Sertraline Pediatric Registry for the Evaluation of Safety (SPRITES)

• 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 ]

• change in cognitive function as measured by BRIEF (Behavior Rating Inventory of Executive Function) exam [ 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 ]
• change in cognitive function as measured by Trails B (Trail Making Test) exam [ Time Frame: baseline, 36 months ] [ Designated as safety issue: No ]

• 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 ]

• 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: No ]

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.

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.

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.

• Drug: sertraline
  Non interventional study - drug, dose, duration etc as per USPI and clinician discretion
• Behavioral: psychotherapy
  Non-interventional study- as above

• Sertraline-treated
  inception cohort of enrolled subjects beginning treatment for one of the study qualifying disorders with sertraline
  Intervention: Drug: sertraline
• pyschotherapy only
  inception cohort of enrolled subjects beginning treatment for one of the study qualifying disorders with psychotherapy
  Intervention: Behavioral: psychotherapy

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