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Sertraline Pediatric Registry for the Evaluation of Safety (SPRITES)

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NCT01302080

Last updated on August 22, 2018
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FOR MORE INFORMATION
Study Location
Harmonex Neuroscience Research
Dothan, Alabama, 36303 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
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

NCT01302080
Pfizer
Active, not recruiting
Sertraline Pediatric Registry for the Evaluation of Safety (SPRITES)

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Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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Sertraline Pediatric Registry for the Evaluation of Safety (SPRITES)
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
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.
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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
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.
Obsessive Compulsive Disorder
  • Drug: sertraline
    Non interventional study - drug, dose, duration etc as per USPI and clinician discretion
  • Behavioral: psychotherapy
    Non-interventional study- as above
  • Sertraline-treated
    inception cohort of enrolled subjects beginning treatment for one of the study qualifying disorders with sertraline
    Intervention: Drug: sertraline
  • pyschotherapy only
    inception cohort of enrolled subjects beginning treatment for one of the study qualifying disorders with psychotherapy
    Intervention: Behavioral: psychotherapy
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
941
October 2020
October 2020   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
6 Years to 16 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01302080
A0501093
SPRITES ( Other Identifier: Alias Study Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2017

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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