Pregnenolone in the Management of Schizophrenia Patients

Either pregnenolone (30 mg/d or 200 mg/d), DHEA (400 mg/d)or placebo will be added to regular treatment for 8 weeks. Subjects will be assessed at baseline and after 2, 4, 6 and 8 weeks of treatment. An extensive battery of research instruments will be used for assessment of the following domains of interest: psychopathology, insight, side effects, and cognitive functions. Plasma pregnenolone, DHEA(S), cortisol and other relevant steroids will be assayed at baseline, 2, 4, 6 and 8 weeks of treatment. Efficacy and safety of augmentation of antipsychotic treatment with pregnenolone will be analyzed.

Inclusion criteria

• DSM-IV criteria for schizophrenia or schizoaffective disorder
• Ability and willingness to sign informed consent for participation in the study

Exclusion criteria

• Evidence of organic brain damage, mental retardation, alcohol or drug abuse
• Prostate nodules or cancer.
• Moderate symptoms of benign prostatic hypertrophy such as hesitancy, urgency, frequent voiding and feeling of incomplete voiding.
• History of ischemic cardiac disease.
• Renal disease.
• Hepatic dysfunction.
• Women with a history of carcinoma of the breast, or any women with a family history of the following: premenopausal breast cancer or bilateral breast cancer in a first degree relative; multiple family members (greater than three relatives) with postmenopausal breast cancer.
• Women with a history of uterine cancer.
• Patients with a known hypersensitivity to androgens.
• Pregnant women.