Obsessive-compulsive Disorder With Acute OnsetNCT02190292
PANS - A Detailed Study of the Patients, Their Symptoms, Biomarkers and Treatment Offered in a Scandinavian Cohort
An observational study of Obsessive-compulsive Disorder With Acute Onset and PANDAS, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
Background: Obsessive-compulsive disorder (OCD) is considered one of the most debilitating of the psychiatric illnesses, yet much remains unclear regarding causes and cures. A diagnostic subgroup with acute onset of obsessive-compulsive symptoms (and sometimes tics or anorexia nervosa) possibly due to an autoimmune… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Obsessive-compulsive Disorder With Acute Onset, PANDAS, Pediatric Autoimmune Neuropsychiatric Disorders Associated With Streptococcal Infections
- How many people
- 185 participants
- Where
- 1 siteSweden
- Study dates
- Jun 2014to 30 Jun 2017
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Consecutive cases that have been assumed to have PANS and have been assessed with the Cunningham panel in Scandinavia.
Who may be able to join
- Scandinavian patients assessed with the Cunningham panel through Wieslab, Lund, Sweden or Statens Serum Institut (SSI), Copenhagen, Denmark.
- diagnosed with a psychiatric disorder
- age <40 years
- age and sex matched to the PANS-group
Who cannot join
- intellectual disability, non-Swedish speaking
- intellectual disability, non-Swedish speaking
- intellectual disability, non-Swedish speaking
Trial locations and contacts
1 site in 1 country.
About this study
Background: Obsessive-compulsive disorder (OCD) is considered one of the most debilitating of the psychiatric illnesses, yet much remains unclear regarding causes and cures. A diagnostic subgroup with acute onset of obsessive-compulsive symptoms (and sometimes tics or anorexia nervosa) possibly due to an autoimmune response, has been entitled Pediatric Acute onset Neuropsychiatric Syndrome (PANS). PANS is sometimes treated with immunomodulatory therapy or antibiotics, with a variable outcome. A diagnosis of PANS is supported by elevated levels of auto-antibodies and antibody-enzyme activity measured with the Cunningham panel, but the relationship between these biomarkers and the patients' symptoms remains unclear. A clinician rated symptom scale for PANS (the PANS scale) has been developed, but needs to be further evaluated regarding sensitivity and specificity.
Aims:
Read more
- To assess a Swedish cohort of patients diagnosed with PANS and compile their psychiatric health status, biomarkers, psychiatric symptoms, soft neurological signs and treatment outcomes in a systematic way
- To compare psychiatric health status, biomarkers and psychiatric, neurologic and motor symptoms in this PANS cohort with a control group of psychiatric patients and with healthy children.
- To evaluate the Cunningham panel as a diagnostic tool for PANS.
- To evaluate a clinician rated symptom scale (the PANS scale) as a diagnostic tool for PANS.
Method: Observational study Participants: Patients (n≈150) who have been tested with the Cunningham panel of PANS biomarkers in Sweden (or Swedish patients tested in Denmark) will be asked to participate.
Procedure: Assessment of current symptoms, psychiatric health, neurological and motor symptoms and possible biomarkers for PANS will be collected for all patients. Retrospective assessment through interview and medical records, including results from the first assessment with the Cunningham panel of PANS-biomarkers is made with all patients. 50 out of the total PANS cohort of 150 patients will be re-tested with the Cunningham panel. A control group consisting of psychiatric patients (n=60) and healthy children (n=25) will be examined with a similar test battery and signs and symptoms will be compared with the PANS group.
Significance:
Previous and current symptoms of PANS, levels of PANS biomarkers and treatment outcome will be investigated, thus knowledge regarding long-term outcome and evidence for the use of clinical assessment tools and biomarkers for diagnosing PANS will be gained.
Read the detailed description
Data collected comprises:
Retrospective data
- Interview
- Medical records
- Five to Fifteen (FTF)
- Cunningham panel of PANS biomarkers result prior to inclusion (at time point 1)
- Change in Clinical Global Impression-Improvement (CGI-I) since the first assessment of the Cunningham panel
Current data
Current levels of Cunningham panel of PANS biomarkers
- Cunningham panel of PANS biomarkers at time point 2
Current neuropsychiatric status
- Psychiatric interview
- PANS symptom scale
Standardized assessment for children:
- Child behavior checklist (CBCL)
- The Autism spectrum Quotient: Children's version (AQ-Child)
- Brief Obsessive-Compulsive Scale (BOCS)
- Mini international Neuropsychiatric Interview - KID (M.I.N.I. KID)
- Five to Fifteen (FTF)
Standardized assessment for adults:
- Schizotypal Personality Disorder Questionnaire (SPQ)
- Liebowitz social anxiety scale (LSAS)
- The Autism spectrum Quotient (AQ)
- Adult ADHD Self-Report Scale (ASRS)
- Brown Attention-Deficit Disorder Scales (Brown ADD Scales)
- Quality of Life Inventory (QOLI)
- Brief obsessive-compulsive scale (BOCS)
- Mini international Neuropsychiatric Interview (M.I.N.I.)
- FTF retrospective data
Current soft neurological signs
- Alternating skips
- Romberg's balance test
- Diadochokinesia
- Involuntary finger movements
Current neuropsychological status
- Drawing exercises
- Writing exercises
- WAIS/WISC Block design
- WAIS/WISC Digit Span
- WAIS/WISC Letter Number Sequencing
- WAIS/WISC Digit Symbol Coding
Current biomarkers in blood/serum
- D8/17 antigen expression
- Human leukocyte antigen (HLA)
- C-reactive protein (CRP)
- T-cell activation
- Human proteome serum analysis
- Conditions
- Obsessive-compulsive Disorder With Acute Onset, PANDAS, Pediatric Autoimmune Neuropsychiatric Disorders Associated With Streptococcal Infections, Pediatric Acute-onset Neuropsychiatric Syndrome (PANS), Childhood Acute Neuropsychiatric Symptoms (CANS), Obsessive-compulsive Disorder
- Medical subject headings
- Pediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcal infections, Pediatric acute-onset neuropsychiatric syndrome, Obsessive-Compulsive Disorder
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 |
|---|---|---|
| PANS group | All current Swedish cases investigated with the Cunningham panel (approximately 150 individuals) will be invited to participate in the study. 50 of these will be re-assessed with the Cunningham panel. | |
| Psychiatric controls | 60 individuals with psychiatric disorder (eg. ADHD, autism spectrum disorder, psychosis, major depression, obsessive-compulsive disorder) will be recruited. | |
| Healthy controls | 25 age and sex matched children to the PANS group will be recruited. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychiatric health of individuals assessed with the Cunningham Panel of PANS-biomarkers
Measured: up to 4 years
Secondary outcomes (1)
Sensitivity and Specificity of the Cuningham-Panel of PANS biomarkers as a diagnostic tool for PANS
Measured: up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2014 (estimated)
- Study startJun 2014
- Primary completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Obsessive-compulsive Disorder With Acute OnsetStudies 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
- Other
- Enrolment
- 185 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- The Swedish Research Council
- Responsible party
- Principal investigator, Susanne Bejerot, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02190292
- Sponsor's protocol ID
- 523-2011-3646_1
- Status last verified
- Oct 2020
- First submitted
- 17 Jun 2014
- Last updated
- 22 Oct 2020
- Results posted
- No
Publications
Bejerot S, Bruno K, Gerland G, Lindquist L, Nordin V, Pelling H, Humble MB. [Suspect PANDAS in children with acute neuropsychiatric symptoms. Infection behind the disease - long-term antibiotic therapy should be considered]. Lakartidningen. 2013 Oct 9-15;110(41):1803-6. No abstract available. Swedish.
PubMed 24187894Bernstein GA, Victor AM, Pipal AJ, Williams KA. Comparison of clinical characteristics of pediatric autoimmune neuropsychiatric disorders associated with streptococcal infections and childhood obsessive-compulsive disorder. J Child Adolesc Psychopharmacol. 2010 Aug;20(4):333-40. doi: 10.1089/cap.2010.0034.
