Trial · NCT01617083
Antibiotic Treatment Trial for the PANDAS/PANS Phenotype
NCT01617083, Phase 2, Completed, University of South Florida; results first posted 2018-04-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Antibiotic Treatment Trial for the PANDAS/PANS Phenotype. Trials, record NCT01617083. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01617083
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Antibiotic Treatment Trial for the PANDAS/PANS Phenotype
- NCT number
- NCT01617083
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 47 participants, actual
- Lead sponsor
- University of South Florida
- Conditions
- PANS, PANDAS, Obsessive Compulsive Disorder (OCD)
- Interventions
- Azithromycin, Placebo
- First posted
- 2012-06-12
- Last updated
- 2018-04-10
- Results first posted
- 2018-04-10
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) | Before and after 4 week randomization | The CYBOCS is a clinician rated, semi-structured interview for rating the severity of OCD (Scahill, et al., 1997). Total scores range from 0 to 50, with higher scores representing greater severity. The total score is comprised of two subscores, obsessions and compulsions, each with a range of 0-25. |
| Secondary | Clinical Global Impressions-Severity OCD | Before and after 4 week randomization | The CGI-S scale is a 7-point clinician rating of severity of psychopathology. Severity ratings range from 1 (no illness) to 7 (extremely severe). This instrument has been successfully used in treatment studies (Cook, et al., 2001; Storch, et al., 2007). |
| Secondary | Screen for Childhood Anxiety-Related Emotional Disorders (SCARED) | Before and after 4 week randomization | The Screen for Childhood Anxiety-Related Emotional Disorders (SCARED) is a 41-item parent and participant-completed tool used to measure symptoms of anxiety, including the most common symptoms of panic/somatic, generalized anxiety, separation anxiety, social phobia, and school phobia. Scores range from 0-82, with higher scores indicating more severe symptoms.The child and parent versions of the SCARED have moderate parent-child agreement and good internal consistency, test-retest reliability, and discriminant validity; it is also sensitive to treatment response (Birmaher et al. 1999). The target population for this rating is 8-18 years of age (Birmaher et al. 1997). The parent and child version of the SCARED were administered before and after week 4 randomization. This measure is not validated for use in 4-7 year olds. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) | Before and after 4 week randomization | units on a scale | MEAN | |
| SECONDARY | Clinical Global Impressions-Severity OCD | Before and after 4 week randomization | units on a scale | MEAN | |
| SECONDARY | Screen for Childhood Anxiety-Related Emotional Disorders (SCARED) | Before and after 4 week randomization | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) | Azithromycin | Baseline | 29.49 | Standard Error 1.85 | units on a scale |
| Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) | Placebo | Baseline | 28.43 | Standard Error 2.04 | units on a scale |
| Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) | Azithromycin | After 4 week randomization | 20.53 | Standard Error 1.85 | units on a scale |
| Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) | Placebo | After 4 week randomization | 23.45 | Standard Error 2.09 | units on a scale |
| Clinical Global Impressions-Severity OCD | Azithromycin | Baseline | 5.24 | Standard Error 0.23 | units on a scale |
| Clinical Global Impressions-Severity OCD | Placebo | Baseline | 5.00 | Standard Error 0.25 | units on a scale |
| Clinical Global Impressions-Severity OCD | Azithromycin | After 4 week randomization | 4.06 | Standard Error .23 | units on a scale |
| Clinical Global Impressions-Severity OCD | Placebo | After 4 week randomization | 4.93 | Standard Error .25 | units on a scale |
| Screen for Childhood Anxiety-Related Emotional Disorders (SCARED) | Azithromycin | Baseline | 31.82 | Standard Error 3.75 | units on a scale |
| Screen for Childhood Anxiety-Related Emotional Disorders (SCARED) | Placebo | Baseline | 20.43 | Standard Error 4.13 | units on a scale |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Azithromycin | 18 | |
| Overall Study | STARTED | Placebo | 14 | |
| Overall Study | STARTED | Not Randomized | 15 | |
| Overall Study | COMPLETED | Azithromycin | 18 | |
| Overall Study | COMPLETED | Placebo | 14 | |
| Overall Study | COMPLETED | Not Randomized | 15 | |
| Overall Study | NOT COMPLETED | Azithromycin | 0 | |
| Overall Study | NOT COMPLETED | Placebo | 0 | |
| Overall Study | NOT COMPLETED | Not Randomized | 0 |
Source ClinicalTrials.gov
Adverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Loose stools | Gastrointestinal disorders | Azithromycin | 9 | 18 | |
| other | Loose stools | Gastrointestinal disorders | Placebo | 1 | 14 | |
| other | Constipation | Gastrointestinal disorders | Azithromycin | 0 | 18 | |
| other | Constipation | Gastrointestinal disorders | Placebo | 5 | 14 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Azithromycin | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Azithromycin | 9 | 18 |
| Total, other adverse events | Placebo | 6 | 14 |
| Total, serious adverse events | Azithromycin | 0 | 18 |
| Total, serious adverse events | Placebo | 0 | 14 |
Source ClinicalTrials.gov
Papers91
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Azithromycin vs Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01617083
GET https://conductscience.org/api/trials/v1/NCT01617083/papers?page=2