Clinical trials: Treatment-resistant Depression
Treatment Resistant Depression
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…
- Trial name
- RECOVER (NCT03887715)
- Testing
- Vagus Nerve Stimulation (VNS)
- Where
- 101 sites in United States
- Volunteers
- 6,800 people
- Sponsor
- LivaNova
Treatment Resistant Depression, Treatment Resistant Depression (TRD)
A Randomized, Double-Blind Controlled Comparison of NRX-101 vs. Placebo for Adults Being Treated With Robotic Transcranial Magnetic Stimulation for Treatment Resistant Depression: The SPARC-TMS Trial
Major depressive disorder (MDD) is a significant public health problem and leading cause of worldwide disability. Treatment resistance is common in MDD, however, for these individuals, targeted noninvasive brain stimulation is an…
- Trial name
- SPARC-TMS (NCT07227103)
- Testing
- Neuronavigated robotic-enabled TMS, NRX-101
- Where
- 3 sites in United States
- Volunteers
- 240 people
- Sponsor
- NeuroRx, Inc.
Major Depressive Disorder
Regulated Stimulation for Optimized Network Activity and Therapeutic Equilibrium
The objective of this study is to evaluate the safety, tolerability, and preliminary efficacy of the Motif eXternally powered Cortical Stimulation (XCS) System when used as indicated for treatment-resistant depression (TRD).
- Trial name
- RESONATE (NCT07594483)
- Testing
- Motif XCS System
- Where
- 3 sites in United States
- Volunteers
- 20 people
- Sponsor
- Motif Neurotech, Inc.
Treatment Resistant Depression (TRD)
Ketamine Biomarker Validation
An EEG-based biomarker will be developed for the effects of ketamine infusion in patients with Depression. The effects of ketamine infusion on Depression symptoms and EEG signals will be analyzed.
- Trial name
- NCT07307768
- Testing
- Ketamine (0.25 mg/kg), Ketamine (0.5 mg/kg), Ketamine (0.75 mg/kg)
- Where
- United States
- Sponsor
- Soterix Medical
Treatment Resistant Depression
Treatment ResistAnt Depression Subcallosal CingulatE Network DBS (TRANSCEND)
The goal of this clinical trial is to evaluate the effectiveness and safety of bilateral stimulation of the subcallosal cingulate white matter (SCCwm) using Deep Brain Stimulation (DBS) as an adjunctive treatment of non-psychotic…
- Trial name
- TRANSCEND (NCT06423430)
- Testing
- Active-stimulation
- Where
- 26 sites in United States
- Volunteers
- 100 people
- Sponsor
- Abbott Medical Devices
Treatment-Resistant Depression
NRX-101 Expanded Access
The purpose of this Expanded Access Treatment Protocol is to make NRX-101 available to patients who have treatment-resistant depression and who are unable to participate in, or do not have access to, the ongoing NRX-101 clinical…
- Trial name
- NRX-101 EAP (NCT05779267)
- Testing
- NRX-101
- Where
- United States
- Sponsor
- NeuroRx, Inc.
Treatment Resistant Depression
BPL-003 Efficacy and Safety in Treatment Resistant Depression
This is a Phase 2 study randomized, quadruple-masked, multi-center trial with an open-label extension (OLE), designed to investigate the efficacy and safety of BPL-003 in patients with treatment resistant depression (TRD).
- Trial name
- NCT05870540
- Testing
- BPL-003
- Where
- 42 sites in United States, Australia and 4 more
- Volunteers
- 196 people
- Sponsor
- Beckley Psytech Limited
Treatment Resistant Depression
A Study to Assess Effectiveness and Efficiency of VNS Therapy in Patients With Difficult to Treat Depression.
The primary objective of this study is to assess short, mid and long-term clinical outcomes in patients with difficult to treat depression (such as patients with treatment resistant depression) treated with Vagus Nerve…
- Trial name
- RESTORE-LIFE (NCT03320304)
- Testing
- Vagal Nerve Simulation (VNS) Therapy
- Where
- 18 sites in Austria, Belgium and 2 more
- Volunteers
- 500 people
- Sponsor
- LivaNova
Treatment Resistant Depression
Efficacy, Safety, and Tolerability of COMP360 in Participants With TRD
Efficacy, Safety, and Tolerability of a single administration of COMP360 in participants with treatment-resistant depression (TRD)
- Trial name
- NCT05624268
- Testing
- Psilocybin
- Where
- 40 sites in United States
- Volunteers
- 258 people
- Sponsor
- COMPASS Pathways
Treatment Resistant Depression
Efficacy, Safety, and Tolerability of Two Administrations of COMP360 in Participants With TRD
Efficacy, Safety, and Tolerability of two administrations of COMP360 in participants with treatment-resistant depression (TRD)
- Trial name
- NCT05711940
- Testing
- Psilocybin
- Where
- 116 sites in United States, Canada and 10 more
- Volunteers
- 572 people
- Sponsor
- COMPASS Pathways
Treatment Resistant Depression
An Open-Label Study to Evaluate the Safety, Tolerability and Pharmacodynamics of BPL-003 in Patients With Treatment Resistant Depression
An open-label, multi-centre, Phase 2a study to evaluate the safety, tolerability, and pharmacodynamics of one and two doses of intranasal BPL-003 combined with psychological support, in patients with treatment resistant…
- Trial name
- NCT05660642
- Testing
- BPL-003
- Where
- 3 sites in United Kingdom
- Volunteers
- 72 people
- Sponsor
- Beckley Psytech Limited
Major Depressive Disorder (MDD)
Regulated Stimulation for Optimized Network Activity and Therapeutic Equilibrium - Maintenance
The objective of this study is to evaluate the safety, tolerability, and preliminary efficacy of the Motif XCS System when used as indicated for treatment-resistant depression (TRD).