PubMed 20807071Brimberg L, Benhar I, Mascaro-Blanco A, Alvarez K, Lotan D, Winter C, Klein J, Moses AE, Somnier FE, Leckman JF, Swedo SE, Cunningham MW, Joel D. Behavioral, pharmacological, and immunological abnormalities after streptococcal exposure: a novel rat model of Sydenham chorea and related neuropsychiatric disorders. Neuropsychopharmacology. 2012 Aug;37(9):2076-87. doi: 10.1038/npp.2012.56. Epub 2012 Apr 25.
PubMed 22534626Demiroren K, Yavuz H, Cam L, Oran B, Karaaslan S, Demiroren S. Sydenham's chorea: a clinical follow-up of 65 patients. J Child Neurol. 2007 May;22(5):550-4. doi: 10.1177/0883073807302614.
PubMed 17690060Hachiya Y, Miyata R, Tanuma N, Hongou K, Tanaka K, Shimoda K, Kanda S, Hoshino A, Hanafusa Y, Kumada S, Kurihara E, Hayashi M. Autoimmune neurological disorders associated with group-A beta-hemolytic streptococcal infection. Brain Dev. 2013 Aug;35(7):670-4. doi: 10.1016/j.braindev.2012.10.003. Epub 2012 Nov 9.
PubMed 23142103Kirvan CA, Swedo SE, Heuser JS, Cunningham MW. Mimicry and autoantibody-mediated neuronal cell signaling in Sydenham chorea. Nat Med. 2003 Jul;9(7):914-20. doi: 10.1038/nm892.
PubMed 12819778Kirvan CA, Swedo SE, Snider LA, Cunningham MW. Antibody-mediated neuronal cell signaling in behavior and movement disorders. J Neuroimmunol. 2006 Oct;179(1-2):173-9. doi: 10.1016/j.jneuroim.2006.06.017. Epub 2006 Jul 27.
PubMed 16875742Kurlan R, Johnson D, Kaplan EL; Tourette Syndrome Study Group. Streptococcal infection and exacerbations of childhood tics and obsessive-compulsive symptoms: a prospective blinded cohort study. Pediatrics. 2008 Jun;121(6):1188-97. doi: 10.1542/peds.2007-2657.
PubMed 18519489Leckman JF, King RA, Gilbert DL, Coffey BJ, Singer HS, Dure LS 4th, Grantz H, Katsovich L, Lin H, Lombroso PJ, Kawikova I, Johnson DR, Kurlan RM, Kaplan EL. Streptococcal upper respiratory tract infections and exacerbations of tic and obsessive-compulsive symptoms: a prospective longitudinal study. J Am Acad Child Adolesc Psychiatry. 2011 Feb;50(2):108-118.e3. doi: 10.1016/j.jaac.2010.10.011. Epub 2010 Dec 31.
PubMed 21241948Leonard HL, Swedo SE. Paediatric autoimmune neuropsychiatric disorders associated with streptococcal infection (PANDAS). Int J Neuropsychopharmacol. 2001 Jun;4(2):191-8. doi: 10.1017/S1461145701002371.
PubMed 11466169Mabrouk AA, Eapen V. Challenges in the identification and treatment of PANDAS: a case series. J Trop Pediatr. 2009 Feb;55(1):46-8. doi: 10.1093/tropej/fmn039. Epub 2008 May 22.
PubMed 18499734Morris-Berry CM, Pollard M, Gao S, Thompson C; Tourette Syndrome Study Group; Singer HS. Anti-streptococcal, tubulin, and dopamine receptor 2 antibodies in children with PANDAS and Tourette syndrome: single-point and longitudinal assessments. J Neuroimmunol. 2013 Nov 15;264(1-2):106-13. doi: 10.1016/j.jneuroim.2013.09.010. Epub 2013 Sep 18.
PubMed 24080310Murphy TK, Goodman WK, Fudge MW, Williams RC Jr, Ayoub EM, Dalal M, Lewis MH, Zabriskie JB. B lymphocyte antigen D8/17: a peripheral marker for childhood-onset obsessive-compulsive disorder and Tourette's syndrome? Am J Psychiatry. 1997 Mar;154(3):402-7. doi: 10.1176/ajp.154.3.402.
PubMed 9054790Murphy TK, Kurlan R, Leckman J. The immunobiology of Tourette's disorder, pediatric autoimmune neuropsychiatric disorders associated with Streptococcus, and related disorders: a way forward. J Child Adolesc Psychopharmacol. 2010 Aug;20(4):317-31. doi: 10.1089/cap.2010.0043.
PubMed 20807070Murphy TK, Sajid M, Soto O, Shapira N, Edge P, Yang M, Lewis MH, Goodman WK. Detecting pediatric autoimmune neuropsychiatric disorders associated with streptococcus in children with obsessive-compulsive disorder and tics. Biol Psychiatry. 2004 Jan 1;55(1):61-8. doi: 10.1016/s0006-3223(03)00704-2.
PubMed 14706426
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PANS - A Detailed Study of the Patients, Their Symptoms, Biomarkers and Treatment Offered in a Scandinavian Cohort
- ClinicalTrials.gov ID
- NCT02190292
- Acronym / sponsor ID
- 523-2011-3646_1
- Conditions
- Obsessive-compulsive Disorder With Acute Onset, PANDAS, Pediatric Autoimmune Neuropsychiatric Disorders Associated With Streptococcal Infections, Pediatric Acute-onset Neuropsychiatric Syndrome (PANS), Childhood Acute Neuropsychiatric Symptoms (CANS), Obsessive-compulsive Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 185 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- The Swedish Research Council
- Study start
- Jun 2014
- Primary completion
- 30 Jun 2017 (actual)
- First posted
- 15 Jul 2014 (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.
Background: Obsessive-compulsive disorder (OCD) is considered one of the most debilitating of the psychiatric illnesses, yet much remains unclear regarding causes and cures. A diagnostic subgroup with acute onset of obsessive-compulsive symptoms (and sometimes tics or anorexia nervosa) possibly due to an autoimmune response, has been entitled Pediatric Acute onset Neuropsychiatric Syndrome (PANS). PANS is sometimes treated with immunomodulatory therapy or antibiotics, with a variable outcome. A diagnosis of PANS is supported by elevated levels of auto-antibodies and antibody-enzyme activity measured with the Cunningham panel, but the relationship between these biomarkers and the patients' symptoms remains unclear. A clinician rated symptom scale for PANS (the PANS scale) has been developed, but needs to be further evaluated regarding sensitivity and specificity.
Aims:
- To assess a Swedish cohort of patients diagnosed with PANS and compile their psychiatric health status, biomarkers, psychiatric symptoms, soft neurological signs and treatment outcomes in a systematic way
- To compare psychiatric health status, biomarkers and psychiatric, neurologic and motor symptoms in this PANS cohort with a control group of psychiatric patients and with healthy children.
- To evaluate the Cunningham panel as a diagnostic tool for PANS.
- To evaluate a clinician rated symptom scale (the PANS scale) as a diagnostic tool for PANS.
Method: Observational study Participants: Patients (n≈150) who have been tested with the Cunningham panel of PANS biomarkers in Sweden (or Swedish patients tested in Denmark) will be asked to participate.
Procedure: Assessment of current symptoms, psychiatric health, neurological and motor symptoms and possible biomarkers for PANS will be collected for all patients. Retrospective assessment through interview and medical records, including results from the first assessment with the Cunningham panel of PANS-biomarkers is made with all patients. 50 out of the total PANS cohort of 150 patients will be re-tested with the Cunningham panel. A control group consisting of psychiatric patients (n=60) and healthy children (n=25) will be examined with a similar test battery and signs and symptoms will be compared with the PANS group.
Significance:
Previous and current symptoms of PANS, levels of PANS biomarkers and treatment outcome will be investigated, thus knowledge regarding long-term outcome and evidence for the use of clinical assessment tools and biomarkers for diagnosing PANS will be gained.
