Efficacy of Pregnenolone in Patients With Schizophrenia

Study Overview
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Brief Summary
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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
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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.

Official Title
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Efficacy of Pregnenolone in Patients With Schizophrenia

Conditions
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Schizophrenia, Schizoaffective Disorder

Intervention / Treatment
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* Dietary Supplement: placebo pregnenolone
* Dietary Supplement: pregnenolone


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo<br>Approximately one third of subjects | Dietary Supplement: placebo pregnenolone<br>* Sugar pill, taken twice a day<br>|
| Experimental: Pregnenolone<br> | Dietary Supplement: pregnenolone<br>* 500mg in tablet form taken orally twice a day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SANS - Scale for the Assessment of Negative Symptoms |  | every month for 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life |  | every two months for four months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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negative symptoms, schizophrenia, schizoaffective disorder, cognition