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Family Study of Affective and Anxiety Spectrum Disorders

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 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: November 11, 2014
Last verified: January 2014

October 30, 2003
November 11, 2014
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.

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.

This study employs a family study design of probands with mood, anxiety and migraine disorders with nested case control studies of the key study questions described below. 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 (page 12). 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. This will provide information that will be used to validate the diagnostic thresholds and boundaries of the current diagnostic systems. Families enrolled in this phase of research will be invited to participate in the next phase of research which is designed to identify familial endophenotypes of affective disorders that may comprise intermediate forms of expression of underlying genetic factors. These families will be followed longitudinally to evaluate the development of the mood disorder spectrum, subtypes, and syndromes across the lifespan. Separate protocols will be written concurrently to develop the research on specific endophenotypes and longitudinal evaluation as the identification and characterization of families proceed.

The major contributions of this research will include: (1) Identification of clinical phenotypes that breed true in families and are specific to particular subtypes of mood disorders; (2) Refinement of phenotypes for the diagnostic nomenclature; (3) Resolution of the role of comorbid disorders, particularly anxiety and migraine, as indicators of subtypes of mood disorders or the converse; and (4) Elucidation of age and development-specific patterns of expression of salient components of the mood disorder spectrum across the lifespan.

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, 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. Individuals who do not meet criteria are classified as controls.

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
Yes
Contact: Kathleen Merikangas, Ph.D. (301) 496-1172 merikank@mail.nih.gov
United States
 
NCT00071786
030211, 03-M-0211
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National Institutes of Health Clinical Center (CC) ( 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)
January 2014

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