Efficacy of Pregnenolone in Patients With Schizophrenia

Weill Cornell Medicine (WCM)

Status and phase: Completed; Phase 2

Conditions: Schizophrenia; Schizoaffective Disorder

Treatments: Dietary Supplement: pregnenolone; Dietary Supplement: placebo pregnenolone

Study type: Interventional

Funder types: Other

Identifiers

NCT00615511

PRE0504007841

05T-658 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups, including a placebo group

placebo

Placebo Comparator group

Description:

Approximately one third of subjects

Treatment:

Dietary Supplement: placebo pregnenolone

Pregnenolone

Experimental group

Treatment:

Dietary Supplement: pregnenolone