Enrolling pregnant women: issues in clinical research.

Background: Despite the fact that many pregnant women are affected by a range of serious health conditions and take medications for these conditions, there is widespread reticence to include them in clinical intervention research. Hence, their clinical care is typically not informed by evidence derived from pregnant populations.

Method: In October 2010, the National Institutes of Health Office of Research on Women's Health convened a workshop to address ethical, regulatory, and scientific issues raised by the enrollment of pregnant women in clinical research.

Women's mental health research: the emergence of a biomedical field.

This review surveys the field of women's mental health, with particular emphasis on its evolution into a distinct area of biomedical research. The field employs a biomedical disease model but it also emphasizes social and cultural influences on health outcomes. In recent years, its scope has expanded beyond studies of disorders occurring in women at times of reproductive transitions and it now encompasses a broader study of sex and gender differences.

Public health context of women's mental health research.

As more attention is directed to the mental health care of women, sex and gender differences in research design and in regulatory policies have interfaced with clinical care and public policy. An emphasis on women's mental health issues in the provision of treatment and care as well as the design of large-scale screening strategies to identify and treat women with mental disorders promises to be effective public health approaches to reducing the burden of mental illness in women. The past decade has seen increased emphasis on women's mental health and sex/gender differences in the federal sector and in the research community.

Bridging the gap: recruitment of African-American women into mental health research studies.

Objective: To develop a strategy for recruiting African-American women into a research study for pregnant women.

Methods: With few exceptions, NIH-funded investigators must include women and minorities in clinical research. The authors used the recommendations provided in the Outreach Notebook for the NIH Guidelines on Inclusion of Women and Minorities as Subjects in Clinical Research as a guide to help them reach out to African-American women in the community.

Skating to where the puck is going to be: a plan for clinical trials and translation research in mood disorders.

As part of the National Institute of Mental Health Strategic Plan for Mood Disorders Research effort, the Clinical Trials and Translation Workgroup was asked to define priorities for clinical trials in mood disorders and for research on how best to translate the results of such research to clinical practice settings. Through two face-to-face meetings and a series of conference calls, we established priorities based on the literature to date and what was known about research currently in progress in this area. We defined five areas of priority that cut across developmental stages, while noting that research on adult mood disorders was at a more advanced stage in each of these areas than research on child or geriatric disorders.

Traumatic brain injury and schizophrenia in members of schizophrenia and bipolar disorder pedigrees.

Objective: Schizophrenia following a traumatic brain injury could be a phenocopy of genetic schizophrenia or the consequence of a gene-environment interaction. Alternatively, traumatic brain injury and schizophrenia could be spuriously associated if those who are predisposed to develop schizophrenia have greater amounts of trauma for other reasons. The authors investigated the relationship between traumatic brain injury and psychiatric diagnoses in a large group of subjects from families with at least two biologically related first-degree relatives with schizophrenia, schizoaffective disorder, or bipolar disorder.

Suggestive evidence of a locus on chromosome 10p using the NIMH genetics initiative bipolar affective disorder pedigrees.

As part of a four-center NIMH Genetics Initiative on Bipolar Disorder, a genome screen using 365 markers was performed on 540 DNAs from 97 families, enriched for affected relative pairs. This is the largest uniformly ascertained and assessed linkage sample for this disease, and includes 232 subjects diagnosed with bipolar I (BPI), 32 with schizo-affective, bipolar type (SABP), 72 with bipolar II (BPII), and 88 with unipolar recurrent depression (UPR). A hierarchical set of definitions of affected status was examined.

Mental disorders associated with childbearing: report of the Biennial Meeting of the Marcé Society.

This article presents highlights from an international conference focused on mental disorders in association with childbearing. Findings from related research on diagnosis, classification, epidemiology, child outcome, prevention, and treatment are summarized. A need is seen for more research on prevention of childbearing disorders, on the effectiveness of interventions in reducing maternal and child morbidity, on the development of new psychosocial interventions, and on the assessment of the efficacy and safety of somatic treatments in pregnant and lactating women.

Women with bipolar disorder: findings from the NIMH Genetics Initiative sample.

Bipolar I (BPI) mood disorder is a severe recurrent mental Illness with a population prevalence of 1 percent. Evidence is strong for genetic risk factors in onset. However, unlike unipolar mood disorders, in which women outnumber men by 2 to 1, for BPI disorder, the male:female ratio is equal.

Initial genome screen for bipolar disorder in the NIMH genetics initiative pedigrees: chromosomes 2, 11, 13, 14, and X.

We report on an initial genome screen of 540 individuals from 97 families collected as part of the NIMH Genetics Initiative Bipolar Group. Among the individuals studied, 232 were diagnosed with bipolar (BP) I, 72 with BPII, 88 with major depressive disorder-recurrent type (UPR), and 32 with schizoaffective disorder, bipolar type (SA/BP). A total of 53 markers on chromosomes 2, 11, 13, 14, and X (average spacing: 11.

Initial genome scan of the NIMH genetics initiative bipolar pedigrees: chromosomes 1, 6, 8, 10, and 12.

A report on an initial genome screen on 540 individuals in 97 families was collected as part of the NIMH Genetics Initiative on Bipolar Disorder. Families were ascertained to be informative for genetic linkage and underwent a common ascertainment and assessment protocol at four clinical sites. The sample was genotyped for 65 highly polymorphic markers from chromosomes 1, 6, 8, 10, and 12.

Initial genomic scan of the NIMH genetics initiative bipolar pedigrees: chromosomes 3, 5, 15, 16, 17, and 22.

As part of the four-center NIMH Genetics Initiative on Bipolar Disorder we carried out a genomic scan of chromosomes 3, 5, 15, 16,17, and 22. Genotyping was performed on a set of 540 DNAs from 97 families, enriched for affected relative pairs and parents where available. We report here the results of the initial 74 markers that have been typed on this set of DNAs.

Gender Differences in Depression.

Beyond the repeatedly confirmed finding that women diagnosed with mood disorders greatly outnumber men lies a widely varying set of hypotheses that attempt to explain the suspected causes, incidence, symptoms, and comorbidities from various perspectives. Several complex factors, however, have impeded attempts to study why women are so vulnerable to depression. This article examines the problems associated with studying affective disorders in women and reviews the current hypothetical constructs of the etiology and pathophysiology of depression and their potential relevance to the disproportionate number of women with unipolar depression.

A meta-analysis of chromosome 18 linkage data for bipolar illness.

We find a meta-data set (715 families, up to 1,124 sib pairs) for bipolar illness to have a strong signal in a 10 cM region around D18S40, and excess paternal sharing on the q arm near marker D18S64. We describe a method for meta-analysis of microsatellite marker data using affected sib-pair (ASP) methodology. Inherent difficulties in such analysis include heterogeneity of allele frequencies and protocol design, measurement errors in genotyping, and map construction.

Diagnostic accuracy and confusability analyses: an application to the Diagnostic Interview for Genetic Studies.

The dominant, contemporary paradigm for developing and refining diagnoses relies heavily on assessing reliability with kappa coefficients and virtually ignores a core component of psychometric practice: the theory of latent structures. This article describes a psychometric approach to psychiatric nosology that emphasizes the diagnostic accuracy and confusability of diagnostic categories. We apply these methods to the Diagnostic Interview for Genetic Studies (DIGS), a structured psychiatric interview designed by the NIMH Genetics Initiative for genetic studies of schizophrenia and bipolar disorder.

Gender differences in risk factors for mood and anxiety disorders: implications for clinical treatment research.

This article discusses the utility and treatment implications of a focus on gender-related variables in the study of the mood and anxiety disorders. Three clinical areas are considered: (1) Mood and anxiety disorders during female reproductive transitions; (2) gender differences in pathogenesis and pathopsysiology; and (3) gender differences in clinical phenomenology and course. Gender analysis is viewed as useful in specifying variability in treatment response, especially in regard to the menstrual cycle, pregnancy, the postpartum period, and menopause; and in defining clinical covariates modifying treatment course.

Diagnostic interview for genetic studies. Rationale, unique features, and training. NIMH Genetics Initiative.

This article reports on the development and reliability of the Diagnostic Interview for Genetic Studies (DIGS), a clinical interview especially constructed for the assessment of major mood and psychotic disorders and their spectrum conditions. The DIGS, which was developed and piloted as a collaborative effort of investigators from sites in the National Institute of Mental Health (NIMH) Genetics Initiative, has the following additional features: (1) polydiagnostic capacity; (2) a detailed assessment of the course of the illness, chronology of psychotic and mood syndromes, and comorbidity; (3) additional phenomenologic assessments of symptoms; and (4) algorithmic scoring capability. The DIGS is designed to be employed by interviewers who exercise significant clinical judgment and who summarize information in narrative form as well as in ratings.

Seasonal affective disorders and phototherapy. Report of a National Institute of Mental Health-sponsored workshop.

This report summarizes presentations made at a National Institute of Mental Health-sponsored workshop dealing with recurrent winter depression, or seasonal affective disorder (SAD), and with phototherapy as its treatment. Workshop participants reviewed major issues in the following areas: (1) diagnosis, clinical characteristics, and epidemiology of the disorder; (2) critical issues in phototherapy research; (3) biologic effects of light and mechanism of action of phototherapy; (4) biologic abnormalities in SAD; and (5) animal models and their applicability to the study of SAD. Most research evidence to date supports the efficacy of phototherapy in the treatment of SAD.