Pharmacologic Treatment of PTSD in Sexually Abused Children

NCT00078767 | Completed Phase 3 Results DMC

• 1 other identifier: K02MH001938
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Stress Disorders, Post-Traumatic

Keywords

PTSD; Depression; Anxiety

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Mood and Feelings Questionnaire (MFQ) for Depressive Symptoms

  Up to 39 months

• Anxiety Symptoms

  Up to 39 months

• Global Impairment

  Up to 39 months

• Incidence of Suicidality

  Up to 39 months

Study Arms (2)

TF-CBT + sertraline

EXPERIMENTAL

Trauma-Focused CBT provided individually to youth and parent for 12 sessions (90 minute sessions; 45 minutes for youth; 45 minutes for parent); plus Sertraline provided in dosage titrated as clinically indicated by child psychiatrist blind to treatment assignment, from 50mg/day to a maximum dosage of 150 mg/day

Behavioral: Trauma-Focused Cognitive Behavioral Therapy; Drug: Sertraline Pill

TF-CBT +placebo

ACTIVE COMPARATOR

Trauma-Focused CBT provided individually to youth and parent for 12 sessions (90 minute sessions; 45 minutes for youth; 45 minutes for parent); plus placebo identical to Sertraline, provided in pill form and titrated as clinically indicated by child psychiatrist blind to treatment assignment, from 1 to 3 pills/day (identical in appearance to 50 to 150mg/day of Sertraline)

Drug: Sertraline Pill; Drug: Placebo Oral Tablet

Interventions

Trauma-Focused Cognitive Behavioral Therapy BEHAVIORAL

12 weeks of Trauma-Focused CBT (TF-CBT)for youth and parent

TF-CBT + sertraline

Sertraline Pill DRUG

12 weeks of Sertraline pill, flexible dosage of 50-150 mg/day, to be administered while receiving TF-CBT

TF-CBT + sertraline; TF-CBT +placebo

Placebo Oral Tablet DRUG

12 weeks of Placebo pill, flexible dosage, of 50-150 mg/day, to be administered while receiving TF-CBT

TF-CBT +placebo

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Ages 10-17 years, inclusive
• Confirmed sexual abuse
• At least 5 PTSD symptoms on KSADS-PL, with at least one symptom in each of 3 symptom clusters (reexperiencing, avoidance, arousal)
• Parent/primary caregiver available to participate in treatment
• Assent with parental consent to participate

You may not qualify if:

• Non-English speaking
• schizophrenia or other severe psychotic disorder
• MR (IQ\<60) or PDD preventing CBT treatment
• taking current psychotropic medication
• documented substance dependence (substance abuse allowed)

Sponsors & Collaborators

• Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute): lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Allegheny General Hospital Center for Traumatic Stress in Children and Adolescents

Pittsburgh, Pennsylvania, 15212, United States

Location

Related 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. doi: 10.1097/chi.0b013e3180547105.

  PMID: 17581445 BACKGROUND

Related Links

• National Child Traumatic Stress Network

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Depression; Anxiety Disorders

Interventions

Sertraline

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

1-Naphthylamine; Amines; Organic Chemicals; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Judith Cohen, MD
• Organization: Allegheny Singer Research Institute

judith.cohen@ahn.org

Study Officials

• Judith A Cohen, M.D.

  Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: March 5, 2004
• First Posted: March 8, 2004
• Study Start: April 1, 2001
• Primary Completion: March 1, 2006
• Study Completion: March 1, 2006
• Last Updated: April 5, 2017
• Results First Posted: March 28, 2017

Record last verified: 2017-04

Locations

US (1)