Family Study of Affective and Anxiety Spectrum Disorders

National Institute of Mental Health (NIMH) (NIH)
Overall Status
Recruiting ID

Study Details

Study Description

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 Intervention/Treatment Phase

    Detailed Description


    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.


    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

    Study Type:
    Anticipated Enrollment :
    3975 participants
    Observational Model:
    Time Perspective:
    Official Title:
    Family Study of Affective and Anxiety Spectrum Disorders
    Actual Study Start Date :
    May 21, 2004

    Arms and Interventions

    Arm Intervention/Treatment
    Group 1

    All study participants fall into one group for this observational family study regardless of diagnosis.

    Outcome Measures

    Primary Outcome Measures

    1. diagnostic interviews, family history information and clinical evaluation of study participants [Lifetime]

      Diagnoses, Symptoms, Impairment, Biologic parameters

    Eligibility Criteria


    Ages Eligible for Study:
    7 Years and Older
    Sexes Eligible for Study:
    Accepts Healthy Volunteers:
    • 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.
    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).


    The only exclusion criteria include impaired ability to comprehend the interview or inability to read.


    The only inclusion criteria for the study are that the person be English-speaking and ability to read and comprehend the interview.


    Lifetime history of DSM-IV Bipolar I or Manic Episode.


    Lifetime history of DSM-IV Bipolar II with duration of hypomania reduced to 2 or more days (according to RDC)


    Lifetime history of at least 2 episodes of DSM-IV Major Depression


    Lifetime history of DSM-IV diagnosis for Panic Disorder or GAD


    Lifetime history of DSM-IV diagnosis for social anxiety disorder, agoraphobia, or specific phobias (greater than or equal to 3)


    Lifetime history of IHS migraine with or without Aura


    The only exclusion criteria include impaired ability to comprehend the interview or inability to read.

    Contacts and Locations


    Site City State Country Postal Code
    1 National Institutes of Health Clinical Center, 9000 Rockville Pike Bethesda Maryland United States 20892

    Sponsors and Collaborators

    • National Institute of Mental Health (NIMH)


    • Principal Investigator: Kathleen Merikangas, Ph.D., National Institute of Mental Health (NIMH)

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:


    Responsible Party:
    National Institute of Mental Health (NIMH) Identifier:
    Other Study ID Numbers:
    • 030211
    • 03-M-0211
    First Posted:
    Oct 31, 2003
    Last Update Posted:
    Jul 19, 2022
    Last Verified:
    Mar 3, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Studies a U.S. FDA-regulated Device Product:
    Keywords provided by National Institute of Mental Health (NIMH)
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 19, 2022