Active clinical trials for "Depressive Disorder, Major"

The primary objective of this pragmatic clinical trial (Main Study) was to assess the difference between all-cause hospitalizations in participants using Abilify MyCite versus virtual matched controls. In addition, secondary and exploratory objectives were to assess medication adherence, healthcare utilization and costs, and patient-reported outcomes.

Background: Recent studies have suggested that gut-brain axis may be one of the mechanisms of major depression disorder. In animal studies, alteration of gut microbiota can affect animal's depression or anxiety-like behavior, brain neurochemistry and inflammation. In human studies, the composition of gut microbiota is different between patients with MDD and healthy controls. In addition, supplementation of probiotics can improve mood status in community and clinical participants. In preliminary open trial, the investigators found PS-128 can significantly reduce depression severity in patients with MDD. Therefore, the investigators would like to conduct an 8-week randomized, double-blind, placebo controlled trial of PS-128 in patients with MDD. Aims: This study will be an 8-week randomized, double-blind, placebo-controlled trial to investigate the effects of Lactobacillus plantarum PS128 on psychophysiology in patients with MDD. Method: This is a two-phase study. In the first phase, the investigators will recruited patients fulfilling the following inclusion criteria: Age 20-65; fulfill Diagnostic and Statistical Manual of Mental Disorders fifth version (DSM-V) criteria of major depressive episode in recent 2 years; Psychotropics including antidepressants, antipsychotics and hypnotics have been kept unchanged for at least 1 months. The exclusion criteria are: comorbid with schizophrenia, bipolar disorder, or other substance use (except tobacco) disorder; having active suicidal or homicidal ideation; known allergy to probiotics; comorbid with diabetes mellitus, irritable bowel syndrome, inflammatory bowl disease, liver cirrhosis, or autoimmune diseases; known active bacterial, fungal, or viral infections in one month; use of antibiotics, steroid, immunosuppressants, probiotics, or synbiotics in the month before collecting blood and fecal samples; pregnant or lactating women; who state to have dietary pattern changed or in diet within previous two months. Those with HAMD-17 >=14 in the first screen will be randomized to PS-128 or placebo, with the ratio of 1:1, in the second phase intervention. In the second phase intervention, the investigators will give eligible patients Lactobacillus plantarum PS128 or placebo for 8 weeks, and compare depression symptoms, gut microbiota, gut permeability, and serum inflammation level before and after intervention.

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 patients with major depressive disorder (MDD). The purpose of this clinical trial is to investigate the efficacy of LBP in patients with MDD.

According to the local guidelines (Recommendation for General Practitioners), the first choice Anti-Depressant (AD) in Major Depressive Disorder (MDD) in primary care should be selective serotonin reuptake inhibitors (SSRI), e.g. citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, in depression with anxiety and insomnia is preferable trazodone and in severer disorders mirtazapine. Despite all these molecules have a very good antidepressant effect, there are differences in side effect scale and tolerability. The aim of this Study is describing of real treatment practice and MDD management in primary care - aimed to evaluate effectiveness of the treatments in depression and related symptoms: insomnia, anxiety, anhedonia and sexual dysfunction. The primary objective of the Study is to describe the diagnostic process and treatment patterns in MDD- treatment of choice (pharmacologic with details of first choice antidepressant) in the office of GP's. The secondary objective is to evaluate efficiency of the treatments in depression and related symptoms: insomnia, anxiety, anhedonia and sexual dysfunction and to monitor the type of side effects and comedication during the 8-weeks treatment.

