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

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ClinicalTrials.gov Identifier: NCT01302080
Recruitment Status : Active, not recruiting
First Posted : February 23, 2011
Last Update Posted : December 25, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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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.

Condition or disease Intervention/treatment
Obsessive Compulsive Disorder Drug: sertraline Behavioral: psychotherapy

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 Design
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Study Type : Observational
Actual Enrollment : 941 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : April 2012
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. change in suicide/aggression as measured by the HoNOSCA (Health of the Nation Outcome Scale for Children and Adolescents) [ Time Frame: baseline, 36 months ]
  4. change in physical development as measured by height and weight [ Time Frame: baseline, 36 months ]
  5. change in pubertal development as measured by the PDS (Pubertal Development Scale) [ Time Frame: baseline, 36 months ]

Secondary Outcome Measures :
  1. change in clinical global impression scale -Improvement (CGI-I) [ Time Frame: baseline, 36 months ]
  2. change in clinical global impression scale - Acceptability/Tolerability (CGI-A/T) [ Time Frame: baseline, 36 months ]
  3. change in clinical global impression scale -Effectiveness (CGI-E) [ Time Frame: baseline, 36 months ]
  4. change in clinical global impression scale -Severity (CGI-S) [ Time Frame: baseline, 36 months ]
  5. change in clinical global assessment schedule -(CGAS) [ Time Frame: baseline, 36 months ]
  6. Change in adverse event burden [ Time Frame: baseline, 36 months ]
  7. suicide-related events as measured by the Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: baseline, 36 months ]

Eligibility Criteria
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Ages Eligible for Study:   6 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01302080


  Show 44 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01302080     History of Changes
Other Study ID Numbers: A0501093
SPRITES ( Other Identifier: Alias Study Number )
First Posted: February 23, 2011    Key Record Dates
Last Update Posted: December 25, 2018
Last Verified: December 2018
Individual Participant Data (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.

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

Additional relevant MeSH terms:
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Personality Disorders
Mental Disorders
Anxiety Disorders
Sertraline
Antidepressive Agents
Psychotropic Drugs
 Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs