HealthyNCT00025857
Brain Function in Mentally Ill Adolescents
An observational study of Healthy and Posttraumatic Stress Disorder, run by National Institute of Mental Health (NIMH) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 18 years
- Conditions the study is for
- Healthy, Posttraumatic Stress Disorder, Major Depressive Disorder
- How many people
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Oct 2001to 29 Jun 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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:
Show all 13Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Adolescent Medial Temporal Lobe Function in Health and Illness
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.
Read the detailed description
Adults with post-traumatic stress disorder (PTSD) or major depressive disorder (MDD) exhibit abnormalities in the structure and function of the amygdala and hippocampus (temporal lobe), as well as in the prefrontal cortex (PFC) and striatum (four brain structures underlying the emotional processing and reward systems). However, while these psychiatric disorders often emerge in childhood, the integrity of these neural structures has been minimally studied in psychiatrically impaired children and adolescents. In the current proposal, functional MRI (fMRI) will be used to evaluate the amygdala, hippocampus, PFC and striatum in (1) psychiatrically healthy adolescents; (2) adolescents with trauma history and PTSD or anxiety symptoms; (3) adolescents with trauma history, symptoms of depression and either PTSD or anxiety symptoms; and (4) adolescents with only major depressive or PTSD/anxiety symptoms; (5) adolescents with trauma and no trauma related symptoms. The proposed study is conducted in three separate experiments.
At this stage of the protocol, we completed experiment 1, and a pilot study to help guide experiments 2 and 3. In Experiment 1, we determined whether a fear conditioning paradigm elicited amygdala activity in healthy adolescents. The pilot study examined test-retest reliability of the fMRI signal in healthy adolescents and adults.
In Experiment 2, we will examine the functioning of the amygdala, hippocampus, PFC and striatum in healthy adolescents and those with the psychiatric conditions described above. During image acquisition, four cognitive tasks, targeting these regions, will be used: 1) a social interaction task, 2) an inhibition task (the Stop task or the antisaccade task), 3) an emotional rating/explicit memory task and 4) a probe detection task. One hundred twenty five participants (25 in five groups) will be recruited in experiment 2.
Experiment 3 will address the same question as in experiment 2 in relation to treatment response. In other words, in contrast to experiment 2, patients will be studied prior and after treatment of the psychopathology associated with their traumatic experience. The sample will include 125 patients (25 in each of the 4 groups) and 25 controls.
- Keywords
- fMRI, Depression, PTSD, Emotion, Magnetic Resonance Imaging, Anxiety, Normal Volunteers, Adolescence, Memory, Physical/Sexual Abuse History, Post-Traumatic Stress Disorder, Adolescent, Healthy Volunteer, HV, Normal Control
- Medical subject headings
- Stress Disorders, Post-Traumatic, Depressive Disorder, Major, Depression, Anxiety Disorders
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2001 (estimated)
- Study start22 Oct 2001
- Study completion29 Jun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Sponsor type
- US National Institutes of Health
- Investigators
- Monique Ernst, M.D., Principal investigator, National Institute of Mental Health (NIMH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00025857
- Sponsor's protocol ID
- 020007
- Other IDs
- 02-M-0007
- Status last verified
- 29 Jun 2012
- First submitted
- 26 Oct 2001
- Last updated
- 3 Dec 2019
- Results posted
- No
Publications
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.
PubMed 8037246Birmaher 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.
PubMed 1636803Blair 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.
PubMed 10355673
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adolescent Medial Temporal Lobe Function in Health and Illness
- ClinicalTrials.gov ID
- NCT00025857
- Acronym / sponsor ID
- 020007
- Keywords
- fMRI, Depression, PTSD, Emotion, Magnetic Resonance Imaging, Anxiety, Normal Volunteers, Adolescence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Study start
- 22 Oct 2001
- Study completion
- 29 Jun 2012
- First posted
- 29 Oct 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Adults with post-traumatic stress disorder (PTSD) or major depressive disorder (MDD) exhibit abnormalities in the structure and function of the amygdala and hippocampus (temporal lobe), as well as in the prefrontal cortex (PFC) and striatum (four brain structures underlying the emotional processing and reward systems). However, while these psychiatric disorders often emerge in childhood, the integrity of these neural structures has been minimally studied in psychiatrically impaired children and adolescents. In the current proposal, functional MRI (fMRI) will be used to evaluate the amygdala, hippocampus, PFC and striatum in (1) psychiatrically healthy adolescents; (2) adolescents with trauma history and PTSD or anxiety symptoms; (3) adolescents with trauma history, symptoms of depression and either PTSD or anxiety symptoms; and (4) adolescents with only major depressive or PTSD/anxiety symptoms; (5) adolescents with trauma and no trauma related symptoms. The proposed study is conducted in three separate experiments.
At this stage of the protocol, we completed experiment 1, and a pilot study to help guide experiments 2 and 3. In Experiment 1, we determined whether a fear conditioning paradigm elicited amygdala activity in healthy adolescents. The pilot study examined test-retest reliability of the fMRI signal in healthy adolescents and adults.
In Experiment 2, we will examine the functioning of the amygdala, hippocampus, PFC and striatum in healthy adolescents and those with the psychiatric conditions described above. During image acquisition, four cognitive tasks, targeting these regions, will be used: 1) a social interaction task, 2) an inhibition task (the Stop task or the antisaccade task), 3) an emotional rating/explicit memory task and 4) a probe detection task. One hundred twenty five participants (25 in five groups) will be recruited in experiment 2.
Experiment 3 will address the same question as in experiment 2 in relation to treatment response. In other words, in contrast to experiment 2, patients will be studied prior and after treatment of the psychopathology associated with their traumatic experience. The sample will include 125 patients (25 in each of the 4 groups) and 25 controls.
Study design
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2019.
- Background: PubMed 8037246Bernstein 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.
- Background: PubMed 1636803Birmaher 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.
- Background: PubMed 10355673Blair 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Monique Ernst, M.D. principal investigator
National Institute of Mental Health (NIMH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy and Posttraumatic Stress Disorder, run by National Institute of Mental Health (NIMH) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00025857, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2019.