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Obsessive Compulsive Disorder | Sertraline Pediatric Registry for the Evaluation of Safety (SPRITES)

Obsessive Compulsive Disorder research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Obsessive Compulsive Disorder

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:sertralineNon interventional study - drug, dose, duration etc as per USPI and clinician discretion

Behavioral:psychotherapyNon-interventional study- as above

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Sertraline-treatedinception cohort of enrolled subjects beginning treatment for one of the study qualifying disorders with sertraline

pyschotherapy onlyinception cohort of enrolled subjects beginning treatment for one of the study qualifying disorders with psychotherapy

Study Status

Active, not recruiting

Start Date: April 2012

Completed Date: October 2020

Phase:

Type: Observational

Design:

Primary Outcome: change in cognitive function as measured by Trails B (Trail Making Test) and BRIEF (Behavior Rating Inventory of Executive Function) exams

Secondary Outcome: change in clinical global impression scale -Improvement (CGI-I)

Study sponsors, principal investigator, and references

Principal Investigator: Pfizer CT.gov Call Center

Lead Sponsor: Pfizer

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01302080

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