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

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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Azithromycin

Antibiotic used to treat infections.

Azithromycin: Antibiotic used to treat infections

Placebo

Compound thickening agent with sugar and flavor additives.

Placebo: Thickening compound with sugar and flavoring

Not Randomized Participants consented to participate in the study. They completed baseline assessments but did not randomize to treatment.

Participant Flow:   Overall Study
    Azithromycin   Placebo   Not Randomized
STARTED   18   14   15 
COMPLETED   18   14   15 
NOT COMPLETED   0   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Azithromycin

Antibiotic used to treat infections.

Azithromycin: Antibiotic used to treat infections

Placebo

Compound thickening agent with sugar and flavor additives.

Placebo: Thickening compound with sugar and flavoring

Not Randomized Participants only completed the baseline assessments but did not receive treatment.
Total Total of all reporting groups

Baseline Measures
   Azithromycin   Placebo   Not Randomized   Total 
Overall Participants Analyzed 
[Units: Participants]
 18   14   15   47 
Age 
[Units: Participants]
Count of 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 
[Units: Years]
Mean (Standard Deviation)
 7.78  (2.39)   8.86  (3.11)   7.21  (2.58)   8.25  (2.74) 
Sex: Female, Male 
[Units: Participants]
Count of 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 
[Units: Participants]
       
United States   18   14   15   47 


  Outcome Measures

1.  Primary:   Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS)   [ Time Frame: Before and after 4 week randomization ]

2.  Secondary:   Clinical Global Impressions-Severity OCD   [ Time Frame: Before and after 4 week randomization ]

3.  Secondary:   Screen for Childhood Anxiety-Related Emotional Disorders (SCARED)   [ Time Frame: Before and after 4 week randomization ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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
e-mail: ebrenna1@health.usf.edu


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