- Trial name
- RESONATE-M (NCT07684794)
- Testing
- Motif XCS System
- Volunteers
- 10 people
- Sponsor
- Motif Neurotech, Inc.
Treatment Resistant Bipolar Depression
Adjunctive Oral KET-AD Capsules in Treatment Resistant Bipolar Depression
This study is testing a new oral ketamine treatment called KET-AD in adults with treatment-resistant bipolar depression (TRBD). The study will look at how safe and tolerable the treatment is, and whether it may help improve…
- Trial name
- NCT07644767
- Testing
- KET-AD
- Volunteers
- 160 people
- Sponsor
- Neurocentrx Pharma Pty Ltd
Treatment Resistant Depression
A Study to Assess the Efficacy, Safety and Tolerability of VLS-01 Buccal Film, Compared to Placebo in Patients With Treatment Resistant Depression (ELUMINA)
This Phase 2 study (protocol number VLS-01-203) will determine the efficacy, safety, and tolerability of short-term treatment with a VLS-01 transmucosal buccal film (VLS-01-BU) in patients with treatment resistant Major…
- Trial name
- NCT06524830
- Testing
- VLS-01-203 BU
- Where
- 48 sites in United States, Australia and 2 more
- Volunteers
- 142 people
- Sponsor
- atai Therapeutics, Inc.
Treatment Resistant Depression
Efficacy and Safety of MK-1942 When Added to Stable Antidepressant Therapy in Participants With Treatment-Resistant Depression (TRD) (MK-1942-006)
The main purpose of this study is to assess the efficacy and safety of daily and intermittent dosing of MK-1942 compared to placebo among participants with Treatment-Resistant Depression (TRD) on a stable course of antidepressant…
- Trial name
- NCT04663321
- Testing
- MK-1942
- Where
- 45 sites in United States
- Volunteers
- 99 people
- Sponsor
- Merck Sharp & Dohme LLC
Treatment-resistant Depression (TRD)
ALTO-207 in Adults With Treatment-resistant Depression (TRD)
The purpose of this trial is to measure depressive symptoms following treatment with ALTO-207 compared with placebo in participants with TRD.
- Trial name
- NCT07553637
- Testing
- ALTO-207
- Where
- 48 sites in United States, United Kingdom
- Volunteers
- 178 people
- Sponsor
- Alto Neuroscience
Treatment Resistant Depression
Phase 2 Study of NV-5138 in Adults With Treatment Resistant Depression
This study will evaluate the efficacy and safety of NV-5138 in adults with TRD
- Trial name
- NCT05066672
- Testing
- NV-5138
- Where
- United States
- Volunteers
- 250 people
- Sponsor
- Navitor Pharmaceuticals, Inc.
Treatment Resistant Depression, Major Depressive Disorder
Open-Label Safety Study of AXS-05 in Subjects With TRD (EVOLVE)
This study is a multi-center, open-label trial to evaluate the long-term safety and efficacy of AXS-05 in subjects with major depressive disorder with prior treatment failures
- Trial name
- NCT04634669
- Testing
- AXS-05 (dextromethorphan-bupropion)
- Where
- 20 sites in United States
- Volunteers
- 181 people
- Sponsor
- Axsome Therapeutics, Inc.
Treatment Resistant Depression
Multiple Ascending Dose Phase 1 Study of ALA-3000
This is a randomized, double-blind, placebo-controlled, multiple-dose study of ALA-3000 designed to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy in subjects with treatment-resistant depression…
- Trial name
- NCT06965569
- Testing
- ALA-3000, escitalopram, sertraline, duloxetine or venlafaxine XR
- Where
- 4 sites in United States
- Volunteers
- 37 people
- Sponsor
- Alar Pharmaceuticals Inc.
Major Depressive Disorder
Open Label Optimization Study
The goal of this observational study is to demonstrate effectiveness in the treatment of Major Depressive Disorder The primary objective is to assess the effectiveness in the treatment of Major Depressive Disorder using the CGI-I…
- Trial name
- OLO (NCT05819021)
- Testing
- SAINT® Neuromodulation System (NMS)
- Where
- 7 sites in United States
- Volunteers
- 1,000 people
- Sponsor
- Magnus Medical