Mental DisorderASPPNCT05827406
A Useful Support System for Psychiatric Diagnostics and Follow-up in Adult Psychiatry and Primary Care (ASPP)
An observational study of Mental Disorder and Symptoms and Signs, run by Karolinska Institutet at 5 sites in Sweden.
Trial summary
Psychiatric diagnostics involve collecting information about a patient's symptoms, age of onset, development over time, relation to external stress, and ability to function and experience suffering. This information is classified using ICD (World Health Organisation) and DSM (American diagnosis system). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mental Disorder, Symptoms and Signs
- How many people
- 2,200 participants
- Where
- 5 sitesSweden
- Study dates
- 1 May 2023to 31 Dec 2026
- 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: Outpatients with psychiatric problems attend either one of the three adult psychiatric outpatient units or one of the two primary care centers.
Who may be able to join
- Patients with psychiatric problems
Who cannot join
- None
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Sweden5 sites, 5 recruiting
- Recruiting
Wemind
Stockholm, 112 34
Johan Skanberg, MD, +467702669950, johan.skanberg@wemind.se
- Recruiting
Prima vuxen
Stockholm, 117 43
Anders Berntsson, MD, +46733236777, anders.berntsson@prima.se
- Recruiting
Gustavsbergs vårdcentral
Stockholm, 134 40
Kersti Ejeby, MD, +46704848104, kersti.ejeby@regionstockholm.se
- Recruiting
Stuvsta vårdcentral
Stockholm, 141 40
Caroline Wachtler, MD, +46736716255, caroline.wachtler@ki.se
- Recruiting
Psykiatri Sydväst
Stockholm, 141 86
Oscar Norbeck, MD, +46739813746, oscar.norbeck@regionstockholm.se
About this study
Official title: Ett Användbart Stödsystem för Psykiatrisk Diagnostik Och uppföljning Inom Vuxenpsykiatri Och Primärvård (ASPP)
Psychiatric diagnostics involve collecting information about a patient's symptoms, age of onset, development over time, relation to external stress, and ability to function and experience suffering. This information is classified using ICD (World Health Organisation) and DSM (American diagnosis system). Currently, there is a lack of a scientifically evaluated system to support these diagnostics. This project seeks to develop and evaluate a set of self-assessment scales which collect and classify relevant data and serve as support for clinicians. These scales are made up of questions about typical psychiatric symptoms, which are assessed and evaluated using a statistical method (Item Response Theory). After testing and evaluation, a scale could consist of approximately 10 items or less. The scales are then tested together to see if the number of items and scales can be reduced further.
Read the detailed description
Psychiatric diagnostics are based on the systematization of information that can be collected about a patient's symptoms and behavior. The information typically concerns the symptoms a patient exhibits, the age of onset for the symptoms, how they have developed over time, whether they are related to any type of external stress, and whether the symptoms cause suffering and/or functional impairment. The collected information can then be classified using diagnostic manuals. The official one is the WHO's International Classification of Diseases (ICD). The American diagnostic system DSM is also used.
Today, there is a lack of a scientifically evaluated (validated) support system for psychiatric diagnostics. With this project, we aim to develop and scientifically evaluate a set of self-assessment scales that can collect and systematize relevant information about patients' symptom profiles, age of onset, long-term course, any possible relation to external stress, and function and suffering, which can serve as support for clinicians in the diagnostic process. Some of the scales are also intended to be used for follow-up.
Assessment scales consist of sets of questions or statements, which in this context are called "items." They describe deviant psychological symptoms (psychopathology) as gradually increasing phenomena (dimensions). In the project, we develop sets of items based on the most common diagnostic areas within psychiatry and general medicine. These are then tested on patients and evaluated using a modern statistical method specialized for developing scales, called Item Response Theory (IRT). The first sets of items contain between approximately 30 and 60 items. After evaluation, only the best-performing items are retained. Testing is repeated on new patient groups until they function optimally. The goal is for each scale to consist of approximately 10 items. Thereafter, the reduced scales are tested together and evaluated with IRT to, if possible, reduce the number of scales and items.
