Mood DisordersNCT00071786
Family Study of Affective and Anxiety Spectrum Disorders
An observational study of Mood Disorders and Sleep Disorders, run by National Institute of Mental Health (NIMH) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 120 years
- Conditions the study is for
- Mood Disorders, Sleep Disorders, Migraine
- How many people
- 1,944 participants
- Where
- 1 siteUnited States
- Study dates
- 21 May 2004to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 120 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Community Sample
Who may be able to join
- 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).
Who cannot join
- 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
Show all 18Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
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.
Read more
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.
Read the detailed description
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 800 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) will comprise the family study component.
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. In addition, DNA will also be collected from participants. A subset of families will also complete electronic diaries and measures of light exposure and activity in this protocol, and will be invited to participate in another protocol to undergo more comprehensive evaluation of clinical, laboratory, and other functional domans to identify biologic markers and endophentypes for mood and related disorders. Data from the two protocols will be linked. A subset of families will also be followed forward over time.
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 data collected from laboratory, biological, and functional assessments that have been collected as part of the clinical study and their familial correlations. Moving forward, these data will be collected as part of a new protocol and linked with the interview and mobile assessment data collected in this protocol.
- Conditions
- Mood Disorders, Sleep Disorders, Migraine
- Keywords
- Bipolar, Migraine, High Risk Study, Mobile Technologies, Sleep, Natural History
- Medical subject headings
- Mood Disorders, Sleep Wake Disorders, Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | All study participants fall into one group for this observational family study regardless of diagnosis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
diagnostic interviews, family history information and clinical evaluation of study participants
Diagnoses, Symptoms, Impairment, Biologic parameters
Measured: Lifetime
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2003 (estimated)
- Study start21 May 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Mood DisordersStudies of the same condition, open and under way.
- More trials run by National Institute of Mental Health (NIMH)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Family based
- Time perspective
- Retrospective
- Enrolment
- 1,944 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Kathleen R Merikangas, Ph.D., Principal investigator, National Institute of Mental Health (NIMH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00071786
- Sponsor's protocol ID
- 030211
- Other IDs
- 03-M-0211
- Status last verified
- 5 Oct 2026
- First submitted
- 30 Oct 2003
- Last updated
- 26 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kendell RE. Clinical validity. Psychol Med. 1989 Feb;19(1):45-55. doi: 10.1017/s0033291700011016.
PubMed 2657832Tsuang 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.
PubMed 8117756Smoller 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.
PubMed 9734536Stapp 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.
PubMed 37574463Glaus 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.
PubMed 30731280Lamers 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.
PubMed 30335438Glaus 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.
PubMed 29655654Lamers 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.
PubMed 27450632
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family Study of Affective and Anxiety Spectrum Disorders
- ClinicalTrials.gov ID
- NCT00071786
- Acronym / sponsor ID
- 030211
- Conditions
- Mood Disorders, Sleep Disorders, Migraine
- Keywords
- Bipolar, Migraine, High Risk Study, Mobile Technologies, Sleep, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,944 participants (actual)
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Study start
- 21 May 2004 (actual)
- First posted
- 31 Oct 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 800 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) will comprise the family study component.
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. In addition, DNA will also be collected from participants. A subset of families will also complete electronic diaries and measures of light exposure and activity in this protocol, and will be invited to participate in another protocol to undergo more comprehensive evaluation of clinical, laboratory, and other functional domans to identify biologic markers and endophentypes for mood and related disorders. Data from the two protocols will be linked. A subset of families will also be followed forward over time.
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 data collected from laboratory, biological, and functional assessments that have been collected as part of the clinical study and their familial correlations. Moving forward, these data will be collected as part of a new protocol and linked with the interview and mobile assessment data collected in this protocol.
Study design
- Observational model
- Family based
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –All study participants fall into one group for this observational family study regardless of diagnosis. |
Who may qualify
- Ages
- 7 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Community Sample
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (18 listed)
- The only exclusion criteria include impaired ability to comprehend the interview or inability to read.
- The only inclusion criteria for the study are that the person be English-speaking and ability to read and comprehend the interview.
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
diagnostic interviews, family history information and clinical evaluation of study participants
Time frame: Lifetime
Diagnoses, Symptoms, Impairment, Biologic parameters
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Background: PubMed 2657832Kendell RE. Clinical validity. Psychol Med. 1989 Feb;19(1):45-55. doi: 10.1017/s0033291700011016.
- Background: PubMed 8117756Tsuang 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.
- Background: PubMed 9734536Smoller 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.
- Derived from this study: PubMed 37574463Stapp 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.
- Derived from this study: PubMed 30731280Glaus 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.
- Derived from this study: PubMed 30335438Lamers 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.
- Derived from this study: PubMed 29655654Glaus 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.
- Derived from this study: PubMed 27450632Lamers 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.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathleen R Merikangas, Ph.D. principal investigator
National Institute of Mental Health (NIMH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mood Disorders and Sleep Disorders, run by National Institute of Mental Health (NIMH) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
diagnostic interviews, family history information and clinical evaluation of study participants (time frame: Lifetime). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00071786, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.