Clinical trials: Depressive Disorder, Treatment-Resistant
Treatment-resistant Depression
A Trial of GH001 in Patients With Treatment-resistant Depression
The aim of this randomized, double-blind, placebo-controlled, phase 2b clinical trial is to investigate the safety and efficacy of GH001 (containing mebufotenin [5-methoxy-N,N-dimethyltryptamine; 5-MeO-DMT]) in patients with…
- Trial name
- NCT05800860
- Testing
- GH001
- Where
- 11 sites in Czechia, Germany and 4 more
- Volunteers
- 81 people
- Sponsor
- GH Research Ireland Limited
Depressive Disorder, Treatment-Resistant
A Study of Esketamine Nasal Spray, Administered as Monotherapy, in Adult Participants With Treatment-resistant Depression
The purpose of this study is to evaluate the efficacy of each individual dose of esketamine nasal spray, 56 milligram (mg) and 84 mg, compared with placebo nasal spray in improving depressive symptoms in participants with…
- Trial name
- NCT04599855
- Testing
- Esketamine 56 mg, Esketamine 84 mg
- Where
- 54 sites in United States
- Volunteers
- 477 people
- Sponsor
- Janssen Research & Development, LLC
Major Depressive Disorder
Efficacy, Safety and Pharmacokinetic Study of Inhaled Esketamine in Treatment-resistant Depression
The purpose of the study is to determine the efficacy, safety and pharmacokinetics of inhaled Esketamine in participants with treatment-resistant depression (TRD) in the course of Major Depressive Disorder (MDD).
- Trial name
- NCT03965858
- Testing
- Esketamine DPI - low dose, Esketamine DPI - medium dose, Esketamine DPI - high dose
- Where
- 12 sites in Poland
- Volunteers
- 88 people
- Sponsor
- Celon Pharma SA
Major Depressive Disorder, Treatment Resistant Depression
Comparing Quetiapine XR Monotherapy and Augmentation With Lithium Augmentation in TRD Patients
The primary objective of the study is to evaluate the efficacy of Quetiapine extended release (XR) in combination with an selective serotonin reuptake inhibitor (SSRI) or Venlafaxine versus Lithium in combination with an…
- Trial name
- RUBY (NCT00789854)
- Testing
- Quetiapine XR, Lithium carbonate, SSRI/Venlafaxine
- Where
- 106 sites in Australia, Austria and 11 more
- Volunteers
- 688 people
- Sponsor
- AstraZeneca
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.
Treatment Resistant Depression
Development of Neuro-Navigated Transcranial Magnetic Stimulation (TMS) Using MRI
Healthy controls (HC) will be studied once to provide data needed to validate the virtual neuro-navigation system. All subjects will undergo a single MRI session and will then participate in an on-line neuro-navigation session in…
- Trial name
- NCT05598931
- Testing
- Transcranial Magnetic Stimulation
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Soterix Medical
Depressive Disorder, Treatment-Resistant
A Study of Esketamine Nasal Spray in Korean Participants With Treatment-resistant Depression
The purpose of this study is to evaluate how well esketamine nasal spray works in improving depressive symptoms in participants with treatment resistant depression (TRD).
- Trial name
- NCT07053345
- Testing
- Esketamine 56 mg, Esketamine 84 mg
- Where
- 6 sites in South Korea
- Volunteers
- 47 people
- Sponsor
- Janssen Korea, Ltd., Korea
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.
Treatment-Resistant Depression
Efficacy and Safety of TAK-653 in Treatment-Resistant Depression
The purpose of this study is to evaluate the efficacy of TAK-653 compared with placebo in maintaining the effect of ketamine treatment on depressive symptoms.
- Trial name
- NCT03312894
- Testing
- TAK-653
- Sponsor
- Millennium Pharmaceuticals, Inc.
Depressive Disorder, Treatment-Resistant
Treatment Resistant Depression in America Latina
The purpose of this study is to estimate the prevalence of Treatment Resistant Depression (TRD) among Major Depressive Disorder (MDD) participants being treated in a psychiatry reference site (example, clinic, ambulatory…
- Trial name
- TRAL (NCT03207282)
- Where
- 33 sites in Argentina, Brazil and 2 more
- Volunteers
- 1,539 people
- Sponsor
- Janssen-Cilag, S.A.
Treatment-resistant Depression
A Study to Evaluate the Efficacy, Safety, and Tolerability of Fixed Doses of Intranasal Esketamine Plus an Oral Antidepressant in Adult Participants With Treatment-resistant Depression
The purpose of this study is to compare the efficacy and safety of switching treatment-resistant depression (TRD) participants from a prior antidepressant treatment (to which they have not responded) to either intranasal…
- Trial name
- TRANSFORM-1 (NCT02417064)
- Testing
- Esketamine, Duloxetine (Oral Antidepressant), Escitalopram (Oral antidepressant)
- Where
- 90 sites in United States, Belgium and 7 more
- Volunteers
- 346 people
- Sponsor
- Janssen Research & Development, LLC
Depressive Disorder, Treatment-Resistant
A Study of Esketamine Nasal Spray Versus Placebo Spray in Adult Participants With Treatment-resistant Depression
The purpose of this study is to evaluate how well each individual dose of esketamine (56 milligrams [mg] and 84 mg) works when compared with placebo in improving depressive symptoms in participants with treatment resistant…
- Trial name
- NCT07716098
- Testing
- Esketamine 56 mg, Esketamine 84 mg
- Where
- 22 sites in United States, Japan and 1 more
- Volunteers
- 348 people
- Sponsor
- Janssen Research & Development, 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
- 63 sites in United States, United Kingdom
- Volunteers
- 178 people
- Sponsor
- Alto Neuroscience
Treatment-resistant Depression
Effect of Ketamine on Neurological Activity as Measured by Electroencephalogram (EEG)
This observational study will allow data to be collected to demonstrate changes in brain activity following administration of standard of care (SOC) Ketamine.
- Trial name
- NCT05095792
- Testing
- Observational - no intervention
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Entheon Biomedical Corp.
Major Depressive Disorder
Pharmacogenomics for Antidepressant Guidance and Education 1 (PAGE-1_AG1)
One-third or more of individuals treated for major depressive disorder (MDD) do not experience remission of symptoms despite at least two adequate antidepressant trials.
- Trial name
- PAGE-1_AG1 (NCT01426516)
- Testing
- Genecept Assay
- Where
- United States
- Volunteers
- 29 people
- Sponsor
- Genomind, LLC
Depressive Disorder, Major
A Clinical Trial for the Treatment of Depression With Repetitive Transcranial Magnetic Stimulation (rTMS)
The purpose of this study is to determine whether the Cervel Neurotech rTMS device is safe and effective in the treatment of depression in people who do not get better with antidepressant medications or cannot take antidepressant…
- Trial name
- NCT01909232
- Testing
- Active Cervel Neurotech Multi-Coil Transcranial Magnetic Stimulator, Inactive Cervel Neurotech Multi-Coil Transcranial Magnetic Stimulator
- Where
- 6 sites in United States
- Volunteers
- 92 people
- Sponsor
- Cervel Neurotech, Inc.
Depression
Reclaim Deep Brain Stimulation Clinical Study for Treatment-Resistant Depression
Medtronic, Inc. sponsored an investigational study of the Reclaim™ Deep Brain Stimulation (DBS) System in people that have treatment-resistant depression.
- Trial name
- NCT00837486
- Testing
- Reclaim™ DBS System
- Where
- 5 sites in United States
- Volunteers
- 30 people
- Sponsor
- MedtronicNeuro
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.
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.
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.