- Conditions
- Mental Disorder, Symptoms and Signs
- Keywords
- Rating Scale, Descriptive Psychopathology
- Medical subject headings
- Mental Disorders, Signs and Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: item set 1 | A group of patients with psychiatric problems, consecutively recruited from 5 specific sites in Stockholm, are asked to participate in the study. If they agree to participate, they will respond to a group of item sets (item set 1) that measure relevant psychopathological dimensions. Two hundred patients are asked to participate. We assume 50 % participation to receive 100 responses. | |
| Group 2: reduced item set 1 | We analyze data from group 1 and optimize item set 1 for the best measurement with the least number of items. Then, we recruit 200 new patients from the five sites in Stockholm with psychiatric issues for the psychometric validation of the reduced item set. We estimate a 50% participation rate, with the potential to modify that number based on the response rate of the previous recruitment. If the reduced item set 1 fails to validate, we may need to change it and recruit additional groups to optimize it. | |
| Group 3: item set 2 | A group of patients with psychiatric problems, consecutively recruited from 5 specific sites in Stockholm, are asked to participate in the study. If they agree to participate, they will respond to a group of item sets (item set 2) that measure relevant psychopathological dimensions. Two hundred patients are asked to participate. We estimate a 50% participation rate, with the potential to modify that number based on the response rate of the previous recruitment. | |
| Group 4: reduced item set 2 | We analyze data from group 3 and optimize item set 2 for the best measurement with the least number of items. Then, we recruit 200 new patients from the five sites in Stockholm with psychiatric issues for the psychometric validation of the reduced item set. We estimate a 50% participation rate, with the potential to modify that number based on the response rate of the previous recruitment. If the reduced item set 2 fails to validate, we may need to change it and recruit additional groups to optimize it | |
| Group 5: item set 3 | A group of patients with psychiatric problems, consecutively recruited from 5 specific sites in Stockholm, are asked to participate in the study. If they agree to participate, they will respond to a group of item sets (item set 3) that measure relevant psychopathological dimensions. Two hundred patients are asked to participate. We estimate a 50% participation rate, with the potential to modify that number based on the response rate of the previous recruitment. | |
| Group 6: reduced item set 3 | We analyze data from group 5 and optimize item set 3 for the best measurement with the least number of items. Then, we recruit 200 new patients from the five sites in Stockholm with psychiatric issues for the psychometric validation of the reduced item set. We estimate a 50% participation rate, with the potential to modify that number based on the response rate of the previous recruitment. If the reduced item set 3 fails to validate, we may need to change it and recruit additional groups to optimize it | |
| Group 7: item set 4 | A group of patients with psychiatric problems, consecutively recruited from 5 specific sites in Stockholm, are asked to participate in the study. If they agree to participate, they will respond to a group of item sets (item set 4) that measure relevant psychopathological dimensions. Two hundred patients are asked to participate. We estimate a 50% participation rate, with the potential to modify that number based on the response rate of the previous recruitment. | |
| Group 8: reduced item set 4 | We analyze data from group 7 and optimize item set 4 for the best measurement with the least number of items. Then, we recruit 200 new patients from the five sites in Stockholm with psychiatric issues for the psychometric validation of the reduced item set. We estimate a 50% participation rate, with the potential to modify that number based on the response rate of the previous recruitment. If the reduced item set 4 fails to validate, we may need to change it and recruit additional groups to optimize it. | |
| Group 9: item set 5 | A group of patients with psychiatric problems, consecutively recruited from 5 specific sites in Stockholm, are asked to participate in the study. If they agree to participate, they will respond to a group of item sets (item set 5) that measure relevant psychopathological dimensions. Two hundred patients are asked to participate. We estimate a 50% participation rate, with the potential to modify that number based on the response rate of the previous recruitment. | |
| Group 10: reduced item set 5 | We analyze data from group 9 and optimize item set 5 for the best measurement with the least number of items. Then, we recruit 200 new patients from the five sites in Stockholm with psychiatric issues for the psychometric validation of the reduced item set. We estimate a 50% participation rate, with the potential to modify that number based on the response rate of the previous recruitment. If the reduced item set 5 fails to validate, we may need to change it and recruit additional groups to optimize it. | |
