Trial reportNeuropsychopharmacology : official publication of the American College of Neuropsychopharmacology2016
5α-Reductase Inhibition Prevents the Luteal Phase Increase in Plasma Allopregnanolone Levels and Mitigates Symptoms in Women with Premenstrual Dysphoric Disorder.
Trial report in Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 76 papers, 1 of them a synthesis that pooled it.
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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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
76 citing papers in PubMed, 1 synthesis or guideline pooled it, 140 citations in OpenAlex.
- A scoping review of hormonal clinical trials in menstrual cycle-related brain disorders: Studies in premenstrual mood disorder, menstrual migraine, and catamenial epilepsy.Frontiers in neuroendocrinology · 2023Pooled it
- Effects of estrogen and progesterone on neuroactive steroids and cytokines in patients with suicidality.Psychoneuroendocrinology · 2023Trial
- New Pharmacological Approaches to the Management of Premenstrual Dysphoric Disorder.CNS drugs · 2023Trial
- Effects of acute estradiol and progesterone on perimenstrual exacerbation of suicidal ideation and related symptoms: a crossover randomized controlled trial.Translational psychiatry · 2022Trial
- Brain reactivity during aggressive response in women with premenstrual dysphoric disorder treated with a selective progesterone receptor modulator.Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology · 2021Trial
- The steroid metabolome in women with premenstrual dysphoric disorder during GnRH agonist-induced ovarian suppression: effects of estradiol and progesterone addback.Translational psychiatry · 2017Trial
- Steroid 5α-reductases in the brain: From neurosteroidogenesis to therapeutic implications.Frontiers in neuroendocrinology · 2026Review
- Article
- Molecular Mechanisms of Menstrual Cycle-Related Suicide Risk: A Selective Review of Promising Candidate Systems.Biological psychiatry · 2026Review
- Affective Sensitivity to Ovarian Steroid Hormone Flux Across the Menstrual Cycle: Manifestations and Biopsychosocial Risk Factors.Annual review of clinical psychology · 2026Review
- Premenstrual Syndrome and Nutritional Factors: A Narrative Review of Current Evidence and Clinical Implications.Journal of clinical medicine · 2026Review
- Peripheral cyclical expression of GABA-A receptor subunit genes and menstrual cycle affective change: a dimensional, transdiagnostic study.Translational psychiatry · 2025Article
- The role of neuroactive steroids in psychiatric and neurological disorders: Neurobiology and therapeutic perspectives.Neuroscience and biobehavioral reviews · 2025Review
- Toward Precision Reproductive Psychiatry: A Call for Targeted, Transdiagnostic Approaches to Premenstrual Disorders.The American journal of psychiatry · 2025Article
- Neuroactive steroid levels are elevated in the follicular phase and predict premenstrual depression and anxiety symptom severity in women with menstrually related mood disorder.Archives of women's mental health · 2025Article
- Associations between lifetime reproductive events among postmenopausal women with bipolar disorder.Archives of women's mental health · 2025Article
- Biomarkers of reproductive psychiatric disorders.The British journal of psychiatry : the journal of mental science · 2025Review
- Allopregnanolone Regulation of Phasic Dopamine Release and Motivated Behavior.ACS chemical neuroscience · 2025Article
- New directions in neurosteroid therapeutics in neuropsychiatry.Neuroscience and biobehavioral reviews · 2025Review
- The impact of ovulation-suppressing contraceptives on behavioral and functional difficulties in borderline personality disorder.Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology · 2025Article
16 more citing papers are in PubMed but not listed here.
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 2 countries.
Funding
Abstract
Changes in neurosteroid levels during the luteal phase of the menstrual cycle may precipitate affective symptoms. To test this hypothesis, we stabilized neurosteroid levels by administering the 5α-reductase inhibitor dutasteride to block conversion of progesterone to its neurosteroid metabolite allopregnanolone in women with premenstrual dysphoric disorder (PMDD) and in asymptomatic control women. Sixteen women with prospectively confirmed PMDD and 16 control women participated in one of two separate randomized, double-blind, placebo-controlled, cross-over trials, each lasting three menstrual cycles. After one menstrual cycle of single-blind placebo, participants were randomized to receive, for the next two menstrual cycles, either double-blind placebo or dutasteride (low-dose 0.5 mg/day in the first eight PMDD and eight control women or high-dose 2.5 mg/day in the second group of women). All women completed the daily rating form (DRF) and were evaluated in clinic during the follicular and luteal phases of each menstrual cycle. Main outcome measures were the DRF symptoms of irritability, sadness, and anxiety. Analyses were performed with SAS PROC MIXED. In the low-dose group, no significant effect of dutasteride on PMDD symptoms was observed compared with placebo (ie, symptom cyclicity maintained), and plasma allopregnanolone levels increased in women with PMDD from follicular to the luteal phases, suggesting the absence of effect of the low-dose dutasteride on 5α-reductase. In contrast, the high-dose group experienced a statistically significant reduction in several core PMDD symptoms (ie, irritability, sadness, anxiety, food cravings, and bloating) on dutasteride compared with placebo. Dutasteride had no effect on mood in controls. Stabilization of allopregnanolone levels from the follicular to the luteal phase of the menstrual cycle by blocking the conversion of progesterone to its 5α-reduced neurosteroid metabolite mitigates symptoms in PMDD. These data provide preliminary support for the pathophysiologic relevance of neurosteroids in this condition.
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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.