Increased breastfeeding rates in black women after a treatment intervention.

There has been a considerable increase in rates of breastfeeding in the United States. Despite these trends, black women continue to fall below medical recommendations. Impoverished and poorly educated women also have a comparatively lower rate of breastfeeding. Provider encouragement and supportive interventions increase breastfeeding initiation among women of all backgrounds. The data presented come from a three-site randomized controlled bilingual depression treatment trial from 2005 to 2011 that examined the comparative effectiveness of interpersonal psychotherapy and a parenting education program. Breastfeeding education and support were provided for the majority of participants in each intervention. Breastfeeding status was queried at postpartum week 4. We found higher rates of breastfeeding in black women compared with those reported in national surveys. The black breastfeeding rate did not significantly differ from that of white or Hispanic women. American-born black women were just as likely to breastfeed as American-born white women, both at significantly greater rates than American-born Hispanic women. We also found no differences in breastfeeding rate in poorly educated and impoverished women. These data must be seen against the backdrop of a significant intervention to treat depression. Because breastfeeding interventions have been shown to increase breastfeeding rates, the support provided in our study likely increased rates in groups that lag behind.

Assessment of Day-to-Day Functioning in Prodromal and Early Huntington Disease.

The Functional Rating Scale Taskforce for pre-Huntington Disease (FuRST-pHD) is a multinational, multidisciplinary initiative with the goal of developing a data-driven, comprehensive, psychometrically sound, rating scale for assessing symptoms and functional ability in prodromal and early Huntington disease (HD) gene expansion carriers. The process involves input from numerous sources to identify relevant symptom domains, including HD individuals, caregivers, and experts from a variety of fields, as well as knowledge gained from the analysis of data from ongoing large-scale studies in HD using existing clinical scales. This is an iterative process in which an ongoing series of field tests in prodromal (prHD) and early HD individuals provides the team with data on which to make decisions regarding which questions should undergo further development or testing and which should be excluded. We report here the development and assessment of the first iteration of interview questions aimed to assess functional impact in day-to-day activities in prHD and early HD individuals.

The burden of moderate/severe premenstrual syndrome and premenstrual dysphoric disorder in a cohort of Latin American women.

OBJECTIVES: The aim of this study was to investigate the relationship between symptom severity, cost, and impairment in women with moderate/severe premenstrual syndrome (PMS) or premenstrual dysphoric disorder (PMDD) in a Latin American setting. METHODS: A model was constructed based on analysis of an observational dataset. Data were included from four Latin American countries. Responder-level data were analysed according to four categories of symptom severity: Category 1 comprised Daily Record of Severity of Problems score 21 to 41.9, Category 2 score was 42 to 62.9, Category 3 score was 63 to 83.9, and Category 4 was a score of 84 or higher. Burden was estimated in terms of impact on job and activities using the modified work productivity and impairment questionnaire and affect on quality of life using the SF-12 questionnaire. Costs were estimated in Brazilian reals from a Brazilian private health care and societal perspective. The outputs of the analysis were estimates of burden, mean annual cost and affect on quality of life (as measured by quality adjusted life years) by symptom severity. Confidence intervals around key outcomes were generated through nonparametric bootstrapping. RESULTS: Analysis suggests a significant cost burden associated with moderate/severe PMS and PMDD with mean per patient annual costs estimated at 1618 BRL (95% confidence interval 957-2,481). Although the relationship between cost, quality of life, and severity was not clear, analysis showed a consistent relationship between disease severity and measures of disease burden (job and daily activity). Burden on activities increased with disease severity. CONCLUSIONS: Our analysis, conducted from a Latin American perspective, suggests a significant burden and an increasing impairment associated with moderate/severe PMS and PMDD.

Assessment of quality of life enjoyment and satisfaction questionnaire-short form responder thresholds in generalized anxiety disorder and bipolar disorder studies.

Interpretation of change over time in patient-reported outcomes requires appropriate responder definitions. This study compares responder definitions for the short-form version of the Quality of Life Enjoyment and Satisfaction Questionnaire [Q-LES-Q(SF)] in populations with generalized anxiety disorder (GAD) and bipolar disorder. A review of the Q-LES-Q(SF) literature published in English from 1993 through May 2009 identified publications using the Q-LES-Q(SF) in GAD or bipolar disorder clinical trials. In six relevant articles reporting Q-LES-Q(SF) responder definitions in GAD or bipolar disorder, two methods for defining responders emerged: (i) return to a score within 10% of community norms for the Q-LES-Q(SF); and (ii) a change score at or greater than the condition-specific mean change achieved by patients with minimal improvement on the Clinical Global Impression-Improvement (CGI-I) at study endpoint or a 1-point decrease on the CGI-Severity scale between baseline and study endpoint. The magnitude of the CGI-I based responder thresholds differed across mental health conditions. Use of the Q-LES-Q(SF) community norms as a responder definition is discouraged. A responder definition needs to be investigated within each condition or disease using appropriate anchors, and may not be generalizable from one condition or disease to another.

Manic/hypomanic symptom burden and cardiovascular mortality in bipolar disorder.

OBJECTIVES: To compare the risk for cardiovascular mortality between bipolar I and bipolar II subtypes and determine correlates of cardiovascular mortality. Bipolar disorder conveys an increased risk of cardiovascular mortality. METHODS: Participants with major affective disorders were recruited for the National Institute of Mental Health Collaborative Depression Study and followed prospectively for up to 25 years. A total of 435 participants met the diagnostic criteria for bipolar I (n = 288) or bipolar II (n = 147) disorder based on Research Diagnostic Criteria at intake and measures of psychiatric symptoms during follow-up. Diagnostic subtypes were contrasted by cardiovascular mortality risk using Cox proportional hazards regression. Affective symptom burden (the proportion of time with clinically significant manic/hypomanic or depressive symptoms) and treatment exposure were additionally included in the models. RESULTS: Thirty-three participants died from cardiovascular causes. Participants with bipolar I disorder had more than double the cardiovascular mortality risk of those with bipolar II disorder, after controlling for age and gender (hazard ratio = 2.35, 95% Confidence Interval = 1.04-5.33; p = .04). The observed difference in cardiovascular mortality between these subtypes was at least partially confounded by the burden of clinically significant manic/hypomanic symptoms which predicted cardiovascular mortality independent of diagnosis, treatment exposure, age, gender, and cardiovascular risk factors at intake. Selective serotonin uptake inhibitors seemed protective although they were introduced late in follow-up. Depressive symptom burden was not related to cardiovascular mortality. CONCLUSIONS: Participants with bipolar I disorder may face a greater risk of cardiovascular mortality than those with bipolar II disorder. This difference in cardiovascular mortality risk may reflect manic/hypomanic symptom burden.

Functional outcomes in MDD: established and emerging assessment tools.

Currently, the primary efficacy measures for antidepressant clinical trials predominantly assess changes in mood symptoms in patients with major depressive disorder (MDD). When considering treatment options, however, patients and clinicians value improvement in function in important life domains as highly as symptom reduction. MDD patients report that they consider a return to normal functioning an important indicator of remission from depressive episodes. Indeed, many researchers now regard assessment of both mood symptoms and functional outcomes essential to measuring treatment-related improvement and remission from MDD. However, function is a very broad concept. Investigators must consider multiple issues in designing or selecting an instrument that measures function adequately and appropriately in their particular study population. The assessment tool should include dimensions of functioning that are relevant and likely to improve with the treatment, and the instrument should have demonstrated reliability and validity, good discrimination among patients, and sensitivity to meaningful improvement in functioning. The inclusion of well-chosen functional outcome measures in clinical trials will improve the assessment of impairment and improvement with treatment, and provide patients and clinicians with important information about the efficacy of antidepressant treatments.

Development and evaluation of the Daily Assessment of Symptoms - Anxiety (DAS-A) scale to evaluate onset of symptom relief in patients with generalized anxiety disorder.

BACKGROUND: Fast-acting anxiolytics are important to patients and society. Measuring early onset, however, requires a sensitive and clinically responsive measure. This study develops and evaluates the psychometric properties of a new patient-reported instrument, the Daily Assessment of Symptoms - Anxiety (DAS-A), designed to detect reduction of anxiety symptoms in patients with Generalized Anxiety Disorder (GAD) during the first week of treatment. METHODS: Clinician interviews and patient focus groups were conducted to identify relevant constructs; discussions focused on early symptom improvement and meaningful changes in GAD symptoms. The draft questionnaire underwent iterative sets of cognitive interviews to inform item reduction and revision. A double-blind, randomized, placebo-controlled study of paroxetine and lorazepam assessed the performance of the new instrument in GAD patients. Analyses evaluated the structure, reliability, validity, and utility of the instrument. RESULTS: There was consistency across focus groups and clinicians in the description of symptoms that improve first. The final item set was easily understood by interview participants. Factor analyses indicated that a unidimensional structure best described the data. Item-level descriptive statistics, Cronbach's alphas, effect sizes, and validity correlations with other scales were favorable. Most importantly, the DAS-A demonstrated separation of lorazepam from placebo within 24h of first dose and correlated with other anxiety measures. CONCLUSIONS: This study resulted in the development of a reliable and valid instrument addressing the DSM-IV dimensions of GAD. The DAS-A is capable of detecting reduction in anxiety symptoms within 24h, making it a desirable measure to include in future trials of fast-acting anxiety medications.

Distinguishing bipolar major depression from unipolar major depression with the screening assessment of depression-polarity (SAD-P).

BACKGROUND: Patients with bipolar I or II major depression are often misdiagnosed with unipolar major depression. The goal of this study was to develop and validate a brief instrument to screen for bipolar disorder in patients actively ill with major depression. METHOD: The sample consisted of subjects who enrolled in the National Institute of Mental Health-Collaborative Program on the Psychobiology of Depression-Clinical Studies from 1978 to 1981 during an episode of major depression and included 91 subjects with bipolar I major depression, 52 with bipolar II major depression, and 338 with unipolar major depression diagnosed according to Research Diagnostic Criteria. Most of the subjects were inpatients at the time of enrollment, and subjects were prospectively followed for up to 20 years. In order to create, test, and cross-validate the screening instrument, a split-sample data analytic procedure was performed. This procedure yielded 3 groups of subjects: the bipolar I index sample, the bipolar I cross-validation sample, and the bipolar II cross-validation sample. Each group included subjects with bipolar major depression and subjects with unipolar major depression. Within the bipolar I index sample, subjects with bipolar I major depression at study intake were compared with subjects with unipolar major depression at study intake on a pool of 59 sociodemographic and clinical candidate variables. The 3 variables showing the greatest disparity between bipolar I subjects and unipolar subjects were selected for the screen, the Screening Assessment of Depression-Polarity (SAD-P). The operating characteristics of the SAD-P were then examined within the bipolar I index sample, bipolar I cross-validation sample, and bipolar II cross-validation sample. RESULTS: The items selected for the screening instrument were (1) presence of delusions during the current episode of major depression, (2) number of prior episodes of major depression, and (3) family history of major depression or mania. The screen identified bipolar major depression with a sensitivity of 0.82 in the bipolar I index sample, 0.72 in the bipolar I cross-validation sample, and 0.58 in the bipolar II cross-validation sample. With regard to misclassifying subjects with unipolar major depression, the screen provided a positive predictive value of 0.36 in the bipolar I index sample, 0.29 in the bipolar I cross-validation sample, and 0.27 in the bipolar II cross-validation sample. CONCLUSION: We suggest using the 3-item SAD-P as a preliminary screen for bipolar disorder in patients who present with an active episode of major depression.

Psychosocial disability in the course of bipolar I and II disorders: a prospective, comparative, longitudinal study.

CONTEXT: Evidence of psychosocial disability in bipolar disorder is based primarily on bipolar I disorder (BP-I) and does not relate disability to affective symptom severity and polarity or to bipolar II disorder (BP-II). OBJECTIVE: To provide detailed data on psychosocial disability in relation to symptom status during the long-term course of BP-I and BP-II. DESIGN: A naturalistic study with 20 years of prospective, systematic follow-up. SETTING: Inpatient and outpatient treatment facilities at 5 US academic centers. Patients One hundred fifty-eight patients with BP-I and 133 patients with BP-II who were followed up for a mean (SD) of 15 (4.8) years in the National Institute of Mental Health Collaborative Depression Study. MAIN OUTCOME MEASURES: The relationship, by random regression, between Range of Impaired Functioning Tool psychosocial impairment scores and affective symptom status in 1-month periods during the long-term course of illness from 6-month and yearly Longitudinal Interval Follow-up Evaluation interviews. RESULTS: Psychosocial impairment increases significantly with each increment in depressive symptom severity for BP-I and BP-II and with most increments in manic symptom severity for BP-I. Subsyndromal hypomanic symptoms are not disabling in BP-II, and they may even enhance functioning. Depressive symptoms are at least as disabling as manic or hypomanic symptoms at corresponding severity levels and, in some cases, significantly more so. At each level of depressive symptom severity, BP-I and BP-II are equally impairing. When asymptomatic, patients with bipolar disorder have good psychosocial functioning, although it is not as good as that of well controls. CONCLUSIONS: Psychosocial disability fluctuates in parallel with changes in affective symptom severity in BP-I and BP-II. Important findings for clinical management are the following: (1) depressive episodes and symptoms, which dominate the course of BP-I and BP-II, are equal to or more disabling than corresponding levels of manic or hypomanic symptoms; (2) subsyndromal depressive symptoms, but not subsyndromal manic or hypomanic symptoms, are associated with significant impairment; and (3) subsyndromal hypomanic symptoms appear to enhance functioning in BP-II.

