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69 active trials for Treatment Resistant Depression

Antidepressant Effects of TS-161 in Treatment-Resistant Depression

Background: Major depressive disorder (MDD) is a common, chronic mental illness. It can take weeks to months for antidepressants to work. Researchers want to test a new drug that might act more rapidly. Objective: To see if TS-161 will improve symptoms of depression in people with MDD. Eligibility: Adults ages 18-65 with MDD without psychotic features. Design: Participants will be screened under a separate protocol. They will have blood tests. They will complete surveys about their symptoms. Participants will have an inpatient visit at NIH. Participation may last 12-16 weeks. During the first phase of the study, participants will be tapered off their psychiatric medicines. For 2 weeks they will have a drug-free period. During Phase II participants will take TS-161 or placebo. They will take TS-161 for 3 weeks and placebo for 3 weeks. In between the 3-week time period, they will have 2-3 weeks where they will be drug free. Participants will also have the following tests during this time: Interviews Physical exams Psychological tests and surveys about their symptoms Blood draws and urine samples They may complete tests of mood and thinking MRI (Magnetic resonance imaging): Participants will lie in a machine that takes pictures of their brain. Functional MRIs: They will perform tasks displayed on a computer screen inside the MRI scanner MEG (magnetoencephalography): Participants will lie down and do tasks of memory, attention, and thinking. A cone lowered on their head will record brain activity. Electrocardiograms to record the heart s electrical activity. Electrodes will be placed on the skin....

Start: June 2021

Antidepressant Discontinuation in Treatment Resistant Depression

The purpose of this study is to compare the effects on depressive symptoms of subjects who discontinue serotonergic antidepressants (a certain type of antidepressant, such as Prozac, that works on serotonin receptors in the brain) with the effects on depressive symptoms of subjects who continue to take serotonergic antidepressants. During this study, subjects will also be presented with the opportunity to undergo genetic testing for the serotonin gene transporter which has a short or long form. This is being done because it has been demonstrated that genetic testing improves outcome while treating treatment-resistant depression.

Start: June 2019

A Prospective, Multi-center, Randomized Controlled Blinded Trial Demonstrating the Safety and Effectiveness of VNS Therapy® System as Adjunctive Therapy Versus a No Stimulation Control in Subjects With Treatment-Resistant Depression

Objectives of this study are to determine whether active VNS Therapy treatment is superior to a no stimulation control in producing a reduction in baseline depressive symptom severity, based on multiple depression scale assessment tools at 12 months from randomization.

Start: September 2019

The RECOVER sUb-study, Which Leverages quaNtitative and Credible Research tOols From Verily, Will providE Assessment measuRes for Depressive Episodes

The objective of this study is to collect both active and passive data using a wearable, multi-sensor device (Verily Study Watch) and phone application (Mood App) which aims to capture mental health status, in subjects participating in the RECOVER clinical trial (A Prospective, Multi-center, Randomized Controlled Blinded Trial Demonstrating the Safety and Effectiveness of VNS Therapy® System as Adjunctive Therapy Versus a No Stimulation Control in Subjects With Treatment-Resistant Depression).

Start: March 2021

Brain Reactivity to Nitrous Oxyde in Depression : an MRI and Ultrasound Study (PROTOBRAIN Pilote)

Recent evidence suggest that Nitrous Oxyde (N2O) could exhibit antidepressant effect in treatment-resistant depression (TRD). However, the pathophysiology of this effect remains unclear and could include glutamatergic activity but also cerebrovascular effects and changes in brain connectivity. The goal of our study is to characterize brain reactivity to N2O in TRD patients, as assessed with Ultrasound Tissue Pulsatility Imaging (TPI) and Magnetic Resonance Imaging (MRI) (including Arterial Spin Labeling - ASL - for brain perfusion and Blood-Oxygen-Level Dependent - BOLD - for brain connectivity and pulsatility). Ultrasound and MRI Neuroimaging will be measured before, during and after a single one-hour exposure of a 50%N20/50%O2 mixture, in depressed individuals (n=20) and healthy volunteers (n=10). We make the hypothesis that brain reactivity will be lower in depressed individuals nonresponders to N2O compared to responders and healthy controls. This study would provide further characterisation of the pathophysiology of the antidepressant response to N2O, as well as providing potential biomakers (Ultrasound and MRI) for treatment response to N2O in TRD.

Start: February 2020

Neural and Antidepressant Effects of Propofol

This study will compare the antidepressant effects of propofol at two different doses while measuring potential treatment-related biomarkers.

Start: April 2019

EpCS in Severe Treatment Resistant Depression

Purpose: Treatment-resistant depression (TRD) is a leading cause of premature mortality and healthcare costs. Negative stimuli capture the attention of depressed patients. The more entrenched these core attentional processes are, the longer patients remain ill. The parietal Late Positive Potential (LPP) [an event-related potential (ERP) measured by electroencephalography (EEG)], reliably captures biased attention and early affective responses to environmental stimuli. LPP is top-down modulated by the prefrontal cortex (PFC), an important target for depression treatment. Using a combination of anatomical, functional and electric-field simulation localization methods, the investigators will stereotactically implant 15 TRD patients with bilateral EpCS in a 2-phase approach. The investigators will confirm target engagement, reduction of LPP response, as well as examine the relationship between reductions in LPP and changes in depressive symptoms in TRD patients.

