Proof-of-concept trial with the neurosteroid pregnenolone targeting cognitive and negative symptoms in schizophrenia
Open accessAbstract
The neurosteroid pregnenolone and its sulfated derivative enhance learning and memory in rodents. Pregnenolone sulfate also positively modulates NMDA receptors and could thus ameliorate hypothesized NMDA receptor hypofunction in schizophrenia. Furthermore, clozapine increases pregnenolone in rodent hippocampus, possibly contributing to its superior efficacy. We therefore investigated adjunctive pregnenolone for cognitive and negative symptoms in patients with schizophrenia or schizoaffective disorder receiving stable doses of second-generation antipsychotics in a pilot randomized, placebo-controlled, double-blind trial. Following a 2-week single-blind placebo lead-in, patients were randomized to pregnenolone (fixed escalating doses to 500 mg/day) or placebo, for 8 weeks. Primary end points were changes in BACS and MCCB composite and total SANS scores. Of 21 patients randomized, 18 completed at least 4 weeks of treatment (n=9/group). Pregnenolone was well tolerated. Patients receiving pregnenolone demonstrated significantly greater improvements in SANS scores (mean change=10.38) compared with patients receiving placebo (mean change=2.33), p=0.048. Mean composite changes in BACS and MCCB scores were not significantly different in patients randomized to pregnenolone compared with placebo. However, serum pregnenolone increases predicted BACS composite scores at 8 weeks in the pregnenolone group (r(s)=0.81, p=0.022). Increases in allopregnanolone, a GABAergic pregnenolone metabolite, also predicted BACS composite scores (r(s)=0.74, p=0.046). In addition, baseline pregnenolone (r(s)=-0.76, p=0.037), pregnenolone sulfate (r(s)=-0.83, p=0.015), and allopregnanolone levels (r(s)=-0.83, p=0.015) were inversely correlated with improvements in MCCB composite scores, further supporting a possible role for neurosteroids in cognition. Mean BACS and MCCB composite scores were correlated (r(s)=0.74, p<0.0001). Pregnenolone may be a promising therapeutic agent for negative symptoms and merits further investigation for cognitive symptoms in schizophrenia.
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In the Marx et al trial, serum pregnenolone increases predicted BACS composite scores at 8 weeks in the pregnenolone group.
“• Serum pregnenolone increases predicted BACS composite scores at 8 weeks in the pregnenolone group,”
From Clinical trials of potential cognitive-enhancing drugs in schizophrenia: what have we learned so far? (2013) · cites this paper as [44]
In the Marx et al trial, increases in allopregnanolone, a GABAergic pregnenolone metabolite, also predicted BACS composite scores.
“• Increases in allopregnanolone, a GABAergic pregnenolone metabolite, also predicted BACS composite scores”
From Clinical trials of potential cognitive-enhancing drugs in schizophrenia: what have we learned so far? (2013) · cites this paper as [44]
The neurosteroid findings further support a possible role for neurosteroids in cognition.
“• Baseline pregnenolone, pregnenolone sulfate allopregnanolone levels were inversely correlated with improvements in MCCB composite scores, further supporting a possible role for neurosteroids in cognition.”
From Clinical trials of potential cognitive-enhancing drugs in schizophrenia: what have we learned so far? (2013) · cites this paper as [44]
In the Marx et al trial, mean changes in composite BACS and MCCB scores were not significantly different in patients randomized to pregnenolone compared with placebo.
“• Mean changes in composite BACS and MCCB scores were not significantly different in patients randomized to pregnenolone compared with placebo”
From Clinical trials of potential cognitive-enhancing drugs in schizophrenia: what have we learned so far? (2013) · cites this paper as [44]
In the Marx et al trial, baseline pregnenolone, pregnenolone sulfate and allopregnanolone levels were inversely correlated with improvements in MCCB composite scores.
“• Baseline pregnenolone, pregnenolone sulfate allopregnanolone levels were inversely correlated with improvements in MCCB composite scores, further supporting a possible role for neurosteroids in cognition.”
From Clinical trials of potential cognitive-enhancing drugs in schizophrenia: what have we learned so far? (2013) · cites this paper as [44]
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A Randomized, Double-Blind, Placebo-Controlled Trial of Pregnenolone for Bipolar Depression
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Self-citationNeurosteroid Actions in Memory and Neurologic/Neuropsychiatric Disorders
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- Authors
- Marx, C. E., Keefe, R. S. E., Buchanan, R. W., Hamer, R. M., Kilts, J. D., Bradford, D. W., Strauss, J. L., Naylor, J. C., Payne, V. M., Lieberman, J. A., Savitz, A. J., Leimone, L. A., Dunn, L., Porcu, P., Morrow, A. L., & Shampine, L. J.
- Affiliations
- Duke University (US)
- Duke Medical Center (US)
- University of Maryland, Baltimore (US)
- University of North Carolina at Chapel Hill (US)
- Columbia University (US)
- Cornell University (US)
- Durham VA Medical Center (US)
- Corresponding author
- Marx, Christine E
- ORCID
- Venue
- Neuropsychopharmacology
- Published
- 2009-04-01
- Volume
- 34
- Issue
- 8
- Pages
- 1885-1903
- ISSN
- 0893-133X (ISSN-L)
- 1740-634X
- PMC
- PMC3427920
- OpenAlex
- W2032359153
- Cited by
- 193
- References
- 152
- Citations by year
- 2026: 4 · 2025: 10 · 2024: 6 · 2023: 8 · 2022: 6 · 2021: 7 · 2020: 11 · 2019: 12 · 2018: 13 · 2017: 8 · 2016: 4 · 2015: 19 · 2014: 18 · 2013: 18 · 2012: 10
- FWCI
- 10.07
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Licence
- www.springer.com/tdm (tdm)
- Locations
- Neuropsychopharmacology (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- Carolina Digital Repository (University of North Carolina at Chapel Hill) (submittedVersion)
- UNC Libraries
- Funders
- National Institute on Alcohol Abuse and Alcoholism (R37 AA10564, R37AA010564)
- National Institute of Mental Health (K23 MH 65080, K23MH065080)
- NIH Clinical Center
- Topics
- Health Sciences › Medicine › Psychiatry and Mental health › Schizophrenia research and treatment
- Health Sciences › Medicine › Pharmacology › Treatment of Major Depression
- Life Sciences › Neuroscience › Cellular and Molecular Neuroscience › Neuroscience and Neuropharmacology Research
- Keywords
- pregnenolone, neurosteroids, schizophrenia, negative symptoms, cognitive impairment, schizoaffective disorder, allopregnanolone, NMDA receptor hypofunction, atypical antipsychotics, adjunctive therapy, learning and memory
- MeSH terms
- Adult, Aged, Brain, Brain Chemistry, Cognition Disorders, Double-Blind Method, Female, Humans, Male, Memory Disorders, Middle Aged, Neuropsychological Tests, Pilot Projects, Placebos, Pregnanolone, Pregnenolone, Schizophrenia, Up-Regulation, Treatment Outcome, Nootropic Agents
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
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