Mood DisorderNCT00001654
The Role of Emotion in the Development of Psychopathology
An observational study of Mood Disorder, run by National Institute of Mental Health (NIMH) at 1 site in United States.
Trial summary
The dysregulated experience and expression of emotion is implicated in psychiatric disorders associated both with externalizing problems (aggressive, antisocial behaviors) and internalizing problems (anxiety, depression). Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Mood Disorder
- How many people
- 1,200 participants
- Where
- 1 siteUnited States
- Study dates
- May 1997to May 2003
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Subjects and their families will be recruited from the community.
- Inclusionary criteria will be based on mother and youth report of (a) emotion regulation problems and (b) the presence of subclinical or clinical symptomatology based on broad-band scales of the Youth Self-Report or mother's report of behavior problems.
- Individuals meeting entry criteria will be offered entry into the study, and others will be notified.
Who cannot join
- A debilitating physical impairment (e.g., seizure disorder, cerebral palsy, head trauma).
- Significant intellectual impairment (i.e., IQ less than 70).
- History of psychosis.
- Any condition that would impair a participant's ability to respond to the study's paradigms will be excluded from this study at the time of screening.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Mental Health (NIMH)
Bethesda, Maryland, 20892
About this study
The dysregulated experience and expression of emotion is implicated in psychiatric disorders associated both with externalizing problems (aggressive, antisocial behaviors) and internalizing problems (anxiety, depression). Adolescence is a critical juncture in the development of these disorders because of the increased incidence and differentiation of clinical problems during this time period. This is a biobehavioral, longitudinal investigation of the role of emotion in the development of psychopathology in adolescence. The focus is on socialization experiences and biological processes that contribute to emotion dysregulation and disorder in male and female youths between 11 and 16 years of age. Groups studied include (1) comorbid externalizers and internalizers, (2) externalizers only, (3) internalizers only, and (4) asymptomatic youth. The adolescents are assessed again two years later, with instruments and paradigms similar to those used at Time 1. One theme pertains to the integration and disconnection of emotions across systems (e.g., physiological and self-report of experience), and how different patterns of emotion relate to psychopathology. A second theme pertains to development changes in how disorders are manifested (e.g., increased differentiation along gender specific pathways). The anticipated number of patient days per year is 240 for adolescents and mothers, and 120 days for fathers.
Read the detailed description
Dysregulated emotions are central features of psychiatric disorders associated with both externalizing problems (aggressive, antisocial behaviors) and internalizing problems (anxiety, depression). Adolescence is a critical juncture in the development of these disorders because of the increased incidence and differentiation of clinical problems particularly along gender-based lines. This is a biobehavioral, longitudinal investigation of the role of emotion in the development of psychopathology in adolescence. The focus is on socialization experiences and biological processes that contribute to emotion dysregulation and disorder. Younger (11-13) years) and older (14-16 years) male and female adolescents are followed over time to assess outcomes (psychiatric and psychological problems; adaptive functioning). Groups studied include (1) comorbid externalizers and internalizers, (2) externalizers, (3) internalizers, and (4) asymptomatic youth. Longitudinal analyses will examine factors that contribute to continuation, exacerbation, shifts, or improvement in symptoms over time. Time 1 data collection is complete and 30% of Time 2 cases have been seen. The current anticipated number of patient days per year is 150 for adolescents and mothers. Data collection will be completed by January, 2003.
- Conditions
- Mood Disorder
- Keywords
- Adolescence, Comorbid Disorders, Physiology, Socialization, Gender, Conduct Problems, Anxiety, Sadness, Emotion, Psychophysiology
- Medical subject headings
- Mood Disorders, Coitus, Anxiety Disorders
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 1999 (estimated)
- Study startMay 1997
- Study completionMay 2003
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 Mood DisorderStudies of the same condition, open and under way.
- More trials run by National Institute of Mental Health (NIMH)The sponsor's other registered studies.
- 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
- 1,200 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001654
- Sponsor's protocol ID
- 970116
- Other IDs
- 97-M-0116
- Status last verified
- May 2003
- First submitted
- 3 Nov 1999
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Akil H, Haskett RF, Young EA, Grunhaus L, Kotun J, Weinberg V, Greden J, Watson SJ. Multiple HPA profiles in endogenous depression: effect of age and sex on cortisol and beta-endorphin. Biol Psychiatry. 1993 Jan 15;33(2):73-85. doi: 10.1016/0006-3223(93)90305-w.
PubMed 8382535Angold A, Costello EJ. Depressive comorbidity in children and adolescents: empirical, theoretical, and methodological issues. Am J Psychiatry. 1993 Dec;150(12):1779-91. doi: 10.1176/ajp.150.12.1779.
