Sertraline Pediatric Registry for the Evaluation of Safety (SPRITES)

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

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.


Condition Intervention Phase
Obsessive Compulsive Disorder
Drug: sertraline
Behavioral: psychotherapy
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Sertraline Pediatric Registry for the Evaluation of Safety (SPRITES)

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 900
Study Start Date: March 2012
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Sertraline-treated
inception cohort of enrolled subjects beginning treatment for one of the study qualifying disorders with sertraline
Drug: sertraline
Non interventional study - drug, dose, duration etc as per USPI and clinician discretion
pyschotherapy only
inception cohort of enrolled subjects beginning treatment for one of the study qualifying disorders with psychotherapy
Behavioral: psychotherapy
Non-interventional study- as above

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.

  Eligibility

Ages Eligible for Study:   6 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01302080

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

  Show 46 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01302080     History of Changes
Other Study ID Numbers: A0501093
Study First Received: February 1, 2011
Last Updated: August 11, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
prospective
cohort
sertraline
long-term impact
cognition
emotional and physical development
pubertal maturation

Additional relevant MeSH terms:
Obsessive-Compulsive Disorder
Compulsive Personality Disorder
Anxiety Disorders
Mental Disorders
Personality Disorders
Sertraline
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 18, 2014