Autistic DisorderA-CATNCT02945423
Improving the Understanding of Catatonia in Autism
An observational study of Autistic Disorder and Catatonia, run by University of Michigan.
Trial summary
Catatonia is a neuropsychiatric syndrome which is frequently missed or misdiagnosed among psychiatric patients. The current project is a systematic examination of catatonia which will characterize the phenotype and identify biological correlates that play a central role in the pathophysiology and effective… Read more about this study
- Who is it for?
- Ages 10 to 30 years
- Conditions the study is for
- Autistic Disorder, Catatonia
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2020to Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 10 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Participants will be determined through University of Michigan medical record screening. Participants will be both male and female, between the ages of 10-30 years old (inclusive) and will have a previous diagnosis of catatonia, not secondary to a medical condition.
Who may be able to join
- Age range = 10 to 30 years.
- Already diagnosed with Catatonia during 2005 to 2015.
- Inclusive of current symptoms or have had symptoms in past (symptom
Who cannot join
- 1. Onset of catatonia is clearly secondary to general medical condition
- -
About this study
Catatonia is a neuropsychiatric syndrome which is frequently missed or misdiagnosed among psychiatric patients. The current project is a systematic examination of catatonia which will characterize the phenotype and identify biological correlates that play a central role in the pathophysiology and effective pharmacological treatment of this condition.
Read the detailed description
The specific aims of the study are to:
- Identify and phenotype participants ranging in age from 10-30 years old who are already diagnosed with catatonia.
- Review laboratory investigations already complete and further conduct any laboratory tests which were not previously completed, to exclude a general medical etiology of catatonia.
- Obtain skin biopsy for fibroblast from participant to reprogram somatic cells to iPSC (induced pluripotent cell lines) which will be differentiated to cortical neurons for in vitro pharmacological studies against the target tissue.
Up to 30 patients will be consented. Eligibility will be determined through UM medical record screening. When a potential participant is identified, the study team will reach out to the treating clinician to make contact with participant about research interest. Informed consent will be obtained prior to initiation of any study-related procedures. Consent may be emailed at request of potential participants or their representative in advance of a scheduled research appointment for their review. Additionally, informed consent will take place in person both verbally and in writing, with adequate time for participants to ask questions.
Following informed consent, a comprehensive psychiatric interview will be completed to identify overall psychiatric diagnoses and symptoms of catatonia. Based on this evaluation, a decision will be made whether or not the individual is testable or untestable for neurocognitive assessments.
A physical exam will be performed which will include weight, height, waist and head circumference, as well as vital signs that include blood pressure and pulse rate.
Electronic medical record (EMR) will be reviewed to identify any comorbid medical condition, lab results and medications received including the response to each agent. The medical disorders (current or past) may include infective 26 27,28, metabolic/ endocrine 29, autoimmune 30, toxic/ drug related 31 and seizure disorders.
Neuropsychological testing (NP): Standardized, well-validated tests will be used to assess emotional, behavioral and neuropsychological functioning where possible. Clinician completed ratings of autism symptoms will be completed, as well as parental rating scales for autism, general behavioral issues, and quality of life. In addition, each participant will undergo brief face-to face evaluations when catatonic symptoms do not preclude testing covering the domains of intellectual functioning, academic achievement, receptive language, executive functioning, and motor skills. These domains are typically included in neuropsychological testing protocols, are brief, and place minimal demands on participants.
Laboratory tests: Laboratory work up required for the purpose of this study will include CBC, CMP, free T4, TSH, thyroid antibodies, ANA, ASO, CRP, urine toxicology, urine or serum organic acids, Cu and ceruloplasmin, anti-NMDAR receptor antibodies, CMA (chromosomal microarray), fragile X, and EEG. If labs have been performed and are in the participant's medical record, they may be used as part of this study and not re-requested based upon physician judgment.
DNA: one 8ml vial of blood will be drawn and stored for future DNA analysis. DNA will be stored as part of the Heinz C. Prechter Genetics Repository.
Skin biopsy: a skin biopsy will be obtained from a subset of participants who meet inclusion and exclusion criteria.
Assessment: Standardized interviews and questionnaires will be completed by the participant or their representative.
Reliability: will be established between the interviewers, at the level of the interview and by best estimate diagnosis. All available sources of clinical information, including medical records, informant data, the ADOS and the ADI-R, will be independently reviewed by a non-interviewing psychiatrist or psychologist. Reviewers' "best-estimate" diagnoses will be established at regular investigator meetings. If all are in agreement, the consensus diagnosis is confirmed.
Quality Assurance: The PI and co-investigators will review all interviews to check for completeness and accuracy. Interviewers will be given feedback and subjects will be re-contacted as needed to correct problems or complete questions. This will reduce errors and missing data.
- Conditions
- Autistic Disorder, Catatonia
- Medical subject headings
- Autistic Disorder, Catatonia
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychiatric, cognitive and biological identification of catatonia in psychiatric illness
Psychiatric, medical, neuropsychological and biological testing will be completed in approximately 30 subjects and analyzed and reviewed by PI and Co-PIs to determine parameters of catatonia diagnosis in psychiatric patients.
