PandasPhase 2ATIVPANDASNCT01769027
Antibiotic Treatment and Intravenous Immunoglobulin Trial for PANDAS
A Phase 2 study testing Sertraline+Antibiotic (penicillin/azithromycin) and IVIG in people with Pandas, run by CNS Onlus.
Trial summary
An increasing body of evidence indicates that an immune basis might underline a number of pediatric neuropsychiatric disorders. Research studies found a subgroup of children who had Obsessive compulsive (OCD) and/or tic disorders following a Group A beta-hemolytic streptococcal (GAS) infection. Read more about this study
- Who is it for?
- Ages 4 to 40 years
- Conditions the study is for
- Pandas
- What is being tested?
- Sertraline+Antibiotic (penicillin/azithromycin) and IVIG
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2013to Jun 2016
- Phase
- Phase 2
- 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 4 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Ages 4 -40 years
- Presence of DSM-IV-R obsessive compulsive disorder or tic disorder and at least two of the following:
- Anxieties e.g. new onset separation anxiety
- Sensory abnormalities (tactile/auditory/visual defensiveness or visual misperceptions)
- Behavioral Regression (e.g. new onset impulsivity, hyperactivity, meltdowns)
- Deterioration in school performance or in handwriting
Show all 12Show fewer
- Emotional lability and/or depression
- Urinary symptoms (frequent urination or enuresis)
- Sleep disturbances
- Anorexia
- Sudden onset of symptoms or episodic course of symptom severity following infections
- Laboratory documentation of infection
Who cannot join
- Exclusion criteria for all subjects are: non-tic neurologic disorder, presence of immunologic disorder, presence of serious medical illness, IgA deficiency (< 20mg/dL), hyperviscosity syndromes, psychotropic therapy.
About this study
Official title: Antibiotic Treatment and Intravenous Immunoglobulin Double-blind, Randomized, Placebo-controlled Trial for PANDAS
An increasing body of evidence indicates that an immune basis might underline a number of pediatric neuropsychiatric disorders. Research studies found a subgroup of children who had Obsessive compulsive (OCD) and/or tic disorders following a Group A beta-hemolytic streptococcal (GAS) infection. The subgroup is identified by the acronym, PANDAS (pediatric autoimmune neuropsychiatric disorders associated with streptococcal infections. More recently, several PANDAS variants have been described, including adult-onset variant. There are many evidences that OCD/tic symptoms could be due to an immunologic reaction against brain tissues following a streptococcal infection.
The purpose of this study is to know if sertraline (one of the SSRI approved by FDA to improve OCD/tic symptoms in these patients) plus antibiotic (benzathine penicillin G or azithromycin in case of penicillin allergy) is more effective than SSRI only.
Read more
Patients who will not respond to antibiotic will be treated with intravenous immunoglobulin (IVIG) in order to inactivate the immune reaction versus brain tissues.(No treatment response is based on the lack of a Y-BOCS score improvement of at least 35%).
Objectives:
- To determine the safety and efficacy of SSRI+AB compared to SSRI only.
- To test the safety and additional beneficial effects of high dose of IVIG on antibiotic prophylaxis for the treatment of OCD symptoms in non-responders patients with PANDAS.
Study methodology:
- Participants will be screened to obtain medical history and other information at Neurologic and Psychiatric Sciences Department of Florence University Hospital and at Paris-est University.
- Participants will receive a treatment of either SSRI+AB or SSRI+placebo for 12 weeks (double-blind randomized trial)
- Patients who will not respond to AB will be admitted to the hospital to receive IVIG for 5 days, for 5 consecutive months.
- Follow-up visits will take place 3 and 6 months after the first evaluation, followed by 6 months follow-ups for 3 additional years.
Blood samples (including blood cytokine determination), ECG, Doppler and 2-dimensional echocardiogram EEG, imaging studies (2 tesla MRI), and other tests will be performed both before and after the treatment with SSRI+AB or SSRI+placebo and in case also after IVIG treatment.
Read the detailed description
Inclusion criteria for PANDAS subjects are:
- Ages 4 -40 years
- Presence of DSM-IV-R obsessive compulsive disorder or tic disorder and at least two of the following:
- Anxieties e.g. new onset separation anxiety
- Sensory abnormalities (tactile/auditory/visual defensiveness or visual misperceptions)
- Behavioral Regression (e.g. new onset impulsivity, hyperactivity, meltdowns)
- Deterioration in school performance or in handwriting
- Emotional lability and/or depression
- Urinary symptoms (frequent urination or enuresis)
- Sleep disturbances
- Anorexia
- Sudden onset of symptoms or episodic course of symptom severity following infections.
