CatatoniaNCT07315386
Catatonic Syndrome in Adult Patients at Basurto Hospital: A Descriptive Study of Incidence, Comorbidity, and Short-Term Outcomes
An observational study of Catatonia, run by Beatriz Rodriguez Cabo at 1 site in Spain.
Trial summary
This study aims to assess the incidence, sociodemographic and clinical characteristics, treatment response, and short-term outcomes of adult patients with catatonic syndrome in the Bilbao area (Spain). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Catatonia
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2024to 31 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of adult patients aged 18 years or older who are attended at Basurto University Hospital, a general university hospital providing secondary-level care to the Bilbao area (Spain), and who are diagnosed with catatonic syndrome during routine hospital care. Eligible participants include patients evaluated in any clinical setting, including the Emergency Department and inpatient medical or psychiatric units. Catatonia is diagnosed according to DSM-5 criteria and supported by systematic clinical assessment and severity quantification using the Bush-Francis Catatonia Rating Scale. Patients with catatonia of any etiology are included, reflecting an unselected adult hospital population.
Who may be able to join
- Age ≥ 18 years at the time of hospital care.
- Diagnosis of catatonic syndrome established according to DSM-5 criteria.
- Patients attended at Basurto University Hospital in any clinical setting, including the Emergency Department or inpatient physical or psychiatric units.
- Diagnosis made during the study period, from 1 January 2024 to 31 December 2025.
- Catatonia of any etiology, including psychiatric, neurological, medical, metabolic, toxic, or autoimmune causes.
- Provision of informed consent by the patient or their legal representative, when clinically feasible; deferred consent accepted in cases of acute catatonia.
Who cannot join
- Refusal to participate in the study by the patient or their legal representative.
- Withdrawal of informed consent at any point during the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Beatriz Rodriguez Cabo
Bilbao, Vizcaya
Beatriz Rodriguez Cabo, Professor, +349446066, beatriz.rodriguez@ehu.eus
About this study
This study aims to assess the incidence, sociodemographic and clinical characteristics, treatment response, and short-term outcomes of adult patients with catatonic syndrome in the Bilbao area (Spain). Data will be collected from January 2024 to December 2025 from all patients aged 18 years or older diagnosed with catatonia of any etiology at Basurto University Hospital who provide informed consent to participate.
Read the detailed description
Catatonic syndrome is a severe neuropsychiatric condition characterized by motor, behavioral, and speech abnormalities, frequently accompanied by autonomic and affective disturbances. Although historically conceptualized as a subtype of schizophrenia, current diagnostic classifications (DSM-5, ICD 11) recognize catatonia as a transdiagnostic syndrome that may occur in association with a wide range of psychiatric, neurological, metabolic, toxic, autoimmune and other medical conditions. Early recognition is clinically relevant, as catatonia is potentially reversible and timely treatment is associated with improved short-term outcomes.
Available epidemiological data indicate marked variability in the reported incidence and prevalence of catatonia across populations and clinical settings. Population-based studies from high-income countries (UK, USA) have reported incidence rates of approximately 4-5 catatonic episodes per 100,000 person-years. In contrast, studies conducted in acute psychiatric inpatient settings have described substantially higher prevalence rates, ranging from approximately 20% to over 40% of admitted patients.
In Spain, published data are limited to selected hospital-based subpopulations. Prevalence rates of approximately 8-9% have been reported in older adults assessed by liaison psychiatry services in general hospitals, while markedly higher rates have been described in specific psychiatric inpatient samples, including geriatric psychiatry wards (nearly 40%) and patients hospitalized for first-episode psychosis (approximately 20-25%). These findings highlight the influence of age, clinical setting, and underlying diagnosis on observed prevalence estimates.
To date, however, no studies have been conducted in Spain that systematically examine the incidence or prevalence of catatonic syndrome across an unselected adult hospital population, irrespective of underlying diagnoses or specific clinical subgroups. Consequently, the epidemiology and short-term clinical course of catatonia in a general hospital setting encompassing all medical and psychiatric services remain insufficiently characterized.
This prospective observational cohort study aims to address this gap by describing the incidence, sociodemographic and clinical characteristics, comorbidity profile, treatment response, and short-term outcomes of adult patients diagnosed with catatonic syndrome at Basurto University Hospital, a general university hospital providing secondary-level care to the Bilbao area (Spain). The study includes patients attended in any hospital service, including the emergency department and inpatient medical or psychiatric units.
