Pharmacologic Treatment of PTSD in Sexually Abused Children

Stress Disorders, Post-Traumatic Clinical Trial

Official title:

Pharmacologic Treatment of PTSD in Sexually Abused Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00078767
• Other study ID #: K02MH001938
• Secondary ID: K02MH001938
• Status: Completed
• Phase: Phase 3
• First received: March 5, 2004
• Last updated: April 3, 2017
• Start date: April 2001
• Est. completion date: March 2006

Study information

• Verified date: April 2017
• Source: Allegheny Singer Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the benefit of adding sertraline (Zoloft®) to Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) for sexually abused children who have Posttraumatic Stress Disorder (PTSD).

Description:

Adult research has demonstrated the efficacy of selective serotonin reuptake inhibitors (SSRIs) in decreasing Posttraumatic Stress Disorder (PTSD) symptoms; to date the SSRIs are the only medication class with demonstrated efficacy in treating all three PTSD symptom clusters (reexperiencing, avoidance, and hyperarousal). No studies have evaluated the impact of SSRIs on PTSD symptoms in children or adolescents. Trauma-focused CBT has been shown in several studies to be efficacious in decreasing PTSD symptoms in sexually abused children and adolescents. Many children and youth with PTSD are currently prescribed SSRIs and other medications. This study will evaluate whether adding the SSRI sertraline provides additional benefits over TF-CBT treatment for sexually abused children and adolescents with PTSD. If adequate numbers of children with comorbid PTSD and depressive and/or anxiety disorders are included, it may also be possible to evaluate whether any benefit of adding sertraline is restricted to those children with comorbid disorders.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: March 2006
• Est. primary completion date: March 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 17 Years

Eligibility

Inclusion:

1. Ages 10-17 years, inclusive

2. Confirmed sexual abuse

3. At least 5 PTSD symptoms on KSADS-PL, with at least one symptom in each of 3 symptom clusters (reexperiencing, avoidance, arousal)

4. Parent/primary caregiver available to participate in treatment

5. Assent with parental consent to participate

Exclusion:

1. Non-English speaking

2. schizophrenia or other severe psychotic disorder

3. MR (IQ<60) or PDD preventing CBT treatment

4. taking current psychotropic medication

5. documented substance dependence (substance abuse allowed)

Related Conditions & MeSH terms

• Stress Disorders, Post-Traumatic

Intervention

Behavioral:
• Trauma-Focused Cognitive Behavioral Therapy
12 weeks of Trauma-Focused CBT (TF-CBT)for youth and parent

Drug:
• Sertraline Pill
12 weeks of Sertraline pill, flexible dosage of 50-150 mg/day, to be administered while receiving TF-CBT
• Placebo Oral Tablet
12 weeks of Placebo pill, flexible dosage, of 50-150 mg/day, to be administered while receiving TF-CBT

Locations

Country	Name	City	State
United States	Allegheny General Hospital Center for Traumatic Stress in Children and Adolescents	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Allegheny Singer Research Institute	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Cohen JA, Mannarino AP, Perel JM, Staron V. A pilot randomized controlled trial of combined trauma-focused CBT and sertraline for childhood PTSD symptoms. J Am Acad Child Adolesc Psychiatry. 2007 Jul;46(7):811-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Kiddie-Sads-Present and Lifetime (KSADS-PL) Scale for PTSD	Change in PTSD parameters as determined by changes in score. At enrollment, participants either did or did not have a PTSD diagnosis. The three categories displayed show participants who had the PTSD diagnosis at the time of enrollment but did have evidence of PTSD at the end of their participation, participants who had PTSD at enrollment and who continued to exhibit PTSD at the end of their participation, and those who did not have a PTSD diagnosis at the start of the trial. There are numerous criteria used to determine a PTSD diagnosis; they are not individually listed. The diagnosis was sufficient for the purposes of the study.	Up to 39 months
Secondary	Mood and Feelings Questionnaire (MFQ) for Depressive Symptoms	Change in depressive symptoms as determined by change in score	Up to 39 months
Secondary	Anxiety Symptoms	Change in SCARED scores between treatment groups.There were two categories of depression: participants that had clinical signs of depression at the time of enrollment, and participants that did not have clinical signs of depression. Participants in the "clinical symptom present at enrollment" category were tested to see if their status changed during the trial.	Up to 39 months
Secondary	Global Impairment	Change in Children's Global Assessment Scale (CGAS) between the two groups	Up to 39 months
Secondary	Incidence of Suicidality	Change in degree of suicidal ideation during study	Up to 39 months

External Links

•   National Child Traumatic Stress Network