Health and economic impact of the premenstrual syndrome.

OBJECTIVE: To explore the effect of the premenstrual syndrome (PMS) on health-related quality of life, health care utilization and occupational functioning. STUDY DESIGN: A cross-sectional cohort study of women prospectively diagnosed with PMS. RESULTS: Among women completing the survey, 28.7% were diagnosed with PMS. Women with PMS had significantly lower scores on the Mental Component Summary (MCS) and Physical Component Summary (PCS) scale scores of the Medical Outcomes Study Short Form-36 as compared to women without PMS (MCS = 42.8 vs. 49.5, P < .001, and PCS = 51.1 vs. 53.0, P = .04). Women with PMS reported reduced work productivity, interference with hobbies and greater number of work days missed for health reasons (P < .001). In addition, women with PMS experienced an increased frequency of ambulatory health care provider visits (P = .04) and were more likely to accrue > $500 in visit costs over 2 years (P < .006). CONCLUSION: Findings from this study suggest that premenstrual symptoms significantly affect health-related quality of life and may result in increased health care utilization and decreased occupational productivity.

Comparison of managed care charges among patients treated with selective serotonin reuptake inhibitors for premenstrual dysphoric disorder.

OBJECTIVE: To determine the impact on managed care charges of selecting citalopram, fluoxetine, paroxetine, or sertraline as first-line pharmacotherapy for newly diagnosed premenstrual dysphoric disorder (PMDD). METHOD: This retrospective study analyzed administrative claims data from 14 managed care plans in the United States. The study population was identified from an integrated outcomes database for the period Jan. 1, 1998, to Dec. 31, 1999. Patients aged 18 years or older, newly diagnosed with PMDD, and initiating therapy with a selective serotonin reuptake inhibitor (SSRI) within 30 days of the diagnosis were eligible for analysis. To date, there is no specific ICD-9 diagnosis code for PMDD; thus, patients were required to have an ICD-9 diagnosis of premenstrual tension syndrome (ICD-9 625.4). Patients with documented previous psychiatric disorders/treatment were excluded. All inpatient, outpatient, and pharmacy claims incurred by each patient during the study period were included in the analysis. PMDD-related treatment charges for the 6-month period following treatment initiation were compared using multivariate regression. RESULTS: A total of 1413 patients met the study criteria. Fluoxetine and sertraline were the most common agents selected as first-line therapy. After differences in age, managed care plan, pretreatment resource utilization, physician specialty, index prescription year, treatment charges, presence of mental health and nonmental health comorbid conditions, and changes in medication were controlled for, patients taking paroxetine and citalopram had significantly higher PMDD-related treatment charges than sertraline patients (paroxetine, p =.0430; citalopram, p =.0226). Fluoxetine patients also had higher treatment charges than sertraline patients, though statistical significance was not reached. CONCLUSIONS: Sertraline, as first-line therapy for PMDD, was associated with lower PMDD-related treatment charges compared with other SSRIs during the first 6 months after treatment initiation.

Improving clinical trials: American Society of Clinical Psychopharmacology recommendations.

The major purpose of this American Society of Clinical Psychopharmacology-sponsored meeting was to identify strategies for more efficiently detecting clinical drug effects, thus reducing the economic and scientific risks of investigating new chemical entities in psychiatric disorders. The meeting consisted of presentations and discussions by experts who repeatedly had difficulty pursuing scientific, public health--relevant goals. Many approaches to improving the detection of potentially beneficial agents were reviewed. In this article, we discuss technically feasible study improvements. The scope of inquiry included identifying means of shifting institutional and regulatory assumptions and processes, even to the point of seeking appropriate national incentives.