| Group 11: item set 6 | A group of patients with psychiatric problems, consecutively recruited from 5 specific sites in Stockholm, are asked to participate in the study. If they agree to participate, they will respond to a group of item sets (item set 6) that measure relevant psychopathological dimensions. Two hundred patients are asked to participate. We estimate a 50% participation rate, with the potential to modify that number based on the response rate of the previous recruitment. | |
| Group 12: reduced item set 6 | We analyze data from group 11 and optimize item set 6 for the best measurement with the least number of items. Then, we recruit 200 new patients from the five sites in Stockholm with psychiatric issues for the psychometric validation of the reduced item set. We estimate a 50% participation rate, with the potential to modify that number based on the response rate of the previous recruitment. If the reduced item set 6 fails to validate, we may need to change it and recruit additional groups to optimize it. | |
| Group 13: combined item sets | In this group, we aim to combine the optimized item sets in item sets 1-6. We recruit 1000 new patients from the five sites in Stockholm with psychiatric issues for the psychometric validation of the combined item set. We estimate a 50% participation rate, with the potential to modify that number based on the response rate of the previous recruitment. | |
| Group 14: reduced combined item sets | We analyze data from group 13 and optimize the combined item set for the best measurement with the least number of items and the least number of dimensions. We estimate a 50% participation rate, with the potential to modify that number based on the response rate of the previous recruitment. If the reduced combined item set fails to validate, we may need to change it and recruit additional groups to optimize it. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scalability H
Scalability coefficient H (ranging from 0 to 1) of each subdimension as assessed with Mokken Item Response Theory. A minimal requirement of H ≥ 0.4 is deemed necessary for inclusion in the DPS.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2023
- Study start1 May 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Mental DisorderStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 2,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mats Adler, Karolinska Institutet
- Investigators
- Mats O Adler, MD, Principal investigator, Karolinska Institutet, Department of Clinical Neuroscience
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05827406
- Sponsor's protocol ID
- 2022-07160-01
- Acronym
- ASPP
- Status last verified
- Oct 2023
- First submitted
- 23 Mar 2023
- Last updated
- 18 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Adler M, Liberg B, Andersson S, Isacsson G, Hetta J. Development and validation of the Affective Self Rating Scale for manic, depressive, and mixed affective states. Nord J Psychiatry. 2008;62(2):130-5. doi: 10.1080/08039480801960354.
PubMed 18569776Adler M, Brodin U. An IRT validation of the Affective Self Rating Scale. Nord J Psychiatry. 2011 Dec;65(6):396-402. doi: 10.3109/08039488.2011.577187. Epub 2011 May 4.
PubMed 21539501Adler M, Backlund L, Edman G, Osby U. Symptoms and treatment of bipolar patients in Sweden. Int J Psychiatry Clin Pract. 2012 Sep;16(3):170-7. doi: 10.3109/13651501.2011.653377. Epub 2012 Mar 21.
PubMed 22432978Adler M, Hetta J, Isacsson G, Brodin U. An item response theory evaluation of three depression assessment instruments in a clinical sample. BMC Med Res Methodol. 2012 Jun 21;12:84. doi: 10.1186/1471-2288-12-84.
PubMed 22721257Isacsson G, Adler M. Randomized clinical trials underestimate the efficacy of antidepressants in less severe depression. Acta Psychiatr Scand. 2012 Jun;125(6):453-9. doi: 10.1111/j.1600-0447.2011.01815.x. Epub 2011 Dec 19.
PubMed 22176585Cameron IM, Scott NW, Adler M, Reid IC. A comparison of three methods of assessing differential item functioning (DIF) in the Hospital Anxiety Depression Scale: ordinal logistic regression, Rasch analysis and the Mantel chi-square procedure. Qual Life Res. 2014 Dec;23(10):2883-8. doi: 10.1007/s11136-014-0719-3. Epub 2014 May 22.
PubMed 24848597Abe C, Liberg B, Song J, Bergen SE, Petrovic P, Ekman CJ, Sellgren CM, Ingvar M, Landen M. Longitudinal Cortical Thickness Changes in Bipolar Disorder and the Relationship to Genetic Risk, Mania, and Lithium Use. Biol Psychiatry. 2020 Feb 1;87(3):271-281. doi: 10.1016/j.biopsych.2019.08.015. Epub 2019 Aug 29.
PubMed 31635761Liberg B, Rahm C, Panayiotou A, Pantelis C. Brain change trajectories that differentiate the major psychoses. Eur J Clin Invest. 2016 Jul;46(7):658-74. doi: 10.1111/eci.12641. Epub 2016 Jun 15.
