Sertraline Pediatric Registry for the Evaluation of Safety (SPRITES)

This study is currently recruiting participants.
Verified April 2014 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01302080
First received: February 1, 2011
Last updated: April 11, 2014
Last verified: April 2014

February 1, 2011
April 11, 2014
March 2012
September 2017   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • change in suicide/aggression as measured by the HoNOSCA (Health of the Nation Outcome Scale for Children and Adolescents) [ Time Frame: baseline, 36 months ] [ Designated as safety issue: Yes ]
  • change in physical development as measured by height and weight [ Time Frame: baseline, 36 months ] [ Designated as safety issue: No ]
  • change in pubertal development as measured by the PDS (Pubertal Development Scale) [ Time Frame: baseline, 36 months ] [ Designated as safety issue: No ]
  • change in cognitive function as measured by BRIEF (Behavior Rating Inventory of Executive Function) exam [ Time Frame: baseline, 36 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • change in suicide/aggression as measured by the HoNOSCA (Health of the Nation Outcome Scale for Children and Adolescents) [ Time Frame: baseline, 36 months ] [ Designated as safety issue: Yes ]
  • change in physical development as measured by height and weight [ Time Frame: baseline, 36 months ] [ Designated as safety issue: No ]
  • change in pubertal development as measured by the PDS (Pubertal Development Scale) [ Time Frame: baseline, 36 months ] [ Designated as safety issue: No ]
  • change in cognitive function as measured by Trails B (Trail Making Test) exam [ Time Frame: baseline, 36 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01302080 on ClinicalTrials.gov Archive Site
  • change in clinical global impression scale -Improvement (CGI-I) [ Time Frame: baseline, 36 months ] [ Designated as safety issue: No ]
  • change in clinical global impression scale - Acceptability/Tolerability (CGI-A/T) [ Time Frame: baseline, 36 months ] [ Designated as safety issue: No ]
  • change in clinical global impression scale -Effectiveness (CGI-E) [ Time Frame: baseline, 36 months ] [ Designated as safety issue: No ]
  • change in clinical global impression scale -Severity (CGI-S) [ Time Frame: baseline, 36 months ] [ Designated as safety issue: No ]
  • change in clinical global assessment schedule -(CGAS) [ Time Frame: baseline, 36 months ] [ Designated as safety issue: No ]
  • Change in adverse event burden [ Time Frame: baseline, 36 months ] [ Designated as safety issue: Yes ]
  • suicide-related events as measured by the Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: baseline, 36 months ] [ Designated as safety issue: Yes ]
  • change in clinical global impression scale -Improvement (CGI-I) [ Time Frame: baseline, 36 months ] [ Designated as safety issue: No ]
  • change in clinical global impression scale - Acceptability/Tolerability (CGI-A/T) [ Time Frame: baseline, 36 months ] [ Designated as safety issue: No ]
  • change in clinical global impression scale -Effectiveness (CGI-E) [ Time Frame: baseline, 36 months ] [ Designated as safety issue: No ]
  • change in clinical global impression scale -Severity (CGI-S) [ Time Frame: baseline, 36 months ] [ Designated as safety issue: No ]
  • change in clinical global assessment schedule -(CGAS) [ Time Frame: baseline, 36 months ] [ Designated as safety issue: No ]
  • Change in adverse event burden [ Time Frame: baseline, 36 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Sertraline Pediatric Registry for the Evaluation of Safety (SPRITES)
Sertraline Pediatric Registry for the Evaluation of Safety (SPRITES)

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.
 
Recruiting
900
September 2017
September 2017   (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
Both
6 Years to 16 Years
No
Contact: Pfizer CT.gov Call Center 1-800-718-1021
United States
 
NCT01302080
A0501093
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP