Asperger SyndromeNCT02800681
Psychopathological Differences Between Asperger Syndrome and Schizotypal Disorder in an Adult Sample
An observational study of Asperger Syndrome and Autism Spectrum Disorder, run by Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital at 2 sites in Denmark.
Trial summary
The purpose of this study is to identify psychopathology (psychiatric symptoms) that can differentiate between Schizotypal Disorder (SD) and Asperger Syndrome (normal IQ, no language impairment Autism Spectrum Disorder) (AS) in young adults. Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Asperger Syndrome, Autism Spectrum Disorder, Schizotypal Personality Disorder
- What is being tested?
- Expert panel evaluation, Semi-structured psychopathological interviews and Self-administered rating scales
- How many people
- 59 participants
- Where
- 2 sitesDenmark
- Study dates
- Jun 2016to Dec 2018
- 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 18 to 30 years
- All sexes
- No healthy volunteers
- Adult
Study population: Only already diagnosed participants are recruited, from specialised units. This is essential, as inclusion of participants with typical symptoms, reduces confounding of the results by diagnostic uncertainty. Participants with SD will be recruited from OPUS-teams (a specialized treatment program for patients with first episode of schizophrenia spectrum disorder), within the Mental Health Services in the Capitol Region of Denmark, and participants with AS from The Danish Autism Centre (a non-profit organization for people with ASD).
Who may be able to join
- ICD-10 diagnosis of Asperger syndrome (F84.5) or infantile autism (F84.0) with normal IQ and no language impairments or schizotypal disorder (F21)
- Age 18-30 (both inclusive)
Who cannot join
- Known non-verbal IQ < 80 (verbal IQ < 70) or an educational level corresponding to <9 years of primary education
- Diagnosed with both Schizophrenia Spectrum Disorder and Autism Spectrum Disorder
- Psychotic symptoms (< 1 day of duration, lifetime)
- Severe physical illness (life-limiting, or limiting interview capacity)
- Organic brain disorder (corresponding to ICD-10 chapter F00-09)
- Active heavy alcohol or substance abuse (corresponding to ICD-10 definitions)
- Not fluent in the Danish language
- Forensic patients
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Mental Health Centre Ballerup, Mental Health Services, The Capitol Region, Copenhagen
Ballerup Municipality, Copenhagen, 2750
The Danish Autism Centre
Herlev, 2730
About this study
Official title: Psychopathological Differences Between Asperger Syndrome/Normal IQ, no Language Impairment Autism Spectrum Disorder and Schizotypal Disorder in an Adult Sample
The purpose of this study is to identify psychopathology (psychiatric symptoms) that can differentiate between Schizotypal Disorder (SD) and Asperger Syndrome (normal IQ, no language impairment Autism Spectrum Disorder) (AS) in young adults.
With our present knowledge, the differentiation between AS and SD can be difficult, as they both present with social difficulties, odd (but not psychotic) behaviour, and a 'feeling of not being as everyone else'. Studies suggest that adults with AS symptoms are either overlooked, or diagnosed within the schizophrenia spectrum in Adult Psychiatry.
Read more
A 'correct' diagnosis is important, as it is the first step towards the most optimal plan, treatment and rehabilitation for the patient. The only way to diagnose psychiatric illness is the description of present psychopathology.
To identify symptoms that can differentiate between the two disorders, we will use semi-structured interviews to explore present psychopathology in young adults with typical symptoms of SD and AS respectively, with special focus on presence of alterations in self-experience. Alterations in self-experience are typical for the schizophrenia spectrum, and are therefore not thought to be equally present in AS and SD.
The hypotheses are that the total level of altered experiences is higher in SD, than in AS, and with a different pattern of altered experiences in SD than in AS. If the hypotheses are true, an examination of altered self-experience will be valuable to aid clinical differentiation between the two disorders.
Read the detailed description
Background: SD is a non-psychotic disorder within the Schizophrenia Spectrum (in ICD-10), and has a prevalence of 3.9 % in adult samples. Autism Spectrum Disorder (ASD), a pervasive developmental disorder (including AS), has a prevalence of 1 %.
SD is typically diagnosed in young adults, whereas AS typically is diagnosed in childhood. Sometimes however, the AS symptoms first become invalidating in young adulthood, where social demands exceed the individual's capacity. In these cases, patients with symptoms corresponding to AS, might first be diagnosed as young adults. In Adult Psychiatry though, experience with diagnosing ASD is scarce, and studies suggest that adult patients presenting with symptoms corresponding to AS, are either overlooked, or diagnosed within the schizophrenia spectrum.
