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Biomedical subjects

U Halbreich

Publications and source records attributed to U Halbreich.

At least 19 recordsLinked to original sources
PubMed2001

Effectiveness of St John's wort in major depression: a randomized controlled trial.

CONTEXT: Extracts of St John's wort are widely used to treat depression. Although more than 2 dozen clinical trials have been conducted with St John's wort, most have significant flaws in design and do not enable meaningful interpretation. OBJECTIVE: To compare the efficacy and safety of a standardized extract of St John's wort with placebo in outpatients with major depression. DESIGN AND SETTING: Randomized, double-blind, placebo-controlled clinical trial conducted between November 1998 and January 2000 in 11 academic medical centers in the United States. PARTICIPANTS: Two hundred adult outpatients (mean age, 42.4 years; 67.0% female; 85.9% white) diagnosed as having major depression and having a baseline Hamilton Rating Scale for Depression (HAM-D) score of at least 20. INTERVENTION: Participants completed a 1-week, single-blind run-in of placebo, then were randomly assigned to receive either St John's wort extract (n = 98; 900 mg/d for 4 weeks, increased to 1200 mg/d in the absence of an adequate response thereafter) or placebo (n = 102) for 8 weeks. MAIN OUTCOME MEASURES: The primary outcome measure was rate of change on the HAM-D over the treatment period. Secondary measures included the Beck Depression Inventory (BDI), Hamilton Rating Scale for Anxiety (HAM-A), the Global Assessment of Function (GAF) scale, and the Clinical Global Impression-Severity and -Improvement scales (CGI-S and CGI-I). RESULTS: The random coefficient analyses for the HAM-D, HAM-A, CGI-S, and CGI-I all showed significant effects for time but not for treatment or time-by-treatment interaction (for HAM-D scores, P<.001, P =.16, and P =.58, respectively). Analysis of covariance showed nonsignificant effects for BDI and GAF scores. The proportion of participants achieving an a priori definition of response did not differ between groups. The number reaching remission of illness was significantly higher with St John's wort than with placebo (P =.02), but the rates were very low in the full intention-to-treat analysis (14/98 [14.3%] vs 5/102 [4.9%], respectively). St John's wort was safe and well tolerated. Headache was the only adverse event that occurred with greater frequency with St John's wort than placebo (39/95 [41%] vs 25/100 [25%], respectively). CONCLUSION: In this study, St John's wort was not effective for treatment of major depression.

Adult↗
PubMed2001

Oral contraceptives and mood.

The past 40 years of research on the mood and behavioural effects of combined oral contraceptives (OCs) have yielded inconclusive results due to dramatic changes in the compounds and to methodological flaws inherent in studies undertaken to assess the effects of OCs. Since the late 1960s, the dosages of oestrogen and progestin in marketed OCs significantly declined and novel progestins were developed to deliver higher levels of progestogenic activity with a lower risk of adverse oestrogenic and androgenic effects. This review evaluates controlled, comparative studies that have focused on the efficaciousness of OCs as treatment for premenstrual syndrome (PMS) and those examining whether OCs may cause negative mood. It is suggested that the mood and behavioural effects of OCs might be attributed to different progestin compounds and possibly, their oestrogen ratios. There is a great need for more longitudinal, randomised, placebo-controlled studies to further clarify the mood and behavioural effects of OCs.

Affect↗
PubMed2001

Role of estrogen in the aetiology and treatment of mood disorders.

