Trial reportNeuropsychopharmacology : official publication of the American College of Neuropsychopharmacology2014
A randomized, double-blind, placebo-controlled trial of pregnenolone for bipolar depression.
Trial report in Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 42 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Advancing Pregnenolone as a Novel Therapy for Co-Occurring Cannabis Use Disorder and Depression
Targeting Neurosteroid Pathways in Alcohol Use Disorder: Clinical and Neural Impact of Pregnenolone Therapy
Who cites it
42 citing papers in PubMed, 2 syntheses or guidelines pooled it, 93 citations in OpenAlex.
- The CINP Guidelines on the Definition and Evidence-Based Interventions for Treatment-Resistant Bipolar Disorder.The international journal of neuropsychopharmacology · 2020Pooled it
- Canadian Network for Mood and Anxiety Treatments (CANMAT) and International Society for Bipolar Disorders (ISBD) 2018 guidelines for the management of patients with bipolar disorder.Bipolar disorders · 2018Guideline
- Pregnenolone reduces provoked craving and cocaine use in men and women with cocaine use disorder: A pilot trial.Drug and alcohol dependence · 2025Trial
- Effect of Pregnenolone vs Placebo on Self-reported Chronic Low Back Pain Among US Military Veterans: A Randomized Clinical Trial.JAMA network open · 2020Trial
- Neuroactive steroid levels and cocaine use chronicity in men and women with cocaine use disorder receiving progesterone or placebo.The American journal on addictions · 2019Trial
- The Estrogen-Mitochondria Axis in Bipolar Disorder: Promise, Complexity, and Future Directions.Biological psychiatry global open science · 2026Article
- Pregnenolone Reduces L-Dopa-Induced Dyskinesias in Female Parkinsonian Monkeys.Movement disorders : official journal of the Movement Disorder Society · 2025Article
- Childhood insulin resistance and neural stem cell dysfunction in psychiatric disorders: Role ofWorld journal of stem cells · 2025Review
- Neurosteroids Progesterone and Dehydroepiandrosterone: Molecular Mechanisms of Action in Neuroprotection and Neuroinflammation.Pharmaceuticals (Basel, Switzerland) · 2025Review
- Stability and Reliability of Repeated Plasma Pregnenolone Levels After Oral Pregnenolone Dosing in Individuals with Cocaine Use Disorder: Pilot Findings.Life (Basel, Switzerland) · 2024Article
- Metabolic complications of psychotropic medications in psychiatric disorders: Emerging role ofWorld journal of psychiatry · 2024Review
- A Critical View on New and Future Antidepressants.Clinical psychopharmacology and neuroscience : the official scientific journal of the Korean College of Neuropsychopharmacology · 2024Review
- Neuroactive Steroids, Toll-like Receptors, and Neuroimmune Regulation: Insights into Their Impact on Neuropsychiatric Disorders.Life (Basel, Switzerland) · 2024Review
- The role of neurosteroids in posttraumatic stress disorder and alcohol use disorder: A review of 10 years of clinical literature and treatment implications.Frontiers in neuroendocrinology · 2024Review
- Steroid-induced mania in a patient with previously well-controlled organic bipolar 1-like affective disorder secondary to acquired brain injury: case report and literature review.Discover mental health · 2024Article
- Novel neurosteroid therapeutics for post-partum depression: perspectives on clinical trials, program development, active research, and future directions.Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology · 2024Review
- Neurosteroid influence on affective tone.Neuroscience and biobehavioral reviews · 2023Review
- Pregnenolone Inhibits Doxorubicin-Induced Cardiac Oxidative Stress, Inflammation, and Apoptosis-Role of Matrix Metalloproteinase 2 and NADPH Oxidase 1.Pharmaceuticals (Basel, Switzerland) · 2023Article
- Zuranolone - synthetic neurosteroid in treatment of mental disorders: narrative review.Frontiers in psychiatry · 2023Review
- A synthetic pregnenolone analog promotes microtubule dynamics and neural development.Cell & bioscience · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors at 4 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Depression in bipolar disorder (BPD) is challenging to treat. Therefore, additional medication options are needed. In the current report, the effect of the neurosteroid pregnenolone on depressive symptoms in BPD was examined. Adults (n=80) with BPD, depressed mood state, were randomized to pregnenolone (titrated to 500 mg/day) or placebo, as add-on therapy, for 12 weeks. Outcome measures included the 17-item Hamilton Rating Scale for Depression (HRSD), Inventory of Depressive Symptomatology-Self-Report (IDS-SR), Hamilton Rating Scale for Anxiety (HRSA), and Young Mania Rating Scale (YMRS). Serum neurosteroid levels were assessed at baseline and week 12. Data were analyzed using a mixed model ANCOVA with a between factor of treatment assignment, a within factor (repeated) of visit, and the baseline value, as well as age and gender, as covariates. In participants with at least one postbaseline visit (n=73), a significant treatment by week interaction for the HRSD (F(5,288)=2.61, p=0.025), but not IDS-SR, was observed. Depression remission rates were greater in the pregnenolone group (61%) compared with the placebo group (37%), as assessed by the IDS-SR (χ(2)(1)=3.99, p=0.046), but not the HRSD. Large baseline-to-exit changes in neurosteroid levels were observed in the pregnenolone group but not in the placebo group. In the pregnenolone group, baseline-to-exit change in the HRSA correlated negatively with changes in allopregnanolone (r(22)=-0.43, p=0.036) and pregNANolone (r(22)=-0.48, p=0.019) levels. Pregnenolone was well tolerated. The results suggest that pregnenolone may improve depressive symptoms in patients with BPD and can be safely administered.
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.