Drugs / Pregnenolone
Pregnenolone
Trials 19
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial · 1 met primary | ||||||
| Phase 0 | NCT03953612 | Mar 2019 → May 2023 | substance-related disorder | Yale University | Completed | Met primary |
| Phase 15 trials · 1 missed | ||||||
| Phase 1 | NCT04464148 | Dec 2021 | alcohol-related disorders, post-traumatic stress disorder | University of Texas Southwestern Medical Center | Withdrawn | No outcome recorded |
| Phase 1 | NCT03645096 | Sep 2019 → May 2022 | major depressive disorder | University of Texas Southwestern Medical Center | Completed | Missed primary |
| Phase 1 | NCT02811939 | Apr 2016 → Jun 2017 | — | Yale University | Completed | No outcome recorded |
| Phase 1 | NCT02576912 | Feb 2015 → Jun 2019 | — | Yale University | Completed | No outcome recorded |
| Phase 1 | NCT00174889 | Jan 2005 → May 2007 | schizophrenia | Sha'ar Menashe Mental Health Center | Completed | No outcome recorded |
| Phase 1/22 trials · 1 missed | ||||||
| Phase 1/2 | NCT07685964 | Sep 2026 → Aug 2028 expected | cannabis dependence, major depressive disorder | University of Texas Southwestern Medical Center | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT03505905 | Sep 2018 → Dec 2024 | major depressive disorder | University of Texas Southwestern Medical Center | Completed | Missed primary |
| Phase 28 trials · 1 met primary | ||||||
| Phase 2 | NCT07216690 | Apr 2026 → Jan 2028 expected | psychiatric disorder | Johns Hopkins University | Recruiting | No outcome recorded |
| Phase 2 | NCT05570812 | Mar 2023 → Jun 2027 expected | HIV infectious disease, major depressive disorder, mixed anxiety and depressive disorder | Massachusetts General Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT03799562 | May 2019 → Jul 2025 | post-traumatic stress disorder | VA Office of Research and Development | Completed | No outcome recorded |
| Phase 2 | NCT02627508 | Jan 2016 → Mar 2026 | autism | Stanford University | Completed | No outcome recorded |
| Phase 2 | NCT02439814 | Jun 2015 → Apr 2016 | cannabis dependence | Medical University of South Carolina | Completed | No outcome recorded |
| Phase 2 | NCT01956279 | Oct 2013 → Oct 2018 | musculoskeletal system disorder, subjective cognitive decline | VA Office of Research and Development | Completed | No outcome recorded |
| Phase 2 | NCT01881737 | Jul 2011 → Sep 2013 | autism | Stanford University | Completed | Met primary |
| Phase 2 | NCT00900900 | Jul 2009 → Mar 2011 | substance withdrawal syndrome | Jed E. Rose | Completed | No outcome recorded |
| Phase 43 trials | ||||||
| Phase 4 | NCT04762316 | Jan 2019 → Dec 2025 | uterine corpus leiomyoma | Trieu, Nguyen Thi, M.D. | Completed | No outcome recorded |
| Phase 4 | NCT02582905 | May 2016 → May 2023 | alcohol-related disorders, bipolar disorder, schizoaffective bipolar disorder | Sherwood Brown, MD, PhD | Completed | No outcome recorded |
| Phase 4 | NCT00223197 | Feb 2004 → Apr 2006 | bipolar disorder, major depressive disorder, substance abuse | University of Texas Southwestern Medical Center | Completed | No outcome recorded |
| Comparator or background therapy16 trials | ||||||
| Phase 1 | NCT03872128 Comparator | Sep 2018 → Nov 2022 | alcohol-related disorders | Yale University | Completed | No outcome recorded |
| Phase 2 | NCT05935761 Comparator | Dec 2026 → Oct 2029 expected | chronic pain syndrome | VA Office of Research and Development | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06188923 Comparator | Aug 2025 → Jun 2028 expected | mixed anxiety and depressive disorder | VA Office of Research and Development | Recruiting | No outcome recorded |
| Phase 2 | NCT05671692 Comparator | Sep 2024 → Aug 2026 | traumatic brain injury | Christine Marx, MD | Suspended | No outcome recorded |
