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Protocol Details

Family Study of Affective and Anxiety Spectrum Disorders

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

03-M-0211

Sponsoring Institute

National Institute of Mental Health (NIMH)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 7 Years
Max Age: 120 Years

Referral Letter Required

No

Population Exclusion(s)

None

Keywords

Bipolar;
Migraine;
High Risk Study;
Mobile Technologies;
Sleep;
Natural History

Recruitment Keyword(s)

None

Condition(s)

Mood Disorders;
Sleep Disorders;
Migraine

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute of Mental Health

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.

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Eligibility

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.


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Citations:

Kendell RE. Abstract Clinical validity. Psychol Med. 1989 Feb;19(1):45-55.

Tsuang MT, Abstract Identification of the phenotype in psychiatric genetics. Eur Arch Psychiatry Clin Neurosci. 1993;243(3-4):131-42.

Smoller JW, Panic and phobic anxiety: defining phenotypes for genetic studies. Am J Psychiatry. 1998 Sep;155(9):1152-62.

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Contacts:

Principal Investigator

Referral Contact

For more information:

Kathleen Merikangas, Ph.D.
National Institute of Mental Health (NIMH)
National Institutes of Health
Building 35
Room 1A201
15 North Drive
Bethesda, Maryland 20892
(301) 496-7773
familystudy@nih.gov

Kathleen Merikangas, Ph.D.
National Institute of Mental Health (NIMH)
National Institutes of Health
Building 35
Room 1A201
15 North Drive
Bethesda, Maryland 20892
(301) 496-7773
familystudy@nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1
ccopr@nih.gov

Clinical Trials Number:

NCT00071786

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