Efficacy Study of CLR3001 in Depression
DepressionThe purpose of this study is to assess the ability of CLR3001 to reverse depressive symptoms relatively quickly in adult patients with major depressive disorder (MDD).
Bupropion and Specific Cardiovascular Malformations
Depressive DisorderPregnancy1 moreThe study is an extension of earlier work based on a retrospective epidemiologic study of infants born to women who were exposed to bupropion in their estimated first trimester of pregnancy using data from a large US health plan affiliated with i3 Drug Safety (Clinical study ID WWE113694) (Cole JA, Oh KS, Chiang CC, Walker AM, Haight BR, Modell JG. Bupropion in pregnancy and the prevalence of congenital malformations Pharmacoepidemiology and Drug Safety, 2007; 16: 474-484). The cohorts developed for the earlier work consisted of all infants born to women exposed to bupropion during the estimated first trimester and outside the first trimester, and a random sample of infants born to women exposed to other antidepressants during the first trimester between 01 January 1995 and 30 September 2004. The objectives for this study include refining of both the original first trimester bupropion cohort and the original bupropion outside the first trimester cohort into mono-therapy and mono- or poly-therapy. Exposure to other antidepressants during the first trimester will also be refined into mono-therapy and mono- or poly-therapy. With input from pediatric cardiology expert, lists of specific cardiovascular malformations and malformation groupings will be created. The groupings will be created among the refined first trimester bupropion cohort as well as in two comparison cohorts of bupropion outside the first trimester and first trimester antidepressant use (mono-therapy and mono-or poly-therapy). The prevalence in each cohort will be calculated as the number of infants with a specific cardiovascular malformation divided by the number of live born infants. Prevalence will be reported per 1,000 infants. Confidence intervals will be calculated using Wilson's approximation to exact binomial intervals when the number of cases is five or greater and exact binomial intervals when the number of cases is fewer than five. The appropriateness of further calculations will be evaluated. Where numbers permit, adjusted odds ratios for specific cardiovascular groups/malformations will be calculated and if appropriate, stratified according to maternal dispensing of medications suspected to be teratogenic. The following comparisons, if numbers permit, will be performed: 1) bupropion first trimester mono-therapy cohort versus other antidepressant first trimester mono-therapy cohort; 2) bupropion first trimester mono- or poly-therapy cohort versus other antidepressant first trimester mono- or poly-therapy cohort; 3) bupropion first trimester mono-therapy cohort versus bupropion outside of first trimester mono-therapy cohort, and 4) bupropion first trimester mono- or poly-therapy cohort versus bupropion outside of first trimester mono- or poly-therapy cohort. Adjusted odds ratios will be calculated through a generalized estimated equations form of multivariate logistic regression to account for births associated with multiple infants. The same covariates identified in the original study will be included in this re-analysis. Covariates included: diagnoses of bipolar disorder and eclampsia within one year before delivery; dispensings of lithium, phenytoin, and fluconazole within one year before delivery through the end of the first trimester; and the number of physician visits within 10 to 12 months before delivery, maternal age, geographic region of the health plan, and infant gender. If generalized estimating equation form of the logistic regression model does not converge, adjusted odds ratios will be presented from a conventional multivariate logistic model. If the conventional multivariate logistic model does not converge, only the crude odds ratio will be presented.
Second-Generation Antipsychotic Treatment Indication Effectiveness And Tolerability In Youth (Satiety)...
SchizophreniaSchizoaffective Disorder12 moreThe purpose of this study is to get a better understanding of the side effect burden and identify predictors of psychotic, mood and aggressive disorders in children and adolescents. The study's primary aim is to identify genetic risk factors for weight gain and metabolic abnormalities.
Comparative Study of Physiological and Cerebrovascular Reactivity in Depression, at the Three Phases...
Major Depressive DisorderThe main objective is to compare the physiological reactivity (heart and respiratory rates, galvanic skin response, cerebral perfusion, and startle) in the three phases of emotion between depressive subjects, subjects remitted from depression and control subjects.
