ClinicalTrials.gov
ClinicalTrials.gov Menu

Antibiotic Treatment Trial for the PANDAS/PANS Phenotype (AZT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01617083
Recruitment Status : Completed
First Posted : June 12, 2012
Results First Posted : April 10, 2018
Last Update Posted : April 10, 2018
Sponsor:
Collaborator:
Massachusetts General Hospital
Information provided by (Responsible Party):
University of South Florida

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions PANS
PANDAS
Obsessive Compulsive Disorder (OCD)
Interventions Drug: Azithromycin
Drug: Placebo
Enrollment 47
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Azithromycin Placebo Not Randomized
Hide Arm/Group Description

Antibiotic used to treat infections.

Azithromycin: Antibiotic used to treat infections

Compound thickening agent with sugar and flavor additives.

Placebo: Thickening compound with sugar and flavoring

Participants consented to participate in the study. They completed baseline assessments but did not randomize to treatment.
Period Title: Overall Study
Started 18 14 15
Completed 18 14 15
Not Completed 0 0 0
Arm/Group Title Azithromycin Placebo Not Randomized Total
Hide Arm/Group Description

Antibiotic used to treat infections.

Azithromycin: Antibiotic used to treat infections

Compound thickening agent with sugar and flavor additives.

Placebo: Thickening compound with sugar and flavoring

Participants only completed the baseline assessments but did not receive treatment. Total of all reporting groups
Overall Number of Baseline Participants 18 14 15 47
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 14 participants 15 participants 47 participants
<=18 years
18
 100.0%
14
 100.0%
15
 100.0%
47
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants 14 participants 15 participants 47 participants
7.78  (2.39) 8.86  (3.11) 7.21  (2.58) 8.25  (2.74)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 14 participants 15 participants 47 participants
Female
7
  38.9%
5
  35.7%
9
  60.0%
21
  44.7%
Male
11
  61.1%
9
  64.3%
6
  40.0%
26
  55.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 18 participants 14 participants 15 participants 47 participants
18 14 15 47
1.Primary Outcome
Title Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS)
Hide Description 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.
Time Frame Before and after 4 week randomization
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Azithromycin Placebo
Hide Arm/Group Description:

Antibiotic used to treat infections.

Azithromycin: Antibiotic used to treat infections

Compound thickening agent with sugar and flavor additives.

Placebo: Thickening compound with sugar and flavoring

Overall Number of Participants Analyzed 18 14
Mean (Standard Error)
Unit of Measure: units on a scale
Baseline 29.49  (1.85) 28.43  (2.04)
After 4 week randomization 20.53  (1.85) 23.45  (2.09)
2.Secondary Outcome
Title Clinical Global Impressions-Severity OCD
Hide Description 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).
Time Frame Before and after 4 week randomization
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Azithromycin Placebo Not Randomized
Hide Arm/Group Description:

Antibiotic used to treat infections.

Azithromycin: Antibiotic used to treat infections

Compound thickening agent with sugar and flavor additives.

Placebo: Thickening compound with sugar and flavoring

Participants consented to participate in the study. They completed baseline assessments but did not randomize to treatment.
Overall Number of Participants Analyzed 18 14 0
Mean (Standard Error)
Unit of Measure: units on a scale
Baseline 5.24  (0.23) 5.00  (0.25)
After 4 week randomization 4.06  (.23) 4.93  (.25)
3.Secondary Outcome
Title Screen for Childhood Anxiety-Related Emotional Disorders (SCARED)
Hide Description 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.
Time Frame Before and after 4 week randomization
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Azithromycin Placebo
Hide Arm/Group Description:

Antibiotic used to treat infections.

Azithromycin: Antibiotic used to treat infections

Compound thickening agent with sugar and flavor additives.

Placebo: Thickening compound with sugar and flavoring

Overall Number of Participants Analyzed 18 14
Mean (Standard Error)
Unit of Measure: units on a scale
Baseline 31.82  (3.75) 20.43  (4.13)
After 4 week randomization 30.88  (3.75) 21.97  (4.17)
Time Frame Before and after 4 week randomization
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Azithromycin Placebo
Hide Arm/Group Description This group was assigned to receive azithromycin (antibiotic). This group was assigned to receive placebo (compound thickening agent with sugar and flavor additives - not active treatment).
All-Cause Mortality
Azithromycin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Azithromycin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)   0/14 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Azithromycin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   9/18 (50.00%)   6/14 (42.86%) 
Gastrointestinal disorders     
Loose stools   9/18 (50.00%)  1/14 (7.14%) 
Constipation   0/18 (0.00%)  5/14 (35.71%) 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Study Coordinator
Organization: University of South Florida Rothman Center
Phone: 7277678393
Publications:
Constantino, J., & CP, G. The Social Responsiveness Scale (SRS) Manual. Los Angeles: Western Psychological Services, 2005.
Diggle, P. Analysis of longitudinal data. Oxford University Press, 2002.
Guy, W. Assessment Manual for Psychopharmacology, rev. edn. Rockville, MD: National Institute of Mental Health, 1976.
Landgraf, J. M., Abetz, L., & Ware, J. E. The CHQ user's manual. Boston: The Health Institute, New England Medical Center, 1996.
Meyers, J., & Meyers, K. Rey Complex Figure Test and recognition trial: Professional manual. Psychological Assessment Resources, 1995.
Murphy, T. K., Storch, E. A., & Strawser, M. S. Case Report: Selective Serotonin Reuptake Inhibitor-Induced Behavioral Activation in the PANDAS Subtype. [case report]. Primary Psychiatry, 13(8), 87-89, 2006.
Piacentini, J. C., & Jaffer, M. P., J. C., & Jaffer, M. Measuring functional impairment in youngsters with OCD: Manual for the Child OCD Impact Scale (COIS). Los Angeles, UCLA Department of Psychiatry, 1999.
Seber, G. A. F. Multivariate Observations. New York: Wiley, 1984.
Swanson, J. M. School-based assessments and interventions for ADD students. Irvine, CA: K C Publishing, 1992.
Wood, H. F., Feinstein, A. R., Taranta, A., & Simpson, R. Rheumatic fever in children and adolescents III. Comparative effectiveness of three prophylaxis regimens in preventing streptococcal infections and rheumatic fever. Annuals of Internal Medicine, 60(supplement 5), 31-46, 1964.
Responsible Party: University of South Florida
ClinicalTrials.gov Identifier: NCT01617083     History of Changes
Other Study ID Numbers: 6119-128500
270332 ( Other Grant/Funding Number: Massachusetts General Hospital (MGH) )
First Submitted: May 23, 2012
First Posted: June 12, 2012
Results First Submitted: June 21, 2016
Results First Posted: April 10, 2018
Last Update Posted: April 10, 2018