Psychiatric diagnosis: Description of present psychopathology is the only way to diagnose psychiatric illness. An accurate diagnosis is crucial for a relevant treatment and rehabilitation plan for the individual patient, as the diagnosis guides the help and support offered. Further, to properly guide neuro-psychiatric research, high diagnostic accuracy is imperative. This study will refer to the diagnostic criteria defined in ICD-10, when including participants, as ICD-10 is the principal diagnostic system in Denmark.
Altered self-experience: Alterations in self-experience are considered highly specific for the schizophrenia spectrum, and are therefore not thought to be present in equal amounts and/or distribution in ASD. If this is true, an examination of anomalous self-experiences would be valuable to aid clinical differentiation between SD and AS. For patients with altered self-experience, the experience of him-/herself as a subject is disturbed. This means that the form and structure (rather than content) of the patients' thoughts and experiences is altered.
Aim, objectives and hypotheses: The aim is to do an in depth exploration of differences in present psychopathology (psychiatric symptoms) in young adults with SD and AS. This will elaborate and refine our understanding of SD and AS specifically, and ASD and schizophrenia spectrum disorders in general.
The objectives are to; 1. Explore differences in psychopathology between young adults with SD and AS and, 2. Contribute to both the general and the specific (in SD and AS respectively) description of the autism concept.
The hypotheses are that; 1. The total level of altered experiences (EASE total score) is higher in SD than in AS and, 2. The pattern of most occurring altered experiences (individual EASE items) is different in AS, compared to SD.
Material and methods: The study is observational and comparative in design, and will include 100 participants; 50 diagnosed with SD, and 50 with AS. The included subjects medical history will be revised by two senior psychiatric consultants, ensuring identification of participants with typical symptoms. Further, all included participants will be assessed with three semi-structured psychopathological interviews, general symptom and functional scores and self-reports.
Co-ratings: All study interviews will be videotaped, and a subset of the taped SCAN and EASE interviews will be co-rated within the research group. Co-ratings will also routinely be performed amongst psychologists at The Danish Autism Centre, who conducts the ADOS interviews.
Statistical analyses: To investigate between group differences, group wise comparisons between SCAN algorithms, ADOS algorithms and EASE outcomes will be applied. Further, secondary correlations across psychopathological domains will be explored, and explorative cross-diagnostic factor analysis will be performed.
Ethical considerations: Prior to inclusion a differentiated informed consent will be obtained from all participants.
- Being tested
- Expert panel evaluation, Semi-structured psychopathological interviews, Self-administered rating scales, Other general interviewer ratings
- Keywords
- Asperger Syndrome, Autism Spectrum Disorder, Schizotypal disorder, Schizophrenia Spectrum Disorder, Psychopathology, Examination of Anomalous Self Disorder, Autism Diagnostic Observation Schedule, Phenomenology, Differential diagnosis, Young Adult
- Medical subject headings
- Asperger Syndrome, Autism Spectrum Disorder, Schizotypal Personality Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Expert panel evaluationOther
From the medical records, described social and psychiatric history and observed psychiatric symptoms will be summarized and presented to two senior psychiatric consultants. The panels evaluation ensures the identification of subjects with typical symptoms, according to a best estimate clinical consensus.
The panel divides the participants into 4 groups: 'participant with symptoms typical of AS', 'participant with symptoms typical of SD', 'participant with inconclusive/non typical symptoms' and 'non eligible participant'.
Semi-structured psychopathological interviewsOther
Included participants are asked for a detailed social and developmental history and interviewed with 3 semi-structured interviews: 1. Schedules for Assessment in Neuropsychiatry (SCAN); Covering psychopathology and behaviour associated with the major psychiatric disorders. 2. Autism Diagnostic Observation Schedule (ADOS), module 4; An assessment to identify symptoms within the autism spectrum. 3. Examination of anomalous self-experience (EASE); A checklist for exploration of experiential anomalies. The Ph.D.-student will obtain social and developmental history and carry out SCAN and EASE interviews. ADOS will be carried out by a consultant psychologist at The Danish Autism Centre.
Self-administered rating scalesOther
1.The Autism Quotient (AQ), a 50 question scale, for the assessment of autistic traits, 2. The Schizotypal Personality Questionnaire (SPQ), a 74 item scale, for the assessment of schizotypal personality, 3. The WHO-5 Well-Being Index (WHO-5), a 5 item scale, for the assessment of subjective psychological well-being.