PubMed 27208657Liberg B, Klauser P, Harding IH, Adler M, Rahm C, Lundberg J, Masterman T, Wachtler C, Jonsson T, Kristoffersen-Wiberg M, Pantelis C, Wahlund B. Functional and structural alterations in the cingulate motor area relate to decreased fronto-striatal coupling in major depressive disorder with psychomotor disturbances. Front Psychiatry. 2014 Dec 4;5:176. doi: 10.3389/fpsyt.2014.00176. eCollection 2014.
PubMed 25538633
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ett Användbart Stödsystem för Psykiatrisk Diagnostik Och uppföljning Inom Vuxenpsykiatri Och Primärvård (ASPP)
- ClinicalTrials.gov ID
- NCT05827406
- Acronym / sponsor ID
- ASPP / 2022-07160-01
- Conditions
- Mental Disorder, Symptoms and Signs
- Keywords
- Rating Scale, Descriptive Psychopathology
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,200 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 25 Apr 2023 (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.
Psychiatric diagnostics involve collecting information about a patient's symptoms, age of onset, development over time, relation to external stress, and ability to function and experience suffering. This information is classified using ICD (World Health Organisation) and DSM (American diagnosis system). Currently, there is a lack of a scientifically evaluated system to support these diagnostics. This project seeks to develop and evaluate a set of self-assessment scales which collect and classify relevant data and serve as support for clinicians. These scales are made up of questions about typical psychiatric symptoms, which are assessed and evaluated using a statistical method (Item Response Theory). After testing and evaluation, a scale could consist of approximately 10 items or less. The scales are then tested together to see if the number of items and scales can be reduced further.
Detailed description
Psychiatric diagnostics are based on the systematization of information that can be collected about a patient's symptoms and behavior. The information typically concerns the symptoms a patient exhibits, the age of onset for the symptoms, how they have developed over time, whether they are related to any type of external stress, and whether the symptoms cause suffering and/or functional impairment. The collected information can then be classified using diagnostic manuals. The official one is the WHO's International Classification of Diseases (ICD). The American diagnostic system DSM is also used.
Today, there is a lack of a scientifically evaluated (validated) support system for psychiatric diagnostics. With this project, we aim to develop and scientifically evaluate a set of self-assessment scales that can collect and systematize relevant information about patients' symptom profiles, age of onset, long-term course, any possible relation to external stress, and function and suffering, which can serve as support for clinicians in the diagnostic process. Some of the scales are also intended to be used for follow-up.
Assessment scales consist of sets of questions or statements, which in this context are called "items." They describe deviant psychological symptoms (psychopathology) as gradually increasing phenomena (dimensions). In the project, we develop sets of items based on the most common diagnostic areas within psychiatry and general medicine. These are then tested on patients and evaluated using a modern statistical method specialized for developing scales, called Item Response Theory (IRT). The first sets of items contain between approximately 30 and 60 items. After evaluation, only the best-performing items are retained. Testing is repeated on new patient groups until they function optimally. The goal is for each scale to consist of approximately 10 items. Thereafter, the reduced scales are tested together and evaluated with IRT to, if possible, reduce the number of scales and items.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 14
| Arm | Type | Receives |
|---|---|---|
| Group 1: item set 1 | – | –A group of patients with psychiatric problems, consecutively recruited from 5 specific sites in Stockholm, are asked to participate in the study. If they agree to participate, they will respond to a group of item sets (item set 1) that measure relevant psychopathological dimensions. Two hundred patients are asked to participate. We assume 50 % participation to receive 100 responses. |
| Group 2: reduced item set 1 | – | –We analyze data from group 1 and optimize item set 1 for the best measurement with the least number of items. Then, we recruit 200 new patients from the five sites in Stockholm with psychiatric issues for the psychometric validation of the reduced item set. We estimate a 50% participation rate, with the potential to modify that number based on the response rate of the previous recruitment. If the reduced item set 1 fails to validate, we may need to change it and recruit additional groups to optimize it. |
| Group 3: item set 2 | – | –A group of patients with psychiatric problems, consecutively recruited from 5 specific sites in Stockholm, are asked to participate in the study. If they agree to participate, they will respond to a group of item sets (item set 2) that measure relevant psychopathological dimensions. Two hundred patients are asked to participate. We estimate a 50% participation rate, with the potential to modify that number based on the response rate of the previous recruitment. |
