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| ID | Type | Description | Link |
|---|---|---|---|
| 05T-658 | Other Grant/Funding Number | Stanley Medical Research Institute |
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| Name | Class |
|---|---|
| Stanley Medical Research Institute | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| placebo | Placebo Comparator | Approximately one third of subjects |
|
| Pregnenolone | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| placebo pregnenolone | Dietary Supplement | Sugar pill, taken twice a day |
| |
| Measure | Description | Time Frame |
|---|---|---|
| SANS - Scale for the Assessment of Negative Symptoms | every month for 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life | every two months for four months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jason J Kim, MD | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Medicine & Dentistry of New Jersey- University Behavioral HealthCare | Piscataway | New Jersey | 08854 | United States | ||
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D011284 | Pregnenolone |
| ID | Term |
|---|---|
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| pregnenolone |
| Dietary Supplement |
500mg in tablet form taken orally twice a day |
|
| Weill Medical College of Cornell University |
| New York |
| New York |
| 10065 |
| United States |
| Weill Medical College of Cornell University | White Plains | New York | 10605 | United States |
| D011083 |
| Polycyclic Compounds |
| D006889 | Hydroxycorticosteroids |
| D000305 | Adrenal Cortex Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045167 | Progesterone Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |