NCT00025857

Brief Summary

The purpose of this study is to use brain imaging technology to examine the brain activity of adolescents with post-traumatic stress disorder (PTSD) and/or major depressive disorder (MDD) before and after treatment. Adults with PTSD or MDD exhibit abnormalities in the structure and function of certain parts of the brain. Although PTSD and MDD are psychiatric disorders that often emerge in childhood, the relationship between these disorders and brain structures has not been thoroughly studied in adolescents with the disorders. This study will use functional magnetic resonance imaging (fMRI) to study the parts of the brain that are involved in PTSD and MDD in adolescents. Adolescents with PTSD and/or MDD will be enrolled along with healthy adolescents with or without a history of abuse. Healthy adults will also be enrolled. Participants will be screened with a physical examination; blood tests; and interviews about mood, general degree of nervousness, and behavior. Adolescents and their parents will be interviewed separately and together. Following the interviews, participants will undergo psychological tests. Participants with PTSD and/or MDD will have two weekly sessions of talk therapy. Participants who continue to experience PTSD or MDD symptoms after the talk therapy may continue the talk therapy alone, begin treatment with fluoxetine (Prozac ) alone, or begin fluoxetine in addition to the talk therapy. Participants who take fluoxetine will have blood collected before treatment and 8 weeks after treatment has begun. If participants do not respond to the treatment, the treatment will be stopped and the participants will be offered another treatment. Participants who respond to treatment will continue treatment at NIH until a referral to an outside physician is made. Depending on the experiment in which they are enrolled, participants will undergo one or four MRI scans. Participants who will have four MRI scans will undergo the scans on separate days. During the MRI, participants will complete tasks on a computer. Saliva samples will be collected before and after the scans. Participants with PTSD and/or MDD will collect their saliva one or two days before the MRI scan.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2001

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 22, 2001

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

October 26, 2001

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 29, 2001

Completed
10.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 29, 2012

Completed
Last Updated

December 3, 2019

Status Verified

June 29, 2012

First QC Date

October 26, 2001

Last Update Submit

November 30, 2019

Conditions

Keywords

fMRIDepressionPTSDEmotionMagnetic Resonance ImagingAnxietyNormal VolunteersAdolescenceMemoryPhysical/Sexual Abuse HistoryPost-Traumatic Stress DisorderAdolescentHealthy VolunteerHVNormal Control

Eligibility Criteria

Age7 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • All subjects 7-18 (adolescents).
  • Consent: can give consent/assent.
  • IQ: all subjects will have IQ greater than 70.
  • Subjects currently on antidepressants or benzodiazepines medication.
  • Subjects suffering from ADHD and currently on stimulants.
  • SUBJECTS WITH MAJOR DEPRESSION:
  • Diagnosis: Current diagnosis of MDD.
  • Clinical Impairment: CGAS less than 60.
  • SUBJECTS WITH PTSD:
  • Diagnosis: current diagnosis of PTSD.
  • Clinical Impairment: CGAS of less than 60.
  • SUBJECTS WITH HISTORY OF TRAUMA:
  • Trauma (i.e., sexual or physical abuse, exposure to an accident, etc.) will be defined according to the KSADS, the Child Trauma Questionnaire, the Life Events Survey and the history of adoption.

You may not qualify if:

  • Any medical condition that increases risk for MRI (e.g. pacemaker, metallic foreign material in eye).
  • Any medical condition that increases risk for fluoxetine treatment for patients with MDD/PTSD.
  • Pregnancy.
  • Participants suffering from acute psychosis or suicidal ideation; current abuse/dependency to alcohol or drugs.
  • Currently in an abusive situation at home.
  • Weight that is 15% more or less than ideal body weight for sex and height.
  • Current tobacco use.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Bernstein DP, Fink L, Handelsman L, Foote J, Lovejoy M, Wenzel K, Sapareto E, Ruggiero J. Initial reliability and validity of a new retrospective measure of child abuse and neglect. Am J Psychiatry. 1994 Aug;151(8):1132-6. doi: 10.1176/ajp.151.8.1132.

    PMID: 8037246BACKGROUND
  • Birmaher B, Dahl RE, Ryan ND, Rabinovich H, Ambrosini P, al-Shabbout M, Novacenko H, Nelson B, Puig-Antich J. The dexamethasone suppression test in adolescent outpatients with major depressive disorder. Am J Psychiatry. 1992 Aug;149(8):1040-5. doi: 10.1176/ajp.149.8.1040.

    PMID: 1636803BACKGROUND
  • Blair RJ, Morris JS, Frith CD, Perrett DI, Dolan RJ. Dissociable neural responses to facial expressions of sadness and anger. Brain. 1999 May;122 ( Pt 5):883-93. doi: 10.1093/brain/122.5.883.

    PMID: 10355673BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticDepressive Disorder, MajorDepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersDepressive DisorderMood DisordersBehavioral SymptomsBehavior

Study Officials

  • Monique Ernst, M.D.

    National Institute of Mental Health (NIMH)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

October 26, 2001

First Posted

October 29, 2001

Study Start

October 22, 2001

Study Completion

June 29, 2012

Last Updated

December 3, 2019

Record last verified: 2012-06-29

Locations