View clinical trials related to Depression, Postpartum.
Filter by:Perinatal depression is a major public health problem, affecting 15% of women during pregnancy through the postpartum period, with adverse consequences for the mother, the fetus, the infant, and the family. Despite increasing evidence of the importance of this critical risk interval, little research has investigated the effects of depression treatment during pregnancy on infant outcomes. The purpose of this study is to test the feasibility, acceptability, and effectiveness of a new intervention, Interpersonal psychotherapy for the mother-infant dyad (IPT-Dyad). This intervention begins during pregnancy and continues with the mother and infant until one year postpartum. The investigators hypothesize that IPT-Dyad will be better than treatment as usual in reducing depressive symptoms, improving psychosocial functioning,increasing parenting self-efficacy, improving infant emotional development, and enhancing mother-infant relationship quality.
"The prevalence of postpartum depression (PPD) is approximately 13%. PPD is associated with a higher maternal morbidity and mortality, and also with pervasive effects on the emotional, cognitive and behavioral development of the infant. Stressful life events, socio-demographic and obstetrical risk factors have been associated with the risk of PPD. Genetics risk factors of PPD have also been identified. We are presently studying for the first time how maternal stressors may interact with genetic factors to increase the risk of PPD (Gene x Environment interaction)".
In the U.S., rates of preterm birth and low birth weight have increased over the past 30 years. Poor birth outcomes are especially high among racial/ethnic minority populations. Maternal stress is an important factor that can lead to negative birth outcomes. Thus, programs that reduce stress during pregnancy could improve birth outcomes. Initial pilot work tested a mindfulness-based approach to stress reduction during pregnancy. Women in the pilot study had lower stress and improved coping after the program. For the current study, mindfulness is added to an existing prenatal healthcare program called CenteringPregnancy (CP). CP provides prenatal care through 10 group sessions. This study compares CP with a version of CP infused with mindfulness skills training. Effects of the two versions of CP on psychological stress and coping, stress hormones, and birth outcomes will be tested. Data will be collected from participants three times: twice during pregnancy and once after birth. Medical records will provide data on birth outcomes and other health factors. The study will provide initial information about a mind-body program to reduce stress and improve birth outcomes. Data from the study will inform the development of an R01 proposal for a larger study. The study will also help advance the long term goal of reducing health disparities.
Type 2 Diabetes (T2DM) is a life-long, chronic condition affecting an individuals' ability to regulate glucose levels in the blood. Diabetes can cause many severe complications if not treated properly. Hyperglycemia is a regular effect of uncontrolled diabetes and can lead to complications such as cardiovascular disease, chronic renal failure, diabetic retinopathy and inability to maintain a healthy body weight. Cardiovascular Disease (CVD) is now the leading cause of death worldwide, affecting millions of people in both developed and non-developed countries. The buildup of cholesterol in the bloodstream may cause the excess to be deposited in the coronary arteries of the heart and the carotid arteries of the brain. The cholesterol deposits are a factor of the plaques that cause blockage of the arteries which can in turn lead to heart disease and stroke. By lowering the blood levels of cholesterol, risks of heart disease, strokes and heart attacks are reduced. Medications such as HMG-CoA reductase inhibitors and fibrates are useful in the prevention of CVD. Pravastatin is a member of the drug class of statins, also known as HMG-CoA reductase inhibitors, and is shown as an adjunctive therapy to diet. It is known to reduce the amount of cholesterol and other fatty substances in the blood. In addition, pravastatin is indicated to reduce the risk of myocardial infarction, revascularization and cardiovascular mortality in hypercholesterolemic patients who do not have clinically apparent coronary heart disease. The recommended starting dose for adults is 40 mg once daily. For patients who do not reach the LDL-C goal with 40 mg, it is recommended to use an 80 mg dose. For persons with significant renal impairment the recommended dose is 10 mg. Children aged 8-13 years have a recommended starting dose of 20 mg daily. Adolescents aged 14 to 18 years have a recommended starting dose of 40 mg daily. Depression is known as the most common mental disorder and most prevalent type of mood disorder today. It can be seen as a state of mood, a symptom, a syndrome or as a clinical diagnosis. Depression is a common disorder, affecting about 121 million people worldwide. Depression is more likely to co-occur with medical illnesses such as stroke, heart disease, cancer and diabetes. Up to one-quarter of people with diabetes are estimated to experience depression which is two times more than those who do not suffer from diabetes. Studies have shown that major depression mainly occurs in 2¬4 percent of people in the community, in 5-10 percent of primary care patients and 10-14 percent of medical inpatients. Also, recent studies have estimated that the symptoms continue over a 6 month to one year period in patients with major depression. The severity of the symptoms and the incidence of medical illness are expected to predict the persistence of depression. Depression can be treated effectively by a variety of antidepressants and/or psychotherapies. If treated appropriately, over 80 percent of people who suffer from depression can be helped. Paroxetine is an orally administered selective serotonin reuptake inhibitor (SSRI) antidepressant. It was the first antidepressant that was formally approved in the United States for the treatment of panic attacks, major depression, post¬traumatic stress disorder, social anxiety, generalized anxiety disorder, panic disorder and obsessive-compulsive disorder. Paroxetine has a well-established safety profile and it shares the common side effects and contraindications of other SSRI's which include nausea and somnolence and is associated with weight gain. This study proposes to conduct a retrospective cohort study to assess the risk of new onset diabetes among patients undergoing treatment with Pravastatin or other statins, and Paroxetine or other SSRI's. This study will compare the risk of co administration of two drug classes versus the use of each agent alone. In addition, the risk among patients prescribed Paroxetine and fibrates in combination, relative to the use of Paroxetine singly, will be examined to determine whether any interaction found between Paroxetine and statins extends to other drugs indicated for hypercholesterolemia. The first primary objective of the study is to estimate the incidence of Type 2 Diabetes (T2DM) among patients newly exposed to pravastatin in combination with paroxetine, or other SSRIs, compared to those newly exposed to pravastatin alone. The second primary objective is to estimate the incidence of Type 2 Diabetes (T2DM) among patients newly exposed to paroxetine in combination with pravastatin, other statins, or fibrates, compared to those newly exposed to paroxetine alone.
The studies described in this protocol are all performed within the framework of PROTECT (Pharmacoepidemiological Research on Outcomes of Therapeutics by a European ConsorTium) Workpackage 2 and Workgroup 1. Primary aim of these studies is to develop, test and disseminate methodological standards for the design, conduct and analysis of Pharmacoepidemiological (PE) studies applicable to different safety issues and using different data sources. To achieve this, results from PE studies on five key adverse events (AEs) performed in different databases will be evaluated. Therefore, emphasis will be on the methodological aspects of the studies in this protocol and not on the clinical consequences of the association under investigation. Fracture of the proximal end of the femur or hip is associated with considerable morbidity and mortality. Hip/femur fractures impair quality of life and impose a considerable economic burden, and occur with 20% mortality rate within the first year. Antidepressants (AD), mainly tricyclic AD (TCAs) and selective serotonin re-uptake inhibitors (SSRIs) have been associated with fractures in several studies. A review of 13 observational studies showed risk ratios ranging from 1.2 to 3.7 for current TCA users and a wide range of 1.5 to 8.6 for SSRI users. The majority of the studies in the aforementioned review reported increased risks of fractures in general with SSRIs use and more mixed risk outcomes for TCA use. Several mechanisms underlying this adverse effect have been postulated in the literature: e.g. through decrease in bone mineral density (BMD) or through blocking the serotonin transporter activity (5-hydroxytryptamine re-uptake) and hence affecting bone metabolism and structure or simply by falling or through co-morbidities such as depression itself. Previous observational studies differ in design, conduct and analysis of the considered association with varying degree of accounting for confounders. Confounding factors such as depression and other co-morbidities, previous fractures, concomitant drug use and lifestyle factors such as smoking have usually not been accounted for in most of the studies. In addition, small sample size, different methods used to ascertain exposure, selection bias and lack of data on compliance as well as important covariates limit the use of these results in benefit-risk analyses. Furthermore, studies evaluating different types of SSRI and TCA are few and dose-response relationship for most of the AD remains to be studied. We will study effects of cumulative exposure focusing on acute (less than 6 months) and long term exposure (at least 5 years) and doses of exposure. The objective of the study is to assess the association between AD use and hip/femur fracture using different study designs (descriptive, cohort, nested case-control and case crossover) across different databases and to compare the results between and across databases and designs. This is to evaluate the impact of design/database /population difference in the outcome of the studies association. Data will be collected from the following databases: The Health Improvement Network [(THIN]), a UK-based primary care electronic medical record database, the Dutch Mondriaan project (a primarily general physician based database with some linkage to survey data from the Netherlands), Base de Datos para la Investigación Farmacoepidemiológica en Atencion Primaria [(BIFAP] (Spanish primary care database)), and the Bavarian statutory health insurance physicians' association database (German health insurance database from primary and secondary care).