PubMed 8238631Anderson JC, Williams S, McGee R, Silva PA. DSM-III disorders in preadolescent children. Prevalence in a large sample from the general population. Arch Gen Psychiatry. 1987 Jan;44(1):69-76. doi: 10.1001/archpsyc.1987.01800130081010.
PubMed 2432848
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Emotion in the Development of Psychopathology
- ClinicalTrials.gov ID
- NCT00001654
- Acronym / sponsor ID
- 970116
- Conditions
- Mood Disorder
- Keywords
- Adolescence, Comorbid Disorders, Physiology, Socialization, Gender, Conduct Problems, Anxiety, Sadness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,200 participants
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Study start
- May 1997
- Study completion
- May 2003
- First posted
- 4 Nov 1999 (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 dysregulated experience and expression of emotion is implicated in psychiatric disorders associated both with externalizing problems (aggressive, antisocial behaviors) and internalizing problems (anxiety, depression). Adolescence is a critical juncture in the development of these disorders because of the increased incidence and differentiation of clinical problems during this time period. This is a biobehavioral, longitudinal investigation of the role of emotion in the development of psychopathology in adolescence. The focus is on socialization experiences and biological processes that contribute to emotion dysregulation and disorder in male and female youths between 11 and 16 years of age. Groups studied include (1) comorbid externalizers and internalizers, (2) externalizers only, (3) internalizers only, and (4) asymptomatic youth. The adolescents are assessed again two years later, with instruments and paradigms similar to those used at Time 1. One theme pertains to the integration and disconnection of emotions across systems (e.g., physiological and self-report of experience), and how different patterns of emotion relate to psychopathology. A second theme pertains to development changes in how disorders are manifested (e.g., increased differentiation along gender specific pathways). The anticipated number of patient days per year is 240 for adolescents and mothers, and 120 days for fathers.
Detailed description
Dysregulated emotions are central features of psychiatric disorders associated with both externalizing problems (aggressive, antisocial behaviors) and internalizing problems (anxiety, depression). Adolescence is a critical juncture in the development of these disorders because of the increased incidence and differentiation of clinical problems particularly along gender-based lines. This is a biobehavioral, longitudinal investigation of the role of emotion in the development of psychopathology in adolescence. The focus is on socialization experiences and biological processes that contribute to emotion dysregulation and disorder. Younger (11-13) years) and older (14-16 years) male and female adolescents are followed over time to assess outcomes (psychiatric and psychological problems; adaptive functioning). Groups studied include (1) comorbid externalizers and internalizers, (2) externalizers, (3) internalizers, and (4) asymptomatic youth. Longitudinal analyses will examine factors that contribute to continuation, exacerbation, shifts, or improvement in symptoms over time. Time 1 data collection is complete and 30% of Time 2 cases have been seen. The current anticipated number of patient days per year is 150 for adolescents and mothers. Data collection will be completed by January, 2003.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects and their families will be recruited from the community.
- Inclusionary criteria will be based on mother and youth report of (a) emotion regulation problems and (b) the presence of subclinical or clinical symptomatology based on broad-band scales of the Youth Self-Report or mother's report of behavior problems.
- Individuals meeting entry criteria will be offered entry into the study, and others will be notified.
Key exclusion criteria (4 listed)
- A debilitating physical impairment (e.g., seizure disorder, cerebral palsy, head trauma).
- Significant intellectual impairment (i.e., IQ less than 70).
- History of psychosis.
- Any condition that would impair a participant's ability to respond to the study's paradigms will be excluded from this study at the time of screening.
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 4 Mar 2008.
- Background: PubMed 8382535Akil H, Haskett RF, Young EA, Grunhaus L, Kotun J, Weinberg V, Greden J, Watson SJ. Multiple HPA profiles in endogenous depression: effect of age and sex on cortisol and beta-endorphin. Biol Psychiatry. 1993 Jan 15;33(2):73-85. doi: 10.1016/0006-3223(93)90305-w.
- Background: PubMed 8238631Angold A, Costello EJ. Depressive comorbidity in children and adolescents: empirical, theoretical, and methodological issues. Am J Psychiatry. 1993 Dec;150(12):1779-91. doi: 10.1176/ajp.150.12.1779.
- Background: PubMed 2432848Anderson JC, Williams S, McGee R, Silva PA. DSM-III disorders in preadolescent children. Prevalence in a large sample from the general population. Arch Gen Psychiatry. 1987 Jan;44(1):69-76. doi: 10.1001/archpsyc.1987.01800130081010.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Mood 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 3 inclusion and 4 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 4 Mar 2008. 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 NCT00001654, 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 4 Mar 2008.