All consecutive patients aged 18 years or older who are diagnosed with catatonia of any etiology during hospital care between 1 January 2024 and 31 December 2025 will be eligible for inclusion. The diagnosis of catatonia will be established according to DSM-5 criteria, requiring the presence of at least three characteristic catatonic signs identified through systematic clinical assessment. In addition, the Bush-Francis Catatonia Rating Scale (BFCRS) will be administered to support diagnostic assessment and severity quantification at presentation and during follow-up. Participants will be followed prospectively throughout their hospital stay, from diagnosis until medical discharge.
-
Hypotheses
Given the descriptive and observational nature of the study, the following hypotheses are formulated as expected patterns based on existing literature.
Primary hypothesis
-The incidence, sociodemographic characteristics, clinical presentation, comorbidity profile, treatment response, and short-term outcomes of catatonic syndrome observed in this study are expected to be broadly consistent with those reported in previous studies conducted in comparable healthcare settings.
Secondary hypotheses
- The incidence of catatonic syndrome in the adult hospital population is expected to fall within the range reported in population-based studies from high-income countries.
- The age distribution of catatonia is expected to show a bimodal pattern, with higher occurrence in early adulthood and later life.
- Hypokinetic presentations are expected to be more frequent than hyperkinetic or mixed forms in the hospital setting.
- Catatonic syndrome is expected to be associated with a heterogeneous range of underlying psychiatric and medical conditions, including affective and psychotic disorders as well as neurological and autoimmune conditions.
- Treatment with benzodiazepines is expected to be associated with a high rate of short-term clinical improvement.
- In the short term, catatonia is expected to be associated with an increased risk of medical complications related to immobility, without a marked increase in in-hospital mortality.
Study Variables
The following variables will be systematically collected and classified as primary and secondary variables.
Primary variable
-Annual incidence of catatonic syndrome, calculated as the number of new cases diagnosed at Basurto University Hospital per year divided by the reference population of the Bilbao catchment area, expressed as cases per 100,000 inhabitants per year.
Secondary variables
- Sociodemographic variables: age and sex.
- Catatonia-related variables: catatonia subtype (hypokinetic, hyperkinetic, or dyskinetic/mixed), BFCRS total score, and Global Clinical Impression scores at admission and discharge.
- Comorbidity variables: underlying psychiatric diagnoses and medical conditions, including neurological, autoimmune, metabolic, and toxic etiologies.
- Treatment-related variables: type of treatment administered (benzodiazepines, electroconvulsive therapy, or other pharmacological interventions) and response to benzodiazepine treatment (yes/no).
- Outcome variables: short-term clinical evolution categorized as complete recovery, incomplete recovery, lack of response, or death during hospitalization.
- Hospitalization-related variables: occurrence of medical complications during admission, length of hospital stay, and discharge destination.
Statistical Analysis
Statistical analysis will be primarily descriptive, in line with the observational design of the study. Incidence rates will be calculated annually and expressed per 100,000 inhabitants. Categorical variables will be summarized using frequencies and percentages, and quantitative variables will be described using appropriate measures of central tendency and dispersion. Missing data and losses will be documented and considered in the interpretation of results.
-
Ethical and Legal Considerations
The study will be conducted in accordance with the principles of the Declaration of Helsinki and with applicable national and European legislation governing biomedical research and the protection of personal data, including Regulation (EU) 2016/679 (General Data Protection Regulation), Spanish Organic Law 3/2018 on Personal Data Protection and Guarantee of Digital Rights, and Law 14/2007 on Biomedical Research.
The study protocol has been submitted for evaluation and approval by the corresponding Research Ethics Committee. Participation is voluntary, and refusal to participate or withdrawal from the study will not affect the medical care provided.
Clinical data will be collected from electronic medical records by authorized study personnel and subsequently pseudonymized prior to analysis. Identifiable data will be stored separately from the study database under restricted access and appropriate technical and organizational security measures.
Written informed consent will be obtained from participants or their legal representatives whenever clinically feasible. In cases of acute catatonia in which the patient lacks decision-making capacity at the time of diagnosis, informed consent will be sought once clinical recovery allows adequate understanding (deferred consent). In the event of in-hospital death before consent can be obtained, clinical data may be included in accordance with ethical committee guidance and applicable legal provisions, in order to minimize information bias.
