Active clinical trials for "Depressive Disorder, Major"

The purpose of this study is to assess the efficacy of esketamine compared with placebo in improving symptoms of depression in patients with treatment resistant depression.

The objectives of this study were to examine the cardiovascular sensitivity to oral tyramine after establishment of steady state with CX157 Modified Release (MR) Tablets, 125 mg administered twice per day (BID) in healthy volunteers compared to placebo; and to investigate the general safety, tolerability and pharmacokinetic profile of CX157 tablets at steady state compared to placebo.

The Institute of Medicine identifies Prolonged Grief (PG) as a critical under-addressed public health problem for which are no empirically supported treatments. The purpose of this application is to pilot-test Behavioral Activation (BA) therapy for PG. BA is a well supported, stand alone intervention for depression and recently applied to posttraumatic stress disorder, which reduces rumination and avoidance behaviors that otherwise thwart access to natural rewarding contingencies and resources. The treatment focuses on promoting stable, active routines, self-care behaviors, enhanced self-efficacy, and reengagement with pleasurable activities and significant social resources. Rumination, disengagement, and low self-efficacy are defining features of PG. Further, in response to loss of intimates, the key factors that differentiate resilient people from those that have difficulties adapting is the maintenance or fast resumption of social and occupational functioning. Thus, the main hypothesis of this study is that BA for PG will result in clinically significant reductions in rumination and functional disengagement. This is a preliminary small-scale pilot assessment of potential efficacy and feasibility of completing a large scale study of BA for PG.

Transcranial direct cranial stimulation (tDCS) is a novel technique based on the application of a weak electrical current over the scalp through two electrodes - the anode, which facilitates neuronal depolarization, and the cathode, which leads to neuronal hyper-polarization. Recently, several open-label and sham-controlled clinical trials applied daily tDCS sessions for the treatment of major depressive disorder (MDD). Theoretically, tDCS displays depression improvement through anodal stimulation over the left dorsolateral prefrontal, inducing excitability-enhancing effects over this area, which is hypoactive during the acute depressive episode. The present study is aimed at comparing two different tDCS protocols: (1) active anodic stimulation over left dorsolateral prefrontal cortex with cathode placed over an extra cephalic area; (2) active cathode placed over the right dorsolateral prefrontal cortex with anode placed over an extra cephalic area.

Existing drug and talking therapies for major depressive disorder (MDD) fail to produce complete recovery. This study will determine if substantial improvements to one of the most promising therapies, cognitive therapy (CT), can be achieved by administering a carefully designed procedure to improve memory for the content of CT sessions. This is important because (a) memory deficits are common in MDD patients and (b) each CT therapy session typically covers a complex array of topics and various skills are taught.

The study examines the efficacy of a stepped care approach for depressed diabetes patients (first study objective). 256 patients with diabetes and comorbid subthreshold or clinical depression will be randomly assigned to either a stepped care approach or a treatment-as-usual condition. The stepped care approach consists of three treatment steps comprising diabetes-specific cognitive-behavioral therapy (CBT) (group), depression-specific CBT (single), and psychotherapeutic and/or psychiatric treatment (single). Patients assigned to the stepped care approach will be treated stepwise until a clinically significant reduction of depressive symptoms is attained or all three treatment steps are passed. The primary outcome of the first study objective is a clinically significant reduction of depressive symptoms in the 12-month follow-up. Secondary outcomes are reduction of diabetes-related distress and improvement of well-being, health-related quality of life, diabetes acceptance, diabetes self-care, and glycaemic control. Additionally, cost-benefit analyses will be performed. The second study objective is to analyse associations between diabetes, depression, and the serum levels of inflammatory markers. The third study objective is to analyse the courses of depressive conditions in diabetes with regard to recovery rates and incidence of major depression.

The purpose of this pilot study is to determine if taking a low dose of naltrexone in addition to an antidepressant medication can help treat relapse or recurrence in people with Major Depressive Disorder (MDD). The U.S. Food and Drug Administration (FDA) has approved naltrexone for the treatment of alcohol dependence and opioid dependence, but the FDA has not approved naltrexone to treat depression. The investigators hypothesize that patients with breakthrough depression on an antidepressant regimen containing a pro-dopaminergic agent assigned to treatment with low dose naltrexone will demonstrate higher rates of response compared to those patients taking placebo.

Depression is a serious mental health problem that affects millions. Depression is usually treated using drugs and/or psychotherapy, but neither approach is successful for everyone, and some people do not respond to either. Therefore it is crucial that we continue to seek new methods for treating depression, and develop enhancements to existing treatments. In recent years, trials have documented improvements in depressive symptoms using noninvasive brain stimulation techniques, such as transcranial direct current stimulation, or tDCS. Our aim in this research is to investigate the effects of brain stimulation combined with psychological therapy in depression, an area that remains largely unexplored. Specifically, stimulation of the dorsolateral prefrontal cortex (DLPFC), a brain region known to work inefficiently in depression, has been shown to result in an improvement of depressive symptoms, as well as in the patient's 'cognitive control' abilities. Because 'cognitive control' processes, such as concentrating and ignoring distracting thoughts, are engaged during psychological therapies for depression, we predict that DLPFC stimulation should improve how patients respond to psychological therapy. This study has considerable implications as it will potentially benefit a large number of patients for which current treatments are ineffective.

MIN-117C03 is a 6-week, 3-arm, randomized, double-blind, placebo controlled study to investigate the safety and efficacy of MIN-117 in male and female patients with Major Depressive Disorder, aged 18 to 65 years. Approximately 324 patients were to be randomly assigned to 1 of 3 treatment arms, including placebo, 2.5 mg MIN-117, or 5.0 mg MIN-117, in a 2:1:1 ratio.

Major depressive disorder (MDD) is a serious medical illness associated with significant suicidal risk and marked disability. Despite the availability of numerous treatments, achievement of consistent and favorable long-term outcomes remains challenging. This study will assess the safety, efficacy and tolerability of brexpiprazole as adjunctive therapy to protocol-specific open-label antidepressant therapy.