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Pharmacologic Treatment of PTSD in Sexually Abused Children Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or professional assistance by using a genuine doctor. We aren't mDs. Always consult your physician about Pharmacologic Treatment of PTSD in Sexually Abused Children conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Pharmacologic Treatment of PTSD in Sexually Abused Children Clinical research trials and Pharmacologic Treatment of PTSD in Sexually Abused Children health trials occur in a lot of of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the potency of new does drugs. The role of the studies / undertakings is to figure out specific human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Pharmacologic Treatment of PTSD in Sexually Abused Children. Pharmacologic Treatment of PTSD in Sexually Abused Children Clinical Trials and other clinical trials permit volunteers to get medical treatment choices before they are available to the general public. Many times the test subjects get professional assistance for free of charge, and occasionally they are compensated for their time. Sometimes there is a cost for a Pharmacologic Treatment of PTSD in Sexually Abused Children clinical trial. Human subjects often get the best healthcare possible for their Pharmacologic Treatment of PTSD in Sexually Abused Children condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, medical hazards (perhaps life-threatening), and/or the treatment being ineffectual. Trials are federally governed with exacting guidelines to protect clinical trials patients.
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Home > "P" Clinical Trials Conditions > Pharmacologic Treatment of PTSD in Sexually Abused Children  Pharmacologic Treatment of PTSD in Sexually Abused Children
Pharmacologic Treatment of PTSD in Sexually Abused Children
For Condition: Major Depressive Disorder,Posttraumatic Stress Disorder,Anxiety Disorders
Status: Recruiting
Sponsor(s): National Institute of Mental Health (NIMH) ,
Synopsis: This study is evaluating the benefit of adding sertraline (Zoloft) to Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) for sexually abused children who have Posttraumatic Stress Disorder (PTSD). Sixty of these children ages 10-18 years, will be randomly assigned to receive 12 weeks of TF-CBT plus sertraline versus TF-CBT lus placebo. In addition to evaluating PTSD symptoms during the course of treatment, depressive and anxiety symptoms, functional impairment, medication side effects, parental emotional distress and support of the child, and the child's sexual abuse-related cognitions will be assessed at pre- and post-treatment.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study
Minimum Age/Maximum Age: 10 Years/18 Years
Genders: Both
Protocol Entry Criteria: - Children and adolescents ages 10-18 years old who have PTSD related to sexual abuse which has been independently verified
Total Enrollment: 60
Location and Contact Information:
Allegheny General Hospital Center for Traumatic Stress in Children and Adolescents *Recruiting*
Pittsburgh, Pennsylvania, 15212
United States
Recruiting Judith Cohen 412-330-4321
Additional Information:
Study ID Numbers: K02 MH1938;
Study Start Date: April 2001
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00078767
Other Major Depressive Disorder Studies:
1. Family and Peer Involvement in the Treatment of Anxiety Disorders in Children
2. Expectation of Unpleasant Events in Anxiety Disorders
3. Brain Changes in Fear
4. Family-Based Prevention Program for Childhood Anxiety
5. Therapeutic Processes and Treatment Outcome in Adolescents with Anxiety Disorders
Related Studies:
Other Major Depressive Disorder Clinical Trials
Other Pennsylvania Clinical Trials
Other Pittsburgh Clinical Trials
Pharmacologic Treatment of PTSD in Sexually Abused Children
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