Pregnenolone for Cognitive and Negative Symptoms in Schizophrenia
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Intervention: Dietary Supplement: Pregnenolone; Placebo
Intervention description: 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
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 88.0
Sex: All
Minimum age: 21 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: pregnenolone; schizophrenia; cognitive; positive symptom; negative symptom; placebo control

Summary:

      This study will investigate adjunctive pregnenolone for patients with schizophrenia and
      schizoaffective disorder.
    

Eligibility criteria:

        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.