Other general interviewer ratingsOther
- Global Assessment of Functioning (GAF), a numeric scale (1 through 100) for assessing social, occupational, and psychological functioning, 2. The Clinical Global Impressions scale (CGI-Severity), an assessment of the clinician's global view of the patient's severity of psychopathology on a 7 point scale.
| Study group | Role | What they receive |
|---|---|---|
| Asperger syndrome | 1. Expert panel evaluation for identification of participants with typical symptoms
2. Semi-structured psychopathological interviews for general psychopathology, psychopathology within the schizophrenia spectrum, and psychopathology within the autism spectrum
3. Self-administered rating scales for assessment of autistic traits, schizotypal personality and subjective psychological well-being
4. Other general interviewer ratings for assessing functioning and severity of psychopathology Receives: Other: Expert panel evaluation; Other: Semi-structured psychopathological interviews; Other: Self-administered rating scales; Other: Other general interviewer ratings | |
| Schizotypal disorder | 1. Expert panel evaluation for identification of participants with typical symptoms
2. Semi-structured psychopathological interviews for general psychopathology, psychopathology within the schizophrenia spectrum, and psychopathology within the autism spectrum
3. Self-administered rating scales for assessment of autistic traits, schizotypal personality and subjective psychological well-being
4. Other general interviewer ratings for assessing functioning and severity of psychopathology Receives: Other: Expert panel evaluation; Other: Semi-structured psychopathological interviews; Other: Self-administered rating scales; Other: Other general interviewer ratings |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of altered experiences
Total score, Examination of Anomalous Self Experience (EASE)
Measured: Assessed within 1,5 years from study inclusion start
Pattern of most occurring altered experiences
Pattern of individual items, Examination of Anomalous Self Experience (EASE)
Measured: Assessed within 1,5 years from study inclusion start
Secondary outcomes (5)
Autism Spectrum symptom load
Total score, Autism Diagnostic Observation Schedule (ADOS), module 4
Measured: Assessed within 1,5 years from study inclusion start
Schizophrenia Spectrum symptom load
Score, Schedules for Assessment in Neuropsychiatry (SCAN)
Measured: Assessed within 1,5 years from study inclusion start
Self-reported Autism Spectrum symptom load
Score, The Autism Quotient (AQ)
Measured: Assessed within 1,5 years from study inclusion start
Self-reported Schizotypia symptom load
Score, Schizotypal Personality Questionnaire (SPQ)
Measured: Assessed within 1,5 years from study inclusion start
Self-reported well-being
Score, World Health Organization Well-Being Index (WHO-5)
Measured: Assessed within 1,5 years from study inclusion start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asperger SyndromeStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Danish Autism Centre
- Responsible party
- Principal investigator, Maria Elisabeth Nilsson, Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
- Investigators
- Sidse Arnfred, MD, dr.med., Study chair, Mental Health Services, Region Zealand, DenmarkPeter Handest, MD, Ph.d., Study chair, Mental Health Services, the Capitol Region, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02800681
- Sponsor's protocol ID
- E-61120-06
- Status last verified
- Mar 2020
- First submitted
- 24 May 2016
- Last updated
- 10 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychopathological Differences Between Asperger Syndrome/Normal IQ, no Language Impairment Autism Spectrum Disorder and Schizotypal Disorder in an Adult Sample
- ClinicalTrials.gov ID
- NCT02800681
- Acronym / sponsor ID
- E-61120-06
- Keywords
- Asperger Syndrome, Autism Spectrum Disorder, Schizotypal disorder, Schizophrenia Spectrum Disorder, Psychopathology, Examination of Anomalous Self Disorder, Autism Diagnostic Observation Schedule, Phenomenology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg HospitalUniversity, hospital or other
- Collaborators
- The Danish Autism Centre
- Study start
- Jun 2016
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 15 Jun 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.
The purpose of this study is to identify psychopathology (psychiatric symptoms) that can differentiate between Schizotypal Disorder (SD) and Asperger Syndrome (normal IQ, no language impairment Autism Spectrum Disorder) (AS) in young adults.
With our present knowledge, the differentiation between AS and SD can be difficult, as they both present with social difficulties, odd (but not psychotic) behaviour, and a 'feeling of not being as everyone else'. Studies suggest that adults with AS symptoms are either overlooked, or diagnosed within the schizophrenia spectrum in Adult Psychiatry.
A 'correct' diagnosis is important, as it is the first step towards the most optimal plan, treatment and rehabilitation for the patient. The only way to diagnose psychiatric illness is the description of present psychopathology.
To identify symptoms that can differentiate between the two disorders, we will use semi-structured interviews to explore present psychopathology in young adults with typical symptoms of SD and AS respectively, with special focus on presence of alterations in self-experience. Alterations in self-experience are typical for the schizophrenia spectrum, and are therefore not thought to be equally present in AS and SD.
