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Depressive Disorder, Major clinical trials

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NCT ID: NCT05347719 Recruiting - Clinical trials for Major Depressive Disorder

Virtual Mindfulness Training for Adults With History of Depression

Start date: September 1, 2022
Phase: N/A
Study type: Interventional

Mindfulness Based Cognitive Therapy (MBCT) has shown to be an effective method of preventing relapse of an episode Major Depressive Disorder (MDD). MBCT is a group program that integrates mindfulness skills training with cognitive-behavioral strategies. However, the cost of MBCT is not affordable to many families. The aim of this study is to explore the feasibility and efficacy of an MBCT intervention designed to be delivered at low cost through a virtual delivery format. This study will recruit 240 participants who are in remission from depression and randomize them to an MBCT intervention group or treatment as usual (TAU) for the wait list control group. The wait list control group will complete the intervention after the MBCT intervention group. Assessment administered at pre-intervention (baseline), post-intervention for experimental group, and post-intervention for the wait list control group and follow-up for experimental group. The primary outcome is to test the efficacy of this community-based delivery in reducing depression severity and psychiatric distress in the relapse of an episode of MDD. The secondary outcomes include perceived stress, post-traumatic stress symptoms, adherence to treatment plans not given as part of this study, frequency of relapse of MDD, mindfulness skills, and quality of life. This study will also examine the following potential moderators and correlates of intervention outcomes: comorbid diagnoses, life events history, and MBCT intervention adherence. Finally, the study will examine the following mediators of intervention outcome: mindfulness skills, emotion regulation skills, executive functioning skills, savoring, and positive and negative affect.

NCT ID: NCT05347199 Completed - Clinical trials for Major Depressive Disorder

Effects of a Single Dose of Amisulpride on Functional Brain Changes

Start date: May 17, 2022
Phase: Phase 1
Study type: Interventional

This study is designed to investigate effects of a single dose of amisulpride on functional brain changes during reward- and motivation-related processing and at rest in healthy volunteers (HV) and in patients with Major Depressive Disorder (MDD).

NCT ID: NCT05327699 Recruiting - Clinical trials for Major Depressive Disorder

Glutamatergic Adaptation to Stress as a Mechanism for Anhedonia and Treatment Response With Ketamine

Start date: November 8, 2022
Phase: Early Phase 1
Study type: Interventional

The main purpose of this study is to investigate the effects of ketamine on decision-making and emotion processing in a sample of individuals diagnosed with Major Depressive Disorder (MDD).

NCT ID: NCT05324735 Completed - Clinical trials for Resistant Major Depression

Pentoxifylline for Treatment of Resistant Major Depression

Start date: December 15, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

A growing body of evidence has highlighted the role of inflammation and phosphodiesterases (PDE)-related pathways in the pathogenesis of neuropsychiatric illnesses such as depression/mood disorders. Herein, we aimed to evaluate the therapeutic benefits of pentoxifylline (PTX) in the treatment of therapy-resistant depression (TRD) in adult patients with bipolar depression.

NCT ID: NCT05323019 Terminated - Clinical trials for Treatment Resistant Major Depressive Disorder

Repeated Intranasal Esketamine Plus Almond Therapy in Patients With Treatment Resistant Depression

ZYL-730-01
Start date: October 13, 2022
Phase: Phase 2
Study type: Interventional

To examine the efficacy of Almond Therapy compared to Treatment as Usual when used in addition to an approved version of intranasal esketamine.

NCT ID: NCT05320107 Recruiting - Clinical trials for Major Depressive Disorder

The Effect of Ketamine on Aesthetics and Role for Antidepressant Effects

Start date: June 1, 2022
Phase: Phase 1
Study type: Interventional

The aim of this study is to assess the impact of ketamine on aesthetic perception and processing. This study assesses the role of these effects in facilitating ketamine's antidepressant properties, with a focus on anhedonia. To address this aim, 25 patients with major depressive disorder and 35 healthy controls will be assessed twice with magnetic resonance imaging, once after administration of intravenous ketamine (subanesthetic dose) and once after administration of placebo.This study has a single-center, placebo-controlled, cross-over study design. During MRI, structural, resting state, and functional imaging will be performed. Functional imaging will comprise aesthetic processing, reward, and sexual arousal paradigms. In addition, various neuropsychological scales assessing depressive symptoms, anhedonia, and aesthetic processing will be performed. Eligibility for participation will be assessed during a screening visit, a follow up visit will end study participation.

