Clinical trials: Depressions, Refractory
Major Depressive Disorder
Pivotal Trial (D02) of Vagus Nerve Stimulation (VNS) for Treatment-Resistant Depression (TRD)
To confirm the safety and efficacy of the NCP System in treating patients in a nmajor depressive episode.
- Trial name
- NCT00533832
- Testing
- vagus nerve stimulation (VNS)
- Where
- United States
- Volunteers
- 266 people
- Sponsor
- Cyberonics, Inc.
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
Depression
A Study to Assess Feasibility of Using Clinician-directed and Digital Application Supported Cognitive Behavior Therapy (CBT) in Conjunction With Esketamine in Participants With Treatment-resistant Depression
The purpose of this study is to explore feasibility of combining clinician-directed cognitive behavioral therapy (CBT) supplemented with the Mindset app with esketamine therapy in participants with Treatment-resistant Depression.
- Trial name
- NCT05268497
- Testing
- Esketamine, Cognitive Behavioral Therapy (CBT), Antidepressant
- Where
- 5 sites in United States
- Sponsor
- Janssen Research & Development, LLC
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 Biomarker-Guided, Randomized, Placebo-Controlled Efficacy and Safety Study of Liafensine in Patients With TRD
This study was conducted as a randomized, double-blind, placebo-controlled, multi-center Phase 2b study. Approximately 180 subjects with treatment resistant depression who meet all eligibility criteria will be enrolled.
- Trial name
- ENLIGHTEN (NCT05113771)
- Testing
- Liafensine
- Where
- 45 sites in United States, Canada
- Volunteers
- 197 people
- Sponsor
- Denovo Biopharma LLC
Treatment Resistant Depression
A Study of Olanzapine and Fluoxetine for Treatment-resistant Depression
The purpose of this study is to assess the efficacy and safety of olanzapine and fluoxetine compared to placebo and fluoxetine as treatment for treatment-resistant depression (TRD) in Chinese participants.
- Trial name
- NCT01687478
- Testing
- Olanzapine, Fluoxetine
- Where
- 11 sites in China
- Volunteers
- 176 people
- Sponsor
- Eli Lilly and Company
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 Major Depressive Disorder
Repeated Intranasal Esketamine Plus Almond Therapy in Participants With Treatment Resistant Depressive Disorder - 3 Month Extension Study
The purpose of this study is to determine if any improvements in depressive symptoms are maintained in the medium and longer-term (up to 3 months)
- Trial name
- ZYL-730-02 (NCT05438758)
- Testing
- Almond Therapy, Intranasal ketamine (Esketamine), Treatment as Usual
- Sponsor
- Zylorion Health
Depressive Disorder, Major, Depressive Disorder, Treatment-Resistant
Safety, Tolerability, PK Profile, and Symptom Response of a 7-Day Dosing With 25 mg or 50 mg Daily of REL-1017 in MDD
This a Phase 2a, multicenter, randomized, double-blind, placebo controlled 3 arm study to assess the safety and tolerability of multiple oral doses of REL-1017 25 mg and 50 mg as adjunctive therapy in the treatment of patients…
- Trial name
- NCT03051256
- Testing
- REL-1017
- Where
- 10 sites in United States
- Volunteers
- 62 people
- Sponsor
- Relmada Therapeutics, Inc.
Treatment Resistant Depressive Disorder
Efficacy and Safety of DBS in Patients With Treatment-Resistant Depression
The habenula (Hb) is an ancient structure, located at the center of the dorsal diencephalic conduction system, a pathway involved in linking forebrain to midbrain regions.
- Trial name
- NCT03667872
- Testing
- Bilateral implantation of DBS system to Habeluna
- Where
- China
- Volunteers
- 6 people
- Sponsor
- Beijing Pins Medical Co., Ltd
Depressive Disorder, Treatment-Resistant
A Study to Evaluate the Efficacy, Pharmacokinetics, Safety and Tolerability of Flexible Doses of Intranasal Esketamine Plus an Oral Antidepressant in Adult Participants With Treatment-resistant Depression
The purpose of this study is to evaluate the efficacy of switching adult participants with treatment-resistant depression (TRD) from a prior antidepressant treatment (to which they have not responded) to flexibly dosed intranasal…
- Trial name
- NCT03434041
- Testing
- Esketamine 56 mg, Esketamine 84 mg, Duloxetine (Oral Antidepressant)
- Where
- 30 sites in United States, China
- Volunteers
- 252 people
- Sponsor
- Janssen Research & Development, LLC
Treatment Resistant Depression
A Study in Relapse Prevention of Treatment-Resistant Depression
The purpose of this study is to determine whether olanzapine and fluoxetine combination (OFC) if used for a long time (47 weeks) makes patients suffering from Treatment Resistant Depression stable, determine if OFC is safe when…
- Trial name
- NCT00958568
- Testing
- Olanzapine and Fluoxetine combination (OFC), Fluoxetine
- Where
- 66 sites in United States, Argentina and 6 more
- Volunteers
- 892 people
- Sponsor
- Eli Lilly and Company
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
Depressive Disorder, Treatment-Resistant
A Study of Esketamine Nasal Spray Plus a New Standard-of-care Oral Antidepressant or Placebo Nasal Spray Plus a New Standard-of-care Oral Antidepressant in Adult and Elderly Participants With Treatment-resistant Depression
The purpose of this study is to evaluate the efficacy of treating participants with treatment-resistant depression (TRD) who have failed at least 2 (and no more than 6) prior antidepressant (AD) treatments in the current moderate…
- Trial name
- NCT03852160
- Testing
- Esketamine 28 mg, Esketamine 56 mg, Esketamine 84 mg
- Sponsor
- Janssen-Cilag International NV
Depression
AZD6765 for Treatment Resistant Depression
The purpose of this study is to determine whether treatment with AZD6765 will have an antidepressant effect with patients who have treatment resistant depression.
- Trial name
- NCT00491686
- Testing
- AZD6765
- Where
- 5 sites in United States
- Volunteers
- 34 people
- Sponsor
- AstraZeneca
Treatment Resistant Depression
Virtual Neuro-Navigation System for Personalized Community Based TMS
Phase I study of a virtual neuro-navigation package with built-in support for identifying specific "surface-based" targets to optimze TMS treatment.
- Trial name
- NCT04956081
- Testing
- Neuro-navigated Transcranial Magnetic Stimulation (TMS)
- Where
- United States
- Volunteers
- 22 people
- Sponsor
- Soterix Medical
Treatment Resistant Depression, Major Depressive Disorder
Clinical Study of GH001 in Depression
The aim of the study is to investigate the safety of GH001 (containing 5-methoxy-dimethyltryptamine; 5-MeO-DMT), and to investigate its effects on severity of depressive symptoms, and its dose-related psychoactive effects in…
- Conditions
- Treatment Resistant Depression, Major Depressive Disorder, Depression
- Trial name
- NCT04698603
- Testing
- 5 Methoxy N,N Dimethyltryptamine
- Where
- Netherlands
- Volunteers
- 16 people
- Sponsor
- GH Research Ireland Limited
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
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, 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