ORPHA:43116
Serotonin syndrome
Also known as: Serotonergic syndrome · Serotonin storm · Serotonin toxicity · Serotonin toxidrome
Publications
6,456
Trials
2
Interventional, condition-specific
Researchers
833
Distinct authors in sample
Gene link
—
Readiness
3/6
Stages with a signal
Clinical definition (Orphanet)
A rare neurologic disease characterized by an excess of serotonin in the central nervous system, associated with the use of various agents, including selective serotonin reuptake inhibitors (SSRIs) and recreational stimulants.
How rare: How common this is has not been clearly measured.
Cross-references
Joined from Mondo / Orphanet. MeSH labels may enter searches; UMLS / OMIM / NCIT are stored for reference.
- MONDO:0018546
- MeSH:D020230
- UMLS:C0699828
Additional Mondo synonyms (4)
serotonergic syndrome · serotonin storm · serotonin toxicity · serotonin toxidrome
Research stages
Trial readiness signals
Where this condition sits on an open-data research pipeline — not how close a treatment is, and not medical advice. Empty stages often mean “not in these databases under this Mondo ID,” not “impossible.”
3/6 stages with a signal
An interventional trial matched this condition name on ClinicalTrials.gov — see trials below.
- Gene identifiedNot found
No GenCC disease–gene assertion in this build
- LiteraturePresent
6,456 matched papers (3,787 in last 10 years) Source
- Phenotype characterisedPresent
34 HPO annotations (e.g. Anxiety; Confusion; Agitation) Source
- Animal modelNot found
No Alliance genotype “model of” associations via Monarch for these Mondo IDs
- Orphan designationNot found
No FDA or EMA orphan-drug designation matched this disease via UMLS or preferred name Source
- Interventional trialPresent
2 matched on ClinicalTrials.gov
Biology
Genes and phenotypes
Gene–disease validity from GenCC, plus phenotypes and animal models joined from Monarch Initiative via Mondo ID — not a clinical diagnosis aid.
Do we know what causes it?
Not yet — the cause hasn't been pinned down in GenCC.
No strong gene–disease assertion joined for this Orphanet entity.
Phenotypes (Monarch / HPO)
34
Associated phenotypes · MONDO:0018546
- Anxiety
- Confusion
- Agitation
- Hyperreflexia
- Clonus
Showing 5 of 34 — open Monarch for the full list.
Animal models (Monarch / Alliance)
None returned for this Mondo ID. Empty here is not proof that no model organism work exists under another name or gene.
Monarch fetch 2026-07-29
Therapies
Designations, candidates, and chemicals
FDA OOPD and EMA orphan designations, Open Targets clinical candidates, and CTD chemical associations via MyDisease.info. These never change the interventional-trial headline.
Orphan designation (FDA · EMA)
No designation matched this disease via UMLS or preferred name on the FDA OOPD mirror or EMA orphan register. Absence here is not proof that none exists under another wording.
Open Targets candidates
No drugs or clinical candidates returned for this Mondo ID on Open Targets.
CTD chemicals (MyDisease.info)
52 associated chemicals. Therapeutic evidence is listed first when present — not a treatment recommendation.
- Chlorpromazine · therapeutic
- Cyproheptadine · therapeutic
- Diazepam · therapeutic
- Methysergide · therapeutic
- Midazolam · therapeutic
- Propranolol · therapeutic
- 5-(2-aminopropyl)indole · marker/mechanism
- 5-Hydroxytryptophan · marker/mechanism
- Amantadine · marker/mechanism
- Amitriptyline · marker/mechanism
- Bromocriptine · marker/mechanism
- Buspirone · marker/mechanism
Literature
Is anyone studying this?
6,456
6,456 papers — among the better-studied rare conditions, though still a fraction of common-disease literature (breast cancer: over 700,000). Median papers in the last 10 years for a rare disease in this dataset (publications denominator n=3967) is 59.
6,456 papers since the earliest indexed year in this search — median last-10-year count for a rare disease in this dataset is 59 (publications denominator n=3967).
3,787 in the last 10 years · low confidence
Phrase hits: 6,456 · MeSH hits: 0
Who's working on it?
833
Distinct author names in 200 sampled papers — named people below.
Who's working on it?
People publishing on this condition (sampled Europe PMC records). Affiliation is the most recent found in that sample.
- 01Wang H4 papers · 2026
Department of Pharmacy, Chengdu Second People' s Hospital, Chengdu, Sichuan, China.
Papers in Europe PMC - 02Wu J4 papers · 2026
The Affiliated Mental Health Center, Jiangnan University, Wuxi, China.
Papers in Europe PMC - 03Chiew AL3 papers · 2025
New South Wales Poisons Information Centre, Children's Hospital at Westmead, Westmead, New South Wales, Australia.
Papers in Europe PMC - 04Li N3 papers · 2026
Department of Pharmacy, Central People' s Hospital of Zhanjiang, Zhanjiang, Guangdong, China.
Papers in Europe PMC - 05Allen M2 papers · 2026
Department of Pediatrics (AC), Medical College of Wisconsin, Emergency Medicine (MA, JT), Medical College of Wisconsin, Milwaukee, WI.
