Status:
COMPLETED
Efficacy of Pregnenolone in Patients With Schizophrenia
Lead Sponsor:
Weill Medical College of Cornell University
Collaborating Sponsors:
Stanley Medical Research Institute
Conditions:
Schizophrenia
Schizoaffective Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
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 ...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- Age 18-65
- Diagnosis of schizophrenia or schizoaffective disorder
- No new medication for past 3 months and stable dose for past 4 weeks
- SANS (Negative symptom) score of 20 or above
Exclusion
- Significant dementia or head trauma.
- Seizure during past year.
- Substance dependence in past 6 months or positive urine drug screen.
- History of hormone-sensitive cancer such as breast, testicular, prostate, ovarian or uterine cancers.
- Steroid metabolism disorder, e.g.Cushings or Addison's disease.
- Taking steroids other than birth control or post-menopausal hormones.
- Women who are pregnant or nursing.
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00615511
Start Date
June 1 2007
End Date
December 1 2014
Last Update
December 21 2015
Active Locations (3)
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1
University of Medicine & Dentistry of New Jersey- University Behavioral HealthCare
Piscataway, New Jersey, United States, 08854
2
Weill Medical College of Cornell University
New York, New York, United States, 10065
3
Weill Medical College of Cornell University
White Plains, New York, United States, 10605