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2016 (estimated)
- Study startMar 2020 (estimated)
- Primary completionOct 2021 (estimated)
- Study completionOct 2023 (estimated)
Why it stopped: funding issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autistic DisorderStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neera Ghaziuddin, University of Michigan
- Investigators
- Neera Ghaziuddin, M.D., Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02945423
- Sponsor's protocol ID
- HUM00113776
- Acronym
- A-CAT
- Status last verified
- Apr 2020
- First submitted
- 20 Oct 2016
- Last updated
- 10 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving the Understanding of Catatonia in Autism
- ClinicalTrials.gov ID
- NCT02945423
- Acronym / sponsor ID
- A-CAT / HUM00113776
- Conditions
- Autistic Disorder, Catatonia
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: funding issues
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Mar 2020 (estimated)
- Primary completion
- Oct 2021 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 26 Oct 2016 (estimated)
- 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.
Catatonia is a neuropsychiatric syndrome which is frequently missed or misdiagnosed among psychiatric patients. The current project is a systematic examination of catatonia which will characterize the phenotype and identify biological correlates that play a central role in the pathophysiology and effective pharmacological treatment of this condition.
Detailed description
The specific aims of the study are to:
- Identify and phenotype participants ranging in age from 10-30 years old who are already diagnosed with catatonia.
- Review laboratory investigations already complete and further conduct any laboratory tests which were not previously completed, to exclude a general medical etiology of catatonia.
- Obtain skin biopsy for fibroblast from participant to reprogram somatic cells to iPSC (induced pluripotent cell lines) which will be differentiated to cortical neurons for in vitro pharmacological studies against the target tissue.
Up to 30 patients will be consented. Eligibility will be determined through UM medical record screening. When a potential participant is identified, the study team will reach out to the treating clinician to make contact with participant about research interest. Informed consent will be obtained prior to initiation of any study-related procedures. Consent may be emailed at request of potential participants or their representative in advance of a scheduled research appointment for their review. Additionally, informed consent will take place in person both verbally and in writing, with adequate time for participants to ask questions.
Following informed consent, a comprehensive psychiatric interview will be completed to identify overall psychiatric diagnoses and symptoms of catatonia. Based on this evaluation, a decision will be made whether or not the individual is testable or untestable for neurocognitive assessments.
A physical exam will be performed which will include weight, height, waist and head circumference, as well as vital signs that include blood pressure and pulse rate.
Electronic medical record (EMR) will be reviewed to identify any comorbid medical condition, lab results and medications received including the response to each agent. The medical disorders (current or past) may include infective 26 27,28, metabolic/ endocrine 29, autoimmune 30, toxic/ drug related 31 and seizure disorders.
Neuropsychological testing (NP): Standardized, well-validated tests will be used to assess emotional, behavioral and neuropsychological functioning where possible. Clinician completed ratings of autism symptoms will be completed, as well as parental rating scales for autism, general behavioral issues, and quality of life. In addition, each participant will undergo brief face-to face evaluations when catatonic symptoms do not preclude testing covering the domains of intellectual functioning, academic achievement, receptive language, executive functioning, and motor skills. These domains are typically included in neuropsychological testing protocols, are brief, and place minimal demands on participants.
Laboratory tests: Laboratory work up required for the purpose of this study will include CBC, CMP, free T4, TSH, thyroid antibodies, ANA, ASO, CRP, urine toxicology, urine or serum organic acids, Cu and ceruloplasmin, anti-NMDAR receptor antibodies, CMA (chromosomal microarray), fragile X, and EEG. If labs have been performed and are in the participant's medical record, they may be used as part of this study and not re-requested based upon physician judgment.
DNA: one 8ml vial of blood will be drawn and stored for future DNA analysis. DNA will be stored as part of the Heinz C. Prechter Genetics Repository.
Skin biopsy: a skin biopsy will be obtained from a subset of participants who meet inclusion and exclusion criteria.
Assessment: Standardized interviews and questionnaires will be completed by the participant or their representative.
Reliability: will be established between the interviewers, at the level of the interview and by best estimate diagnosis. All available sources of clinical information, including medical records, informant data, the ADOS and the ADI-R, will be independently reviewed by a non-interviewing psychiatrist or psychologist. Reviewers' "best-estimate" diagnoses will be established at regular investigator meetings. If all are in agreement, the consensus diagnosis is confirmed.
Quality Assurance: The PI and co-investigators will review all interviews to check for completeness and accuracy. Interviewers will be given feedback and subjects will be re-contacted as needed to correct problems or complete questions. This will reduce errors and missing data.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 10 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Participants will be determined through University of Michigan medical record screening. Participants will be both male and female, between the ages of 10-30 years old (inclusive) and will have a previous diagnosis of catatonia, not secondary to a medical condition.
Key inclusion criteria (3 listed)
- Age range = 10 to 30 years.
- Already diagnosed with Catatonia during 2005 to 2015.
- Inclusive of current symptoms or have had symptoms in past (symptom
Key exclusion criteria (2 listed)
- 1. Onset of catatonia is clearly secondary to general medical condition
- -
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
Psychiatric, cognitive and biological identification of catatonia in psychiatric illness
Time frame: Three months
Psychiatric, medical, neuropsychological and biological testing will be completed in approximately 30 subjects and analyzed and reviewed by PI and Co-PIs to determine parameters of catatonia diagnosis in psychiatric patients.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2020.
- 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. This study is not recruiting at the moment.
Neera Ghaziuddin, M.D. principal investigator
University of Michigan
Questions about this trial
What is this clinical trial studying?
An observational study of Autistic Disorder and Catatonia, run by University of Michigan.
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 3 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: withdrawn, as of the sponsor's last update on 10 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychiatric, cognitive and biological identification of catatonia in psychiatric illness (time frame: Three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Apr 2020.