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
Mood DIsorders Anxiety Disorders

Further Study Details: 

Expected Total Enrollment:  4000

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 500 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 2500 first-degree adult relatives and spouses and 750 child offspring (ages 8-17), and 250 young child offspring (ages 0 - 7) will comprise the family study component. 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 compromise 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 proceeds.

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.

Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

GENERAL INCLUSION CRITERIA:
Probands will be included if they meet criteria for one of the disorders listed below. Controls will be excluded if they have one of the inclusion disorders. The probands will be required to be 21 years of age and English speaking.
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:
Few probands who consent to participate will be excluded if they meet the inclusion criteria. The only exclusion criteria include impaired ability to comprehend the interview or inability to read.
BIPOLAR II EXCLUSION CRITERIA:
Lifetime history of DSM-IV Bipolar I (or manic episode)
MAJOR DEPRESSION EXCLUSION CRITERIA:
Lifetime history of DSM-IV Bipolar I or II (duration greater than or equal to 2 days)
PHOBIAS EXCLUSION CRITERIA:
Lifetime history of DSM-IV diagnosis for panic disorder or GAD
CONTROLS EXCLUSION CRITERIA:
Lifetime history of a DSM-IV affective or anxiety disorder, IHS migraine disorder or Psychosis

Maryland
      National Institute of Mental Health (NIMH), 9000 Rockville Pike,  Bethesda,  Maryland,  20892,  United States; Recruiting

Study ID Numbers:  030211; 03-M-0211
Record last reviewed:  March 17, 2004
Last Updated:  November 23, 2004
Record first received:  October 30, 2003
ClinicalTrials.gov Identifier:  NCT00071786
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08