Medical Center, Durham, NC
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
VA Office of Research and Development
Principal Investigator: Christine Marx, MD MA Durham VA Medical Center, Durham, NC
  More Information

No publications provided

Responsible Party: VA Office of Research and Development Identifier: NCT00728728     History of Changes
Obsolete Identifiers: NCT00639886
Other Study ID Numbers: MHBB-012-07F
Study First Received: August 1, 2008
Last Updated: October 6, 2015
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Keywords provided by VA Office of Research and Development:
positive symptom
negative symptom
placebo control

Additional relevant MeSH terms:
Psychotic Disorders
Mental Disorders
Schizophrenia and Disorders with Psychotic Features processed this record on October 08, 2015