Sertraline Pediatric Registry for the Evaluation of Safety (SPRITES)
This study is currently recruiting participants.
(see Contacts and Locations)
Verified February 2015 by Pfizer
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01302080
First received: February 1, 2011
Last updated: February 6, 2015
Last verified: February 2015
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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: | Sprites: Sertraline Pediatric Registry For The Evaluation Of Safety |
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: | April 2012 |
| Estimated Study Completion Date: | May 2019 |
| Estimated Primary Completion Date: | May 2019 (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
Show 47 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01302080
Contacts
| Contact: Pfizer CT.gov Call Center | 1-800-718-1021 |
Show 47 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, SPRITES |
| Study First Received: | February 1, 2011 |
| Last Updated: | February 6, 2015 |
| 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 Anxiety Disorders Mental Disorders Sertraline Antidepressive Agents Central Nervous System Agents Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents |
Neurotransmitter Uptake Inhibitors Pharmacologic Actions Physiological Effects of Drugs Psychotropic Drugs Serotonin Agents Serotonin Uptake Inhibitors Therapeutic Uses |
ClinicalTrials.gov processed this record on March 03, 2015