Efficacy of Pregnenolone in Patients With Schizophrenia

Completed · Phase 2 · Has a placebo group

Conditions studied: Schizophrenia, Schizoaffective Disorder

In brief

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.

Key facts

Study ID

NCT00615511

Run by

Weill Medical College of Cornell University

People needed

100

Starts

2007-06-01

Expected to finish

2014-12-01

Last updated by the study team

2015-12-21

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• University of Medicine & Dentistry of New Jersey- University Behavioral HealthCare — Piscataway, New Jersey, United States
• Weill Medical College of Cornell University — New York, New York, United States
• Weill Medical College of Cornell University — White Plains, New York, United States

Full record on ClinicalTrials.gov

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