Efficacy of Pregnenolone in Patients With Schizophrenia

Phase 2

Completed

• Conditions: Schizophrenia; Schizoaffective Disorder
• Interventions: Dietary Supplement: pregnenolone; Dietary Supplement: placebo pregnenolone

• Registration Number: NCT00615511
• Lead Sponsor: Weill Medical College of Cornell University

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 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.

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 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 Timeline

• Study Start: 2007-06
• Study First Submitted: 2008-02-01
• Study First Submitted QC: 2008-02-13
• Study First Posted: 2008-02-14
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-18
• Last Update Posted: 2015-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• 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 Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pregnenolone	pregnenolone	-
placebo	placebo pregnenolone	Approximately one third of subjects

Primary Outcome Measures

Name	Time	Method
SANS - Scale for the Assessment of Negative Symptoms	every month for 4 months

Secondary Outcome Measures

Name	Time	Method
Quality of Life	every two months for four months

Trial Locations

Locations (2)

Weill Medical College of Cornell University; 🇺🇸 White Plains, New York, United States

University of Medicine & Dentistry of New Jersey- University Behavioral HealthCare; 🇺🇸 Piscataway, New Jersey, United States