Papers in Europe PMC - 06Anwar MM2 papers · 2026
Department of Biochemistry, National Organization for Drug Control and Research (NODCAR)/Egyptian Drug Authority (EDA), Cairo, Egypt.
Papers in Europe PMC - 07Buciuc AG2 papers · 2025
Psychiatry and Behavioral Sciences, University of Miami Miller School of Medicine/Jackson Health System, Miami, USA.
Papers in Europe PMC - 08
- 09Chen J2 papers · 2026
Department of Pharmacy, Chengdu Jinniu District People's Hospital, Chengdu, Sichuan, China.
Papers in Europe PMC - 10Cheung N2 papers · 2026
Cheung Ngo Medical Limited, Hong Kong, Hong Kong SAR, China.
Papers in Europe PMC
Clinical research
Is a treatment being tested?
2
interventional trials for this specific condition
2 interventional trials matched this specific condition name; none in our sample are currently recruiting.
Data as of 11 September 2026
2 interventional trials — more than 77.2% of diseases in the trials denominator have none at all (5501 of 7126; this disease is at the 84.5th percentile).
low confidence · 84.5th percentile (trials denominator)
Recruiting interventional trials
From the matched ClinicalTrials.gov set
2 interventional trials matched after quoted-phrase search and title/condition post-filter.
No currently recruiting studies in the matched set. Open the same search on ClinicalTrials.gov.
Observational and natural-history studies
1 observational study matches this condition. These do not test a treatment and are not counted in the interventional-trial headline, but they are genuine research: natural-history work often defines the endpoints needed for a future rare-disease trial, and families may be able to enroll.
None of the matched observational studies is currently listed as recruiting.
Other registries (secondary)
Broader net from EU CTIS, ISRCTN, and ICTRP when available — deduped against ClinicalTrials.gov IDs already counted above. Dual-model LLM relevance gates what we keep. These rows are not added to the interventional headline.
raw 53 · after dedupe 53 · already on CT.gov 0 · kept 0 · parent 0 · uncertain 53 · dropped 0 · fetched 2026-07-29
Source notes: ictrp: Error: ICTRP public search unavailable (WHO portal is SPA-only; SOAP needs partnership). Tried: https://apps.who.int/tri
No secondary-registry studies passed dual-model relevance for this condition name (after dedupe).
Uncertain / not reviewed (53)
- ctis·2025-522967-13-00·Authorised·A multicenter randomized, controlled, single-blind, adaptive phase IV clinical trial to evaluate the efficiency and effectiveness of a pre-emptive pharmacogenetic strategy for antidepressant selection in patients with depressive disorder: The PREDICT adaptive clinical trial.
skipped — LLM skipped (--skip-llm)
- ctis·2024-517770-14-00·Expired·Opioid-Free Analgesia In Intensive Care Unit : A Prospective, Monocentric, Randomized, Double-Blind, Feasibility Clinical Trial
skipped — LLM skipped (--skip-llm)
- isrctn·ISRCTN12142665·No longer recruiting·An innovative nutraceutical formulation for appetite control and premenstrual syndrome symptom management
skipped — LLM skipped (--skip-llm)
- isrctn·ISRCTN21554333·Not yet recruiting·ESTEEM: A clinical trial testing whether testosterone can help improve the quality of life during menopause
skipped — LLM skipped (--skip-llm)
- isrctn·ISRCTN42379352·No longer recruiting·Quantifying and modifying ultra-processed food intake in the management of functional dyspepsia
skipped — LLM skipped (--skip-llm)
- isrctn·ISRCTN73588250·No longer recruiting·The purpose of the trial is to test the safety, tolerability and efficacy of the drug tildacerfont, that is being developed for the treatment of major depressive disorder
skipped — LLM skipped (--skip-llm)
- isrctn·ISRCTN11466016·Recruiting·Study on the impact of methylcellulose and a special carbohydrate on bowel gas in people with IBS and constipation
skipped — LLM skipped (--skip-llm)
- isrctn·ISRCTN15384534·No longer recruiting·Modafinil to optimize the performance of cold-stressed sleep-deprived personnel
skipped — LLM skipped (--skip-llm)
- isrctn·ISRCTN85501054·No longer recruiting·The efficacy of nutraceuticals in the treatment of chronic insomnia
skipped — LLM skipped (--skip-llm)
- isrctn·ISRCTN12126820·No longer recruiting·The beneficial effect on sleep of a food supplement based on Scutellaria lateriflora L. (aerial parts of the plant)
skipped — LLM skipped (--skip-llm)
- isrctn·ISRCTN10974027·No longer recruiting·Safety, tolerability, pharmacokinetics, pharmacodynamics and exploratory efficacy of intravenous dosing of SPL026 drug product (N, N-dimethyltryptamine fumarate; DMT Fumarate [A Serotonergic Psychedelic]) alone or in combination with selective serotonin reuptake inhibitors in patients with major depressive disorder
skipped — LLM skipped (--skip-llm)
- isrctn·ISRCTN12054536·Recruiting·MiTiGate trial: Is Botox more effective than lidocaine and treatment as usual in myalgia temporomandibular disorder (TMD)?
