Clinical trials: Treatment Resistant Major Depression
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
Depression
Safety and Efficacy of EVT 101 in Treatment-Resistant Depression
This study is a 4-week, randomized, double-blind, parallel-group, placebo-controlled monotherapy study in patients with treatment-resistant major depression.
- Trial name
- NCT01128452
- Testing
- EVT 101
- Where
- 14 sites in United States
- Volunteers
- 8 people
- Sponsor
- Janssen Research & Development, LLC
Treatment Resistant Depression, Major Depressive Disorder
Mechanistic Evaluation of Response in TRD (MERIT)
To evaluate the relapse prevention of AXS-05 relative to placebo in subjects with treatment resistant depression (TRD). This is a randomized, double-blind, placebo-controlled study to evaluate AXS-05 compared to placebo in…
- Trial name
- MERIT (NCT04608396)
- Testing
- AXS-05
- Where
- 20 sites in United States
- Volunteers
- 44 people
- Sponsor
- Axsome Therapeutics, Inc.
Major Depressive Disorder, MDD
A Non Interventional Study to Investigating the Ratio of Mis-diagnosed Bipolar Symptoms in Patient With Major Depressive Disorder (MDD)
The study will only detect hypomanic symptoms in treatment resistant MDD patients by mean of HCL-32 administration. Further re-evaluation of MDD diagnosis is not a direct aim of the study.
- Trial name
- Improve (NCT01344733)
- Where
- 29 sites in Italy
- Volunteers
- 660 people
- Sponsor
- AstraZeneca
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.
Depression, Depressive Disorder
Assessment of the Safety and Effectiveness of Cortical Stimulation in Subjects With Major Depressive Disorder
The purpose of this study is to assess the safety and effectiveness of cortical stimulation to the cerebral cortex of subjects who have suffered from treatment-resistant depression and have failed routine attempts at controlling…
- Trial name
- PROSPECT (NCT00380042)
- Testing
- Cortical Stimulation
- Where
- 3 sites in United States
- Volunteers
- 12 people
- Sponsor
- Northstar Neuroscience
Depressive Disorder, Treatment-Resistant
Proof of Concept Study Evaluating the Efficacy and Safety of MIJ821 in Patients With Treatment-resistant Depression
This study evaluated the efficacy and safety of the compound MIJ821 compared to placebo in patients aged from 18 to 65 years diagnosed with treatment-resistant depression. The study was conducted in the US and in Europe (Spain).
- Trial name
- NCT03756129
- Testing
- MIJ821, Ketamine
- Where
- 12 sites in United States, Spain
- Volunteers
- 70 people
- Sponsor
- Novartis Pharmaceuticals
Major Depressive Disorder (MDD), Depressive Disorder, Treatment-Resistant
ACP-211 Monotherapy for Major Depressive Disorder With Inadequate Antidepressant Response
The goal of this clinical trial is to learn if ACP-211 can help treat adults with major depressive disorder (MDD) who have not improved with antidepressant therapy (ADT), including those with treatment resistant depression (TRD).
- Trial name
- NORLIGHT (NCT07284667)
- Testing
- ACP-211
- Where
- 28 sites in United States
- Volunteers
- 153 people
- Sponsor
- ACADIA Pharmaceuticals Inc.
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.
Healthy
A Study of BCI-838 and Several BCI-632 Prodrugs in Healthy Volunteers
This study will evaluate the safety, tolerability and pharmacokinetics of BCI-838, its metabolite BCI-632 and several new pro-drugs in healthy male subjects.
- Trial name
- NCT01546051
- Testing
- BCI-838, BCI-1038, BCI-1206 & BCI-1283
- Where
- Netherlands
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- BrainCells Inc.