| Group 4: reduced item set 2 | – | –We analyze data from group 3 and optimize item set 2 for the best measurement with the least number of items. Then, we recruit 200 new patients from the five sites in Stockholm with psychiatric issues for the psychometric validation of the reduced item set. We estimate a 50% participation rate, with the potential to modify that number based on the response rate of the previous recruitment. If the reduced item set 2 fails to validate, we may need to change it and recruit additional groups to optimize it |
| Group 5: item set 3 | – | –A group of patients with psychiatric problems, consecutively recruited from 5 specific sites in Stockholm, are asked to participate in the study. If they agree to participate, they will respond to a group of item sets (item set 3) that measure relevant psychopathological dimensions. Two hundred patients are asked to participate. We estimate a 50% participation rate, with the potential to modify that number based on the response rate of the previous recruitment. |
| Group 6: reduced item set 3 | – | –We analyze data from group 5 and optimize item set 3 for the best measurement with the least number of items. Then, we recruit 200 new patients from the five sites in Stockholm with psychiatric issues for the psychometric validation of the reduced item set. We estimate a 50% participation rate, with the potential to modify that number based on the response rate of the previous recruitment. If the reduced item set 3 fails to validate, we may need to change it and recruit additional groups to optimize it |
| Group 7: item set 4 | – | –A group of patients with psychiatric problems, consecutively recruited from 5 specific sites in Stockholm, are asked to participate in the study. If they agree to participate, they will respond to a group of item sets (item set 4) that measure relevant psychopathological dimensions. Two hundred patients are asked to participate. We estimate a 50% participation rate, with the potential to modify that number based on the response rate of the previous recruitment. |
| Group 8: reduced item set 4 | – | –We analyze data from group 7 and optimize item set 4 for the best measurement with the least number of items. Then, we recruit 200 new patients from the five sites in Stockholm with psychiatric issues for the psychometric validation of the reduced item set. We estimate a 50% participation rate, with the potential to modify that number based on the response rate of the previous recruitment. If the reduced item set 4 fails to validate, we may need to change it and recruit additional groups to optimize it. |
| Group 9: item set 5 | – | –A group of patients with psychiatric problems, consecutively recruited from 5 specific sites in Stockholm, are asked to participate in the study. If they agree to participate, they will respond to a group of item sets (item set 5) that measure relevant psychopathological dimensions. Two hundred patients are asked to participate. We estimate a 50% participation rate, with the potential to modify that number based on the response rate of the previous recruitment. |
| Group 10: reduced item set 5 | – | –We analyze data from group 9 and optimize item set 5 for the best measurement with the least number of items. Then, we recruit 200 new patients from the five sites in Stockholm with psychiatric issues for the psychometric validation of the reduced item set. We estimate a 50% participation rate, with the potential to modify that number based on the response rate of the previous recruitment. If the reduced item set 5 fails to validate, we may need to change it and recruit additional groups to optimize it. |
| Group 11: item set 6 | – | –A group of patients with psychiatric problems, consecutively recruited from 5 specific sites in Stockholm, are asked to participate in the study. If they agree to participate, they will respond to a group of item sets (item set 6) that measure relevant psychopathological dimensions. Two hundred patients are asked to participate. We estimate a 50% participation rate, with the potential to modify that number based on the response rate of the previous recruitment. |
| Group 12: reduced item set 6 | – | –We analyze data from group 11 and optimize item set 6 for the best measurement with the least number of items. Then, we recruit 200 new patients from the five sites in Stockholm with psychiatric issues for the psychometric validation of the reduced item set. We estimate a 50% participation rate, with the potential to modify that number based on the response rate of the previous recruitment. If the reduced item set 6 fails to validate, we may need to change it and recruit additional groups to optimize it. |
| Group 13: combined item sets | – | –In this group, we aim to combine the optimized item sets in item sets 1-6. We recruit 1000 new patients from the five sites in Stockholm with psychiatric issues for the psychometric validation of the combined item set. We estimate a 50% participation rate, with the potential to modify that number based on the response rate of the previous recruitment. |
| Group 14: reduced combined item sets | – | –We analyze data from group 13 and optimize the combined item set for the best measurement with the least number of items and the least number of dimensions. We estimate a 50% participation rate, with the potential to modify that number based on the response rate of the previous recruitment. If the reduced combined item set fails to validate, we may need to change it and recruit additional groups to optimize it. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Outpatients with psychiatric problems attend either one of the three adult psychiatric outpatient units or one of the two primary care centers.
