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

Conditions: Post-Traumatic Stress Disorder
Therapeutic area: Not possible to specify

Registration Number: EUCTR2014-004162-17-Outside-EU/EEA

Lead Sponsor: Pfizer Inc

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: A

Sex: All

Target Recruitment: 129

Inclusion Criteria

1.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.
2.Subjects must be male or non-pregnant, non-lactating female outpatients.
3.Females of childbearing potential must have a negative serum pregnancy test prior to entry into the study.
4.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).
5.Subjects must be at least moderately ill, as indicated by a score of at least 30 on the University of California, Los Angeles (UCLA) PTSD-I and a Clinical Global Impression - Severity of Illness (CGI-S) score of higher than 4 at Screening Day 1, Screening Day 7, and Baseline (Screening Day 14).
6.Subjects must be free of psychotropic medication for at least 2 weeks prior to the Baseline Visit (Screening Day 14) with the exception of fluoxetine. Subjects must be free of fluoxetine for at least 4 weeks prior to the Baseline Visit. Subjects were not to receive treatment with monoamine oxidase inhibitors (MAOIs) for at least 2 weeks after completion of this study.
7.Subjects and their parent or legal guardian (in the case of abuse, the nonabusive parent or legal guardian) must be judged reliable for medication compliance. They must agree to keep appointments for study visits and for all tests and examinations required by the protocol.
8.Prior to the subject’s participation in this study, informed assent or written informed consent must be obtained from the subject and written informed consent must be obtained from at least one parent or one legal guardian.
Are the trial subjects under 18? yes
Number of subjects for this age range: 129
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.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.
2.Subjects who are likely to or are at high risk for experiencing reexposure to their index trauma.
3.Subjects who currently meet DSM-IV diagnosis or have a history of Bipolar Affective Disorder, Mania, Schizophrenia, Schizoaffective Disorder, Psychotic Disorder, Not Otherwise Specified (NOS), Autistic Spectrum Disorder, or Psychotic Disorder due to a general medical condition or substance use.
4.Subjects who currently meet Diagnostic and Statistical Manual of Mental Disorders (DSM) -IV criteria for Obsessive Compulsive Disorder, Conduct Disorder, Dissociative Identity Disorder, or Delusional Disorder (defined by KSADS-PL).
5.Subjects with a current primary diagnosis of Major Depressive Disorder, Panic Disorder, or Generalized Anxiety Disorder.
6.Subjects with DSM-IV defined Attention Deficit/Hyperactivity Disorder whose management includes pharmacological management with agents other than central nervous system stimulants.
7.Subjects with a history of, or who at screening currently meet DSM-IV criteria for bulimia or anorexia nervosa.
8.Subjects with a history of suicide attempt or who would pose a significant suicidal or homicidal risk during the course of the study.
9.Subjects who have met DSM-IV criteria for Substance Abuse or Dependence within the past 6 months.
10.Subjects who have been responding to cognitive behavioral therapy or other psychotherapy as a treatment for PTSD within 2 months of the baseline visit. Subjects who are receiving supportive psychotherapy and/or family therapy, not specifically addressing symptoms of PTSD, may participate in the study as long as the therapy was begun at least 2 months prior to the baseline visit and is not discontinued during the course of the study.
11.Subjects with a history of seizure disorder or who have cognitive or neurological deficits that would significantly limit their ability to perform the rating scales.
12.Subjects who have clinically significant abnormalities based on physical examination, medical history, ECG or laboratory tests.
13.Subjects with any liver function test greater than twice the upper limit of the normal (ULN) range. If any liver function test is between 1.5 and twice the upper limit of the normal range, the subject’s eligibility must be discussed with the Pfizer Clinician.
14.Subjects with a thyroid stimulating hormone (TSH) level significantly outside the range of normal, or who have a positive urine drug screen.
15.Subjects who have taken any investigational drug within two weeks prior to Screening Visit 1.
16.Subjects who require concomitant psychotropic medication, other than diphenhydramine or chloral hydrate for sleep.
17.Subjects with a previous history of intolerance or hypersensitivity to selective serotonin reuptake inhibitors (SSRIs) or sertraline, or who have previously failed to respond to a clinically adequate dose of SSRIs as defined by the American Academy of Child and Adolescent Psychiatry (Cohen, 1998).
18.Subjects with any other condition which, in the investigator's judgment might increase the risk to the subject or decrease the chance of obtaining satisfactory data to achieve the objectives of the st

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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 the diagnosis of Posttraumatic Stress Disorder.;Secondary Objective: not applicable;Primary end point(s): Change From Baseline in University of California at Los Angeles Post-Traumatic Stress Disorder Index (UCLA PTSD-I).Total Symptom Score for Diagnostic and Statistical Manual of Mental Disorders -IV (DSM-IV) at Week 10;Timepoint(s) of evaluation of this end point: Baseline, End of Week 10

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1. Change From Baseline in UCLA PTSD-I. Total Symptom Score for DSM-IV at Week 1, 3, 5 and 7<br>2. Child Stress Disorder Checklist (CSDC)<br>3. Change From Baseline in Child Depression Rating Scale - Revised (CDRS-R)<br>4. Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q)<br>5. Change From Baseline in Clinical Global Impression Severity (CGI-S) Scale score at Week 1, 3, 5, 7, 10<br>6. Clinical Global Impression - Improvement (CGI-I) Score;Timepoint(s) of evaluation of this end point: 1. Baseline, Week 1, 3, 5, 7<br>2. Baseline, End of Week 10<br>3. Baseline, End of Week 10<br>4. Baseline, End of Week 10<br>5.Baseline, Week 1, 3, 5, 7, 10<br>6. Week 1, 3, 5, 7, 10