- Symptoms are of moderate severity with Yale-Brown Obsessive Compulsive Scale (Y-BOCS) (or with the children's version for subjects below 16 years of age) of more or equal to 16 and/or Yale Global Tic Severity Scale (YGTSS) of more or equal to 21 and with significant impairment (CGI of moderate or worse).
- Laboratory documentation of infection as documented by at least two of these: positive throat culture, documented rise in one or more anti-GAS antibody titers such as anti-streptolysin O, anti-streptococcal DNAaseB.
Exclusion criteria for all subjects are: non-tic neurologic disorder, presence of immunologic disorder, presence of serious medical illness, IgA deficiency (< 20mg/dL), hyperviscosity syndromes, psychotropic therapy.
Interventions:
All patients will be treated with sertraline (to a maximum of 200 mg/day. This study will involve a 12 week double-blind, placebo-controlled, randomized trial with benzathine penicillin G (1.200.000 U every 3 weeks) or azithromycin (500 mg/week) in case of penicillin allergy. Non-responders patients will be treated with IVIG (2 g/kg of body weight over 5 days, for 5 consecutive months)
Outcomes:
Primary Outcome Measures:
- Significant reduction of OC/tic symptoms severity, as assessed by YBOCS/YGTSS, compared to placebo, after antibiotic prophylaxis. [ Time Frame: 6 months ]
- Significant reduction of OC/tic symptoms severity, as assessed by YBOCS/YGTSS, compared to placebo, after IVIG treatment. [ Time Frame: 6 months ]
Secondary Outcome Measures:
- The degree of treatment response is expected to correlate with the percentage reduction in antibodies titers following IVIG administration. [ Time Frame: 6 months]
- The degree of treatment response is also expected to correlate with decreased inflammation in specific regions of the brain, as demonstrated by macroscopic changes and microstructural alterations on MRI and serum and CSF cytokines and chemokines [ Time Frame: 6 months ]
Expected impact:
- To clarify the utility of antibiotic and IVIG therapy in PANDAS and how the IVIG produce their effects.
- To individualize the treatment.
- To disseminate new data for the treatment of PANDAS.
- Conditions
- Pandas
- Being tested
- Sertraline+Antibiotic (penicillin/azithromycin), Sertraline+placebo, IVIG
- Medical subject headings
- Pediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcal infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sertraline+Antibiotic (penicillin/azithromycin)Drug
Also called Zoloft, Lustral, Bicillin L-A, Permapen
12 weeks treatment with a combination of Sertraline (to a maximum of 200 mg/day) and an antibiotic (benzathine penicillin G 1.200.000 U every 3 weeks or, in case of allergy, azithromycin 500 mg/week.
Non-responder patients will be treated with IVIG (2g/kg over 5 days for 5 consecutive months)
Sertraline+placeboDrug
Also called Zoloft, Lustral
12 weeks treatment with a combination of sertraline (to a maximum of 200 mg/day) and placebo
IVIGBiological
Also called Gamimune N, Gammagard
Patients who will not respond to SSRI+antibiotic (penicillin/azithromycin) will be treated with IVIG (2g/kg over 5 days for 5 consecutive months)
| Study group | Role | What they receive |
|---|---|---|
| SSRI+AB | Active comparator | Intervention: sertraline+antibiotic (penicillin/azithromycin) 12 weeks treatment with a combination of sertraline (to a maximum of 200 mg/day)and one antibiotic ( benzathine penicillin G 1.200.000 U every 3 weeks or, in case of allergy, azithromycin 500 mg/week ). Patients who will not respond to SSRI+antibiotic (penicillin/azithromycin) will be treated with IVIG (2g/kg over 5 days for 5 consecutive months) Receives: Drug: Sertraline+Antibiotic (penicillin/azithromycin); Biological: IVIG |
| SSRI+placebo | Placebo comparator | Intervention: Sertraline+placebo 12 weeks treatment with a combination of sertraline (to a maximum of 200 mg/day) and a placebo Receives: Drug: Sertraline+placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The improvement of OC/tic symptoms will be superior in patients treated with SSRI+AB and in case with IVIG, compared with those treated with SSRI+placebo, as assessed by the YBOCS/YGTSS
Measured: 6 months
Secondary outcomes (2)