Ketamine is a dissociative anesthetic and powerful analgesic. At low doses, ketamine can desensitize the central pain pathway and modulate opioid receptors. Studies have generally found that preoperative use of ketamine can reduce opioid consumption by approximately 50% and sub-anaesthetic doses of it have a rapid antidepressant effect, especially refractory depression. Studies have confirmed that esketamine, the S(+) enantiomer of ketamine, has a stronger affinity for NMDA receptors, which can achieve the same effect at smaller doses. While the incidence of neuropsychiatric side effects is significantly lower. On March 4, 2019, the U.S. Food and Drug Administration (FDA) first approved esketamine nasal spray with a new mechanism of action for the treatment of adult patients with refractory depression. Based on the analgesic and antidepressant effects of ketamine, the investigators speculate that esketamine may be effective for patients with chronic visceral pain comorbid depression. At present, the research evidence in this area is relatively lacking. Therefore, this study aims to explore the difference in the efficacy and safety of esketamine as an adjuvant therapy and positive control drug-pregabalin in patients with chronic visceral pain comorbid depression. Detailed Description: According to the inclusion criteria and exclusion criteria, select patients with chronic visceral pain comorbid depression. Filtering and grouping period: During this phase, the patient will sign an informed consent form, and then conduct a structured clinical evaluation to determine whether it meets the "depressive disorder" in the DSM-IV-TR diagnostic criteria. According to the ICD-11, determine whether the patients have chronic visceral pain. Acute treatment period: Randomize patients into the following treatment groups: intravenous administration of esketamine (3 groups, 0.125, 0.25, 0.50 mg/kg)， and duloxetine is co- administered orally. Pregabalin capsules were administered combined with duloxetine orally. observation period: After 2 weeks, esketamine treatment was discontinued, and observation was continued for 2 weeks. Maintain duloxetine and pregabalin treatment.

The purpose of this study is to assess the safety (adverse events, serious adverse events, deaths, suicidality) of participants with major depressive disorder (MDD) treated according to the standard of care (SOC).

Major depressive disorder (MDD) is a highly prevalent and disabling condition for which the currently available treatments are not fully effective. Existing unmet needs include rapid onset of action and optimal management of concurrent agitation. Preliminary data support Dexmedetomidine as an antidepressant with fast onset of action, which would be especially helpful for patients experiencing treatment resistant depression, and agitation This trial will recruit 76 participants from the ECT waiting list at department of psychiatry and randomize them to either Dexmedetomidine infusion (0.5µg/kg/hr for 15 mins ) adjunct to ECT or Placebo adjunct to ECT( Saline) treatment arm added to standard anesthetic induction in depressed patients who have been prescribed ECT utilizing fixed randomization schedule that allocate subjects in to a 1:1 ratio between two arms.. Participants will receive ECT as described in the study schedule and as decided by their treating physician. Throughout the study, clinical, neuroimaging, molecular, and cognitive assessments will be conducted. The trial aims to show that compared with Placebo adjunct to ECT( Saline) treatment, Dexmedetomidine infusion adjunctive treatment will lead to higher and faster response rate in depression, lesser number of ECT sessions required to achieve antidepressant response, less incidence of confusion post ECT and comparable incidence of side effects . This could lead to faster, more effective treatment for patient with depression

The aim is to evaluate aerobic group exercise versus leisure group activities in adolescents with mild to moderate depression. Primary outcome is Children's Depression Rating Scale - Revised (CDRS-R). Secondary outcomes are Clinical Global Impressions - Severity and Improvement scales (CGI), self-reported Quick Inventory of Depression Symptomatology (QIDS- A17-SR), the self-reported Outcome Rating Scale (ORS), clinician rated Children Global Assessment Scale (C-GAS), aerobic capacity (VO2max), muscular strength, body, Body Mass Index (BMI), presence or activity of selected biological markers of neuroprotection and neuroinflammation in blood samples and a cost evaluation rated by parents with Trimbos/iMTA questionnaire for Costs associated with Psychiatric Illness - Child version (Tic-P). Further objectives are qualitative interviews to explore adolescents' experiences of the intervention as well as how their health and lifestyle are influenced and a validation of QIDS- A17-C and QIDS- A17-SR versus CDRS-R will be performed.

The present aim of the study is to to adapt an established, manualized enhanced Group CBT (CBT-E) for seniors to a telehealth format, which will allow us to offer the group virtually during the COVID-19 pandemic.

The study will be a multi-centre parallel group, double blind, non-commercial, randomised controlled superiority trial. Study participants will be referred from Primary Care GP practices via their GP and randomised into active Alpha-Stim AID Cranial Electrotherapy Stimulations (CES) or sham Alpha-Stim AID CES.