The study does not involve any additional diagnostic procedures or therapeutic interventions beyond standard clinical care. No financial compensation is provided to participants, and no commercial funding is involved. Study results will be disseminated through scientific publications and presentations, ensuring full confidentiality of participant data.
- Conditions
- Catatonia
- Medical subject headings
- Catatonia
What is being measured
The primary outcome is the main question the study is designed to answer.
Annual incidence of catatonic syndrome
Annual incidence of catatonic syndrome in the adult hospital catchment population, defined as the number of new cases of catatonia diagnosed according to DSM-5 criteria at Basurto University Hospital during the study period, divided by the reference population of the Bilbao area and expressed as cases per 100,000 inhabitants per year. Diagnosis will be supported by systematic clinical assessment and severity quantification using the Bush-Francis Catatonia Rating Scale.
Measured: From 1 January 2024 to 31 December 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2026
- Study start1 Jan 2024
- Primary completion31 Dec 2025
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (31)Papers the sponsor has linked to this study.
- Other trials for CatatoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beatriz Rodriguez Cabo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Beatriz Rodriguez Cabo, University of the Basque Country (UPV/EHU)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07315386
- Sponsor's protocol ID
- HUB271125
- Status last verified
- Dec 2025
- First submitted
- 18 Dec 2025
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Cuevas-Esteban J, Serrat F, Iglesias-Gonzalez M, Motta N, Jimenez-Fernandez B, Vila-Badia R, Colomer-Salvans A, Serra-Arumi C, Cacho ND, Corbella-Sotil A, Butjosa A, Pardo M; PROFEP Group; Usall J. Catatonia in first-episode psychosis: prevalence and psychopathological association. BJPsych Open. 2025 Sep 23;11(5):e220. doi: 10.1192/bjo.2025.10834.
PubMed 40985102Cuevas-Esteban J, Iglesias-Gonzalez M, Rubio-Valera M, Serra-Mestres J, Serrano-Blanco A, Baladon L. Prevalence and characteristics of catatonia on admission to an acute geriatric psychiatry ward. Prog Neuropsychopharmacol Biol Psychiatry. 2017 Aug 1;78:27-33. doi: 10.1016/j.pnpbp.2017.05.013. Epub 2017 May 19.
PubMed 28533149Peralta V, Cuesta MJ. Motor features in psychotic disorders. II. Development of diagnostic criteria for catatonia. Schizophr Res. 2001 Mar 1;47(2-3):117-26. doi: 10.1016/s0920-9964(00)00035-9.
PubMed 11278128Smith JR, Lim S, Bindra S, Marler S, Rajah B, Williams ZJ, Baldwin I, Hossain N, Wilson JE, Fuchs DC, Luccarelli J. Longitudinal Symptom Burden and Pharmacologic Management of Catatonia in Autism With Intellectual Disability: An Observational Study. Autism Res. 2025 Feb;18(2):449-462. doi: 10.1002/aur.3315. Epub 2025 Jan 27.
PubMed 39866085Ramirez-Bermudez J, Medina-Gutierrez A, Gomez-Cianca H, Arias P, Perez-Gonzalez A, Lebrija-Reyes PA, Espinola-Nadurille M, Aguilar-Venegas LC, Ojeda-Lopez C, Restrepo-Martinez M, Bayliss L, Juarez-Jaramillo CA, Penaloza G, Rivas-Alonso V, Flores-Rivera J, Gomez-Amador JL, Rios C, Sachdev PS. Clinical Significance of Delirium With Catatonic Signs in Patients With Neurological Disorders. J Neuropsychiatry Clin Neurosci. 2022 Spring;34(2):132-140. doi: 10.1176/appi.neuropsych.18120364. Epub 2022 Jan 18.
PubMed 35040665Rogers JP, Pollak TA, Begum N, Griffin A, Carter B, Pritchard M, et al. Catatonia: demographic, clinical and laboratory associations. Psychological Medicine [Internet]. 2021 Nov 2 [cited 2022 Feb 14];1-11. Available from: https://www.cambridge.org/core/journals/psychological-medicine/article/catatonia- demographic-clinical-and-laboratory- associations/2676547CEE9AA7C0AC726A2E6CA4AA9B
Luccarelli J, Kalinich M, Fricchione G, Smith F, Beach SR, Smith JR. Diagnostic and demographic factors of pediatric and adult catatonia hospitalizations: A 2016-2020 National Inpatient Sample Study. Acta Psychiatr Scand. 2024 Oct;150(4):234-244. doi: 10.1111/acps.13744. Epub 2024 Aug 8.
