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
This prospective cohort study will evaluate the risks and benefits of treatment with sertraline under real-world conditions in subjects ages 6 to 14 years of age who are prescribed sertraline by their physician for up to a 3-year period. a total of 900 subjects (720 exposed to sertraline as prescribed by their physician, with or without psychotherapy, and 180 exposed to psychotherapy alone as a control group) will be enrolled at sites around the u.S. Subjects who consent to this non-interventional study will undergo assessments at baseline, 12 weeks, 6 months, and every 6 months thereafter for 3 years. enrolled subjects who discontinue sertraline, take another antidepressant, switch to psychotherapy alone, or need no mental health treatment will be asked to continue participation in the study. The study does not in any way constrain the nature of the treatment administered, and sertraline administration will be conducted in accordance with usual and customary [Quote]real world[Quote] practice. The primary outcomes assessments are measures of cognitive development, cognitive and emotional development, height, weight, and pubertal maturation.
Inclusion Criteria for all Subjects:
1. Subject and parent must understand the nature of the study and be able to comply with protocol requirements. The parent must provide written permission and the subject must provide written assent, per local IRB requirements.
2. Male or female, ages 6 to 16 (inclusive) on the day of parental/guardian permission/assent.
3. English or Spanish speaking.
*Please see clarification in 9.3.1 below.
4. Receiving treatment in an outpatient setting.
5. May be receiving stable treatment with another drug or psychosocial intervention except as noted in the study exclusion criteria. For this study, stability is defined as no change in does or form of drug or psychosocial treatment for at least 2 weeks at the time of parental/guardian permission/assent. Subjects in the sertraline arm may also receive stable treatment with a psychosocial intervention (as defined above) or may begin both sertraline and a psychosocial intervention simultaneously, i.e., within 2 weeks.
6. Parents/guardians must be able to complete the BRIEF, which will be offered in English and Spanish. All other treatment and study-specific assessments may be obtained independent of language if the treatment provider and the person administering the test are fluent speakers in the subject's/parent's native language.
7. Subject has no plans to move out of the area and expects to remain in contact with the treating clinic for the duration of the study.
Inclusion Criteria for Sertraline-exposed Subjects Only:
8. Provided a new prescription for sertraline at baseline or within 45 days of enrollment in SPRITES.
9. Subject is expected to remain on sertraline beyond initial acute treatment response, defined as change from baseline.
Inclusion Criteria for Non-exposed Comparison Group:
10. Initiating psychosocial, rather than pharmacological treatment from a member of the SPRITES treatment practice for the same spectrum of mental health diseases that would be appropriately treated with and SSRI medication on or within 45 days of enrollment in SPRITES.
11. Not taking sertraline or have failed a trial of sertraline judged adequate in dose and duration.