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| Name | Class |
|---|---|
| Simons Foundation | OTHER |
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This is a research study to examine the tolerability and effectiveness of pregnenolone in individuals with autism. Pregnenolone is a naturally occurring steroid hormone in the brain that has been implicated in treating various psychiatric conditions. The investigators hope to learn the effects and safety of using pregnenolone in reducing irritability and sensitivity to sensory differences and improving social communication in individuals with autism. The investigators hope by studying the effects of pregnenolone in more detail, the investigators can design better ways to treat individuals with autism.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pregnenolone (up to 500 mg per day) | Experimental | Twice daily intake of orally administered Pregnenolone will occur on a schedule as described below. Weeks 1 and 2: 30mg twice daily (total 60mg per day) Weeks 3 and 4: 60mg twice daily (total: 120mg per day) Weeks 5 and 6: 90mg twice daily (total: 180mg per day) Weeks 7 and 8: 150mg twice daily (total: 300mg per day) Weeks 9 and 10: 210mg twice daily (total: 420mg per day) Weeks 11 to 14: 250mg twice daily (total: 500mg per day) |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pregnenolone | Drug | orally administered Pregnenolone capsules |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in parent rated Aberrant Behavior Checklist Irritability (ABC-I) score during treatment | 2-week, 4-week, 6-week, 8-week, 10-week, 14-week |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in parent rated Aberrant Behavior Checklist (ABC) scores during treatment | 2-week, 4-week, 6-week, 8-week, 10-week, 14-week | |
| Change from baseline in parent rated Sensory Profile Questionnaire (SPQ) scores during treatment | 2-week, 4-week, 6-week, 8-week, 10-week, 14-week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Antonio Y. Hardan, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Stanford | California | 94305 | United States |
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| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D001321 | Autistic Disorder |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental 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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| Placebo |
| Drug |
orally administered placebo capsules |
|
| Change from baseline in Vineland Adaptive Behavior Scales Second Edition (VABS-II) | 2-week, 6-week, 10-week, 14-week |
| Change from baseline in Clinical Global Impression (CGI) scores during treatment | 2-week, 4-week, 6-week, 8-week, 10-week, 14-week |
| Change from baseline in levels of pregnenolone and its related neurosteroids in peripheral blood | 14-week |
| Change from baseline on the Autism Diagnostic Observation Schedule (ADOS) | 14-week |
| Change from baseline in laboratory based eye-gaze measures | 14-week |
| Change from baseline in laboratory based electroencephalography (EEG) measures | 14-week |
| Change from baseline in laboratory clinical lab values including complete metabolic panel, complete blood count with differential, cholesterol panel and routine urinalysis. | 14-week |
| Change from baseline in parent rated Social Responsiveness Scale (SRS) scores during treatment | 2-week, 6-week, 10-week, 14-week |
| Change from baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) scores during treatment | 2-week, 4-week, 6-week, 8-week, 10-week, 14-week |
| 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 |