Family Study of Affective and Anxiety Spectrum Disorders
概览
- 阶段
- 不适用
- 干预措施
- Group 1
- 疾病 / 适应症
- Mood Disorders
- 发起方
- National Institute of Mental Health (NIMH)
- 入组人数
- 1944
- 试验地点
- 1
- 主要终点
- diagnostic interviews, family history information and clinical evaluation of study participants
- 状态
- 已完成
- 最后更新
- 18天前
概览
简要总结
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.
详细描述
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.
研究者
入排标准
入选标准
- •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
排除标准
- •. 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
- •Individuals who do not meet criteria are classified as controls.
- •INCLUSION CRITERIA:
- •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).
- •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.
研究组 & 干预措施
Group 1
All study participants fall into one group for this observational family study regardless of diagnosis.
结局指标
主要结局
diagnostic interviews, family history information and clinical evaluation of study participants
时间窗: Lifetime
Diagnoses, Symptoms, Impairment, Biologic parameters