Sertraline Pediatric Registry for the Evaluation of Safety (SPRITES)

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NCT01302080

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Study Location
Harmonex Neuroscience Research
Dothan, Alabama, 36303, United States
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Contact
1-800-718-1021
[email protected]
Related Links

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Obsessive Compulsive Disorder
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
6-16 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Children age 6 to 16 (inclusive) with anxiety, depression, or obsessive-compulsive disorder, receiving treatment in outpatient setting, and who are prescribed a new prescription for sertraline to treat one of the above study-qualifying disorders or beginning psychotherapy for same.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Psychotic at study entry


- Diagnosis of bipolar disorder


- Diagnosis of schizoaffective or schizophrenia


- Anorexia


- Bulimia or eating disorder not otherwise specified (NOS)


- Autism


- Pervasive developmental disorder


- High risk of suicide within 2 weeks of initiating study treatment


- Significant mental retardation


- Taking an antidepressant medication other than sertraline, first or second generation
antipsychotic, lithium, psychostimulant

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Obsessive Compulsive DisorderSertraline Pediatric Registry for the Evaluation of Safety (SPRITES)
NCT01302080
  1. Dothan, Alabama
  2. Imperial, California
  3. Los Angeles, California
  4. Hartford, Connecticut
  5. Norwich, Connecticut
  6. Gainesville, Florida
  7. Jacksonville, Florida
  8. Orange City, Florida
  9. Pensacola, Florida
  10. Saint Petersburg, Florida
  11. Augusta, Georgia
  12. Smyrna, Georgia
  13. Plainfield, Illinois
  14. Kansas City, Kansas
  15. Topeka, Kansas
  16. Baltimore, Maryland
  17. Rockville, Maryland
  18. Boston, Massachusetts
  19. South Yarmouth, Massachusetts
  20. Springfield, Massachusetts
  21. Rochester, Minnesota
  22. Gladstone, Missouri
  23. Springfield, Missouri
  24. Neptune, New Jersey
  25. Toms River, New Jersey
  26. Rochester, New York
  27. Cary, North Carolina
  28. Durham, North Carolina
  29. Wilmington, North Carolina
  30. Chagrin Falls, Ohio
  31. Cincinnati, Ohio
  32. Cincinnati, Ohio
  33. Cleveland, Ohio
  34. Oklahoma City, Oklahoma
  35. Havertown, Pennsylvania
  36. Tullahoma, Tennessee
  37. Dallas, Texas
  38. Friendswood, Texas
  39. Houston, Texas
  40. Houston, Texas
  41. San Antonio, Texas
  42. Charlottesville, Virginia
  43. Petersburg, Virginia
  44. Milwaukee, Wisconsin
ALL GENDERS
6 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title Sertraline Pediatric Registry for the Evaluation of Safety (SPRITES)
Official Title SPRITES: SERTRALINE PEDIATRIC REGISTRY FOR THE EVALUATION OF SAFETY A NON-INTERVENTIONAL, LONGITUDINAL, COHORT STUDY TO EVALUATE THE EFFECTS OF LONG-TERM SERTRALINE TREATMENT IN CHILDREN AND ADOLESCENTS
Brief Summary To evaluate the long-term impact of treatment with sertraline on aspects of cognitive, emotional and physical development and pubertal maturation in pediatric subjects ages 6 to 16 years (inclusive) with a diagnosis of anxiety disorder, depressive disorder or obsessive compulsive disorder.
Detailed Description Purposive sample: patients are not randomly selected, that is, he or she must meet certain inclusion criteria in order to qualify as a potential study participant.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population The accessible population is children meeting inclusion/exclusion criteria from US centers in various clinical settings, including the Child and Adolescent Psychiatry Trials Network (CAPTN). From these, the study-eligible population (all children age 6 to 16 (inclusive) with an anxiety, depressive, or obsessive-compulsive disorder, who are exposed to sertraline under real-world conditions) will comprise an inception cohort of enrolled subjects beginning treatment for one of the study-qualifying disorders with sertraline or psychotherapy.
Condition Obsessive Compulsive Disorder
Intervention
  • Drug: sertraline
    Non interventional study - drug, dose, duration etc as per USPI and clinician discretion
  • Behavioral: psychotherapy
    Non-interventional study- as above
Study Groups/Cohorts
  • Sertraline-treated
    enrolled subjects beginning treatment for one of the study qualifying disorders with sertraline
    Intervention: Drug: sertraline
  • psychotherapy only
    enrolled subjects beginning treatment for one of the study qualifying disorders with psychotherapy
    Intervention: Behavioral: psychotherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 12, 2017)		941
Original Estimated Enrollment
 (submitted: February 18, 2011)		900
Actual Study Completion Date September 9, 2020
Actual Primary Completion Date September 9, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Children age 6 to 16 (inclusive) with anxiety, depression, or obsessive-compulsive disorder, receiving treatment in outpatient setting, and who are prescribed a new prescription for sertraline to treat one of the above study-qualifying disorders or beginning psychotherapy for same.

Exclusion Criteria:

  • Psychotic at study entry
  • Diagnosis of bipolar disorder
  • Diagnosis of schizoaffective or schizophrenia
  • Anorexia
  • Bulimia or eating disorder not otherwise specified (NOS)
  • Autism
  • Pervasive developmental disorder
  • High risk of suicide within 2 weeks of initiating study treatment
  • Significant mental retardation
  • Taking an antidepressant medication other than sertraline, first or second generation antipsychotic, lithium, psychostimulant
Sex/Gender
Sexes Eligible for Study:All
Ages 6 Years to 16 Years   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01302080
Other Study ID Numbers A0501093
SPRITES ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD:No
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date November 2020