skipped — LLM skipped (--skip-llm)
- isrctn·ISRCTN12358813·Recruiting·Asp-PSC: effect of aspirin on reducing cancer & improving outcomes in primary sclerosing cholangitis
skipped — LLM skipped (--skip-llm)
- isrctn·ISRCTN31103960·No longer recruiting·A dose-finding and proof-of-concept study of the efficacy and safety of MSP-1014.OX in patients with major depressive disorder
skipped — LLM skipped (--skip-llm)
- isrctn·ISRCTN15259909·No longer recruiting·Phase I psilocybin safety trial
skipped — LLM skipped (--skip-llm)
- isrctn·ISRCTN15110275·No longer recruiting·Cell therapy clinical trial of BOXR1030 in GPC3 positive liver, squamous lung, Merkel cell cancer, and myxoid/round cell liposarcoma
skipped — LLM skipped (--skip-llm)
- isrctn·ISRCTN11577984·No longer recruiting·A study on the safety and effects of the drug DMT in healthy smoking individuals
skipped — LLM skipped (--skip-llm)
- isrctn·ISRCTN42835524·No longer recruiting·Phase I Single- and Multiple-Ascending Dose Trial of EVX-101
skipped — LLM skipped (--skip-llm)
- isrctn·ISRCTN97695350·Recruiting·Tranexamic acid (and Desmopressin) for very early bleeds in the brain
skipped — LLM skipped (--skip-llm)
- isrctn·ISRCTN11573190·No longer recruiting·Comparative study about the distribution of Ialuril® in the bladder wall using a normal catheter or a specific device named Ialuadapter®
skipped — LLM skipped (--skip-llm)
- isrctn·ISRCTN13848689·No longer recruiting·Sumatriptan (a drug used for the treatment of migraine) and blood sugar
skipped — LLM skipped (--skip-llm)
- isrctn·ISRCTN12682719·No longer recruiting·Antidepressant for the prevention of depression following first-episode psychosis
skipped — LLM skipped (--skip-llm)
- isrctn·ISRCTN48548553·No longer recruiting·A randomised trial to compare the effectiveness of two antidepressants (escitalopram, a selective serotonin re-uptake inhibitor, SSRI) and (nortriptyline, a tricyclic antidepressant, TCA) compared to placebo for the treatment of depression in patients with Parkinson’s disease
skipped — LLM skipped (--skip-llm)
- isrctn·ISRCTN10584863·No longer recruiting·Psilocybin vs escitalopram for depression
skipped — LLM skipped (--skip-llm)
- isrctn·ISRCTN10616794·No longer recruiting·Understanding how increasing some of the brain's chemicals can help thinking and behaviour in people with frontotemporal dementia and progressive supranuclear palsy
skipped — LLM skipped (--skip-llm)
Where to find support
Condition-specific patient organisations, when Orphanet lists them, are on the disease’s Orphanet page. We also link umbrella groups that support undiagnosed and ultra-rare families.
Orphanet entry for Serotonin syndrome — check Associations / patient organisations on that page.
India — NPRD
Last verified 2026-07-26This ORPHAcode is not on our curated NPRD list (direct or Mondo-parent match). That does not decide clinical eligibility; families in India should ask a notified Centre of Excellence about current coverage.
Hand-curated for this project. ORPHAcode mappings are best-effort and may be incomplete or imprecise for umbrella categories. Parent (Mondo) matches mean the policy lists a broader category — confirm eligibility with a Centre of Excellence. Financial entitlements summarised from public policy statements and may change. This is not official government guidance.
How we counted this
Europe PMC query (preferred label + any corrected label + Orphanet and Mondo exact synonyms, stoplisted; unioned with resolved MeSH labels when available). UMLS / OMIM / NCIT cross-references are stored on the overview but are not added to the query string.
"Serotonin syndrome" OR "Serotonergic syndrome" OR "Serotonin storm" OR "Serotonin toxicity" OR "Serotonin toxidrome"
ClinicalTrials.gov query (quoted phrases + MeSH via query.cond, plus recall-expansion terms when used):
"Serotonin syndrome" OR "Serotonergic syndrome" OR "Serotonin storm" OR "Serotonin toxicity" OR "Serotonin toxidrome"
Interventional trials matched via: phrase (mesh = registered under a MeSH descriptor no name phrase would catch; recall-expansion = gene / selected parent terms used only for trials).
Study-type breakdown: 2 interventional · 1 observational · 0 expanded access. Only interventional studies enter the trial headline.
Query health: ok — strategies attempted: phrase; with hits: phrase
Run this search on ClinicalTrials.gov
Confidence reasoning
- Preferred label is short or not clearly distinctive
- No synonyms dropped by stoplist
- No label/synonym collisions with other diseases in this corpus
- Publication count (6456) is extremely high with unknown/missing prevalence — treat as possible over-matching, not proven research intensity
Ingested 2026-07-27T00:06:12.537Z
