Clinical trial NCT01302080: Sertraline Pediatric Registry for the Evaluation of Safety (SPRITES)
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obsessive Compulsive Disorder
Keywords: prospective
cohort
sertraline
long-term impact
cognition
emotional and physical development
pubertal maturation
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-02-23
Enrollment: 941
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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 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
* Taking an antidepressant medication other than sertraline, first or second generation antipsychotic, lithium, psychostimulant

Primary outcomes:
measure: Change From Baseline in Cognitive Function Using Trails B at Month 3
timeFrame: Baseline, Month 3
measure: Change From Baseline in Cognitive Function Using Trails B at Month 6
timeFrame: Baseline, Month 6
measure: Change From Baseline in Cognitive Function Using Trails B at Month 12
timeFrame: Baseline, Month 12
measure: Change From Baseline in Cognitive Function Using Trails B at Month 18
timeFrame: Baseline, Month 18
measure: Change From Baseline in Cognitive Function Using Trails B at Month 24
timeFrame: Baseline, Month 24
measure: Change From Baseline in Cognitive Function Using Trails B at Month 30
timeFrame: Baseline, Month 30
measure: Change From Baseline in Cognitive Function Using Trails B at Month 36
timeFrame: Baseline, Month 36
measure: Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 3
timeFrame: Baseline, Month 3
measure: Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 6
timeFrame: Baseline, Month 6
measure: Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 12
timeFrame: Baseline, Month 12
measure: Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 18
timeFrame: Baseline, Month 18
measure: Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 24
timeFrame: Baseline, Month 24
measure: Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 30
timeFrame: Baseline, Month 30
measure: Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 36
timeFrame: Baseline, Month 36
measure: Change From Baseline in Behavioral/Emotional Regulation Using the Behavior Regulation Index From BRIEF at Month 3
timeFrame: Baseline, Month 3
measure: Change From Baseline in Behavioral/Emotional Regulation Using the Behavior Regulation Index From BRIEF at Month 6
timeFrame: Baseline, Month 6
measure: Change From Baseline in Behavioral/Emotional Regulation Using the Behavior Regulation Index From BRIEF at Month 12
timeFrame: Baseline, Month 12
measure: Change From Baseline in Behavioral/Emotional Regulation Using the Behavior Regulation Index From BRIEF at Month 18
timeFrame: Baseline, Month 18
measure: Change From Baseline in Behavioral/Emotional Regulation Using the Behavior Regulation Index From BRIEF at Month 24
timeFrame: Baseline, Month 24
measure: Change From Baseline in Behavioral/Emotional Regulation Using the Behavior Regulation Index From BRIEF at Month 30
timeFrame: Baseline, Month 30
measure: Change From Baseline in Behavioral/Emotional Regulation Using the Behavior Regulation Index From BRIEF at Month 36
timeFrame: Baseline, Month 36
measure: Change From Baseline in Height at Month 3
timeFrame: Baseline, Month 3
measure: Change From Baseline in Height at Month 6
timeFrame: Baseline, Month 6
measure: Change From Baseline in Height at Month 12
timeFrame: Baseline, Month 12
measure: Change From Baseline in Height at Month 18
timeFrame: Baseline, Month 18
measure: Change From Baseline in Height at Month 24
timeFrame: Baseline, Month 24
measure: Change From Baseline in Height at Month 30
timeFrame: Baseline, Month 30
measure: Change From Baseline in Height at Month 36
timeFrame: Baseline, Month 36
measure: Change From Baseline in Weight at Month 3
timeFrame: Baseline, Month 3
measure: Change From Baseline in Weight at Month 6
timeFrame: Baseline, Month 6
measure: Change From Baseline in Weight at Month 12
timeFrame: Baseline, Month 12
measure: Change From Baseline in Weight at Month 18
timeFrame: Baseline, Month 18
measure: Change From Baseline in Weight at Month 24
timeFrame: Baseline, Month 24
