Sertraline Pediatric Registry for the Evaluation of Safety (SPRITES)
This study is currently recruiting participants.
Verified May 2013 by Pfizer
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01302080
First received: February 1, 2011
Last updated: May 8, 2013
Last verified: May 2013
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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 14 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 14 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 of the study sites in the NIMH funded clincal trials network in pediatric psychiatry (CAPTN). From these, the study-eligible population (all children age 6 to 14 (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 14 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01302080
Contacts
| Contact: Pfizer CT.gov Call Center | 1-800-718-1021 |
Locations
| United States, North Carolina | |
| Duke University Medical Center, Division of Child & Adolescent Psychiatry | Recruiting |
| Durham, North Carolina, United States, 27705 | |
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: | May 8, 2013 |
| 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 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 May 23, 2013