Detailed description
Data collected comprises:
Retrospective data
- Interview
- Medical records
- Five to Fifteen (FTF)
- Cunningham panel of PANS biomarkers result prior to inclusion (at time point 1)
- Change in Clinical Global Impression-Improvement (CGI-I) since the first assessment of the Cunningham panel
Current data
Current levels of Cunningham panel of PANS biomarkers
- Cunningham panel of PANS biomarkers at time point 2
Current neuropsychiatric status
- Psychiatric interview
- PANS symptom scale
Standardized assessment for children:
- Child behavior checklist (CBCL)
- The Autism spectrum Quotient: Children's version (AQ-Child)
- Brief Obsessive-Compulsive Scale (BOCS)
- Mini international Neuropsychiatric Interview - KID (M.I.N.I. KID)
- Five to Fifteen (FTF)
Standardized assessment for adults:
- Schizotypal Personality Disorder Questionnaire (SPQ)
- Liebowitz social anxiety scale (LSAS)
- The Autism spectrum Quotient (AQ)
- Adult ADHD Self-Report Scale (ASRS)
- Brown Attention-Deficit Disorder Scales (Brown ADD Scales)
- Quality of Life Inventory (QOLI)
- Brief obsessive-compulsive scale (BOCS)
- Mini international Neuropsychiatric Interview (M.I.N.I.)
- FTF retrospective data
Current soft neurological signs
- Alternating skips
- Romberg's balance test
- Diadochokinesia
- Involuntary finger movements
Current neuropsychological status
- Drawing exercises
- Writing exercises
- WAIS/WISC Block design
- WAIS/WISC Digit Span
- WAIS/WISC Letter Number Sequencing
- WAIS/WISC Digit Symbol Coding
Current biomarkers in blood/serum
- D8/17 antigen expression
- Human leukocyte antigen (HLA)
- C-reactive protein (CRP)
- T-cell activation
- Human proteome serum analysis
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PANS group | – | –All current Swedish cases investigated with the Cunningham panel (approximately 150 individuals) will be invited to participate in the study. 50 of these will be re-assessed with the Cunningham panel. |
| Psychiatric controls | – | –60 individuals with psychiatric disorder (eg. ADHD, autism spectrum disorder, psychosis, major depression, obsessive-compulsive disorder) will be recruited. |
| Healthy controls | – | –25 age and sex matched children to the PANS group will be recruited. |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Consecutive cases that have been assumed to have PANS and have been assessed with the Cunningham panel in Scandinavia.
Key inclusion criteria (4 listed)
- Scandinavian patients assessed with the Cunningham panel through Wieslab, Lund, Sweden or Statens Serum Institut (SSI), Copenhagen, Denmark.
- diagnosed with a psychiatric disorder
- age <40 years
- age and sex matched to the PANS-group
Key exclusion criteria (3 listed)
- intellectual disability, non-Swedish speaking
- intellectual disability, non-Swedish speaking
- intellectual disability, non-Swedish speaking
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 health of individuals assessed with the Cunningham Panel of PANS-biomarkers
Time frame: up to 4 years
1 secondary outcome
Sensitivity and Specificity of the Cuningham-Panel of PANS biomarkers as a diagnostic tool for PANS
Time frame: up to 4 years
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 22 Oct 2020.
- Background: PubMed 24187894Bejerot S, Bruno K, Gerland G, Lindquist L, Nordin V, Pelling H, Humble MB. [Suspect PANDAS in children with acute neuropsychiatric symptoms. Infection behind the disease - long-term antibiotic therapy should be considered]. Lakartidningen. 2013 Oct 9-15;110(41):1803-6. No abstract available. Swedish.
- Background: PubMed 20807071Bernstein GA, Victor AM, Pipal AJ, Williams KA. Comparison of clinical characteristics of pediatric autoimmune neuropsychiatric disorders associated with streptococcal infections and childhood obsessive-compulsive disorder. J Child Adolesc Psychopharmacol. 2010 Aug;20(4):333-40. doi: 10.1089/cap.2010.0034.
- Background: PubMed 22534626Brimberg L, Benhar I, Mascaro-Blanco A, Alvarez K, Lotan D, Winter C, Klein J, Moses AE, Somnier FE, Leckman JF, Swedo SE, Cunningham MW, Joel D. Behavioral, pharmacological, and immunological abnormalities after streptococcal exposure: a novel rat model of Sydenham chorea and related neuropsychiatric disorders. Neuropsychopharmacology. 2012 Aug;37(9):2076-87. doi: 10.1038/npp.2012.56. Epub 2012 Apr 25.