PubMed 39118275Funayama M, Koreki A, Takata T, Kurose S. Catatonia, bedridden status, choking, water intoxication, and suicide are involved in deaths of schizophrenia inpatients. Asian J Psychiatr. 2020 Jun;51:102054. doi: 10.1016/j.ajp.2020.102054. Epub 2020 Apr 8. No abstract available.
PubMed 32283511Funayama M, Takata T, Koreki A, Ogino S, Mimura M. Catatonic Stupor in Schizophrenic Disorders and Subsequent Medical Complications and Mortality. Psychosom Med. 2018 May;80(4):370-376. doi: 10.1097/PSY.0000000000000574.
PubMed 29521882Jaimes-Albornoz W, Serra-Mestres J. Prevalence and clinical correlations of catatonia in older adults referred to a liaison psychiatry service in a general hospital. Gen Hosp Psychiatry. 2013 Sep-Oct;35(5):512-6. doi: 10.1016/j.genhosppsych.2013.04.009. Epub 2013 May 15.
PubMed 23684045Pelzer AC, van der Heijden FM, den Boer E. Systematic review of catatonia treatment. Neuropsychiatr Dis Treat. 2018 Jan 17;14:317-326. doi: 10.2147/NDT.S147897. eCollection 2018.
PubMed 29398916Hirjak D, Fricchione G, Wolf RC, Northoff G. Lorazepam in catatonia - Past, present and future of a clinical success story. Schizophr Res. 2024 Jan;263:27-34. doi: 10.1016/j.schres.2023.02.015. Epub 2023 Feb 18.
PubMed 36805317Cuevas-Esteban J, Serrat F, Baladon L, Rabaneda-Lombarte N, Díez-Quevedo C, Iglesias- González M. Factor analysis and validation of the Bush Francis catatonia rating scale-Spain version. The European Journal of Psychiatry [Internet]. 2023 Oct 1 [cited 2023 Nov 20];37(4):100221. Available from: https://www.sciencedirect.com/science/article/pii/S0213616323000344
Bush G, Fink M, Petrides G, Dowling F, Francis A. Catatonia. I. Rating scale and standardized examination. Acta Psychiatr Scand. 1996 Feb;93(2):129-36. doi: 10.1111/j.1600-0447.1996.tb09814.x.
PubMed 8686483Luccarelli J, Kalinich M, Rogers JP, Donovan AL, Smith FA, Beach SR, Smith JR. Emergency Department Presentations for Catatonia: A 2019-2021 National Emergency Department Sample Study. J Acad Consult Liaison Psychiatry. 2025 Sep-Oct;66(5):380-388. doi: 10.1016/j.jaclp.2025.08.006. Epub 2025 Aug 8.
PubMed 40784551
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Catatonic Syndrome in Adult Patients at Basurto Hospital: A Descriptive Study of Incidence, Comorbidity, and Short-Term Outcomes
- ClinicalTrials.gov ID
- NCT07315386
- Acronym / sponsor ID
- HUB271125
- Conditions
- Catatonia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Beatriz Rodriguez CaboUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 2 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to assess the incidence, sociodemographic and clinical characteristics, treatment response, and short-term outcomes of adult patients with catatonic syndrome in the Bilbao area (Spain). Data will be collected from January 2024 to December 2025 from all patients aged 18 years or older diagnosed with catatonia of any etiology at Basurto University Hospital who provide informed consent to participate.
Detailed description
Catatonic syndrome is a severe neuropsychiatric condition characterized by motor, behavioral, and speech abnormalities, frequently accompanied by autonomic and affective disturbances. Although historically conceptualized as a subtype of schizophrenia, current diagnostic classifications (DSM-5, ICD 11) recognize catatonia as a transdiagnostic syndrome that may occur in association with a wide range of psychiatric, neurological, metabolic, toxic, autoimmune and other medical conditions. Early recognition is clinically relevant, as catatonia is potentially reversible and timely treatment is associated with improved short-term outcomes.
