Safety and Efficacy of Levomilnacipran ER in Adolescent Participants With Major Depressive Disorder...
Major Depressive DisorderThe purpose of this study is to evaluate the efficacy, safety, and tolerability of levomilnacipran ER relative to placebo in adolescent outpatients (12-17 years) with Major Depressive Disorder (MDD). In addition, the study is designed to obtain pharmacokinetics (PK) data to guide dose selection for future pediatric studies of levomilnacipran.
Cognitive Dysfunction and Glucagon-like Peptide-1 Agonists
Bipolar DisorderMajor Depressive DisorderCognitive deficits are a core feature across disparate brain disorders, being highly prevalent and pervasive. Impairments in executive function are one of the most consistent findings in clinical and meta-analytical studies and were reported to be a principal mediator of psychosocial impairment and disability. Cognitive dysfunction is thought to be underlied by abnormalities in distributed brain circuits, at the cellular and molecular levels. Nonetheless, the neural mechanisms underlying the dysregulation in these circuits are poorly understood. Emerging evidence indicates that metabolic abnormalities are highly relevant for the domain of cognitive function and indicate that alterations in metabolic pathways may be relevant to neurocognitive decline across different populations. The incretin glucagon-like peptide-1 (GLP-1) is a hormone secreted by intestinal epithelial cells. GLP-1 receptors are widely expressed in the central nervous systems. Pre-clinical trials have demonstrated significant neuroprotective effects of GLP-1. Ongoing clinical trials measuring cognition and mood in populations with various psychiatric disorders lend further impetus to explore the effects of GLP-1R agonists on brain structure and cognitive function. We hypothesize that GLP-1 and the GLP-1R are relevant for molecular and cellular processes that are thought to underlie the formation and maintenance of brain circuits. A derivative of this hypothesis is that the administration of GLP-1 agonists may result in enhanced neuronal survival and consequential increase in gray matter volume. We therefore propose to explore the cellular and molecular abnormalities within and between neural circuits subserving cognition using the GLP-1R agonist liraglutide. The overall goal of this study is to explore the relationship between a metabolic molecular target (i.e. the GLP1 system), the neural circuits of interest and the behavioral phenotype cognitive function.
Mindfulness Based Cognitive Therapy and Antidepressant Medication in Recurrent Depression
Depressive DisorderMajorThe purpose of this study is to investigate the (cost)effectiveness of mindfulness based cognitive therapy (MBCT) compared to that of antidepressant medication, and its combination with regard to the prevention of relapse or recurrence in patients with recurrent depression.
Neurophysiologic Predictors of Outcome With rTMS Treatment of Major Depressive Disorder
DepressionTranscranial magnetic stimulation (TMS) therapy has proven to lead to symptom improvement in many individuals with major depressive disorder (MDD), yet there is heterogeneity in outcome, with some patients showing robust remission and other showing minimal symptom change. Identifying which individuals are likely to benefit from TMS therapy early in the course of treatment would support continued treatment for those predicted to do well, and consideration of alternative treatments for others individuals. This study will test specific hypotheses about the relationships between early neurophysiologic changes and later clinical outcome with TMS treatment.
Light, Ion, and Fluoxetine Efficacy (LIFE) in Depression
Major Depressive Disorder (MDD)This study will investigate the additional benefits of light and ion therapy as added treatments to an antidepressant (fluoxetine) in subjects with major depressive disorder (MDD), versus treatment with fluoxetine alone. Outcomes will include depressive symptom rating scales and measures of quality of life, work absence and productivity, and use of health care services. The primary hypotheses are that, in patients with nonseasonal major depressive disorder (MDD) of at least moderate severity: 1) bright light therapy or negative ion therapy will be superior to a placebo condition in reducing symptoms of depression, and 2) the combination of fluoxetine and either bright light or negative ion therapy is more effective than either monotherapy condition.
A Comprehensive Intervention for Diabetes and Comorbid Depression in Primary Care
Type 2 DiabetesMajor Depressive DisorderThe study involves a 32-week randomized controlled trial in primary care of a comprehensive diabetic and depression intervention in patients with type 2 diabetes and comorbid MDD, compared to a group treated with usual care for MDD plus disease self-management and measurement-based care for diabetes.
A Study of LY2216684 in Participants With Impaired Hepatic Function
Depressive DisorderMajorThe purpose of this study is to evaluate the effect of liver function on how much of the study drug (LY2216684) gets into the blood stream and how long it takes the body to get rid of it. Information about any side effects that may occur will also be collected. The duration of participation in this study is approximately 12 days, not including the screening visit. This study requires 1 clinic confinement of 5 days/4 nights followed by 1 out-patient follow-up visit. A screening visit is required within 30 days prior to the start of the study. This research study will be an open-label study. The study involves a single oral dose of 18 milligrams (mg) LY2216684 given as 2 tablets.
Study of Transcranial Direct Current Stimulation (tDCS) as add-on Treatment for Resistant Major...
Resistant Major DepressionThe purpose of the study is to investigate the effect of tDCS applied at the anodic left DLPFC of patients with resistant depression compared to patients treated with conventional therapy. The tDCS is used in add-on drug treatment with antidepressants of reference in resistant depression.
Efficacy Study of Vortioxetine on Cognitive Dysfunction in Adult Patients With Major Depressive...
Major Depressive DisorderMajor Depressive Disorder (MDD) is a severe and common psychiatric disorder. Although MDD primarily involves mood disturbances, patients also usually present alterations in cognitive function (attention, memory, executive functioning and psychomotor speed). Even though antidepressants are suggested in the literature to potentially improve cognitive dysfunction in patients with MDD to some degree, there is a lack of adequate and well-controlled studies to investigate this effect. This study will evaluate the efficacy, safety and tolerability of a new antidepressant Vortioxetine versus placebo on cognitive dysfunction in adult patients with MDD.
Safety and Pharmacodynamic Study of ABT-436 in Major Depressive Disorder
Major Depressive DisorderThis is a multiple-dose study to assess the safety and pharmacology of ABT-436 in physically healthy subjects with mild to moderate depressive symptoms who are not taking any antidepressant medication. Efficacy for treatment of depressive symptoms is not a goal of this study.