- Background: PubMed 17690060Demiroren K, Yavuz H, Cam L, Oran B, Karaaslan S, Demiroren S. Sydenham's chorea: a clinical follow-up of 65 patients. J Child Neurol. 2007 May;22(5):550-4. doi: 10.1177/0883073807302614.
- Background: PubMed 23142103Hachiya Y, Miyata R, Tanuma N, Hongou K, Tanaka K, Shimoda K, Kanda S, Hoshino A, Hanafusa Y, Kumada S, Kurihara E, Hayashi M. Autoimmune neurological disorders associated with group-A beta-hemolytic streptococcal infection. Brain Dev. 2013 Aug;35(7):670-4. doi: 10.1016/j.braindev.2012.10.003. Epub 2012 Nov 9.
- Background: PubMed 12819778Kirvan CA, Swedo SE, Heuser JS, Cunningham MW. Mimicry and autoantibody-mediated neuronal cell signaling in Sydenham chorea. Nat Med. 2003 Jul;9(7):914-20. doi: 10.1038/nm892.
- Background: PubMed 16875742Kirvan CA, Swedo SE, Snider LA, Cunningham MW. Antibody-mediated neuronal cell signaling in behavior and movement disorders. J Neuroimmunol. 2006 Oct;179(1-2):173-9. doi: 10.1016/j.jneuroim.2006.06.017. Epub 2006 Jul 27.
- Background: PubMed 18519489Kurlan R, Johnson D, Kaplan EL; Tourette Syndrome Study Group. Streptococcal infection and exacerbations of childhood tics and obsessive-compulsive symptoms: a prospective blinded cohort study. Pediatrics. 2008 Jun;121(6):1188-97. doi: 10.1542/peds.2007-2657.
- Background: PubMed 21241948Leckman JF, King RA, Gilbert DL, Coffey BJ, Singer HS, Dure LS 4th, Grantz H, Katsovich L, Lin H, Lombroso PJ, Kawikova I, Johnson DR, Kurlan RM, Kaplan EL. Streptococcal upper respiratory tract infections and exacerbations of tic and obsessive-compulsive symptoms: a prospective longitudinal study. J Am Acad Child Adolesc Psychiatry. 2011 Feb;50(2):108-118.e3. doi: 10.1016/j.jaac.2010.10.011. Epub 2010 Dec 31.
- Background: PubMed 11466169Leonard HL, Swedo SE. Paediatric autoimmune neuropsychiatric disorders associated with streptococcal infection (PANDAS). Int J Neuropsychopharmacol. 2001 Jun;4(2):191-8. doi: 10.1017/S1461145701002371.
- Background: PubMed 18499734Mabrouk AA, Eapen V. Challenges in the identification and treatment of PANDAS: a case series. J Trop Pediatr. 2009 Feb;55(1):46-8. doi: 10.1093/tropej/fmn039. Epub 2008 May 22.
- Background: PubMed 24080310Morris-Berry CM, Pollard M, Gao S, Thompson C; Tourette Syndrome Study Group; Singer HS. Anti-streptococcal, tubulin, and dopamine receptor 2 antibodies in children with PANDAS and Tourette syndrome: single-point and longitudinal assessments. J Neuroimmunol. 2013 Nov 15;264(1-2):106-13. doi: 10.1016/j.jneuroim.2013.09.010. Epub 2013 Sep 18.
Related trials for Obsessive-compulsive Disorder With Acute Onset
Recruiting
Anxiety Skills Study
Anxiety, Anxiety Acute
RecruitingObservational study
Unhide® Project: A Digital Health Platform to Collect Lifestyle Data for Brain Inflammation Research
Post-Acute COVID-19 Syndrome, ME/CFS
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Obsessive-compulsive Disorder With Acute Onset and PANDAS, run by Karolinska Institutet at 1 site 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 4 inclusion and 3 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 22 Oct 2020. 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 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?
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?
Psychiatric health of individuals assessed with the Cunningham Panel of PANS-biomarkers (time frame: up to 4 years). 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 NCT02190292, which also lists 23 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 22 Oct 2020.