The hypotheses are that the total level of altered experiences is higher in SD, than in AS, and with a different pattern of altered experiences in SD than in AS. If the hypotheses are true, an examination of altered self-experience will be valuable to aid clinical differentiation between the two disorders.
Detailed description
Background: SD is a non-psychotic disorder within the Schizophrenia Spectrum (in ICD-10), and has a prevalence of 3.9 % in adult samples. Autism Spectrum Disorder (ASD), a pervasive developmental disorder (including AS), has a prevalence of 1 %.
SD is typically diagnosed in young adults, whereas AS typically is diagnosed in childhood. Sometimes however, the AS symptoms first become invalidating in young adulthood, where social demands exceed the individual's capacity. In these cases, patients with symptoms corresponding to AS, might first be diagnosed as young adults. In Adult Psychiatry though, experience with diagnosing ASD is scarce, and studies suggest that adult patients presenting with symptoms corresponding to AS, are either overlooked, or diagnosed within the schizophrenia spectrum.
Psychiatric diagnosis: Description of present psychopathology is the only way to diagnose psychiatric illness. An accurate diagnosis is crucial for a relevant treatment and rehabilitation plan for the individual patient, as the diagnosis guides the help and support offered. Further, to properly guide neuro-psychiatric research, high diagnostic accuracy is imperative. This study will refer to the diagnostic criteria defined in ICD-10, when including participants, as ICD-10 is the principal diagnostic system in Denmark.
Altered self-experience: Alterations in self-experience are considered highly specific for the schizophrenia spectrum, and are therefore not thought to be present in equal amounts and/or distribution in ASD. If this is true, an examination of anomalous self-experiences would be valuable to aid clinical differentiation between SD and AS. For patients with altered self-experience, the experience of him-/herself as a subject is disturbed. This means that the form and structure (rather than content) of the patients' thoughts and experiences is altered.
Aim, objectives and hypotheses: The aim is to do an in depth exploration of differences in present psychopathology (psychiatric symptoms) in young adults with SD and AS. This will elaborate and refine our understanding of SD and AS specifically, and ASD and schizophrenia spectrum disorders in general.
The objectives are to; 1. Explore differences in psychopathology between young adults with SD and AS and, 2. Contribute to both the general and the specific (in SD and AS respectively) description of the autism concept.
The hypotheses are that; 1. The total level of altered experiences (EASE total score) is higher in SD than in AS and, 2. The pattern of most occurring altered experiences (individual EASE items) is different in AS, compared to SD.
Material and methods: The study is observational and comparative in design, and will include 100 participants; 50 diagnosed with SD, and 50 with AS. The included subjects medical history will be revised by two senior psychiatric consultants, ensuring identification of participants with typical symptoms. Further, all included participants will be assessed with three semi-structured psychopathological interviews, general symptom and functional scores and self-reports.
Co-ratings: All study interviews will be videotaped, and a subset of the taped SCAN and EASE interviews will be co-rated within the research group. Co-ratings will also routinely be performed amongst psychologists at The Danish Autism Centre, who conducts the ADOS interviews.
Statistical analyses: To investigate between group differences, group wise comparisons between SCAN algorithms, ADOS algorithms and EASE outcomes will be applied. Further, secondary correlations across psychopathological domains will be explored, and explorative cross-diagnostic factor analysis will be performed.
Ethical considerations: Prior to inclusion a differentiated informed consent will be obtained from all participants.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Asperger syndrome | – | Other: Expert panel evaluation, Other: Semi-structured psychopathological interviews, Other: Self-administered rating scales, Other: Other general interviewer ratings1. Expert panel evaluation for identification of participants with typical symptoms 2. Semi-structured psychopathological interviews for general psychopathology, psychopathology within the schizophrenia spectrum, and psychopathology within the autism spectrum 3. Self-administered rating scales for assessment of autistic traits, schizotypal personality and subjective psychological well-being 4. Other general interviewer ratings for assessing functioning and severity of psychopathology |
| Schizotypal disorder | – | Other: Expert panel evaluation, Other: Semi-structured psychopathological interviews, Other: Self-administered rating scales, Other: Other general interviewer ratings1. Expert panel evaluation for identification of participants with typical symptoms 2. Semi-structured psychopathological interviews for general psychopathology, psychopathology within the schizophrenia spectrum, and psychopathology within the autism spectrum 3. Self-administered rating scales for assessment of autistic traits, schizotypal personality and subjective psychological well-being 4. Other general interviewer ratings for assessing functioning and severity of psychopathology |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Only already diagnosed participants are recruited, from specialised units. This is essential, as inclusion of participants with typical symptoms, reduces confounding of the results by diagnostic uncertainty. Participants with SD will be recruited from OPUS-teams (a specialized treatment program for patients with first episode of schizophrenia spectrum disorder), within the Mental Health Services in the Capitol Region of Denmark, and participants with AS from The Danish Autism Centre (a non-profit organization for people with ASD).