Available epidemiological data indicate marked variability in the reported incidence and prevalence of catatonia across populations and clinical settings. Population-based studies from high-income countries (UK, USA) have reported incidence rates of approximately 4-5 catatonic episodes per 100,000 person-years. In contrast, studies conducted in acute psychiatric inpatient settings have described substantially higher prevalence rates, ranging from approximately 20% to over 40% of admitted patients.
In Spain, published data are limited to selected hospital-based subpopulations. Prevalence rates of approximately 8-9% have been reported in older adults assessed by liaison psychiatry services in general hospitals, while markedly higher rates have been described in specific psychiatric inpatient samples, including geriatric psychiatry wards (nearly 40%) and patients hospitalized for first-episode psychosis (approximately 20-25%). These findings highlight the influence of age, clinical setting, and underlying diagnosis on observed prevalence estimates.
To date, however, no studies have been conducted in Spain that systematically examine the incidence or prevalence of catatonic syndrome across an unselected adult hospital population, irrespective of underlying diagnoses or specific clinical subgroups. Consequently, the epidemiology and short-term clinical course of catatonia in a general hospital setting encompassing all medical and psychiatric services remain insufficiently characterized.
This prospective observational cohort study aims to address this gap by describing the incidence, sociodemographic and clinical characteristics, comorbidity profile, treatment response, and short-term outcomes of adult patients diagnosed with catatonic syndrome at Basurto University Hospital, a general university hospital providing secondary-level care to the Bilbao area (Spain). The study includes patients attended in any hospital service, including the emergency department and inpatient medical or psychiatric units.
All consecutive patients aged 18 years or older who are diagnosed with catatonia of any etiology during hospital care between 1 January 2024 and 31 December 2025 will be eligible for inclusion. The diagnosis of catatonia will be established according to DSM-5 criteria, requiring the presence of at least three characteristic catatonic signs identified through systematic clinical assessment. In addition, the Bush-Francis Catatonia Rating Scale (BFCRS) will be administered to support diagnostic assessment and severity quantification at presentation and during follow-up. Participants will be followed prospectively throughout their hospital stay, from diagnosis until medical discharge.
-
Hypotheses
Given the descriptive and observational nature of the study, the following hypotheses are formulated as expected patterns based on existing literature.
Primary hypothesis
-The incidence, sociodemographic characteristics, clinical presentation, comorbidity profile, treatment response, and short-term outcomes of catatonic syndrome observed in this study are expected to be broadly consistent with those reported in previous studies conducted in comparable healthcare settings.
Secondary hypotheses
- The incidence of catatonic syndrome in the adult hospital population is expected to fall within the range reported in population-based studies from high-income countries.
- The age distribution of catatonia is expected to show a bimodal pattern, with higher occurrence in early adulthood and later life.
- Hypokinetic presentations are expected to be more frequent than hyperkinetic or mixed forms in the hospital setting.
- Catatonic syndrome is expected to be associated with a heterogeneous range of underlying psychiatric and medical conditions, including affective and psychotic disorders as well as neurological and autoimmune conditions.
- Treatment with benzodiazepines is expected to be associated with a high rate of short-term clinical improvement.
- In the short term, catatonia is expected to be associated with an increased risk of medical complications related to immobility, without a marked increase in in-hospital mortality.
Study Variables
The following variables will be systematically collected and classified as primary and secondary variables.
Primary variable
-Annual incidence of catatonic syndrome, calculated as the number of new cases diagnosed at Basurto University Hospital per year divided by the reference population of the Bilbao catchment area, expressed as cases per 100,000 inhabitants per year.
Secondary variables
- Sociodemographic variables: age and sex.
- Catatonia-related variables: catatonia subtype (hypokinetic, hyperkinetic, or dyskinetic/mixed), BFCRS total score, and Global Clinical Impression scores at admission and discharge.
- Comorbidity variables: underlying psychiatric diagnoses and medical conditions, including neurological, autoimmune, metabolic, and toxic etiologies.
- Treatment-related variables: type of treatment administered (benzodiazepines, electroconvulsive therapy, or other pharmacological interventions) and response to benzodiazepine treatment (yes/no).
- Outcome variables: short-term clinical evolution categorized as complete recovery, incomplete recovery, lack of response, or death during hospitalization.
- Hospitalization-related variables: occurrence of medical complications during admission, length of hospital stay, and discharge destination.
