Active clinical trials for "Depressive Disorder"

This study will test clinical and cost effectiveness of an integrated tele- and bachelor's-level counselor/coach delivered behavioral activation (BA) and fall prevention (FP) for low-income homebound older adults. The long-term objective of the proposed study is to improve access to depression treatment and fall prevention for growing numbers of low-income homebound seniors. We plan to recruit 320 low-income, racially diverse homebound seniors who are served by a home-delivered meal (HDM) program and other aging-service agencies in Central Texas. In a 4-arm, pragmatic clinical trial with randomization prior to consent, the participants in the integrated Tele-BA and FP (TBF hereafter) arm will receive 5 Tele-BA sessions and 4 in-home FP sessions. Those in the Tele-BA or FP alone arms will receive the respective intervention and 4 bimonthly telephone check-in (booster) calls, and those in the Attention Control (AC) arm will receive 5 weekly telephone check-in calls followed by 4 bimonthly follow-up calls. Follow-up assessments will be at 12, 24, and 36 weeks after baseline.

This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, fixed-dose study in patients with a primary diagnosis of MDD according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) who have an inadequate response to ongoing ADT.

Methadone is a first-line, evidence-based treatment for opioid use disorder (OUD). Unfortunately, retention and adherence in methadone treatment is a major challenge. OUD patients frequently present with co-morbid depression (OUDCD), a risk factor for poor OUD treatment outcomes, overdose, and suicide. The last two decades have seen an exciting and transformational development in the treatment of depression - ketamine. As a safe, rapid-acting anti-depressant deliverable within the context of methadone maintenance treatment, ketamine could feasibly change the landscape of treatment for OUD patients with comorbid depression. This proposal seeks to evaluate implementation outcomes (feasibility and patient acceptance) as well as preliminary efficacy of ketamine on methadone treatment outcomes for OUD patients (n=6) with comorbid depression and depressive symptoms presenting for methadone treatment.

The study consists of an open label trial designed to treat adult depression with TBS. Our aim is to build capacity in neuroimaging analyses by performing magnetic resonance imaging (MRI) assessments at baseline and after 7-10 days of treatment onset in 70 patients. The scientific goal is to test a hypothesis about treatment action: that TBS will reduce negative bias (which causally maintains negative mood) after 1 week of treatment, and patients who show this neurocognitive change will be the ones who go on to respond clinically after 6 weeks.

This is a randomized, double-blind, sham-controlled multicenter clinical trial. The aim is to provide evidence for efficacy of TBS in the treatment of patients with major depression. There will be a direct comparison between combined cTBS/iTBS with sham TBS. Overall, 236 patients with major depression will be randomized either to active TBS or sham TBS in a 1:1 ratio. The planned stimulation paradigms will be applied as add-on therapy to standard therapy (antidepressive medication and / or psychotherapy). Patients will receive 30 stimulation sessions in a 6-week treatment period (one session daily from Monday to Friday). Follow up assessments are scheduled 1 and 3 months after end of treatment period.

This is a three-armed clinical trial examining the effect of 5-hydroxytryptophan and creatine monohydrate as augmenting agents for the treatment of depression. Subjects will be randomized between 5-HTP + placebo, creatine + placebo, and 5-HTP + creatine, for 8 weeks. The ability of the interventions to affect biomarkers associated with depression will be assessed using brain phosophorus magnetic resonance spectroscopy, functional connectivity imaging, and plasma serotonin levels.

16.2 million American adults are affected by depression each year. The investigators are studying the relationship between sleep/wake cycle and depression. Mounting evidence suggests that abnormalities in circadian rhythms (biological changes that happen over the course of the day or night) are related to mood disorders. This may explain why people with depression frequently suffer with sleeping problems. The purpose of this study is to understand how circadian (sleep/wake) rhythms may be affected in depression and the best way to improve depression caused in this way. This will be performed by comparing circadian (sleep/wake) rhythms in people with and without depression. The study involves being kept awake for one night. For depressed individuals, this technique will likely result in a brief (<1 day) improvement in depression. Following this study, participants with depression will be offered antidepressant medication at no cost. During the study, the investigators use brain scans to learn more about brain chemistry in health and depression.

Lycium barbarum, a traditional Chinese herbal medicine, is a commonly used herb in the traditional Chinese pharmacopoeia . Its main active ingredient, lycium barbarum polysaccharide (LBP), is reported to have neuroprotective effects. Animal studies suggested that LBP has neuroprotective effect on optic ganglion cells. In animal models of depression, LBP can improve depressive symptom by improving synaptic plasticity. However, its clinical effect remains to be studied. We will conduct a 6-week double-blind, randomized, placebo-con-trolled trial in people with subthreshold depression.The purpose of this clinical trial is to investigate the efficacy of LBP in people with subthreshold depression.

The trial will be a four-arm, parallel group, prospective, randomized, double-blind, controlled design that will include 200 participants and will last 20 weeks. The probiotic preparation will contain Lactobacillus helveticus Rosell®-52, Bifidobacterium longum Rosell®-175. We will assess the level of depression, anxiety and stress, quality of life, blood pressure, body mass index and waist circumference, white blood cells count, serum levels of C-reactive protein, HDL cholesterol, triglicerides, fasting glucose, faecal microbiota composition and the level of some faecal microbiota metabolites, as well as inflammation markers and oxidative stress parameters in serum. The trial may establish a safe and easy-to-use treatment option as an adjunct in a subpopulation of depressive patients only partially responsive to pharmacologic treatment.

The glutamate system is emerging as target for the development of novel antidepressant medication, in particular compounds modulating the NMDA receptor. While the NMDA receptor antagonist ketamine is an effective option for many treatment-restistant patients, it is also accompanied by dissociative and cognitive effects and also bears the risk to develop addiction, side effects that are significantly restricting its clinical utility. There is now compelling evidence of the antidepressant potential of D-serine, a NMDAR co-agonist. Compared to ketamine, D-serine goes along without any psychotomimetic effects or other side effects and thus might be a prom-ising novel antidepressant. This study represents the first randomized control trial to test the efficacy of D-serine as an adjuvant therapy in patients with depression and thereby adds to re-cent efforts to establish novel glutamatergic antidepressants. Besides clinical measures, this study also explores the biological mechanisms underlying D-serine's clinical effect.