Key inclusion criteria (1 listed)
- Patients with psychiatric problems
Key exclusion criteria (1 listed)
- None
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
Scalability H
Time frame: Day 1
Scalability coefficient H (ranging from 0 to 1) of each subdimension as assessed with Mokken Item Response Theory. A minimal requirement of H ≥ 0.4 is deemed necessary for inclusion in the DPS.
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 18 Oct 2023.
- Results publication: PubMed 18569776Adler M, Liberg B, Andersson S, Isacsson G, Hetta J. Development and validation of the Affective Self Rating Scale for manic, depressive, and mixed affective states. Nord J Psychiatry. 2008;62(2):130-5. doi: 10.1080/08039480801960354.
- Results publication: PubMed 21539501Adler M, Brodin U. An IRT validation of the Affective Self Rating Scale. Nord J Psychiatry. 2011 Dec;65(6):396-402. doi: 10.3109/08039488.2011.577187. Epub 2011 May 4.
- Results publication: PubMed 22432978Adler M, Backlund L, Edman G, Osby U. Symptoms and treatment of bipolar patients in Sweden. Int J Psychiatry Clin Pract. 2012 Sep;16(3):170-7. doi: 10.3109/13651501.2011.653377. Epub 2012 Mar 21.
- Results publication: PubMed 22721257Adler M, Hetta J, Isacsson G, Brodin U. An item response theory evaluation of three depression assessment instruments in a clinical sample. BMC Med Res Methodol. 2012 Jun 21;12:84. doi: 10.1186/1471-2288-12-84.
- Results publication: PubMed 22176585Isacsson G, Adler M. Randomized clinical trials underestimate the efficacy of antidepressants in less severe depression. Acta Psychiatr Scand. 2012 Jun;125(6):453-9. doi: 10.1111/j.1600-0447.2011.01815.x. Epub 2011 Dec 19.
- Results publication: PubMed 24848597Cameron IM, Scott NW, Adler M, Reid IC. A comparison of three methods of assessing differential item functioning (DIF) in the Hospital Anxiety Depression Scale: ordinal logistic regression, Rasch analysis and the Mantel chi-square procedure. Qual Life Res. 2014 Dec;23(10):2883-8. doi: 10.1007/s11136-014-0719-3. Epub 2014 May 22.
- Results publication: PubMed 31635761Abe C, Liberg B, Song J, Bergen SE, Petrovic P, Ekman CJ, Sellgren CM, Ingvar M, Landen M. Longitudinal Cortical Thickness Changes in Bipolar Disorder and the Relationship to Genetic Risk, Mania, and Lithium Use. Biol Psychiatry. 2020 Feb 1;87(3):271-281. doi: 10.1016/j.biopsych.2019.08.015. Epub 2019 Aug 29.
- Results publication: PubMed 27208657Liberg B, Rahm C, Panayiotou A, Pantelis C. Brain change trajectories that differentiate the major psychoses. Eur J Clin Invest. 2016 Jul;46(7):658-74. doi: 10.1111/eci.12641. Epub 2016 Jun 15.
- Results publication: PubMed 25538633Liberg B, Klauser P, Harding IH, Adler M, Rahm C, Lundberg J, Masterman T, Wachtler C, Jonsson T, Kristoffersen-Wiberg M, Pantelis C, Wahlund B. Functional and structural alterations in the cingulate motor area relate to decreased fronto-striatal coupling in major depressive disorder with psychomotor disturbances. Front Psychiatry. 2014 Dec 4;5:176. doi: 10.3389/fpsyt.2014.00176. eCollection 2014.
- 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.
Mats O Adler, MD principal investigator
Karolinska Institutet, Department of Clinical Neuroscience
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mental Disorder and Symptoms and Signs, run by Karolinska Institutet at 5 sites in Sweden.
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 1 inclusion and 1 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 18 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Sweden. 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 Mats O Adler, MD (+46707717977, mats.adler@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scalability H (time frame: Day 1). 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 NCT05827406, which also lists 9 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 18 Oct 2023.