The degree of treatment response is expected to correlate with the percentage reduction in antibodies titers following IVIG administration
Measured: 6 months
The degree of treatment response is also expected to correlate with decreased inflammation in specific regions of the brain, as demonstrated by macroscopic changes and microstructural alterations on MRI and serum and CSF cytokines and chemokines
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2013 (estimated)
- Study startJun 2013
- Primary completionDec 2013
- Study completionJun 2016
Why it stopped: No participants enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for PandasStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- CNS Onlus
- Sponsor type
- University, hospital or other
- Collaborators
- University of Florence
- Responsible party
- Principal investigator, Stefano Pallanti, CNS Onlus
- Investigators
- Stefano Pallanti, MD; PhD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01769027
- Sponsor's protocol ID
- spallanti
- Acronym
- ATIVPANDAS
- Status last verified
- Feb 2023
- First submitted
- 14 Dec 2012
- Last updated
- 21 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Garvey MA, Perlmutter SJ, Allen AJ, Hamburger S, Lougee L, Leonard HL, Witowski ME, Dubbert B, Swedo SE. A pilot study of penicillin prophylaxis for neuropsychiatric exacerbations triggered by streptococcal infections. Biol Psychiatry. 1999 Jun 15;45(12):1564-71. doi: 10.1016/s0006-3223(99)00020-7.
PubMed 10376116Perlmutter SJ, Leitman SF, Garvey MA, Hamburger S, Feldman E, Leonard HL, Swedo SE. Therapeutic plasma exchange and intravenous immunoglobulin for obsessive-compulsive disorder and tic disorders in childhood. Lancet. 1999 Oct 2;354(9185):1153-8. doi: 10.1016/S0140-6736(98)12297-3.
PubMed 10513708Snider LA, Lougee L, Slattery M, Grant P, Swedo SE. Antibiotic prophylaxis with azithromycin or penicillin for childhood-onset neuropsychiatric disorders. Biol Psychiatry. 2005 Apr 1;57(7):788-92. doi: 10.1016/j.biopsych.2004.12.035.
PubMed 15820236Swedo SE, Leonard HL, Garvey M, Mittleman B, Allen AJ, Perlmutter S, Lougee L, Dow S, Zamkoff J, Dubbert BK. Pediatric autoimmune neuropsychiatric disorders associated with streptococcal infections: clinical description of the first 50 cases. Am J Psychiatry. 1998 Feb;155(2):264-71. doi: 10.1176/ajp.155.2.264.
PubMed 9464208
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibiotic Treatment and Intravenous Immunoglobulin Double-blind, Randomized, Placebo-controlled Trial for PANDAS
- ClinicalTrials.gov ID
- NCT01769027
- Acronym / sponsor ID
- ATIVPANDAS / spallanti
- Conditions
- Pandas
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participants enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- CNS OnlusUniversity, hospital or other
- Collaborators
- University of Florence
- Study start
- Jun 2013 (actual)
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 16 Jan 2013 (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.
An increasing body of evidence indicates that an immune basis might underline a number of pediatric neuropsychiatric disorders. Research studies found a subgroup of children who had Obsessive compulsive (OCD) and/or tic disorders following a Group A beta-hemolytic streptococcal (GAS) infection. The subgroup is identified by the acronym, PANDAS (pediatric autoimmune neuropsychiatric disorders associated with streptococcal infections. More recently, several PANDAS variants have been described, including adult-onset variant. There are many evidences that OCD/tic symptoms could be due to an immunologic reaction against brain tissues following a streptococcal infection.
The purpose of this study is to know if sertraline (one of the SSRI approved by FDA to improve OCD/tic symptoms in these patients) plus antibiotic (benzathine penicillin G or azithromycin in case of penicillin allergy) is more effective than SSRI only.
Patients who will not respond to antibiotic will be treated with intravenous immunoglobulin (IVIG) in order to inactivate the immune reaction versus brain tissues.(No treatment response is based on the lack of a Y-BOCS score improvement of at least 35%).
Objectives:
- To determine the safety and efficacy of SSRI+AB compared to SSRI only.