Worldwide, the prevalence of depression in women is significantly greater than in men. Available data suggest that estrogen, or its absence, is strongly implicated in the regulation of mood and behaviour, as well as in the pathobiology of mood disorders. The multiple effects of estrogens and their complex interactions with the CNS and endocrine system have been well documented, although the specific, multifaceted role of estrogen in each dysphoric state has yet to be elucidated. Several facts suggest that estrogen plays a vital role in the precipitation and course of mood disorders in women. Gender differences in the prevalence of depression first appear after menarche, continue through reproductive age, and dissipate after perimenopause. Periods of hormonal fluctuations or estrogen instability (i.e. premenstrually, postpartum, perimenopausally) have been associated with increased vulnerability to depression among susceptible women. It is plausible that the phenotype of these depressions is distinguishable from those that are not associated with reproductive events or that occur in men. Based on current knowledge, estrogen treatment for affective disorders may be efficacious in two situations: (i) to stabilise and restore disrupted homeostasis - as occurs in premenstrual, postpartum or perimenopausal conditions; and (ii) to act as a psychomodulator during periods of decreased estrogen levels and increased vulnerability to dysphoric mood, as occurs in postmenopausal women. There is growing evidence suggesting that estrogen may be efficacious as a sole antidepressant for depressed perimenopausal women. It is still unclear whether estrogen is efficacious as an adjunct to selective serotonin reuptake inhibitors or as one of the paradigms to manage treatment-resistance depression in menopausal women, but such efficacy is plausible.

Animals↗
PubMed2000

Imidazoline and alpha(2a)-adrenoceptor binding sites in postmenopausal women before and after estrogen replacement therapy.

BACKGROUND: Platelet alpha(2A)-adrenoceptors (alpha(2A)AR) and imidazoline binding sites (subtype I(1)) have been proposed as peripheral markers of brain stem receptors that mediate sympathetic outflow and are reported to be elevated in major depression. METHODS: In our study, p[(125)I]-iodoclonidine was used to assess platelet alpha(2A)AR and I(1) binding sites in healthy postmenopausal women (n = 34) compared with healthy women of reproductive age (n = 26). Receptor determinations were repeated in 19 postmenopausal women following 59-60 days of estrogen replacement therapy (ERT; 0.1 mg estradiol transdermal patches). RESULTS: I(1) binding sites were twofold higher in platelets of postmenopausal women compared with women of reproduction age but were down-regulated (normalized) after 59-60 days of ERT. All other binding parameters, including platelet alpha(2A)AR density, were not different between groups nor were they changed after ERT. Platelet I(1) densities after 59-60 days of ERT were positively correlated with plasma luteinizing hormone concentrations. CONCLUSIONS: It is suggested that increased imidazoline binding sites might be associated with mood and behavioral changes in postmenopausal women.

Adult↗
PubMed2000

Selective oestrogen receptor modulators--current and future brain and behaviour applications.

Selective oestrogen receptor modulators (SERMs) are compounds that act as oestrogen agonists on selected targets while being oestrogen antagonists on others. The main targets of SERMs are oestrogen agonist activity on bone metabolism and several functions of the cardiovascular system, as well as oestrogen antagonism in the breast and uterus. They are indicated for the treatment and/or prevention of breast and endometrial cancer, osteoporosis and coronary heart disease. The extensive documentation of the multiple oestrogen effects on the CNS, greater understanding of the mechanisms of action, and especially the discovery of a second oestrogen receptor with differentiated distribution and mechanisms, have all led the way to the possibility of specific CNS-targeted SERMs. The demonstration that oestrogen selectively improves cognition, delays the appearance of Alzheimer's dementia, improves the feeling of well-being, as well as the response to antidepressant medications, provides targeted CNS indications for SERMs. The CNS effects of the currently marketed SERMs are not sufficiently explored yet. However, in postmenopausal women, tamoxifen and raloxifene probably show the most oestrogen agonist CNS effects. In women of reproductive age, competition with oestrogen probably exists, resulting in antagonist effects. Activity in men is still mostly unknown. It is quite safe to predict that the recent accumulation of knowledge, combined with the large, thirsty anticipated market for these 'designer oestrogens', will lead to clinical trials of CNS-targeted SERMs in the very near future.

Behavior↗
PubMed2000

Psychosocial functioning in women with premenstrual dysphoric disorder before and after treatment with sertraline or placebo.

BACKGROUND: The objective of this study was to evaluate the pretreatment psychosocial functioning of women with premenstrual dysphoric disorder (PMDD) and the effect of sertraline treatment on psychosocial functioning in these patients. METHOD: Two hundred forty-three women recruited from 12 university-affiliated sites and meeting DSM-IV criteria for PMDD completed 1 cycle of single-blind placebo and were randomly assigned to flexible dose sertraline or placebo for 3 cycles. Psychosocial functioning was assessed by the Daily Record of Severity of Problems (DRSP), the Social Adjustment Scale (SAS), and the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q). RESULTS: SAS scores during the follicular phase were similar to SAS scores of community norms, whereas the pretreatment SAS and Q-LES-Q scores during the luteal phase were similar to scores of women with depressive disorders. Sertraline was significantly more effective than placebo in improving psychosocial functioning as measured by the SAS, the Q-LES-Q, and the 3 DRSP items of impaired productivity, interference with social activities, and interference with relationships with others. Improvement in psychosocial functioning assessed by SAS and Q-LES-Q correlated with improvement in symptomatology assessed by the Clinical Global Impressions-Improvement (CGI-I) scale and the Hamilton Rating Scale for Depression (HAM-D). Remitters (CGI-I score of 1) were more likely to function better at baseline and showed larger improvements in functioning and quality of life with treatment compared with nonremitters. CONCLUSION: Sertraline was superior to placebo in improving psychosocial functioning in women with PMDD as reflected by SAS, Q-LES-Q, and DRSP measures. Functional improvement correlated with improvement in premenstrual symptomatology and was apparent by the second cycle of treatment. Comparison of pretreatment SAS scores in women with PMDD with the scores of other populations of women documents the degree of luteal phase functional impairment in women with PMDD and a relative absence of follicular phase impairment.

Adaptation, Psychological↗
PubMed1999

Premenstrual syndromes: closing the 20th century chapters.

The need to re-evaluate premenstrual syndromes became apparent in 1997-1998 and early 1999. The success stories of some symptomatic treatment modalities and more sophisticated studies of pathobiology chart the pathways for future progress: the shift from a descriptive diagnosis to diagnoses based on etiology, the recognition of diversified vulnerabilities and their expression in particular situations, and specific treatment modalities.

Female↗
PubMed1998

Effects of electroconvulsive therapy on plasma vasopressin and oxytocin.

BACKGROUND: Animal studies suggest that vasopressin has cognitive-enhancing properties and oxytocin may have amnestic effects. A clinical report suggests that the acute increase in oxytocin-associated neurophysin predicts clinical response to electroconvulsive therapy (ECT) in depressed patients. METHODS: Medication-free patients with major depression were randomized to receive right unilateral or bilateral ECT administered with electrical stimulus intensity at either just above seizure threshold or at 150% above seizure threshold. The associations between plasma vasopressin, oxytocin, ECT treatment parameters, clinical outcome, and cognitive effects were assessed. RESULTS: The sample comprised 55 patients. At the second ECT, patients receiving ECT at 150% above initial seizure threshold had significantly greater increases in plasma vasopressin than patients receiving low-dose ECT (ps < .01-.04), with no effects of electrode placement. At the second and ninth ECT treatments, the vasopressin or oxytocin surges were not associated with clinical improvement, seizure duration, time to orientation, or memory test performance. There were inverse trend-level associations between the acute surge in oxytocin levels at the ninth ECT and clinical response, contradicting a report in the literature. CONCLUSIONS: Overall, these findings do not support the hypothesis that diencephalic seizure propagation is central to the mechanism of action of ECT.

Cognition↗
PubMed1998

Evaluation of women's mental health: delineation of the field, and needs and steps toward a consensus.

