Family Study of Affective and Anxiety Spectrum Disorders

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2016 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) )
ClinicalTrials.gov Identifier:
NCT00071786
First received: October 30, 2003
Last updated: August 10, 2016
Last verified: August 2016

October 30, 2003
August 10, 2016
August 2003
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Complete list of historical versions of study NCT00071786 on ClinicalTrials.gov Archive Site
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Family Study of Affective and Anxiety Spectrum Disorders
Family Study of Affective and Anxiety Spectrum Disorders

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.

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 600 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.

Observational
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  • Mood Disorders
  • Anxiety Disorders
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
3775
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  • 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.

    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.

Both
up to 60 Years   (Child, Adult)
Yes
Contact: Kathleen Merikangas, Ph.D. (301) 496-1172 merikank@mail.nih.gov
United States
Canada,   China,   Switzerland
 
NCT00071786
030211, 03-M-0211
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National Institute of Mental Health (NIMH)
National Institute of Mental Health (NIMH)
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Principal Investigator: Kathleen Merikangas, Ph.D. National Institute of Mental Health (NIMH)
National Institutes of Health Clinical Center (CC)
August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP