Family Study of Affective and Anxiety Spectrum Disorders

NCT00071786 | Completed

• 2 other identifiers: 03021103-M-0211
• Study Type: observational
• Target: 1,944
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Disorders; Migraine; Mood Disorders

Keywords

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

Outcome Measures

Primary Outcomes (1)

• diagnostic interviews, family history information and clinical evaluation of study participants

  Diagnoses, Symptoms, Impairment, Biologic parameters

  Lifetime

Study Arms (1)

Group 1

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

Eligibility Criteria

• Age: 7 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Community Sample

You may not qualify if:

• the ability to comprehend the interview, and
• 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).
• 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

Sponsors & Collaborators

• National Institute of Mental Health (NIMH): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Publications (8)

• Kendell RE. Clinical validity. Psychol Med. 1989 Feb;19(1):45-55. doi: 10.1017/s0033291700011016.

  PMID: 2657832 BACKGROUND

• Tsuang MT, Faraone SV, Lyons MJ. Identification of the phenotype in psychiatric genetics. Eur Arch Psychiatry Clin Neurosci. 1993;243(3-4):131-42. doi: 10.1007/BF02190719.

  PMID: 8117756 BACKGROUND

• Smoller JW, Tsuang MT. Panic and phobic anxiety: defining phenotypes for genetic studies. Am J Psychiatry. 1998 Sep;155(9):1152-62. doi: 10.1176/ajp.155.9.1152.

  PMID: 9734536 BACKGROUND

• Stapp EK, Zipunnikov V, Leroux A, Cui L, Husky MM, Dey D, Merikangas KR. Specificity of affective dynamics of bipolar and major depressive disorder. Brain Behav. 2023 Sep;13(9):e3134. doi: 10.1002/brb3.3134. Epub 2023 Aug 13.

  PMID: 37574463 DERIVED

• Glaus J, Cui L, Hommer R, Merikangas KR. Association between mood disorders and BMI/overweight using a family study approach. J Affect Disord. 2019 Apr 1;248:131-138. doi: 10.1016/j.jad.2019.01.011. Epub 2019 Jan 15.

  PMID: 30731280 DERIVED

• Lamers F, Swendsen J, Cui L, Husky M, Johns J, Zipunnikov V, Merikangas KR. Mood reactivity and affective dynamics in mood and anxiety disorders. J Abnorm Psychol. 2018 Oct;127(7):659-669. doi: 10.1037/abn0000378.

  PMID: 30335438 DERIVED

• Glaus J, Van Meter A, Cui L, Marangoni C, Merikangas KR. Factorial structure and familial aggregation of the Hypomania Checklist-32 (HCL-32): Results of the NIMH Family Study of Affective Spectrum Disorders. Compr Psychiatry. 2018 Jul;84:7-14. doi: 10.1016/j.comppsych.2018.03.010. Epub 2018 Apr 3.

  PMID: 29655654 DERIVED

• Lamers F, Cui L, Hickie IB, Roca C, Machado-Vieira R, Zarate CA Jr, Merikangas KR. Familial aggregation and heritability of the melancholic and atypical subtypes of depression. J Affect Disord. 2016 Nov 1;204:241-6. doi: 10.1016/j.jad.2016.06.040. Epub 2016 Jun 14.

  PMID: 27450632 DERIVED

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Mood Disorders; Sleep Wake Disorders; Migraine Disorders

Condition Hierarchy (Ancestors)

Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases

Study Officials

• Kathleen R Merikangas, Ph.D.

  National Institute of Mental Health (NIMH)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: FAMILY BASED
• Time Perspective: RETROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2003
• First Posted: October 31, 2003
• Study Start: May 21, 2004
• Last Updated: April 14, 2026

Record last verified: 2025-11-14

Locations

US (1)