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Depressive Disorder, Major clinical trials

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NCT ID: NCT04423757 Terminated - Clinical trials for Depressive Disorder, Major

A Home-based Study Using Mobile Technology to Test Whether BI 1358894 is Effective in People With Depression

Start date: June 22, 2020
Phase: Phase 2
Study type: Interventional

This is a home-based study in adults with depression. People who have been diagnosed with Major Depressive Disorder can participate in the study. Participants can take part if they are being treated for their depression but still have symptoms. The purpose of this study is to find out whether a medicine called BI 1358894 helps people with depression. Participants are in the study for about 2 months and do not need to visit a study site during this time. All study visits are conducted at participant's home by a mobile study nurse, by videoconference, and by phone calls. Participants are put into 2 groups by chance. One group takes BI 1358894 tablets. The other group takes placebo tablets. Placebo tablets look like BI 1358894 tablets but do not contain any medicine. The participants answer questions about the symptoms of their depression. We then compare the results between the BI 1358894 and placebo groups. The doctors and nurses also regularly check the general health of the participants.

NCT ID: NCT04423471 Withdrawn - Clinical trials for Major Depressive Disorder

Neuroinflammation, Affective and Cognitive Symptoms in Major Depression and Psoriasis

INPSYDER
Start date: February 1, 2021
Phase:
Study type: Observational [Patient Registry]

Objectives: To identify peripheral neuroinflammatory markers in patients suffering from major depression or psoriasis in relation to affective symptoms (anxiety, depression, irritability), fatigue and cognitive symptoms; and their change after specific treatments. Methodology: Observational prospective cohort study in patients diagnosed with major depression and patients with plaque psoriasis, who naturalistically undergo different treatments (systemic or biological for psoriasis, antidepressants for depression). Forty-one patients with major depression attending psychiatric consultations and 82 patients with psoriasis attending dermatology consultations at Hospital Universitari Germans Trias i Pujol aged 18 to 65 years old will be selected for inclusion. All of them will be assessed at baseline and after 4 months treatment through a series of demographic and clinical variables, psychiatric diagnosis, psychopathological scales and immunological and biochemical variables after blood draw for obtaining serum, peripheral blood mononuclear cell (PBMC) and extraction of total RNA. Investigators will analyze the correlation between immunological markers and affective and cognitive symptoms at baseline, as well as their variation after treatment. Subsequently, a bivariate comparative analysis will be carried out, where statistically significant or marginally significant variables associated with psychopathological variables will be used to construct a multivariate model of binary logistic regression.

NCT ID: NCT04422652 Recruiting - Clinical trials for Major Depressive Disorder

Combination of Novel Therapies for CKD Comorbid Depression

CONCORD
Start date: September 24, 2020
Phase: Phase 2
Study type: Interventional

The overall goal of the study is to determine if treatment of a Major Depressive Disorder (MDD) improves the outcomes of patients with chronic kidney disease (CKD). We showed that MDD is present in 25% of CKD patients and independently associated with progression to End-Stage Kidney Disease, hospitalization, and death. Depression is also associated with lower quality of life (QOL), fatigue, poor sleep, and non-adherence to diet and medications. However, evidence for efficacy and tolerability of commonly-used antidepressant medications or nonpharmacologic treatments are limited in CKD patients. Our group was the first to conduct a double-blind randomized controlled trial for MDD treatment in 201 patients with non-dialysis CKD, and showed that sertraline, a commonly used selective serotonin reuptake inhibitor (SSRI), was no more efficacious than placebo for improving depressive symptoms. It becomes imperative to test novel strategies to treat MDD in CKD. We propose to compare with a control group, the efficacy and tolerability of two novel treatment strategies - (1) Behavioral Activation Teletherapy (BAT) for 16 weeks, with the addition of bupropion, a non-SSRI antidepressant, at 8 weeks for patients whose depression has not remitted (non-remitters); and (2) bupropion for 16 weeks, with the addition of BAT at 8 weeks for non-remitters. In Aim 1, we will investigate the efficacy and tolerability of these 2 strategies vs. control for improvement in a primary endpoint of depressive symptoms in 201 patients (67 per group) with non-dialysis CKD stages 3b-5 and MDD at 2 sites, randomized 1:1:1 to either strategy or a control group of Clinical Management plus placebo. We hypothesize that either approach vs. control will result in a minimal clinically important difference of 2 points improvement in depressive symptoms, as ascertained blindly by the Quick Inventory of Depressive Symptomatology. In Aim 2 we will investigate the efficacy and tolerability of 8 weeks of (1) single-blind BAT plus placebo or (2) double-blind bupropion plus Clinical Management vs. control for improvement in depressive symptoms. In Aim 3, we will compare the efficacy of these 2 treatments strategies vs. control for improvement in CKD patient-centered outcomes including a. adherence to medications and healthcare visits; b. fatigue; c. sleep; and d. overall functioning. A clinical trial is urgently needed to address the evidence gap that exists for MDD treatment in CKD patients.