Key inclusion criteria (2 listed)
- ICD-10 diagnosis of Asperger syndrome (F84.5) or infantile autism (F84.0) with normal IQ and no language impairments or schizotypal disorder (F21)
- Age 18-30 (both inclusive)
Key exclusion criteria (8 listed)
- Known non-verbal IQ < 80 (verbal IQ < 70) or an educational level corresponding to <9 years of primary education
- Diagnosed with both Schizophrenia Spectrum Disorder and Autism Spectrum Disorder
- Psychotic symptoms (< 1 day of duration, lifetime)
- Severe physical illness (life-limiting, or limiting interview capacity)
- Organic brain disorder (corresponding to ICD-10 chapter F00-09)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Expert panel evaluationFrom the medical records, described social and psychiatric history and observed psychiatric symptoms will be summarized and presented to two senior psychiatric consultants. The panels evaluation ensures the identification of subjects with typical symptoms, according to a best estimate clinical consensus. The panel divides the participants into 4 groups: 'participant with symptoms typical of AS', 'participant with symptoms typical of SD', 'participant with inconclusive/non typical symptoms' and 'non eligible participant'. | Other | Asperger syndrome, Schizotypal disorder |
| Semi-structured psychopathological interviewsIncluded participants are asked for a detailed social and developmental history and interviewed with 3 semi-structured interviews: 1. Schedules for Assessment in Neuropsychiatry (SCAN); Covering psychopathology and behaviour associated with the major psychiatric disorders. 2. Autism Diagnostic Observation Schedule (ADOS), module 4; An assessment to identify symptoms within the autism spectrum. 3. Examination of anomalous self-experience (EASE); A checklist for exploration of experiential anomalies. The Ph.D.-student will obtain social and developmental history and carry out SCAN and EASE interviews. ADOS will be carried out by a consultant psychologist at The Danish Autism Centre. | Other | Asperger syndrome, Schizotypal disorder |
| Self-administered rating scales1.The Autism Quotient (AQ), a 50 question scale, for the assessment of autistic traits, 2. The Schizotypal Personality Questionnaire (SPQ), a 74 item scale, for the assessment of schizotypal personality, 3. The WHO-5 Well-Being Index (WHO-5), a 5 item scale, for the assessment of subjective psychological well-being. | Other | Asperger syndrome, Schizotypal disorder |
| Other general interviewer ratings1. Global Assessment of Functioning (GAF), a numeric scale (1 through 100) for assessing social, occupational, and psychological functioning, 2. The Clinical Global Impressions scale (CGI-Severity), an assessment of the clinician's global view of the patient's severity of psychopathology on a 7 point scale. | Other | Asperger syndrome, Schizotypal disorder |
Primary outcome
Level of altered experiences
Time frame: Assessed within 1,5 years from study inclusion start
Total score, Examination of Anomalous Self Experience (EASE)
Pattern of most occurring altered experiences
Time frame: Assessed within 1,5 years from study inclusion start
Pattern of individual items, Examination of Anomalous Self Experience (EASE)
5 secondary outcomes
Autism Spectrum symptom load
Time frame: Assessed within 1,5 years from study inclusion start
Schizophrenia Spectrum symptom load
Time frame: Assessed within 1,5 years from study inclusion start
Self-reported Autism Spectrum symptom load
Time frame: Assessed within 1,5 years from study inclusion start
Self-reported Schizotypia symptom load
Time frame: Assessed within 1,5 years from study inclusion start
Self-reported well-being
Time frame: Assessed within 1,5 years from study inclusion start
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2020.
- Individual participant dataSharing planned: No
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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.
Sidse Arnfred, MD, dr.med. study chair
Mental Health Services, Region Zealand, Denmark
Peter Handest, MD, Ph.d. study chair
Mental Health Services, the Capitol Region, Denmark
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asperger Syndrome and Autism Spectrum Disorder, run by Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital at 2 sites in Denmark.
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 2 inclusion and 8 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: finished, as of the sponsor's last update on 10 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Level of altered experiences (time frame: Assessed within 1,5 years from study inclusion start). The study lists 2 primary outcomes in all. 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 Mar 2020.