Schizophrenia, Schizoaffective Disorder
Conditions
Keywords
schizophrenia, schizoaffective disorder, negative symptoms, cognition
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.
Interventions
DIETARY_SUPPLEMENTplacebo pregnenolone
Sugar pill, taken twice a day
DIETARY_SUPPLEMENTpregnenolone
500mg in tablet form taken orally twice a day
Sponsors
Stanley Medical Research Institute
Weill Medical College of Cornell University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SANS - Scale for the Assessment of Negative Symptoms | every month for 4 months |
Secondary
| Measure | Time frame |
|---|---|
| Quality of Life | every two months for four months |
Countries
United States
Outcome results
None listed