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Depression, Unipolar clinical trials

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NCT ID: NCT03537547 Recruiting - Depression Clinical Trials

AssureRx Treatment Naive

Start date: May 4, 2018
Phase: Phase 4
Study type: Interventional

Major Depressive Disorder is a chronic psychiatric illness that leads to devastating consequences at the individual and societal levels. Today, the choice of treatment continues to be largely based on subjective factors, primarily the clinician and/or patient's preferences, as well as the individual's history of response to treatment, often tainted by recall bias. Psychiatric medication decisions are even more arbitrary when the subject in question has not had past treatment trials. This often leads to a trial and error process and an increasingly resistant disease with each failed trial. Early implementation of an objective tool designed for tailoring medication choice to an individual may prove highly beneficial in decreasing illness chronicity, individual suffering, and economic burden. GeneSight Psychotropic test is a pharmacogenomic decision support tool, developed to help clinicians make informed, evidence-based decisions about proper drug selection. Therefore, we propose conducting a randomized, double blind, controlled trial to evaluate the impact of the GeneSight Psychotropic test to guide treatment decisions in patients with treatment-naïve (never having taken medication for depression) Major Depressive Disorder. This study will involve 6 visits over about 24 weeks where participants will be randomized to have their study clinician have access to their pharmacogenetic report in order to make treatment decisions, or to not have access to their report for the first 12 weeks. At Visit 5, Week 12, all participants will receive a copy of their pharmacogenetics report and all clinicians will be unblinded to be able to use the results to guide treatment options for an additional 12 weeks.

NCT ID: NCT03518749 Recruiting - Depression Unipolar Clinical Trials

Effects of tDCS-enhanced Cognitive Control Training on Depression

Start date: March 19, 2018
Phase: N/A
Study type: Interventional

Deficient cognitive control (CC) is one of the central characteristics of major depression (MD). Hypoactivation of the dorsolateral prefrontal cortex (dlPFC) has been linked with this deficit. Antidepressants and cognitive-behavioral therapies modify CC most-likely as a common mechanism of treatment. Transcranial direct current stimulation (tDCS) is a safe, simple and effective non-invasive method to modulate the cortical excitability. It has been shown, that the activity of the dlPFC can be modulated by transcranial direct current stimulation (tDCS) with polarity-dependent learning-phase specific effects on performance that, when combined with training, can outlast the stimulation. The goal of this randomized, sham-controlled, rater blind clinical trial is to investigate the effect of a tDCS-enhanced CC Training (CCT) on depressive symptom severity and compare the stimulation intensities 1mA, 2mA and sham tDCS. Overall, the study will include 57 participants (n = 19 per group). Each participant will complete 12 training sessions with online sham/ anodal tDCS. As a training task we will use an adaptive version of the paced auditory serial addition task (PASAT). In the PASAT, digits are presented auditive and participants have to add the current digit to the digit they heard before. In the adaptive version the interstimulus-intervals decrease (increase) when four consecutive trials are correct (incorrect). The PASAT is known to elicit frustration. Participants have to exert cognitive control over these emotions to complete the task successfully. Before, during and after the training symptom severity will be assessed. Baseline and post-training performance in the PASAT and in a transfer task (delayed working memory task, DWM) will be measured. To further explore variables that influence the effect of tDCS on depressive symptom severity we will measure brain activity (EEG, NIRS), heart rate, global functioning (GAF), emotion regulation strategies, self-esteem, mood ratings and subjective performance ratings before and after the training and collect genetic factors. Sustainability of the training effects will be measured at a follow-up visit (3 months later).

NCT ID: NCT03516604 Recruiting - Clinical trials for Depression, Unipolar

PF-04995274 and Emotional Processing in Un-medicated Depression

RESTAND
Start date: May 16, 2018
Phase: Phase 1
Study type: Interventional

This study will test whether seven days administration of a serotonin receptor subtype 4 (5HT4) agonist called PF-04995274 has positive effects on emotional processing and neural activity in unmedicated depressed patients compared to placebo. The study will also include a group of patients randomised to seven days administration of citalopram (20 mg), which is a standard treatment for depression.

NCT ID: NCT03515733 Not yet recruiting - Clinical trials for Treatment Resistant Depression

PF-04995274 and Emotional Processing in Treatment Resistant Depression

RESTART
Start date: May 2018
Phase: Phase 1
Study type: Interventional

This study will test whether seven days adjunctive administration of a serotonin receptor subtype 4 (5HT4) agonist called PF-04995274 has positive effects on emotional processing and neural activity in medicated, treatment-resistant depressed patients compared to placebo.

NCT ID: NCT03466346 Not yet recruiting - Clinical trials for Depression, Unipolar

Depression And Primary-care Partnership for Effectiveness-implementation Research

DAPPER
Start date: June 2018
Phase: N/A
Study type: Interventional

Despite carrying the vast majority of the global mental disorder burden, 75% of adults with mental disorders in Low and Middle Income Countries have no access to services. This study will test strategies for integrating evidence-based depression treatments with primary care services at a large public sector hospital and conduct robust cost and cost-benefit analyses of each treatment to produce a "menu" of cost-benefit options for integrated depression care with corresponding effectiveness and implementation values. The project is relevant to the mission of the National Institutes of Mental Health because it addresses mental health care delivery and related health economics at the individual, clinical and systems levels.