measure: Change From Baseline in Weight at Month 30
timeFrame: Baseline, Month 30
measure: Change From Baseline in Weight at Month 36
timeFrame: Baseline, Month 36
measure: Change From Baseline in Body Mass Index (BMI) at Month 3
timeFrame: Baseline, Month 3
measure: Change From Baseline in Body Mass Index (BMI) at Month 6
timeFrame: Baseline, Month 6
measure: Change From Baseline in Body Mass Index (BMI) at Month 12
timeFrame: Baseline, Month 12
measure: Change From Baseline in Body Mass Index (BMI) at Month 18
timeFrame: Baseline, Month 18
measure: Change From Baseline in Body Mass Index (BMI) at Month 24
timeFrame: Baseline, Month 24
measure: Change From Baseline in Body Mass Index (BMI) at Month 30
timeFrame: Baseline, Month 30
measure: Change From Baseline in Body Mass Index (BMI) at Month 36
timeFrame: Baseline, Month 36
measure: Primary: Number of Participants With Tanner Staging Evaluation at Baseline: All Males
timeFrame: Baseline (prior to or within 45 Days of initiating treatment, if exposed) and after parental/guardian provided permission and assent
measure: Number of Participants With Tanner Staging Evaluation at Month 3: All Males
timeFrame: Month 3
measure: Number of Participants With Tanner Staging Evaluation at Month 6: All Males
timeFrame: Month 6
measure: Number of Participants With Tanner Staging Evaluation at Month 12: All Males
timeFrame: Month 12
measure: Number of Participants With Tanner Staging Evaluation at Month 18: All Males
timeFrame: Month 18
measure: Number of Participants With Tanner Staging Evaluation at Month 24: All Males
timeFrame: Month 24
measure: Number of Participants With Tanner Staging Evaluation at Month 30: All Males
timeFrame: Month 30
measure: Number of Participants With Tanner Staging Evaluation at Month 36: All Males
timeFrame: Month 36
measure: Number of Participants With Tanner Staging Evaluation at Baseline: All Females
timeFrame: Baseline (prior to or within 45 Days of initiating treatment, if exposed) and after parental/guardian provided permission and assent
measure: Number of Participants With Tanner Staging Evaluation at Month 3: All Females
timeFrame: Month 3
measure: Number of Participants With Tanner Staging Evaluation at Month 6: All Females
timeFrame: Month 6
measure: Number of Participants With Tanner Staging Evaluation at Month 12: All Females
timeFrame: Month 12
measure: Number of Participants With Tanner Staging Evaluation at Month 18: All Females
timeFrame: Month 18
measure: Number of Participants With Tanner Staging Evaluation at Month 24: All Females
timeFrame: Month 24
measure: Number of Participants With Tanner Staging Evaluation at Month 30: All Females
timeFrame: Month 30
measure: Number of Participants With Tanner Staging Evaluation at Month 36: All Females
timeFrame: Month 36
Secondary outcomes:
measure: Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36
timeFrame: Month 3, 6, 12, 18, 24, 30 and 36
measure: Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36
timeFrame: Month 3, 6, 12, 18, 24, 30 and 36
measure: Number of Participants Who Were Responders According to Clinical Global Impression-Effectiveness (CGI-E) Scale at Month 3, 6, 12, 18, 24, 30 and 36
timeFrame: Month 3, 6, 12, 18, 24, 30 and 36
measure: Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36
timeFrame: Baseline, Month 3, 6, 12, 18, 24, 30 and 36
measure: Change From Baseline in Child Global Assessment Scale (CGAS) at Month 3, 6, 12, 18, 24, 30 and 36
timeFrame: Baseline, Month 3, 6, 12, 18, 24, 30 and 36
measure: Change From Baseline in General Health and Social Functioning Using the Health of the Nation Outcome Scale for Children and Adolescents (HoNOSCA) Total Score at Month 3, 6, 12, 18, 24, 30 and 36
timeFrame: Baseline, Month 3, 6, 12, 18, 24, 30 and 36
Other outcomes:
Locations:
city: Dothan
country: United States
facility: Harmonex Neuroscience Research
state: Alabama
city: Imperial
country: United States
facility: Sun Valley Research Center
state: California
city: Los Angeles
country: United States
facility: UCLA Semel institute
state: California
city: Hartford
country: United States
facility: Institute of Living/Hartford Hospital
state: Connecticut
city: Norwich
