Pregnenolone in the Management of Schizophrenia Patients

• Status: Completed
• Trial end date: 2007-05-01
• Target enrollment: 0
• Participant gender: All

Summary

Pregnenolone is a "neurosteroid" and possesses intrinsic behavioral and brain effects in animals, affecting the GABA(A) and other receptors. Pregnenolone is serves as the precursor for dehydroepiandrosterone (DHEA) and its sulfate ester (DHEAS). There is evidence of efficacy of DHEA augmentation in schizophrenia, we therefore sought to examine the efficacy of augmentation of antipsychotic treatment of schizophrenia patients with pregnenolone. It is hypothesized that the combined effect of antipsychotic agents and pregnenolone would be beneficial in the treatment of negative,depressive, and cognitive symptoms.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sha'ar Menashe Mental Health Center; Sha’ar Menashe Mental Health Center
• Collaborator: Beersheva Mental Health Center

Criteria

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.