Fevarin® Effectiveness in Treatment of Depression in Patients With Neurological Disorder
DepressionProspective, multicenter, non-comparative, observational program to describe prevalence of depressive symptoms in a variety of neurological disorders and effects of Fevarin® on the severity of anxiety and depression, sleep state, and cognitive function.
Developing Accessible mHealth Programs for Depression Management in Bolivia
DepressionThe purpose of the study is to evaluate the feasibility and potential impact of an automated phone system in monitoring and improving self-care and health outcomes among patients with depression in Bolivia.
The Effects of ECT and/or iTBS on Olfaction and Cognition in Patients With Depression
DepressionThe sense of smell and cognition are known to be closely associated with mood and emotional processes. However, despite the clear links between olfaction and cognitive processes with emotional states, research into the role of olfaction, cognition, and mood disorders has so far yielded variable results. This study proposes to investigate the ability to detect and identify odours and assess cognition in a group of patients with unipolar and bipolar depression prior to and after receiving their scheduled electroconvulsive therapy (ECT) or intermittent theta burst stimulation (iTBS) treatments. Olfaction will be evaluated utilizing standard olfactory testing protocols using commercially available kits. Cognition will be evaluated utilizing standard cognitive test protocols in a functional magnetic resonance imaging protocol. The results will potentially shed light on the link between olfaction, cognition and mood disorders.
Dimensional Approach to Evaluate Reward Processing in Major Depressive Disorder Pre- and Post-Desvenlafaxine...
DepressionAnhedoniaAnhedonia (the lack of pleasure in normally pleasurable things) is a common symptom of major depressive disorder (MDD), and it may impact how patients with depression experience reward. Understanding how anhedonia is related to the experience of reward may help improve how depression is treated. Computer tasks can be used to measure how reward is experienced, and these measures might be able to predict things like who is likely to become depressed, or who will respond to antidepressant medication. Studying the relationship between anhedonia and reward in patients with depression might also tell us something about how to improve diagnosis and treatment of other psychiatric disorders.This is an open label controlled treatment study lasting 8 weeks. The brain scans will be used to find changes in brain areas that may be related to how people perform on the tasks. The investigators goal is to use this information to help us find a reliable predictor that can be used to guide MDD treatment.
Follow up of Mothers Suspected of Postpartum Depression
DepressionPostpartumPostpartum depression (PD) is a serious and disabling mental health condition that affects 10-15% of women after childbirth. Low-income minority women are disproportionately affected. Untreated PD can lead to significant negative outcomes for both mother and child. Pediatricians are being asked to routinely screen for PD and while screening rates are improving, little is known about whether mothers actually adhere to pediatrician recommendations to seek additional help after a positive PD screen. The objective of this study is to describe the rate at which mothers seek treatment for suspected PD after a positive screen at the pediatrician office. Additional examination will look at factors that predict whether a mother recalls a recommendation to seek treatment.
A 7-year Assessment on Subject Understanding of ZYBAN/ WELLBUTRIN Associated Risks
Depressive DisorderMajorBranded bupropion hydrochloride products including ZYBAN and WELLBUTRIN range are approved for the treatment of smoking cessation and depressive disorders respectively. The Risk Evaluation and Mitigation Strategy (REMS) for ZYBAN was initially approved in 2010 and consists of a Medication Guide and a timetable for REMS assessments submission at 18 months, 3 years and 7 years from the date of initial approval of REMS. The present study is a 7-year REMS assessment to evaluate subjects' understanding of the potential serious risk of neuropsychiatric adverse events associated with the use of ZYBAN, WELLBUTRIN, WELLBUTRIN SR, and WELLBUTRIN XL. The assessment will be a 20-minutes Knowledge, Attitudes and Behavior (KAB) survey and will be conducted among approximately 125 subjects currently using or who have filled a prescription for a branded bupropion product for smoking cessation within the 6 months prior to survey administration. ZYBAN, WELLBUTRIN, WELLBUTRIN SR, and WELLBUTRIN XL are registered trade marks of the GSK group of companies.