Statistical Analysis
Statistical analysis will be primarily descriptive, in line with the observational design of the study. Incidence rates will be calculated annually and expressed per 100,000 inhabitants. Categorical variables will be summarized using frequencies and percentages, and quantitative variables will be described using appropriate measures of central tendency and dispersion. Missing data and losses will be documented and considered in the interpretation of results.
-
Ethical and Legal Considerations
The study will be conducted in accordance with the principles of the Declaration of Helsinki and with applicable national and European legislation governing biomedical research and the protection of personal data, including Regulation (EU) 2016/679 (General Data Protection Regulation), Spanish Organic Law 3/2018 on Personal Data Protection and Guarantee of Digital Rights, and Law 14/2007 on Biomedical Research.
The study protocol has been submitted for evaluation and approval by the corresponding Research Ethics Committee. Participation is voluntary, and refusal to participate or withdrawal from the study will not affect the medical care provided.
Clinical data will be collected from electronic medical records by authorized study personnel and subsequently pseudonymized prior to analysis. Identifiable data will be stored separately from the study database under restricted access and appropriate technical and organizational security measures.
Written informed consent will be obtained from participants or their legal representatives whenever clinically feasible. In cases of acute catatonia in which the patient lacks decision-making capacity at the time of diagnosis, informed consent will be sought once clinical recovery allows adequate understanding (deferred consent). In the event of in-hospital death before consent can be obtained, clinical data may be included in accordance with ethical committee guidance and applicable legal provisions, in order to minimize information bias.
The study does not involve any additional diagnostic procedures or therapeutic interventions beyond standard clinical care. No financial compensation is provided to participants, and no commercial funding is involved. Study results will be disseminated through scientific publications and presentations, ensuring full confidentiality of participant data.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult patients aged 18 years or older who are attended at Basurto University Hospital, a general university hospital providing secondary-level care to the Bilbao area (Spain), and who are diagnosed with catatonic syndrome during routine hospital care. Eligible participants include patients evaluated in any clinical setting, including the Emergency Department and inpatient medical or psychiatric units. Catatonia is diagnosed according to DSM-5 criteria and supported by systematic clinical assessment and severity quantification using the Bush-Francis Catatonia Rating Scale. Patients with catatonia of any etiology are included, reflecting an unselected adult hospital population.
Key inclusion criteria (6 listed)
- Age ≥ 18 years at the time of hospital care.
- Diagnosis of catatonic syndrome established according to DSM-5 criteria.
- Patients attended at Basurto University Hospital in any clinical setting, including the Emergency Department or inpatient physical or psychiatric units.
- Diagnosis made during the study period, from 1 January 2024 to 31 December 2025.
- Catatonia of any etiology, including psychiatric, neurological, medical, metabolic, toxic, or autoimmune causes.
Key exclusion criteria (2 listed)
- Refusal to participate in the study by the patient or their legal representative.
- Withdrawal of informed consent at any point during the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Annual incidence of catatonic syndrome
Time frame: From 1 January 2024 to 31 December 2025
Annual incidence of catatonic syndrome in the adult hospital catchment population, defined as the number of new cases of catatonia diagnosed according to DSM-5 criteria at Basurto University Hospital during the study period, divided by the reference population of the Bilbao area and expressed as cases per 100,000 inhabitants per year. Diagnosis will be supported by systematic clinical assessment and severity quantification using the Bush-Francis Catatonia Rating Scale.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Background: PubMed 40985102Cuevas-Esteban J, Serrat F, Iglesias-Gonzalez M, Motta N, Jimenez-Fernandez B, Vila-Badia R, Colomer-Salvans A, Serra-Arumi C, Cacho ND, Corbella-Sotil A, Butjosa A, Pardo M; PROFEP Group; Usall J. Catatonia in first-episode psychosis: prevalence and psychopathological association. BJPsych Open. 2025 Sep 23;11(5):e220. doi: 10.1192/bjo.2025.10834.
- Background: PubMed 28533149Cuevas-Esteban J, Iglesias-Gonzalez M, Rubio-Valera M, Serra-Mestres J, Serrano-Blanco A, Baladon L. Prevalence and characteristics of catatonia on admission to an acute geriatric psychiatry ward. Prog Neuropsychopharmacol Biol Psychiatry. 2017 Aug 1;78:27-33. doi: 10.1016/j.pnpbp.2017.05.013. Epub 2017 May 19.
