Sertraline Pediatric Registry for the Evaluation of Safety (SPRITES) (SPRITES)
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ClinicalTrials.gov Identifier: NCT01302080 |
Recruitment Status
:
Active, not recruiting
First Posted
: February 23, 2011
Last Update Posted
: January 5, 2018
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Condition or disease | Intervention/treatment |
---|---|
Obsessive Compulsive Disorder | Drug: sertraline Behavioral: psychotherapy |
Study Type : | Observational |
Actual Enrollment : | 941 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
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 |
Actual Study Start Date : | April 2012 |
Estimated Primary Completion Date : | October 2020 |
Estimated Study Completion Date : | October 2020 |

Group/Cohort | Intervention/treatment |
---|---|
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
|
- 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 ]
- 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 ]
- change in suicide/aggression as measured by the HoNOSCA (Health of the Nation Outcome Scale for Children and Adolescents) [ Time Frame: baseline, 36 months ]
- change in physical development as measured by height and weight [ Time Frame: baseline, 36 months ]
- change in pubertal development as measured by the PDS (Pubertal Development Scale) [ Time Frame: baseline, 36 months ]
- change in clinical global impression scale -Improvement (CGI-I) [ Time Frame: baseline, 36 months ]
- change in clinical global impression scale - Acceptability/Tolerability (CGI-A/T) [ Time Frame: baseline, 36 months ]
- change in clinical global impression scale -Effectiveness (CGI-E) [ Time Frame: baseline, 36 months ]
- change in clinical global impression scale -Severity (CGI-S) [ Time Frame: baseline, 36 months ]
- change in clinical global assessment schedule -(CGAS) [ Time Frame: baseline, 36 months ]
- Change in adverse event burden [ Time Frame: baseline, 36 months ]
- suicide-related events as measured by the Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: baseline, 36 months ]

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Ages Eligible for Study: | 6 Years to 16 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01302080

Study Director: | Pfizer CT.gov Call Center | Pfizer |
Additional Information:
Responsible Party: | Pfizer |
ClinicalTrials.gov Identifier: | NCT01302080 History of Changes |
Other Study ID Numbers: |
A0501093 SPRITES ( Other Identifier: Alias Study Number ) |
First Posted: | February 23, 2011 Key Record Dates |
Last Update Posted: | January 5, 2018 |
Last Verified: | January 2018 |
Keywords provided by Pfizer:
prospective cohort sertraline long-term impact |
cognition emotional and physical development pubertal maturation |
Additional relevant MeSH terms:
Compulsive Personality Disorder Obsessive-Compulsive Disorder Personality Disorders Mental Disorders Anxiety Disorders Sertraline Antidepressive Agents Psychotropic Drugs |
Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Serotonin Agents Physiological Effects of Drugs |