NCT ID: NCT05318924 Recruiting - Clinical trials for Major Depressive Disorder

Effects of Ghrelin Administration on Dopamine and Effort

Start date: February 21, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

Ghrelin is a stomach-derived hormone and the only known circulating peptide that stimulates appetite. Animal studies have conclusively shown that ghrelin increases dopaminergic neurotransmission and, thereby, enhances effort. However, similar evidence on the putative role of ghrelin in humans is still lacking. Here, the investigators propose to conduct a [11C]-raclopride PET/MR study after intravenous administration of ghrelin vs. saline in healthy individuals. First, during an intake visit, the investigators will assess fasting blood levels of hormones involved in appetitive behavior such as ghrelin, leptin, and insulin. In addition, the investigators will conduct a set of tasks that have been associated with dopamine function (i.e., effort and reinforcement learning). Second, the investigators will assess the effects of intravenous administration of ghrelin on dopamine signaling using a double-blind randomized cross-over design. To this end, participants will be infused with ghrelin (vs. saline) while we determine dopamine release (via PET imaging) and assess cerebral blood flow and functional connectivity at rest (via concurrent MR imaging). Furthermore, the investigators will conduct an instrumental motivation task (IMT) where participants have to exert physical effort to obtain rewards. Based on preclinical studies and indirect evidence from human studies, the investigators hypothesize that ghrelin will increase dopamine release in the striatum and that this will, in turn, lead to an increase in the willingness to work for rewards. Moreover, the investigators expect that ghrelin-induced dopamine release will be associated with an elevated tracking of reward utility in the mesolimbic circuit during the IMT, which is known to be associated with response vigor. Collectively, the proposed project would provide a unique resource to test an important link between the gut and the brain in the regulation of appetitive behavior. If ghrelin were to enhance effort expenditure for rewards via dopamine signaling in humans, then restoring sensitivity to ghrelin might be the more promising therapeutic approach compared to antagonizing the ghrelin receptor.

NCT ID: NCT05317481 Recruiting - Clinical trials for Major Depressive Disorder

Reducing Suicide Risk in Adolescents and Young Adults Via a Psychobehavioral Intervention to Regularize Daily Rhythms

Start date: April 1, 2022
Phase: N/A
Study type: Interventional

The purpose of this study is to advance a non-pharmacologic suicide preventive intervention with wide dissemination potential as an innovative high-yield solution to reduce suicide rates. The investigators aim to achieve this with this study of Brain Emotion Circuitry Self-Monitoring and Regulation Therapy for Daily Rhythms (BE-SMART-DR), that provides self-directed strategies to regularize sleep and other DRs to reduce short-term suicide risk that can be used lifelong to potentially also reduce long-term suicide risk.

NCT ID: NCT05315401 Withdrawn - Clinical trials for Major Depressive Disorder

The Efficacy of Probiotic Compared With Placebo Commitment Therapy for Treatment of Major Depressive Disorder

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

The purpose of this study is to evaluate the efficacy of oral administration of probiotic at 9 log CFU/day as adjunctive treatment in reducing the severity of depression in female patients with major depressive disorder with treatment-as-usual compared to placebo and ACT via the use of questionnaires.

NCT ID: NCT05312203 Recruiting - Clinical trials for Major Depressive Disorder

Alleviating Stress by Mobile Application' for Depression

ASMA-D
Start date: May 15, 2022
Phase: N/A
Study type: Interventional

This study is a single-blind, multicenter, randomized, controlled crossover trial. The App, developed in South Korea, is an application that provides integrated interventions for stress reduction for the general population. The App provides three contents based on MBSR, CBT, and relaxation sounds that are known to be effective in stress reduction ("Meditation category", "Cognitive approach", and "Relaxation Sound", respectively). Participants (n = 215) recruited via medical practitioner referral will be randomized to App first group (fAPP) or a waitlist crossover group (dAPP). Inclusion criteria are age 19-65; diagnosed with mild to moderate major depressive disorders (Score of 7-24 on the Hamilton Rating Scale for Depression); Stable medication for 28 days prior to study participation. The study was conducted over eight weeks, the fAPP group used The App for the first four weeks and the dAPP group for the next four weeks, and during all study periods, the participants received usual pharmacological treatment. Primary outcome measures are the Depression Anxiety Stress Scale-21. The analysis will use mixed-model repeated measures.