- To test the safety and additional beneficial effects of high dose of IVIG on antibiotic prophylaxis for the treatment of OCD symptoms in non-responders patients with PANDAS.
Study methodology:
- Participants will be screened to obtain medical history and other information at Neurologic and Psychiatric Sciences Department of Florence University Hospital and at Paris-est University.
- Participants will receive a treatment of either SSRI+AB or SSRI+placebo for 12 weeks (double-blind randomized trial)
- Patients who will not respond to AB will be admitted to the hospital to receive IVIG for 5 days, for 5 consecutive months.
- Follow-up visits will take place 3 and 6 months after the first evaluation, followed by 6 months follow-ups for 3 additional years.
Blood samples (including blood cytokine determination), ECG, Doppler and 2-dimensional echocardiogram EEG, imaging studies (2 tesla MRI), and other tests will be performed both before and after the treatment with SSRI+AB or SSRI+placebo and in case also after IVIG treatment.
Detailed description
Inclusion criteria for PANDAS subjects are:
- Ages 4 -40 years
- Presence of DSM-IV-R obsessive compulsive disorder or tic disorder and at least two of the following:
- Anxieties e.g. new onset separation anxiety
- Sensory abnormalities (tactile/auditory/visual defensiveness or visual misperceptions)
- Behavioral Regression (e.g. new onset impulsivity, hyperactivity, meltdowns)
- Deterioration in school performance or in handwriting
- Emotional lability and/or depression
- Urinary symptoms (frequent urination or enuresis)
- Sleep disturbances
- Anorexia
- Sudden onset of symptoms or episodic course of symptom severity following infections.
- Symptoms are of moderate severity with Yale-Brown Obsessive Compulsive Scale (Y-BOCS) (or with the children's version for subjects below 16 years of age) of more or equal to 16 and/or Yale Global Tic Severity Scale (YGTSS) of more or equal to 21 and with significant impairment (CGI of moderate or worse).
- Laboratory documentation of infection as documented by at least two of these: positive throat culture, documented rise in one or more anti-GAS antibody titers such as anti-streptolysin O, anti-streptococcal DNAaseB.
Exclusion criteria for all subjects are: non-tic neurologic disorder, presence of immunologic disorder, presence of serious medical illness, IgA deficiency (< 20mg/dL), hyperviscosity syndromes, psychotropic therapy.
Interventions:
All patients will be treated with sertraline (to a maximum of 200 mg/day. This study will involve a 12 week double-blind, placebo-controlled, randomized trial with benzathine penicillin G (1.200.000 U every 3 weeks) or azithromycin (500 mg/week) in case of penicillin allergy. Non-responders patients will be treated with IVIG (2 g/kg of body weight over 5 days, for 5 consecutive months)
Outcomes:
Primary Outcome Measures:
- Significant reduction of OC/tic symptoms severity, as assessed by YBOCS/YGTSS, compared to placebo, after antibiotic prophylaxis. [ Time Frame: 6 months ]
- Significant reduction of OC/tic symptoms severity, as assessed by YBOCS/YGTSS, compared to placebo, after IVIG treatment. [ Time Frame: 6 months ]
Secondary Outcome Measures:
- The degree of treatment response is expected to correlate with the percentage reduction in antibodies titers following IVIG administration. [ Time Frame: 6 months]
- The degree of treatment response is also expected to correlate with decreased inflammation in specific regions of the brain, as demonstrated by macroscopic changes and microstructural alterations on MRI and serum and CSF cytokines and chemokines [ Time Frame: 6 months ]
Expected impact:
- To clarify the utility of antibiotic and IVIG therapy in PANDAS and how the IVIG produce their effects.
- To individualize the treatment.
- To disseminate new data for the treatment of PANDAS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SSRI+AB | Active comparator | Drug: Sertraline+Antibiotic (penicillin/azithromycin), Biological: IVIGIntervention: sertraline+antibiotic (penicillin/azithromycin) 12 weeks treatment with a combination of sertraline (to a maximum of 200 mg/day)and one antibiotic ( benzathine penicillin G 1.200.000 U every 3 weeks or, in case of allergy, azithromycin 500 mg/week ). Patients who will not respond to SSRI+antibiotic (penicillin/azithromycin) will be treated with IVIG (2g/kg over 5 days for 5 consecutive months) |
| SSRI+placebo | Placebo comparator | Drug: Sertraline+placeboIntervention: Sertraline+placebo 12 weeks treatment with a combination of sertraline (to a maximum of 200 mg/day) and a placebo |
Who may qualify
- Ages
- 4 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (12 listed)
- Ages 4 -40 years
- Presence of DSM-IV-R obsessive compulsive disorder or tic disorder and at least two of the following:
- Sudden onset of symptoms or episodic course of symptom severity following infections
- Laboratory documentation of infection
Key exclusion criteria (1 listed)
- Exclusion criteria for all subjects are: non-tic neurologic disorder, presence of immunologic disorder, presence of serious medical illness, IgA deficiency (< 20mg/dL), hyperviscosity syndromes, psychotropic therapy.