PTSD, Alzheimer Disease
First-In-Human (FIH), Single Ascending Dose (SAD) Study of FluoroEthylNorMemantine (FENM)
The goal of this First-In-Human (FIH) trial is to learn about safety and PharmacoKinetics (PK) in healthy adult volunteers. The main questions it aims to answer are: What is the safety of single ascending doses of the…
- Conditions
- PTSD, Alzheimer Disease, Brain Diseases, Neuro-Degenerative Disease
- Trial name
- NCT05921929
- Testing
- Fluoroethylnormemantine (FENM)
- Where
- Belgium
- Volunteers
- healthy volunteers welcome
- Sponsor
- ReST Therapeutics
Major Depressive Disorder
A Study of the Efficacy of Intravenous Esketamine in Adult Patients With Treatment-Resistant Depression
The purpose of this study is to assess the efficacy of esketamine compared with placebo in improving symptoms of depression in patients with treatment resistant depression.
- Trial name
- NCT01640080
- Testing
- Esketamine
- Where
- 9 sites in Belgium, Germany and 1 more
- Volunteers
- 30 people
- Sponsor
- Janssen Research & Development, LLC
Healthy
A Multiple Ascending Dose Study of BCI-838 in Healthy Volunteers
This study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of BCI-838 and its metabolite BCI-632 in healthy male and female subjects.
- Trial name
- NCT01548703
- Testing
- BCI-838
- Where
- Netherlands
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- BrainCells Inc.
Major Depressive Disorder
Pilot Study in Multi-Coil Repetitive Transcranial Magnetic Stimulation (rTMS) for Treatment Resistant Depression
The purpose of this study is to assess the efficacy of a Deep Shaped-Field repetitive transcranial magnetic stimulation (DSF-rTMS) system in the treatment of depression.
- Trial name
- NCT01431001
- Testing
- Cervel Neurotech Deep Shaped-Field repetitive transcranial magnetic stimulator (DSF-rTMS)
- Where
- 4 sites in United States, Australia
- Volunteers
- 40 people
- Sponsor
- Cervel Neurotech, Inc.
Major Depressive Disorder
Single IV Dose of GLYX-13 in Patients With Treatment-Resistant Depression
The purpose of this study is to determine whether GLYX-13 reduces depression score in patients with treatment-resistant depression.
- Trial name
- NCT01234558
- Testing
- GLYX-13
- Where
- United States
- Volunteers
- 115 people
- Sponsor
- Naurex, Inc, an affiliate of Allergan plc
Treatment Resistant Depression, Depressive Disorder
A Clinical Evaluation of Subcallosal Cingulate Gyrus Deep Brain Stimulation for Treatment-Resistant Depression
This is a randomized, placebo-controlled double-blind cross-over trial evaluating the safety, efficacy, daily functioning, and health-related quality of life of Subcallosal Cingulate Gyrus Deep Brain Stimulation (SCG DBS) for…
- Trial name
- NCT01801319
- Testing
- Libra Deep Brain Stimulation System
- Where
- Canada
- Volunteers
- 40 people
- Sponsor
- Abbott Medical Devices
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.
Depressive Disorder, Depressive Disorder, Major
A Study of the Effectiveness and Safety of Risperidone to Augment SSRI Therapy in Patients With Treatment-resistant Depression
The purpose of this study is to evaluate the effectiveness and safety of risperidone to augment SSRI therapy in patients with treatment-resistant depression and to demonstrate the long-term maintenance effect of risperidone as…
- Conditions
- Depressive Disorder, Depressive Disorder, Major, Depression
- Trial name
- NCT00044681
- Testing
- risperidone
- Volunteers
- 258 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Depression, Depressive Disorder
Low Field Magnetic Stimulation (LFMS) in Subjects With Treatment-Resistant Depression (TRD)
The purpose of this study is to compare the relative effectiveness of 20 and 60 minutes of Low-Field Magnetic Stimulation in relieving symptoms in patients with major depression who are treatment resistant.
- Conditions
- Depression, Depressive Disorder, Depressive Disorder, Treatment-resistant, Depressive Disorder, Major
- Trial name
- NCT02452892
- Testing
- LFMS
- Where
- 12 sites in United States
- Volunteers
- 122 people
- Sponsor
- Tal Medical, Inc.
Major Depressive Disorder
Treatment-Resistant Depression Registry
This registry will collect information about patients with treatment-resistant depression (TRD) who are currently in a major depressive episode.
- Trial name
- NCT00320372
- Where
- 55 sites in United States
- Volunteers
- 795 people
- Sponsor
- Cyberonics, Inc.