| Phase 2 | NCT05781009 Comparator | Jan 2024 → Jul 2028 expected | alcohol-related disorders | Yale University | Recruiting | No outcome recorded |
| Phase 2 | NCT02826577 Comparator | May 2017 → Dec 2021 | — | University of Chicago | Terminated | No outcome recorded |
| Phase 2 | NCT01336413 Comparator | Oct 2013 → Feb 2016 | traumatic brain injury | VA Office of Research and Development | Completed | No outcome recorded |
| Phase 2 | NCT01898013 Comparator | Sep 2013 → Apr 2017 | — | Durham VA Medical Center | Completed | No outcome recorded |
| Phase 2 | NCT00993629 Comparator | Jan → May 2010 | major depressive disorder, post-traumatic stress disorder | US Department of Veterans Affairs | Withdrawn | No outcome recorded Stop: Business |
| Phase 2 | NCT00728728 Comparator | Dec 2009 → Mar 2015 | schizoaffective disorder, schizophrenia | VA Office of Research and Development | Completed | No outcome recorded |
| Phase 2/3 | NCT00894842 Comparator | Jun 2009 → Sep 2011 | schizophrenia | National Research Foundation, Singapore | Completed | No outcome recorded |
| Phase 3 | NCT05894954 Background | Jul 2023 → Oct 2025 | cognitive impairment with or without cerebellar ataxia, dementia | Alzheimer's Prevention and Reversal Project, Inc. | Completed | No outcome recorded |
| Phase 4 | NCT01409096 Comparator | Mar 2010 → Nov 2011 | bipolar disorder, major depressive disorder | University of Texas Southwestern Medical Center | Completed | No outcome recorded |
| — | NCT00623506 Comparator | Jan 2008 → Aug 2009 | traumatic brain injury | Durham VA Medical Center | Completed | No outcome recorded |
| — | NCT00560781 Comparator | Apr 2006 → Apr 2007 | post-traumatic stress disorder | Durham VA Medical Center | Completed | No outcome recorded |
| — | NCT00560937 Comparator | Jun 2005 → Apr 2006 | schizophrenia | Durham VA Medical Center | Completed | No outcome recorded |
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 36 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Pregnenolone | “Atrophic subtype support may include: estradiol, progesterone, testosterone, DHEA, pregnenolone, levothyroxine, liothyronine, hydrocortisone.” NCT05894954 ↗34“Pregnenolone 60mg & Pyridoxal Phosphate 20mg & Dydrogesterone 10mg & Impatien balsamina extract 100 mg” NCT04762316 ↗ |
| Known as | PREG | “Pregnenolone (PREG) and dehydroepiandrosterone (DHEA) are reported to have a modulatory effect on neuronal excitability, synaptic plasticity, and response to stress; they are...” PMID 20584515 ↗ Jun 20106“Extensive preclinical and clinical data (from the investigators' group and others) support a novel neurosteroid intervention (pregnenolone/PREG) as a promising new treatment...” NCT06188923 ↗ “Recent preclinical data demonstrate that the neurosteroid pregnenolone (PREG) inhibits THC activation of cannabinoid receptors and decreases symptoms of marijuana intoxication.” NCT02439814 ↗ “The overall purpose of this study is to examine the effect of pregnenolone (PREG) on the acute psychosis-like and cognitive effects of Delta-9-tetrahydrocannabinol (THC).” NCT02576912 ↗ “The NS pregnenolone (PREG) is a logical therapeutic option, since it enhances learning and memory and also increases myelination in rodent models.” NCT01336413 ↗ “Participants will be randomly assigned to 300mg pregnenolone (PREG) treatment b.i.d., or Placebo (PBO).” NCT05781009 ↗ “Pregnenolone (PREG)” NCT03953612 ↗ |
| Known as | pregnenlone | “Pregnenlone (phase 1 and 2)” NCT03505905 ↗ |
| Action | Inhibit | “inhibits THC activation of cannabinoid receptors” NCT02439814 ↗ |
| Modality | Other / unclassified | “Pregnenolone is a "neurosteroid" and possesses intrinsic behavioral and brain effects in animals, affecting the GABA(A) and other receptors.” NCT00174889 ↗ |
| Route | Oral | “one capsule/day” NCT00223197 ↗ |