country: United States
facility: Comprehensive Psychiatric Care
state: Connecticut
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Jacksonville
country: United States
facility: Nemours Children's Clinic, Dept. of Psychology and Psychiatry
state: Florida
city: Orange City
country: United States
facility: Medical Research Group of Central Florida
state: Florida
city: Pensacola
country: United States
facility: Harmonex Neuroscience of Pensacola
state: Florida
city: Saint Petersburg
country: United States
facility: University of South Florida - Rothman Center
state: Florida
city: Augusta
country: United States
facility: Georgia Regents University Augusta
state: Georgia
city: Smyrna
country: United States
facility: Institute for Behavioral Medicine, LLC
state: Georgia
city: Plainfield
country: United States
facility: Family Behavioral Health
state: Illinois
city: Kansas City
country: United States
facility: University of Kansas School of Medicine/Dept. of Psychiatry
state: Kansas
city: Topeka
country: United States
facility: Family Service and Guidance Center
state: Kansas
city: Baltimore
country: United States
facility: Kennedy Krieger Institute
state: Maryland
city: Rockville
country: United States
facility: Neuroscientific Insights
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: South Yarmouth
country: United States
facility: Debora A. LaMonica, MD
state: Massachusetts
city: Springfield
country: United States
facility: Baystate Medical Center, Child Behavioral Health Research
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Gladstone
country: United States
facility: Comprehensive Psychiatric Associates
state: Missouri
city: Springfield
country: United States
facility: Saint John's Clinic
state: Missouri
city: Neptune
country: United States
facility: Jersey Shore University Medical Center/Meridian Health
state: New Jersey
city: Toms River
country: United States
facility: Children's Specialized Hospital
state: New Jersey
city: Rochester
country: United States
facility: Finger Lakes Clinical Research
state: New York
city: Cary
country: United States
facility: 3-C Family Services, P.A.
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center, Division of Child & Adolescent Psychiatry
state: North Carolina
city: Wilmington
country: United States
facility: Scott George Crowder, M.D.
state: North Carolina
city: Chagrin Falls
country: United States
facility: Family Center by the Falls
state: Ohio
city: Cincinnati
country: United States
facility: University Of Cincinnati
state: Ohio
city: Cincinnati
country: United States
facility: Cincinnati Childrens Hospital and Medical Center
state: Ohio
city: Cleveland
country: United States
facility: Case Western Reserve University, Department of Psychiatry Child/Adolescent
state: Ohio
city: Oklahoma City
country: United States
facility: Cutting Edge Research Group
state: Oklahoma
city: Havertown
country: United States
facility: Child Guidance Resource Center
state: Pennsylvania
city: Tullahoma
country: United States
facility: Tullahoma Pediatrics PLLC
state: Tennessee
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center at Dallas
state: Texas
city: Friendswood
country: United States
facility: Bay Pointe Behavioral Health Service, Inc.
state: Texas
city: Houston
country: United States
facility: Midtown Psychiatry and TMS Center
state: Texas
city: Houston
country: United States
facility: Peter Ly MD
state: Texas
city: San Antonio
country: United States
facility: Focus and Balance, LLC
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia Health System
state: Virginia
city: Petersburg
country: United States
facility: Clinical Research Partners, LLC
state: Virginia
city: Milwaukee
country: United States
facility: McLean Hospital - Harvard Medical School
state: Wisconsin
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Kolitsopoulos F, Ramaker S, Compton S, Broderick S, Orazem J, Bao W, Lokhnygina Y, Chappell P. Sertraline Pediatric Registry for the Evaluation of Safety: Design and Clinical Characteristics of Pediatric Patients Prescribed Sertraline. J Child Adolesc Psychopharmacol. 2021 Aug;31(6):411-420. doi: 10.1089/cap.2020.0170. Epub 2021 Jul 21.