NCT ID: NCT04410575 Recruiting - Clinical trials for Major Depressive Disorder

Mental Health Assessment and Prescribing by Alberta Pharmacists

MAP-AP
Start date: March 22, 2023
Phase: N/A
Study type: Interventional

This is a clinical trial evaluating the experimental intervention of enhanced pharmacist care by pharmacists with additional prescribing authorization (APA) in Alberta, for patients newly diagnosed with Major Depressive Disorder (MDD) and Generalized Anxiety Disorder (GAD).

NCT ID: NCT04410341 Active, not recruiting - Clinical trials for Major Depressive Disorder

The DPP-4 Inhibitor Vildagliptin as Adjunct in Major Depressive Disorder Patients

Start date: May 1, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

Vildagliptin, an antidiabetic drug that inhibits the dipeptidyl peptidase- 4 (DPP-4), increases glucagon-like peptide-1 (GLP-1) and regulates blood glucose levels, favoring weight loss and lowering cardiovascular risk. A retrospective longitudinal study by Rizzo et al. showed that DPP-4 inhibitors administration could have protective effects against cognitive decline in diabetic elderly. Is has been observed that GLP-1 affects brain metabolism, increases neuritic growth, and protects neuronal cells from oxidative stress and death.

NCT ID: NCT04405791 Completed - Clinical trials for Major Depressive Disorder(MDD)

Efficacy of Clinical Application of Transcranial Low Intensity Focused Ultrasonic Stimulation for Patients With Major Deperessive Disorder - Exploratory Clinical Trial

Start date: June 12, 2019
Phase: Phase 3
Study type: Interventional

The non-invasive type ultrasonography system is applied to patients with major depressive disorder to evaluate their effectiveness and safety. Brain Computer Tomography(CT) and Magnetic Resonance Image(MRI) are taken to induce images before transcranial low intensity focused ultrasonic stimulation. Through random extraction, the group is divided into treatment group and placebo group. The treatment is started by targeting left Dorsolateral prefrontal cortex(DLPFC) region according to assigned groups. As for women, considering mood change during menstrual cycle, the treatment is taken place 1 week after the menstruation has initiated. The treatment group and the placebo group will be treated three times a week for two weeks. To evaluate clinical symptoms, Quick Inventory of Depressive Symptomatology-Self Report, Scale for Suicidal Ideation, state-trait anxiety scale, frontal lobe management function test, memory test, and continuous performance test are performed before, during, and after treatment. For the assessment of side effects, Systematic Asseseement for Treatment Emergent Events-General Inquiry(SAFTEE) are conducted for treatment presentation events every week during the treatment implementation period and every two weeks after the treatment is completed.

NCT ID: NCT04403373 Completed - Clinical trials for Major Depressive Disorder (MDD)

Effectiveness of Walking Exercise in Improving Depression in Older Adults With Major Depressive Disorder, A Pilot Study

Start date: November 1, 2019
Phase: N/A
Study type: Interventional

1. This pilot randomized controlled trial aims at investigating the effects of different intensities of aerobic walking exercise to alleviate depression in older adults with major depressive disorder. Both baseline and post-intervention measurements will be conducted at the Exercise Physiology Laboratory, Division of Kinesiology, School of Public Health, The University of Hong Kong, while the exercise intervention will be conducted outdoors in a small group setting (3-5 participants). 2. Three-time-per-week moderate-intensity (~3.5 METs) or vigorous-intensity (~7 METs) walking exercise will be prescribed to participants in two exercise groups, while the participants in the waitlist group will receive no intervention. The intervention duration is 12 weeks. 3. We will recruit participants from the community in HK. Interested participants will be invited for a semi-structured interview including an assessment on the Beck Depression Inventory and medical history record to confirm eligibility.

NCT ID: NCT04399070 Not yet recruiting - Clinical trials for Major Depressive Disorder

The Effect of S-ketamine for Patients Undergoing Electroconvulsive Therapy (ECT)

ECT
Start date: August 1, 2020
Phase: N/A
Study type: Interventional

This study will determine the effectiveness and safety of S-Ketamine in depression patients undergoing electroconvulsive therapy.

NCT ID: NCT04395183 Completed - Clinical trials for Major Depressive Disorder

5-HTP and Creatine for Depression

Start date: March 1, 2021
Phase: Phase 2
Study type: Interventional

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.

NCT ID: NCT04392947 Recruiting - Clinical trials for Major Depressive Disorder

Treatment of Major Depressive Disorder With Bilateral Theta Burst Stimulation

TBS-D
Start date: September 29, 2020
Phase: N/A
Study type: Interventional

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.