Start: September 2021

Enhanced Spatial Targeting in ECT Utilizing FEAST

The 'principle' is that FEAST can create a focal seizure in a targeted region that has clinical efficacy. Standardized procedures are used to reduce impedance at ECT and EEG electrode sites. The d'Elia unilateral placement is used for conventional RUL ECT. FEAST will involve the 1.25" circular anterior electrode being centered at the measured Fp2 position by the 10/20 EEG system, with the posterior cathode electrode (1"x2.5") tangential to the mid-sagittal plain and centered at vertex. ECT is delivered with a MECTA Spectrum 5000Q. The only modification in the device used in this study relative to the commercial device is the capacity for unidirectional stimulation. A special Investigational Device Exemption for this research will have to be obtained from the US FDA before initiating the research at The University of Minnesota. The PI has substantial experience with IDE's from previous work with transcranial magnetic stimulation (TMS), vagus nerve stimulation (VNS), deep brain stimulation (DBS), epidural cortical stimulation (EpCS) and of course FEAST. The primary outcome of this study will be and in-depth probe into the onset and seizure drive markers on EEG during FEAST and contrasting it to FEAST with RP or RC. The secondary objectives for this study are to determine remission rates as measured by HDRS and IDS-SR and time for re-orientation recovery after treatment.

Start: September 2021

Cannabidiol for Treatment Resistant Depression

With this study, the investigators will address the following scientific aims: Demonstrate the antidepressant effects of CBD in human adults with treatment refractory MDD as measured by standard rating scales. Confirm CBD's safety profile in human adult patients with MDD.

Start: July 2021

CET- REM (Correlating ECT Response to EEG Markers)

Single-center study to determine the relationship between changes in depression symptoms and electroencephalographic (EEG) patterns induced by electroconvulsive therapy (ECT)

Start: October 2020

Establishing a Dose-response Relationship With Accelerated Transcranial Magnetic Stimulation

This study evaluates an accelerated schedule of theta-burst stimulation using a transcranial magnetic stimulation device for treatment-resistant depression. In a double-blind, randomized, sham-controlled fashion, half the participants will receive accelerated theta-burst stimulation while half will receive sham treatment.

Start: June 2021

SSM vs HEP in Late-Life Depression

The investigators will conduct a randomized controlled trial (RCT), comparing SSM (n=96) versus HEP (n=96) in 192 LLD participants stratified by site and presence of treatment resistant late life depression (TR-LLD). Participants will be blinded to the treatment hypothesis while investigators, raters and treating clinicians will be additionally blinded to the intervention. Both SSM and HEP will be taught over 4 consecutive days in similar sized groups (4-10 participants) followed by weekly reinforcement sessions for subsequent 11 weeks. Trained raters will collect data on depression symptoms (HAM-D 17 scale) and cognition at baseline, 12-week and 26-week follow-up as the primary and secondary outcome measures respectively.

Start: August 2018

Stanford Accelerated Intelligent Neuromodulation Therapy for Treatment-Resistant Depression (SAINT-TRD)

This study evaluates an accelerated schedule of theta-burst stimulation using a transcranial magnetic stimulation device for treatment-resistant depression. In a double-blind fashion, half the participants will receive accelerated theta-burst stimulation while half will receive sham treatment.

Start: March 2017

Optimizing Outcomes of Treatment-Resistant Depression in Older Adults

The purpose of this research study is to assess which antidepressants work the best in older adults who have treatment-resistant depression (TRD).

Start: February 2017

Biomarker-guided rTMS for Treatment Resistant Depression

Repetitive transcranial magnetic stimulation (rTMS) is a treatment for depression. The investigators are continuing to learn how to optimize outcomes from rTMS treatment. The purpose of this research project is to use brain network connectivity patterns as measured by resting state functional magnetic resonance imaging (fMRI) to confirm a way to optimize the use of rTMS to treat depression. In addition, the study aims to gain a better understanding of how rTMS influences brain networks.

Start: August 2021

Rapid Acting Transcranial Magnetic Stimulation

Start: May 2021

Deep Brain Stimulation (DBS) Therapy for Treatment Resistant Depression

We propose a clinical study of medial forebrain bundle DBS as a treatment in 10 patients with treatment refractory depression (TRD). Data from the University of Bonn indicates that surgical lesions of the medical forebrain bundle can produce therapeutic benefits in patients with depressive disorders, and suggest that DBS at the same site may also reduce symptomatology in these TRD patients (Schaepfer, 2013). Depression affects up to 10% of the US population and of those at least 10-15% do not benefit from therapies hence why we must explore new treatments. The Percept™ PC system manufactured by Medtronic Neurological will be used in this study. Study subjects will be between the ages of 22 and 65 years of age and suffer from TRD, have failed multiple treatment regimens, including ECT, and remain symptomatic. Those identified as TRD patients will then be enrolled in a clinical pilot study investigating DBS, targeting the MFB.

Start: November 2013

Stellate Ganglion Block for Major Depressive Disorder.

This is a feasibility study, to investigate a new treatment option for major depressive disorders by performing a Stellate Ganglion Block (SGB). A SGB is an injection of local anesthetic into the sympathetic nervous system (peripheral nervous system) located in the lower part of the neck, to relieve pain in the head, neck, upper arm, and upper chest.

Start: July 2021

Ketamine for Older Adults Pilot

This pilot study will assess the safety and feasibility of intravenous (IV) ketamine in older adults with Treatment-Resistant Depression (TRD). In addition, this study will develop and utilize innovative methodological approaches to demonstrate the feasibility of precision medicine and mobile health approaches in depression treatment.

Start: October 2020

Stanford Accelerated Intelligent Neuromodulation Therapy for Treatment-Resistant Depression: OL Cohort

This study evaluates an accelerated schedule of theta-burst stimulation using a transcranial magnetic stimulation device for treatment-resistant depression. In this open label study, all participants will receive accelerated theta-burst stimulation.

Start: May 2017