Family Study of Affective and Anxiety Spectrum Disorders
| Status: | Recruiting |
|---|---|
| Conditions: | Anxiety, Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | Any - 60 |
| Updated: | 4/5/2019 |
| Start Date: | October 30, 2003 |
| Contact: | Kathleen Merikangas, Ph.D. |
| Email: | merikank@mail.nih.gov |
| Phone: | (301) 496-1172 |
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 people's 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 children's 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.
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 people's 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 children's 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.
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 psychiatry/psychology. The major research questions focus on the specificity of
familial transmission of the mood disorder spectrum (i.e., 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, panic/GAD,
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), and 75 young child offspring (ages 0-7) will
comprise the family study component. For a breakdown of these numbers by diagnostic group see
table 1.
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. A subset of families will receive more comprehensive
evaluation of clinical, laboratory, and other functional domains to identify biologic markers
and endophenotypes for mood and related disorders.
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 laboratory, biological, and
functional assessments that are collected as part of the clinical study and their familial
correlations.
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 psychiatry/psychology. The major research questions focus on the specificity of
familial transmission of the mood disorder spectrum (i.e., 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, panic/GAD,
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), and 75 young child offspring (ages 0-7) will
comprise the family study component. For a breakdown of these numbers by diagnostic group see
table 1.
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. A subset of families will receive more comprehensive
evaluation of clinical, laboratory, and other functional domains to identify biologic markers
and endophenotypes for mood and related disorders.
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 laboratory, biological, and
functional assessments that are collected as part of the clinical study and their familial
correlations.
- Since this study is based on systematic recruitment from the local community and other
non-clinical settings such as screening protocols from volunteers, there are no
specific diagnostic inclusion and exclusion criteria. However, the study targets
individuals with mood spectrum conditions and migraine. Criteria for the specific
subgroups of mood and anxiety disorders are presented in Table 1. Individuals who do
not meet criteria are classified as controls.
INCLUSION CRITERIA:
1. age 18 or greater;
2. the ability to comprehend the interview, and
3. probands must agree to contact at least two relatives (contacting relatives is not
required in cases where the participant is enrolled in just the mobile technologies
assessments (EMA and Actigraphy).
EXCLUSION CRITERIA:
The only exclusion criteria include impaired ability to comprehend the interview or
inability to read.
TABLE 1. Specific Inclusion and Exclusion Criteria by Proband Group:
GENERAL INCLUSION CRITERIA:
The only inclusion criteria for the study are that the person be English-speaking and
ability to read and comprehend the interview.
BIPOLAR I INCLUSION CRITERIA:
Lifetime history of DSM-IV Bipolar I or Manic Episode.
BIPOLAR II INCLUSION CRITERIA:
Lifetime history of DSM-IV Bipolar II with duration of hypomania reduced to 2 or more
days (according to RDC)
MAJOR DEPRESSION INCLUSION CRITERIA:
Lifetime history of at least 2 episodes of DSM-IV Major Depression
PANIC/GAD INCLUSION CRITERIA:
Lifetime history of DSM-IV diagnosis for Panic Disorder or GAD
PHOBIAS INCLUSION CRITERIA:
Lifetime history of DSM-IV diagnosis for social anxiety disorder, agoraphobia, or
specific phobias (greater than or equal to 3)
MIGRAINE INCLUSION CRITERIA:
Lifetime history of IHS migraine with or without Aura
GENERAL EXCLUSION CRITERIA:
The only exclusion criteria include impaired ability to comprehend the interview or
inability to read.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
Phone: 800-411-1222
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