Sertraline Pediatric Registry for the Evaluation of Safety (SPRITES)
NCT01302080
Last updated date
ABOUT THIS STUDY
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.
Study Location
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
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
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
- Dothan, Alabama
- Imperial, California
- Los Angeles, California
- Hartford, Connecticut
- Norwich, Connecticut
- Gainesville, Florida
- Jacksonville, Florida
- Orange City, Florida
- Pensacola, Florida
- Saint Petersburg, Florida
- Augusta, Georgia
- Smyrna, Georgia
- Plainfield, Illinois
- Kansas City, Kansas
- Topeka, Kansas
- Baltimore, Maryland
- Rockville, Maryland
- Boston, Massachusetts
- South Yarmouth, Massachusetts
- Springfield, Massachusetts
- Rochester, Minnesota
- Gladstone, Missouri
- Springfield, Missouri
- Neptune, New Jersey
- Toms River, New Jersey
- Rochester, New York
- Cary, North Carolina
- Durham, North Carolina
- Wilmington, North Carolina
- Chagrin Falls, Ohio
- Cincinnati, Ohio
- Cincinnati, Ohio
- Cleveland, Ohio
- Oklahoma City, Oklahoma
- Havertown, Pennsylvania
- Tullahoma, Tennessee
- Dallas, Texas
- Friendswood, Texas
- Houston, Texas
- Houston, Texas
- San Antonio, Texas
- Charlottesville, Virginia
- Petersburg, Virginia
- 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 |
| ||||
| Study Groups/Cohorts |
| ||||
| 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 | 941 | ||||
| Original Estimated Enrollment | 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:
Exclusion Criteria:
| ||||
| Sex/Gender |
| ||||
| 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 |
| ||||
| Responsible Party | Pfizer | ||||
| Study Sponsor | Pfizer | ||||
| Collaborators | Not Provided | ||||
| Investigators |
| ||||
| PRS Account | Pfizer | ||||
| Verification Date | November 2020 | ||||