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Family Study of Affective and Anxiety Spectrum Disorders

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ClinicalTrials.gov Identifier: NCT00071786
Recruitment Status : Recruiting
First Posted : October 31, 2003
Last Update Posted : May 31, 2023
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) )

Study Description
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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 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.


Condition or disease
Mood Disorders Sleep Disorders Migraine

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 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) 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 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 Design
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Study Type : Observational
Estimated Enrollment : 3975 participants
Observational Model: Family-Based
Time Perspective: Retrospective
Official Title: Family Study of Affective and Anxiety Spectrum Disorders
Actual Study Start Date : May 21, 2004

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine

Groups and Cohorts
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Group/Cohort
Group 1
All study participants fall into one group for this observational family study regardless of diagnosis.


Outcome Measures
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Primary Outcome Measures :
  1. diagnostic interviews, family history information and clinical evaluation of study participants [ Time Frame: Lifetime ]
    Diagnoses, Symptoms, Impairment, Biologic parameters


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   7 Years to 120 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Community Sample
Criteria
  • 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. the ability to comprehend the interview, and

  2. 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.

    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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00071786


Contacts
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Contact: Kathleen Merikangas, Ph.D. (301) 496-7773 familystudy@nih.gov

Locations
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United States, Maryland
National Institutes of Health Clinical Center Recruiting
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Kathleen Merikangas, Ph.D. National Institute of Mental Health (NIMH)
More Information
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Additional Information:

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00071786    
Other Study ID Numbers: 030211
03-M-0211
First Posted: October 31, 2003    Key Record Dates
Last Update Posted: May 31, 2023
Last Verified: March 24, 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) ):
Bipolar
Migraine
High Risk Study
 Mobile Technologies
Sleep
Natural History
Additional relevant MeSH terms:
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Sleep Wake Disorders
Disease
Mood Disorders
Pathologic Processes
 Nervous System Diseases
Neurologic Manifestations
Mental Disorders