Study of the Safety and Efficacy of Fixed Dose OPC-34712 as Adjunctive Therapy in the Treatment...
Depressive DisorderDepression4 moreTo compare the effect of OPC-34712 (brexpiprazole) to the effect of placebo (an inactive substance) as add on treatment to an assigned FDA approved antidepressant treatment (ADT) in patients with Major Depressive Disorder who demonstrate an incomplete response to a prospective trial of the same assigned FDA approved ADT
Trigeminal Nerve Stimulation for Post Traumatic Stress Disorder (PTSD) and Depression
DepressionPost-traumatic Stress DisorderThis is a 20-subject, dose finding study to examine the use of external trigeminal nerve stimulation (TNS) as an adjunctive treatment for adults with major depressive disorder (MDD) co- occurring with posttraumatic stress disorder (PTSD) when added onto antidepressant medications. Our primary objective is the examination of TNS in this patient population. To accomplish our specific aims, the investigators will test the following specific hypotheses: Subjects will show improvement in ratings of mood, PTSD, and other symptoms during the eight-week period. Subjects will show improvement in ratings of life functional capacity and quality of life with TNS. Subjects will report the TNS treatments to be acceptable in terms of side effects and burden of using the device.
Efficacy and Safety of Flexibly Dosed BMS-820836 in the Treatment of Patients With Treatment Resistant...
DepressionThe purpose of the study is to evaluate the efficacy of study drug (BMS-820836) as compared with continued duloxetine in the treatment of patients with treatment resistant depression (TRD).
The Effect of Problem Solving Therapy and Antidepressant Therapy on Cerebral Perfusion and Brain...
Major Depressive DisorderThe focus of this study is to gather preliminary data regarding the effects of a psychological therapy-Problem Solving Therapy-and an antidepressant medication-sertraline-on 1) cerebral perfusion (CP), 2) brain derived neurotrophic factor (BDNF), and 3) measures of cognitive function in subjects with late life major depression (LLMD). This research goal will be achieved by recruiting 38 individuals over the age of 65 with LLMD. The primary outcomes will be change in CP, change in BDNF, and change in cognitive measures from baseline to the end of 12 weeks of either therapy. We will also examine predictors of treatment outcome including severity of executive dysfunction, baseline BDNF concentrations, and baseline CP measures. The baseline neuropsychological testing, brain imaging, and depression assessment will be obtained in a companion study (PI S. Mackin; CHR #H42689-32681-01) that is IRB approved and is already in progress. In the current study a baseline serum BDNF level will be added to Dr. Mackin's protocol. Patients will then receive either 12 weeks of Problem Solving Therapy or antidepressant treatment with sertraline. Both treatments are evidence based and commonly administered in our clinic. Outcome variables will be measures of depression severity, the BDNF serum concentration, cerebral perfusion using a MRI arterial spin labeling (ASL) technique and cognitive changes in memory and executive dysfunction. This is a preliminary or pilot study. The primary objectives are to determine if the methods appear feasible and to determine if change in BDNF or CP occur after treatment and secondarily to determine if there are changes in cognitive functioning. The study is not powered to show differences between treatments. The hypotheses are 1) PST will result in increased perfusion in frontal regions of the brain but that frontal perfusion will not change with sertraline; 2)sertraline will result in an increase in BDNF but PST will not. Change in cognitive measures of memory, learning, and executive dysfunction will be examined on an exploratory basis.
Open-label Safety Extension Study of 15 and 20 mg of Vortioxetine (Lu AA21004) in Long-term Treatment...
Major Depressive DisorderTo evaluate the long-term safety and tolerability of flexible doses, 15 and 20 mg/day, of Vortioxetine over a period of 52 weeks in patients with Major Depressive Disorder (MDD)
Lurasidone HCI - A 6-week Phase 3 Study of Patients With Bipolar I Depression
Bipolar DepressionLurasidone HCI is a compound that is a candidate for the treatment of bipolar I depression. This clinical study is designed to test the hypothesis that Lurasidone in combination with either Lithium or Divalproex is effective among patients with bipolar I depression.
African American Depression Intervention Trial (AADI)
Major Depressive DisorderPrimary Aim 1: Examine effectiveness of the Oh Happy Day Class (OHDC) compared to the Coping With Depression (CWD)in increasing retention, adherence, engagement, satisfaction, and treatment-seeking. The investigators hypothesize the OHDC compared to the CWD will result in greater increases in: 1a. retention, 1b. adherence, 1c. engagement, and 1d. satisfaction at the middle and end of the intervention, and 2.e. greater increase in treatment-seeking 3-, 6-, 9-, and 12- months post-intervention. Outcome measures: logs: attendance, homework completion, class-participation level; Client Satisfaction Inventory; and Cornell Service Index. Primary Aim 2: Examine effectiveness of the OHDC in reducing symptoms of depression at the middle and immediate end of the intervention, and 3-, 6-, 9-, and 12- months post-intervention. The investigators hypothesize the OHDC will result in greater reduction in depressive symptoms compared to the CWD at 3-months post-intervention. Outcome measures: Center for Epidemiologic Studies Depression Scale and Quick Inventory of Depression Symptoms. Secondary Aim 3: Examine the effectiveness of the OHDC in improving self-reports of mental and physical health status and reducing self-reports of perceived disability. The investigators hypothesize the OHDC compared to the CWD will result in greater self-report of: 3a. improved mental and physical health status, and 3b. reduced self-report of disability at the immediate end of the intervention and 3-,6-, 9-, 12- months post-intervention. Outcome measures: SF-12 Health Survey, and World Health Organization Disability Assessment Schedule. Public Health Impact: Based on CAI research, the OHDC has the potential to be four times more effective than the CWD. If our hypotheses are proven, the OHDC will be the first evidence-based culturally adapted depression intervention designed specifically for African American men and women between the ages of 30-60.
Efficacy Study of Vortioxetine (Lu AA21004) for Treatment of Major Depressive Disorder
Major Depressive DisorderThe purpose of this study is to assess the efficacy, safety and tolerability of 8-week treatment with Vortioxetine (Lu AA21004), once daily (QD), in Japanese participants with major depressive disorder. The purpose of this study is to assess the efficacy, safety and tolerability of 8-week treatment with Lu AA21004, once daily (QD), in Japanese participants with major depressive disorder.
Safety and Tolerability of Oral OPC-34712 as Adjunctive Therapy in Adults With Major Depressive...
Depressive DisorderDepression4 moreTo assess the long-term safety and tolerability of oral OPC-34712 (brexpiprazole), given in addition to an FDA approved antidepressant (ADT) for the treatment of adults with Major Depressive Disorder (MDD)
A Study of Fluoxetine in Major Depressive Disorder (MDD) Long-Term Dosing
Major Depressive DisorderThis study will evaluate the safety and effectiveness of fluoxetine flexible dosing in the treatment of MDD in adult Japanese participants. Participants who complete the short-term treatment phase of Study B1Y-JE-HCLV (NCT#: NCT01808612) will be allowed to enroll in this study, and receive fluoxetine treatment for an additional 52 weeks.