Status:
COMPLETED
Pregnenolone in the Management of Schizophrenia Patients
Lead Sponsor:
Sha'ar Menashe Mental Health Center
Collaborating Sponsors:
Beersheva Mental Health Center
Conditions:
Schizophrenia
Eligibility:
All Genders
20-55 years
Phase:
PHASE1
Brief 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 dehydroepiandro...
Detailed Description
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. A...
Eligibility Criteria
Inclusion
- DSM-IV criteria for schizophrenia or schizoaffective disorder
- Ability and willingness to sign informed consent for participation in the study
Exclusion
- 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.
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
End Date :
May 1 2007
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00174889
Start Date
January 1 2005
End Date
May 1 2007
Last Update
May 21 2008
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Sha'ar Menashe Mental Health
Hadera, Israel, 38814