A Ten-Week Study Evaluating The Effectiveness And Safety Of Zoloft In Children And Adolescents With A Diagnosis Of PTSD

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Viatris

Status and phase

Terminated
Phase 3

Conditions

Stress Disorders, Post-Traumatic

Treatments

Drug: Zoloft (Sertraline)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00150306
A0501061

Details and patient eligibility

About

To evaluate the safety and efficacy of sertraline compared to placebo in children and adolescents (6 to 17 years of age) who are outpatients with Posttraumatic Stress Disorder.

Full description

This study was terminated on July 11, 2007. The results of the primary endpoint analysis at the interim showed that the Zoloft group was not significantly different than the placebo on the primary endpoint and therefore the decision was made to terminate the trial. The decision to terminate the trial was not based on any safety concerns.

Sex

All

Ages

6 to 17 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Subjects must be from 6 to 17 years of age and will have a maximum age of 17 at the Baseline Visit of the study.
  • Subjects must have a diagnosis of Posttraumatic Stress Disorder as defined by DSM-IV and determined by the Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL).

Exclusion criteria

  • Subjects whose trauma is ongoing, or who are living in the same home as their abuser, or who are expected to participate in litigation related to their trauma during the course of the study will be excluded from participation.
  • Subjects who are likely to or are at high risk for experiencing re-exposure to their index trauma.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

23

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Data sourced from clinicaltrials.gov

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