Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00071786
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2003-10-30
Brief Title:
Family Study of Affective and Anxiety Spectrum Disorders
Sponsor:
National Institute of Mental Health NIMH
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Family Study of Affective and Anxiety Spectrum Disorders
Status:
RECRUITING
Status Verified Date:
2024-02-15
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will examine how depression anxiety and migraine run in families It will help in defining the risk factors for physical mental and health problems-as well as define ways that those problems may be prevented and treated
A broad range of ages among family members will be included to evaluate the patterns of how these disorders are expressed throughout peoples lives Children of all ages will be included and those ages 8 to 17 will be interviewed directly
Assessments will be collected through criteria of the Diagnostic and Statistical Manual of Mental Disorders IV as well as the spectrum or range of mood disorders and co-existing conditions A member of the study team will visit the participants at home or will do an interview by telephone Participation will take approximately 3 to 4 hours Children will complete questionnaires given by the research team as well as questionnaires that they will do by themselves The questions will pertain to the childrens health including physical and mental health and medical history social relationships problems skills and ways of dealing with important or stressful issues in their lives These questionnaires will take up to 1 hour to complete
Health history gathered from adult participants will pertain to height weight exercise and general function Women will be asked about the use of oral contraceptives estrogen and progesterone In addition there will be questionnaires on personality and temperamental traits that is behavior and impulsiveness Questions will also involve social intuition family and other environmental factors general functioning and basic demographics such as ethnicity race socioeconomic status marital status education level and employment history
Families enrolled in this phase of the research will be invited to participate in the next phase There would be follow-up to evaluate the development of mood disorders subtypes and syndromes across the lifespan
A broad range of ages among family members will be included to evaluate the patterns of how these disorders are expressed throughout peoples lives Children of all ages will be included and those ages 8 to 17 will be interviewed directly
Assessments will be collected through criteria of the Diagnostic and Statistical Manual of Mental Disorders IV as well as the spectrum or range of mood disorders and co-existing conditions A member of the study team will visit the participants at home or will do an interview by telephone Participation will take approximately 3 to 4 hours Children will complete questionnaires given by the research team as well as questionnaires that they will do by themselves The questions will pertain to the childrens health including physical and mental health and medical history social relationships problems skills and ways of dealing with important or stressful issues in their lives These questionnaires will take up to 1 hour to complete
Health history gathered from adult participants will pertain to height weight exercise and general function Women will be asked about the use of oral contraceptives estrogen and progesterone In addition there will be questionnaires on personality and temperamental traits that is behavior and impulsiveness Questions will also involve social intuition family and other environmental factors general functioning and basic demographics such as ethnicity race socioeconomic status marital status education level and employment history
Families enrolled in this phase of the research will be invited to participate in the next phase There would be follow-up to evaluate the development of mood disorders subtypes and syndromes across the lifespan
Detailed Description:
Objective
The chief goal of this study is to identify the endophenotypes of the spectrum of mood disorders using the methods of genetic epidemiology developmental psychopathology and clinical psychiatrypsychology The major research questions focus on the specificity of familial transmission of the mood disorder spectrum ie symptoms symptom clusters subtypes and the role of comorbidity with anxiety disorders and migraine syndromes in defining subtypes of mood disorders
Study Population
We propose to recruit 800 probands with bipolar I bipolar II major depression panicGAD phobias migraine and unaffected controls ascertained through both psychiatric and non-psychiatric clinical settings and systematic community samples in order to enhance generalizability to the population Approximately 2750 first-degree adult relatives and spouses 350 child offspring ages 7-17 will comprise the family study component
Design
This study employs a retrospective cohort family study for the association between mood and other mental and physical disorders in probands and their relatives Probands and relatives will be evaluated using structured diagnostic interviews and standardized diagnostic criteria followed by clinical validation interviews and diagnostic consensus procedures Assessment instruments will collect information on the DSM-IV criteria as well as the spectrum of mood disorders and comorbid conditions In addition DNA will also be collected from participants A subset of families will also complete electronic diaries and measures of light exposure and activity in this protocol and will be invited to participate in another protocol to undergo more comprehensive evaluation of clinical laboratory and other functional domans to identify biologic markers and endophentypes for mood and related disorders Data from the two protocols will be linked A subset of families will also be followed forward over time
Outcome Measures
The primary outcome measure is the familial aggregation of mood disorder subtypes and their co-aggregation with migraine and anxiety disorders with diagnoses based on clinical review of the diagnostic interviews family history information and clinical evaluation of study participants when relevant using traditional family study measures of association Secondary outcomes include associations between mood disorders with the data collected from laboratory biological and functional assessments that have been collected as part of the clinical study and their familial correlations Moving forward these data will be collected as part of a new protocol and linked with the interview and mobile assessment data collected in this protocol
The chief goal of this study is to identify the endophenotypes of the spectrum of mood disorders using the methods of genetic epidemiology developmental psychopathology and clinical psychiatrypsychology The major research questions focus on the specificity of familial transmission of the mood disorder spectrum ie symptoms symptom clusters subtypes and the role of comorbidity with anxiety disorders and migraine syndromes in defining subtypes of mood disorders
Study Population
We propose to recruit 800 probands with bipolar I bipolar II major depression panicGAD phobias migraine and unaffected controls ascertained through both psychiatric and non-psychiatric clinical settings and systematic community samples in order to enhance generalizability to the population Approximately 2750 first-degree adult relatives and spouses 350 child offspring ages 7-17 will comprise the family study component
Design
This study employs a retrospective cohort family study for the association between mood and other mental and physical disorders in probands and their relatives Probands and relatives will be evaluated using structured diagnostic interviews and standardized diagnostic criteria followed by clinical validation interviews and diagnostic consensus procedures Assessment instruments will collect information on the DSM-IV criteria as well as the spectrum of mood disorders and comorbid conditions In addition DNA will also be collected from participants A subset of families will also complete electronic diaries and measures of light exposure and activity in this protocol and will be invited to participate in another protocol to undergo more comprehensive evaluation of clinical laboratory and other functional domans to identify biologic markers and endophentypes for mood and related disorders Data from the two protocols will be linked A subset of families will also be followed forward over time
Outcome Measures
The primary outcome measure is the familial aggregation of mood disorder subtypes and their co-aggregation with migraine and anxiety disorders with diagnoses based on clinical review of the diagnostic interviews family history information and clinical evaluation of study participants when relevant using traditional family study measures of association Secondary outcomes include associations between mood disorders with the data collected from laboratory biological and functional assessments that have been collected as part of the clinical study and their familial correlations Moving forward these data will be collected as part of a new protocol and linked with the interview and mobile assessment data collected in this protocol
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 03-M-0211 | None | None | None |