Postpartum depressed women suffer from functional impairment in their mood, thoughts, cognition and physical well being leading to poor motivation, bonding difficulties, decreased productivity, conflict and neglect. Moderate/ severe depression responds best to a combination of antidepressants and counseling. This study will estimate the proportion of women who return to functionality after treatment with Desvenlafaxine and examine the differential impact of change in depression and anxiety symptoms on functionality over twelve weeks. Depression and anxiety symptoms will be monitored through six mood questionnaires; functional recovery will be monitored through a simple self-report questionnaire at each visit.
This will be an 8-week, open-label trial evaluating the efficacy of escitalopram as monotherapy in the treatment of patients with postpartum depression (PPD). The acute phase of the study will consist of an 8 week treatment phase. Treatment of eligible participants will be initiated at a dose of 10mg/day which will be adjusted by the study clinician based on the presence of depressive symptoms and side effects up to a maximum of 20mg/day. Study objectives are: 1. to investigate the efficacy of escitalopram in the treatment of PPD. 2. to assess the effects of escitalopram on patients quality of life.
This is a 9-week single-centre, open-label, dose-escalating study evaluating the efficacy and safety of Quetiapine XR given as monotherapy in the treatment of non-lactating, post-partum women diagnosed with Bipolar II Disorder. Subjects will need to visit the study doctor up to 8 times over a period of 9 weeks. During the study period, subjects will be receiving a treatment with Quetiapine XR. The starting dose of quetiapine that subjects will receive is 50mg. The response to the treatment of quetiapine will determine whether the study doctor will increase the dosage of the subject's quetiapine. If the study doctor increases the quetiapine during the study, the maximum dosage allowable during the study is 300mg.
Purpose: To evaluate the effectiveness of a telephone-based intervention using cognitive-behavioral approach in preventing postnatal depression and improving quality of life in first-time Chinese mothers. Hypothesis: Women who receive the telephone-based cognitive-behavioral intervention will have a lower level of depressive symptoms (primary outcome) and a higher level of quality of life at 6 weeks and 6 months postpartum than those who receive the usual postpartum care. Design and subjects: Randomized controlled trial is used. A sample of postpartum women with high risk of postnatal depression (EPDS > 9, n = 498) will be randomly assigned to either the experimental (n = 249) or the control groups (n = 249). The experimental group receives the intervention and the control group receives usual postpartum care. Study instruments: EPDS and Medical Outcomes Study Short Form Health Survey (SF-12). Interventions: The intervention is based on the cognitive-behavioral approach. It consists of five, 30-minutes sessions delivered weekly from postpartum week one to week five via telephone. Main outcome measures and analysis: Outcomes on postnatal depression and quality of life will be measured by EPDS and SF-12, respectively, at 6 weeks and 6 months postpartum. A repeated-measures multivariate analysis of variance will be used to compare differences between two groups.
The Specific Aim of this study is to conduct a randomized controlled trial to evaluate whether Project REACH (an interpersonal psychotherapy-based intervention) compared with a didactic attention-control program reduces the risk of PPD in adolescent mothers. Primary Hypothesis: 1. The intervention (Project REACH) will be significantly more efficacious than the control program in reducing the risk of PPD up to six months postpartum in adolescent mothers. Secondary Hypotheses: 2. The decreased rate of major depression in the Project REACH group compared to the control program group will be sustained through one year postpartum. 3. Adolescent mothers in Project REACH compared to the control program group will have higher levels of maternal-child bonding.