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 |
|---|---|---|
| Sertraline+Antibiotic (penicillin/azithromycin)Also: Zoloft, Lustral, Bicillin L-A, Permapen12 weeks treatment with a combination of Sertraline (to a maximum of 200 mg/day) and an antibiotic (benzathine penicillin G 1.200.000 U every 3 weeks or, in case of allergy, azithromycin 500 mg/week. Non-responder patients will be treated with IVIG (2g/kg over 5 days for 5 consecutive months) | Drug | SSRI+AB |
| Sertraline+placeboAlso: Zoloft, Lustral12 weeks treatment with a combination of sertraline (to a maximum of 200 mg/day) and placebo | Drug | SSRI+placebo |
| IVIGAlso: Gamimune N, GammagardPatients who will not respond to SSRI+antibiotic (penicillin/azithromycin) will be treated with IVIG (2g/kg over 5 days for 5 consecutive months) | Biological | SSRI+AB |
Primary outcome
The improvement of OC/tic symptoms will be superior in patients treated with SSRI+AB and in case with IVIG, compared with those treated with SSRI+placebo, as assessed by the YBOCS/YGTSS
Time frame: 6 months
2 secondary outcomes
The degree of treatment response is expected to correlate with the percentage reduction in antibodies titers following IVIG administration
Time frame: 6 months
The degree of treatment response is also expected to correlate with decreased inflammation in specific regions of the brain, as demonstrated by macroscopic changes and microstructural alterations on MRI and serum and CSF cytokines and chemokines
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
- Background: PubMed 10376116Garvey MA, Perlmutter SJ, Allen AJ, Hamburger S, Lougee L, Leonard HL, Witowski ME, Dubbert B, Swedo SE. A pilot study of penicillin prophylaxis for neuropsychiatric exacerbations triggered by streptococcal infections. Biol Psychiatry. 1999 Jun 15;45(12):1564-71. doi: 10.1016/s0006-3223(99)00020-7.
- Background: PubMed 10513708Perlmutter SJ, Leitman SF, Garvey MA, Hamburger S, Feldman E, Leonard HL, Swedo SE. Therapeutic plasma exchange and intravenous immunoglobulin for obsessive-compulsive disorder and tic disorders in childhood. Lancet. 1999 Oct 2;354(9185):1153-8. doi: 10.1016/S0140-6736(98)12297-3.
- Background: PubMed 15820236Snider LA, Lougee L, Slattery M, Grant P, Swedo SE. Antibiotic prophylaxis with azithromycin or penicillin for childhood-onset neuropsychiatric disorders. Biol Psychiatry. 2005 Apr 1;57(7):788-92. doi: 10.1016/j.biopsych.2004.12.035.
- Background: PubMed 9464208Swedo SE, Leonard HL, Garvey M, Mittleman B, Allen AJ, Perlmutter S, Lougee L, Dow S, Zamkoff J, Dubbert BK. Pediatric autoimmune neuropsychiatric disorders associated with streptococcal infections: clinical description of the first 50 cases. Am J Psychiatry. 1998 Feb;155(2):264-71. doi: 10.1176/ajp.155.2.264.
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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.
Stefano Pallanti, MD; PhD principal investigator
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sertraline+Antibiotic (penicillin/azithromycin) and IVIG in people with Pandas, run by CNS Onlus.
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 12 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: withdrawn, as of the sponsor's last update on 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The improvement of OC/tic symptoms will be superior in patients treated with SSRI+AB and in case with IVIG, compared with those treated with SSRI+placebo, as assessed by the YBOCS/YGTSS (time frame: 6 months). 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 NCT01769027, which also lists 4 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 21 Feb 2023.