- Background: PubMed 11278128Peralta V, Cuesta MJ. Motor features in psychotic disorders. II. Development of diagnostic criteria for catatonia. Schizophr Res. 2001 Mar 1;47(2-3):117-26. doi: 10.1016/s0920-9964(00)00035-9.
- Background: PubMed 39866085Smith JR, Lim S, Bindra S, Marler S, Rajah B, Williams ZJ, Baldwin I, Hossain N, Wilson JE, Fuchs DC, Luccarelli J. Longitudinal Symptom Burden and Pharmacologic Management of Catatonia in Autism With Intellectual Disability: An Observational Study. Autism Res. 2025 Feb;18(2):449-462. doi: 10.1002/aur.3315. Epub 2025 Jan 27.
- Background: PubMed 35040665Ramirez-Bermudez J, Medina-Gutierrez A, Gomez-Cianca H, Arias P, Perez-Gonzalez A, Lebrija-Reyes PA, Espinola-Nadurille M, Aguilar-Venegas LC, Ojeda-Lopez C, Restrepo-Martinez M, Bayliss L, Juarez-Jaramillo CA, Penaloza G, Rivas-Alonso V, Flores-Rivera J, Gomez-Amador JL, Rios C, Sachdev PS. Clinical Significance of Delirium With Catatonic Signs in Patients With Neurological Disorders. J Neuropsychiatry Clin Neurosci. 2022 Spring;34(2):132-140. doi: 10.1176/appi.neuropsych.18120364. Epub 2022 Jan 18.
- BackgroundRogers JP, Pollak TA, Begum N, Griffin A, Carter B, Pritchard M, et al. Catatonia: demographic, clinical and laboratory associations. Psychological Medicine [Internet]. 2021 Nov 2 [cited 2022 Feb 14];1-11. Available from: https://www.cambridge.org/core/journals/psychological-medicine/article/catatonia- demographic-clinical-and-laboratory- associations/2676547CEE9AA7C0AC726A2E6CA4AA9B
- Background: PubMed 39118275Luccarelli J, Kalinich M, Fricchione G, Smith F, Beach SR, Smith JR. Diagnostic and demographic factors of pediatric and adult catatonia hospitalizations: A 2016-2020 National Inpatient Sample Study. Acta Psychiatr Scand. 2024 Oct;150(4):234-244. doi: 10.1111/acps.13744. Epub 2024 Aug 8.
- Background: PubMed 32283511Funayama M, Koreki A, Takata T, Kurose S. Catatonia, bedridden status, choking, water intoxication, and suicide are involved in deaths of schizophrenia inpatients. Asian J Psychiatr. 2020 Jun;51:102054. doi: 10.1016/j.ajp.2020.102054. Epub 2020 Apr 8. No abstract available.
- Background: PubMed 29521882Funayama M, Takata T, Koreki A, Ogino S, Mimura M. Catatonic Stupor in Schizophrenic Disorders and Subsequent Medical Complications and Mortality. Psychosom Med. 2018 May;80(4):370-376. doi: 10.1097/PSY.0000000000000574.
- Background: PubMed 23684045Jaimes-Albornoz W, Serra-Mestres J. Prevalence and clinical correlations of catatonia in older adults referred to a liaison psychiatry service in a general hospital. Gen Hosp Psychiatry. 2013 Sep-Oct;35(5):512-6. doi: 10.1016/j.genhosppsych.2013.04.009. Epub 2013 May 15.
- Background: PubMed 29398916Pelzer AC, van der Heijden FM, den Boer E. Systematic review of catatonia treatment. Neuropsychiatr Dis Treat. 2018 Jan 17;14:317-326. doi: 10.2147/NDT.S147897. eCollection 2018.
- Background: PubMed 36805317Hirjak D, Fricchione G, Wolf RC, Northoff G. Lorazepam in catatonia - Past, present and future of a clinical success story. Schizophr Res. 2024 Jan;263:27-34. doi: 10.1016/j.schres.2023.02.015. Epub 2023 Feb 18.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Catatonia, run by Beatriz Rodriguez Cabo at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Beatriz Rodriguez-Cabo, Professor (+34944006066, beatriz.rodriguez@ehu.eus), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Annual incidence of catatonic syndrome (time frame: From 1 January 2024 to 31 December 2025). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07315386, which also lists 31 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.