Mental health studies that investigate the behavior, mood, perception, cognition, and biology associated with specific conditions of women or with situations characterized by substantial gender differences are proliferating in number and progressing in quality, depth, and scope. To solidify the field, there is a need for a consensus on definitions and diagnostic criteria, standardized clinical assessment procedures, and large-scale interdisciplinary collaborative efforts to effectively study and illuminate the diversified aspects of women's mental health. Under a professional services contract with the National Institute of Mental Health, researchers who investigate women's mental health met during the American Psychiatric Association (APA) meeting in San Diego, California, on May 19, 1997. The 18 participants discussed key clinical and biological assessments and subsequently submitted papers reflecting scientific conclusions and recommendations for standardizing these assessments. It was agreed that a unified assessment instrument would be beneficial, but due to the widespread requirements and numerous factors that are critical in assessing all areas of women's health, situation-specific forms are often needed. The background, rationale, and process of the meeting are described here, whereas the details and recommendations are described in individual position papers.

Female↗
PubMed1998

Premenstrual syndromes.

Premenstrual syndromes (PMS) are a group of menstrually related, chronic, cyclical disorders manifested by emotional and physical symptoms in the second half of the menstrual cycle. A diagnosis of PMS is based on the timing and symptom pattern observed in daily symptom reports maintained by the patient. The etiology is unknown but is believed to involve genetic and dynamically evolving vulnerability, reproductive hormones, and neurotransmitters, as well as other brain processes. Effective medications have been identified for acute hormonal and symptomatic treatment of the disorder, but the time course and frequency of relapse and recurrence remain poorly understood. Further studies of PMS in all areas--etiology, pathobiology, diagnosis, course of illness, and treatment efficacy--are needed to increase the body of information about the menstrual cycle's effects on women's health and mood disorders.

Female↗
PubMed1998

Future directions for studies of women's mental health.

Women's mental health is increasingly recognized as a major field with an impact on the well-being of individuals, their families, and society. It is also recognized that this field is in its infancy and needs to be well delineated: Definitions and assessment procedures for the various topics need to be developed; the pathobiologies are as yet unknown; and time course, variations, and treatment outcome of most of the entities included are unknown or not confirmed. Also, interactions among phenomena, biology, environment, and sociopsychological aspects have not been well studied. A group of investigators whose focus is on various aspects of women's mental health, especially reproduction-related dysphorias, met and discussed their respective priorities for studies in the field. Mechanisms and operational vehicles to effectively achieve the expressed goals and to conduct the proposed studies are presented.

Female↗
PubMed1997

Symptomatic improvement of premenstrual dysphoric disorder with sertraline treatment. A randomized controlled trial. Sertraline Premenstrual Dysphoric Collaborative Study Group.

CONTEXT: Premenstrual dysphoric disorder is an important cause of symptoms and functional impairment in menstruating women. OBJECTIVE: To evaluate the efficacy of sertraline hydrochloride for treatment of premenstrual dysphoria by measuring changes in symptom expression and functional impairment. DESIGN: Two screening cycles followed by 1 single-blind placebo cycle and 3 cycles of randomized, double-blind, placebo treatment. SETTING: Twelve university-affiliated outpatient psychiatry and gynecology clinics. PATIENTS: Of the 447 women who requested participation, 243 met criteria for premenstrual dysphoric disorder and were randomized; 200 women completed the study. INTERVENTION: A flexible (50-150 mg) daily dose of sertraline hydrochloride. MAIN OUTCOME MEASURES: The Daily Record of Severity of Problems, Hamilton Rating Scale for Depression, Clinical Global Impression Scale, and Social Adjustment Scale. RESULTS: Mean (+/-SD) total daily symptom scores decreased significantly (P<.001) in the sertraline-treated (64+/-22 to 44+/-19) compared with the placebo-treated (62+/-22 to 54+/-24) groups. Significant improvement (P<.05) was found for all clinically derived symptom clusters (depressive, physical, and anger/irritability symptoms). Hamilton Rating Scale for Depression scores decreased by 44% and 29% in the sertraline and placebo groups, respectively (P<.002). End-point global ratings showed much or very much improvement in 62% of the active treatment group and 34% of the placebo treatment group (P<.001). Reported functional impairment was substantial at baseline. Improvement in psychosocial functioning with treatment was similar to what is found in studies of major depression. CONCLUSIONS: Sertraline was significantly better than placebo for treatment of premenstrual dysphoria as reflected by symptomatic improvement and change in reported functional impairment. Serotonin reuptake inhibitors such as sertraline are useful therapeutic options for women with premenstrual dysphoria.

