Four-month trial of pregnenolone or placebo, as an additional medication, to treat negative symptoms and cognitive decline in schizophrenia. After four months the scores on the negative symptom scale should be lower and the scores on the cognitive tests should be higher than they were at study entry, compared with people who do not take any additional medication.
Pregnenolone is a steroid health supplement which is readily available in health food stores. We are using it in this study at higher doses than you would normally take as a health supplement because preliminary studies have indicated that negative symptoms improve and certain aspects of cognition improve at these doses. We do not require you to stop your existing treatment in order to enter the study. After four months we will test your symptoms and cognition and ask if you would like to continue taking pregnenolone, at no cost, in a follow-up study designed to determine the long-term costs and benefits of taking pregnenolone.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
100
Sugar pill, taken twice a day
500mg in tablet form taken orally twice a day
University of Medicine & Dentistry of New Jersey- University Behavioral HealthCare
Piscataway, New Jersey, United States
Weill Medical College of Cornell University
New York, New York, United States
Weill Medical College of Cornell University
White Plains, New York, United States
SANS - Scale for the Assessment of Negative Symptoms
Time frame: every month for 4 months
Quality of Life
Time frame: every two months for four months
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