Clinical trials: Treatment Resistant Depression (TRD)
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
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
Major Depressive Disorder, Treatment Resistant Depression
An Evaluation of AXS-05 for the Treatment of TRD in Treatment-Adherent Patients
The TARGET study is an active-controlled evaluation of AXS-05 compared to bupropion in patients with treatment-resistant major depressive disorder (MDD) who are adherent to study drug.
- Trial name
- TARGET (NCT04971291)
- Testing
- AXS-05, Bupropion SR
- Where
- United States
- Volunteers
- 312 people
- Sponsor
- Axsome Therapeutics, Inc.
Treatment Resistant Major Depressive Disorder
A Study to Assess the Efficacy and Safety of AXS-05 in Subjects With Treatment Resistant Major Depressive Disorder
To evaluate the efficacy and safety of AXS-05 relative to bupropion in subjects with treatment resistant major depressive disorder (MDD).
- Trial name
- STRIDE-1 (NCT02741791)
- Testing
- AXS-05, Bupropion
- Where
- 74 sites in United States
- Volunteers
- 312 people
- Sponsor
- Axsome Therapeutics, Inc.
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.
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
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.
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
Depression
An Expanded Access Protocol for Esketamine Treatment in Participants With Treatment Resistant Depression (TRD) Who do Not Have Other Treatment Alternatives
The purpose of this expanded access program (EAP) is to provide expanded access to esketamine treatment and collect additional safety data and quality of life until esketamine is commercially available for participants with…
- Trial name
- NCT04476446
- Testing
- Esketamine
- Where
- 8 sites in Mexico
- Volunteers
- 41 people
- Sponsor
- Janssen-Cilag, S.A.
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 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
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.
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.
Depression
Efficacy and Safety of Fixed Doses of BMS 820836 in the Treatment of Patients With Treatment Resistant Major Depression
The purpose of the study is to evaluate the efficacy of study drug (BMS-820836) as compared with continued Duloxetine/Escitalopram in the treatment of patients with treatment resistant depression (TRD).
- Trial name
- NCT01369095
- Testing
- Duloxetine, Escitalopram, BMS-820836
- Where
- 93 sites in United States, Argentina and 10 more
- Volunteers
- 976 people
- Sponsor
- Bristol-Myers Squibb
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
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.
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
Study of Efficacy, Safety, Tolerability and Pharmacokinetics of MIJ821 in Participants With Treatment- Resistant Depression (TRD)
The main purpose of this study was to evaluate safety and efficacy of a single injection of MIJ821 in addition to standard of care (SoC) pharmacological anti-depressant treatment in participants with treatment-resistant…
- Trial name
- NCT05454410
- Testing
- MIJ821 Subcutaneous Injection 1 mg, MIJ821 Subcutaneous Injection 4 mg, MIJ821 Subcutaneous Injection 10 mg
- Where
- 16 sites in United States, Japan and 2 more
- Volunteers
- 60 people
- Sponsor
- Novartis Pharmaceuticals
Treatment Resistant Depression
A Randomized, Placebo-Controlled, Double-Blind Study to Assess Safety and Efficacy of PCN-101 in TRD
This is a double-blind, randomized, placebo-controlled, multicenter study comprised of 3 phases:screening (up to 2 weeks [Day -15 to Day -2]), In-Clinic Treatment (Day -1 to Day 2; including double-blind treatment [Day 1]), and…
- Trial name
- NCT05414422
- Testing
- PCN-101
- Where
- 21 sites in United States, Germany and 1 more
- Volunteers
- 102 people
- Sponsor
- Perception Neuroscience
Treatment Resistant Depression
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…
- Trial name
- UNCOVER (NCT04753385)
- Where
- 33 sites in United States
- Volunteers
- 138 people
- Sponsor
- LivaNova