1-Naphthylamine↗
PubMed1997

Premenstrual dysphoric disorders: a diversified cluster of vulnerability traits to depression.

Some biological factors which have been shown to be abnormal in subgroups of women with dysphoric premenstrual syndromes (PMS) have not been limited to the symptomatic late luteal phase of the menstrual cycle, but also existed during the non-symptomatic mid-follicular phase of the cycle. Personality, cognitive functions, alpha 2 and imidazoline binding, sensitivity to inducement of panic attacks, relative hypothyroidism, and some but not all serotonergic functions of women with dysphoric PMS differ from those with no PMS, and also differ during a non-symptomatic phase of the cycle. It is suggested that premenstrual symptoms are an expression of vulnerability traits that might surface in response to a trigger. Such traits are probably diverse, and the nature of the symptoms might depend upon the underlying trait. It is postulated-that some vulnerability traits to specific premenstrual syndromes might also be vulnerability traits to depression or anxiety in general.

Anxiety Disorders↗
PubMed1997

Double-blind comparison of sertraline, imipramine, and placebo in the treatment of dysthymia: psychosocial outcomes.

OBJECTIVE: The purpose of this study was to determine the effects of antidepressant pharmacotherapy on mood symptoms and psychosocial outcomes in dysthymia. METHOD: In a multicenter, double-blind, parallel-group trial, 416 patients with a diagnosis of early-onset primary dysthymia (DSM-III-R) of at least 5 years' duration without concurrent major depression were randomly assigned to 12 weeks of acute-phase therapy with sertraline, imipramine, or placebo. The psychosocial outcome measures used in the study were the Global Assessment of Functioning Scale, the Social Adjustment Scale, the Longitudinal Interval Follow-up Evaluation psychosocial ratings, and the Quality of Life Enjoyment and Satisfaction Questionnaire. RESULTS: Sertraline and imipramine were significantly better than placebo in improving psychosocial outcomes as measured by the first three instruments. The Quality of Life Enjoyment and Satisfaction Questionnaire scores demonstrated significant improvements from baseline, and both active treatments produced significantly greater improvements than placebo. Significantly fewer patients discontinued sertraline (6.0%) than discontinued imipramine (18.4%) because of adverse events. CONCLUSIONS: Pharmacotherapy is an effective treatment for dysthymia in terms of psychosocial functioning as well as depressive symptoms, even when the dysthymia is long-standing.

1-Naphthylamine↗
PubMed1997

Menstrually related disorders--towards interdisciplinary international diagnostic criteria.

Premenstrual and catamenial disorders are prevalent, diversified and involve various body systems. The mechanisms and management of the menstrually related disorders (MRDs) are hampered by a fragmented approach because each cluster of symptoms is studied and treated by specialists in a number of related disciplines. The apparent common denominator of MRDs, an association with the menstrual cycle, also carries with it associations with ovulation and ovulation-related hormonal and cyclic biological changes. To achieve progress in understanding and treating MRD, an interdisciplinary nomenclature and diagnostic system are needed. Criteria based on temporal occurrences and not on phenomenology have been developed after interdisciplinary discussions and are herein proposed.

Diagnosis, Differential↗
PubMed1997

Role of estrogen in postmenopausal depression.

Estrogen has been reported to improve the cognitive functioning of postmenopausal women. It is suggested that estrogen replacement therapy (ERT) might be beneficial for improvement of mood and cognition in menopausal women. We have shown that this improvement is selective and is probably more apparent in complex integrative functions. We have also shown that estrogen can augment serotonergic activity as well as some norepinephrine-related processes in postmenopausal women. Because of its effects on mood-related neurotransmitter processes, ERT might decrease vulnerability to depression and be effective as an adjunct therapy to prevent treatment nonresponse to conventional antidepressants.

Biogenic Monoamines↗