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View Clinical Trial (Medical Research Study)
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Family Study of Affective and Anxiety Spectrum Disorders - NCT00071786-20037 (Clinical Trial 118501)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy118501.aspx
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Washington |
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State:
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DC |
| Zip Code: |
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20037 |
| Conditions: |
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Mood Disorders - Anxiety Disorders |
| Purpose: |
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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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| Study summary: |
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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 2000 first-degree adult relatives and
spouses, 200 child offspring (ages 8-17), and 50 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 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. |
| Criteria: |
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- 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 18 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. |
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| Study is available at: |
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GW University Medical Center
Washington, DC 20037
United States
Primary Contact:
Patient Recruitment and Public Liaison Office
Email: prpl@mail.cc.nih.gov
Phone: (800) 411-1222 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 15, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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