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Sertraline Pediatric Registry for the Evaluation of Safety (SPRITES) (SPRITES)

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: NCT01302080
Recruitment Status : Active, not recruiting
First Posted : February 23, 2011
Last Update Posted : December 16, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date February 1, 2011
First Posted Date February 23, 2011
Last Update Posted Date December 16, 2019
Actual Study Start Date April 4, 2012
Estimated Primary Completion Date October 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 5, 2011)
  • change in cognitive function as measured by Trails B (Trail Making Test) and BRIEF (Behavior Rating Inventory of Executive Function) exams [ Time Frame: baseline, 36 months ]
  • change in emotional regulation as measured by the emotional regulation factor from the BRIEF (Behavior Rating Inventory of Executive Function) exam [ Time Frame: baseline, 36 months ]
  • change in suicide/aggression as measured by the HoNOSCA (Health of the Nation Outcome Scale for Children and Adolescents) [ Time Frame: baseline, 36 months ]
  • change in physical development as measured by height and weight [ Time Frame: baseline, 36 months ]
  • change in pubertal development as measured by the PDS (Pubertal Development Scale) [ Time Frame: baseline, 36 months ]
Original Primary Outcome Measures
 (submitted: February 18, 2011)
  • change in cognitive function as measured by Trails B (Trail Making Test) exam [ Time Frame: baseline, 36 months ]
  • change in emotional regulation as measured by the emotional regulation factor from the BRIEF (Behavior Rating Inventory of Executive Function) exam [ Time Frame: baseline, 36 months ]
  • change in suicide/aggression as measured by the HoNOSCA (Health of the Nation Outcome Scale for Children and Adolescents) [ Time Frame: baseline, 36 months ]
  • change in physical development as measured by height and weight [ Time Frame: baseline, 36 months ]
  • change in pubertal development as measured by the PDS (Pubertal Development Scale) [ Time Frame: baseline, 36 months ]
  • change in cognitive function as measured by BRIEF (Behavior Rating Inventory of Executive Function) exam [ Time Frame: baseline, 36 months ]
Change History
Current Secondary Outcome Measures
 (submitted: March 1, 2012)
  • change in clinical global impression scale -Improvement (CGI-I) [ Time Frame: baseline, 36 months ]
  • change in clinical global impression scale - Acceptability/Tolerability (CGI-A/T) [ Time Frame: baseline, 36 months ]
  • change in clinical global impression scale -Effectiveness (CGI-E) [ Time Frame: baseline, 36 months ]
  • change in clinical global impression scale -Severity (CGI-S) [ Time Frame: baseline, 36 months ]
  • change in clinical global assessment schedule -(CGAS) [ Time Frame: baseline, 36 months ]
  • Change in adverse event burden [ Time Frame: baseline, 36 months ]
  • suicide-related events as measured by the Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: baseline, 36 months ]
Original Secondary Outcome Measures
 (submitted: February 18, 2011)
  • change in clinical global impression scale -Improvement (CGI-I) [ Time Frame: baseline, 36 months ]
  • change in clinical global impression scale - Acceptability/Tolerability (CGI-A/T) [ Time Frame: baseline, 36 months ]
  • change in clinical global impression scale -Effectiveness (CGI-E) [ Time Frame: baseline, 36 months ]
  • change in clinical global impression scale -Severity (CGI-S) [ Time Frame: baseline, 36 months ]
  • change in clinical global assessment schedule -(CGAS) [ Time Frame: baseline, 36 months ]
  • Change in adverse event burden [ Time Frame: baseline, 36 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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
    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
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 Active, not recruiting
Actual Enrollment
 (submitted: October 12, 2017)
941
Original Estimated Enrollment
 (submitted: February 18, 2011)
900
Estimated Study Completion Date October 1, 2020
Estimated Primary Completion Date October 1, 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
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/data_requests.
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date December 2019