NCT ID: NCT03405493 Recruiting - Depression Clinical Trials

Sleep, Wake and Light Therapy for Depression

Start date: January 18, 2018
Phase: N/A
Study type: Interventional

The aim of this study is to determine if altering the pattern of one's sleep and having light therapy can speed up the treatment of depression. In the UK, the large majority of patients with depression in the NHS are treated in the community, and one of the major objectives of the study one is to determine if this therapy is a practical treatment in the community. We will be comparing two treatments: 1. Sleep Therapy and a Light Box: Participants will be given information and advice on how to get a good night's sleep. Participants will be given a light box to use in the morning for 1 week. Treatment with a light box will last 30 minutes when a person gets up. Participants may continue to have any treatment as usual (for example medication or talking therapies). 2. Wake therapy and a Light Box: Participants will be helped to change the pattern of sleep by depriving participants of sleep for one night. Participants will go bed at 5pm on the following day for 8 hours and get up at 1am. Participants' sleep will then be advanced by 2 hours each night for the next three nights. Participants will be also given a light box to use in the morning for 1 week. Treatment with a light box will last 30 minutes when participants get up. Participants may continue to have any treatment as usual (for example medication or talking therapies).

NCT ID: NCT03246789 Recruiting - Clinical trials for Mental Health Disorder

Reaching and Engaging Depressed Senior Center Clients (REDS)

REDS
Start date: January 1, 2018
Phase: N/A
Study type: Interventional

The purpose of this study is to test the feasibility of two types of group therapy sessions. The research is being done because the researchers are trying to learn if these approaches could be used by therapist in the community social service agencies to treat older adults with depression. There are two study groups. One group is a form of group therapy called "Engage-M", which encourages subjects to engage in physical and social activities that they find pleasurable or rewarding. One group is another form of group therapy called, "Wellness in Mind and Body", which focuses on education and de-stigmatization of health and mental health conditions.

NCT ID: NCT03169543 Recruiting - Clinical trials for Depression, Unipolar

Neural Mechanisms Underlying the Antidepressant Effects of Sleep Deprivation

Start date: April 1, 2016
Phase: N/A
Study type: Interventional

From 40 to 60% of patients with depression experience a rapid and significant improvement of mood with one night of sleep deprivation (SD). The neural mechanisms underlying this effect have not been elucidated. Recent advances in functional neuroimaging have provided new opportunities to investigate state changes in regional brain function, along with a better understanding of the neural networks affected by depression and SD. Here we propose to study a group of N=48 antidepressant-free male and female patients with current depression symptom and N=12 healthy controls with no history of mood disorders before and after SD to provide mechanistic insight into the neural substrates underlying the antidepressant effects of SD. We hypothesize that SD-induced concurrent functional activity and connectivity changes in multiple brain networks related to different depressive symptom dimensions including emotion regulation, attention, arousal, self-referential, and reward processing will underlie the rapid and transient antidepressant effects of SD. Using an ABA design, multimodal brain imaging along with more traditional electroencephalographic (EEG) and neurobehavioral testing data will be acquired at baseline after normal sleep, during one night of total SD, and after one night of recovery sleep using a 5-day in laboratory protocol during which subjects will be continuously monitored by trained staff.

NCT ID: NCT03096886 Recruiting - Depression Clinical Trials

Novel Neural Circuit Biomarkers of Depression Response to CCBT

Start date: June 5, 2017
Phase: N/A
Study type: Interventional

The purpose of the study is to learn more about computer-assisted cognitive behavioral therapy or "CCBT" and to examine connections in the brains of patients with depression. CCBT is approved by the FDA as a form of treatment for depression. It is done partly on the computer and partly with a therapist. This study will enroll participants with depression and participants without depression. The investigators will recruit a total of 100 participants: 60 with Major Depressive Disorder (MDD) and 40 matched comparison participants. Healthy control subjects will participate for approximately 8 weeks. All MDD participants will receive CCBT. Half of the MDD participants will all receive computer-augmented skills training with the Good Days Ahead (GDA) protocol immediately (CCBT Immediate). CCBT Immediate subjects will participate for approximately 10-12 weeks. The other half of the MDD participants initially will be randomized to an 8-week waitlist and subsequently will receive CCBT treatment (Waitlist followed by CCBT). Waitlist followed by CCBT subjects will participate for approximately 18-20 weeks. All participants are asked to complete a screening, which includes a series of clinical interviews and self-report questionnaires about the individual's thoughts, moods, and behaviors. All participants are asked to wear an actigraph, which is a watch-like device that measures activity levels. Additionally, participants are asked to completed short questions and have their activity levels monitored through phone app(s). All participants (Healthy Control and MDD participants) will receive functional magnetic resonance imaging (fMRI) scanning at baseline. CCBT Immediate participants will receive fMRI scanning after 8 weeks of CCBT, and Waitlist followed by CCBT participants will receive fMRI scanning at the conclusion of the 8-week waitlist and after the 8-week course of CCBT. Brain activity will be compared between MDD and controls at baseline and between CCBT Immediate vs 8-week Waitlist followed by CCBT. The 2nd and 3rd brain scans of Waitlist followed by CCBT participants at the end of the 8-week waitlist and 8-week course of CCBT, respectively, will allow within-subject comparison of CCBT vs Waitlist treatment effects.

NCT ID: NCT02969876 Recruiting - Depression Clinical Trials

Pattern Separation, Brain Derived Neurotrophic Factors, and Mechanisms of Vortioxetine

VOR-IISR
Start date: August 24, 2017
Phase: Phase 4
Study type: Interventional

The study is a 6-week, proof-of-concept, open trial of vortioxetine for 20 patients with major depressive disorder.