Clinical trials: Treatment-Resistant Depression
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
Depressive Disorder, Treatment-Resistant
A Study to Evaluate the Efficacy, Safety, and Tolerability of Intranasal Esketamine Plus an Oral Antidepressant in Elderly Participants With Treatment-resistant Depression
The purpose of this study is to evaluate the efficacy and safety of switching elderly participants with treatment-resistant depression (TRD) from a prior antidepressant treatment (to which they have not responded) to either…
- Trial name
- TRANSFORM-3 (NCT02422186)
- Testing
- Esketamine, Duloxetine (Oral Antidepressant), Escitalopram (Oral Antidepressant)
- Where
- 69 sites in United States, Belgium and 10 more
- Volunteers
- 139 people
- Sponsor
- Janssen Research & Development, LLC
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
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
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 Depressive Disorder
A Study to Evaluate the Safety and Efficacy of Intranasal Esketamine in Treatment-resistant Depression
The purpose of this study is to assess the efficacy and dose response of intranasal esketamine (Panel A: 28 mg, 56 mg, and 84 mg and Panel B: 14 mg and 56 mg) compared with placebo in improving depressive symptoms in participants…
- Trial name
- SYNAPSE (NCT01998958)
- Testing
- Esketamine 14 mg, Esketamine 28 mg, Esketamine 56 mg
- Where
- 25 sites in United States, Belgium and 1 more
- Volunteers
- 108 people
- Sponsor
- Janssen Research & Development, LLC
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
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 Intranasal Esketamine Plus an Oral Antidepressant for Relapse Prevention in Adult Participants With Treatment-resistant Depression
The purpose of this study is to assess the efficacy of intranasal esketamine plus an oral antidepressant compared with an oral antidepressant (active comparator) plus intranasal placebo in delaying relapse of depressive symptoms…
- Trial name
- SUSTAIN-1 (NCT02493868)
- Testing
- Esketamine, Duloxetine (Oral Antidepressant), Escitalopram (Oral antidepressant)
- Where
- 155 sites in United States, Belgium and 13 more
- Volunteers
- 719 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
Long-term Safety and Tolerability of BMS-820836 in the Treatment of Patients With Treatment Resistant Major Depression
The purpose of this study it to evaluate the long-term safety and tolerability of BMS-820836 in patients with depression.
- Trial name
- NCT01361555
- Testing
- BMS-820836
- Where
- 144 sites in United States, Argentina and 10 more
- Volunteers
- 789 people
- Sponsor
- Bristol-Myers Squibb
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
Safety, Tolerability, PK and Efficacy of Single Doses of NV-5138 in Healthy Volunteers and Subjects With Treatment-Resistant Depression
Randomized, two-part, placebo-controlled study of single ascending doses of NV-5138 in healthy volunteers, and a single dose of NV-5138 in subjects with Treatment-Resistant Depression (TRD)
- Trial name
- NCT03606395
- Testing
- NV-5138
- Where
- 9 sites in United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Navitor Pharmaceuticals, 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
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
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.
Bipolar Depression
Efficacy, Safety and Pharmacokinetic Study of Inhaled Esketamine in Treatment-resistant Bipolar Depression
The purpose of the study is to determine the efficacy, safety and pharmacokinetics of inhaled Esketamine in participants with treatment-resistant bipolar depression (TRBD).
- Trial name
- NCT03965871
- 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
Depression
Study Comparing Outcomes for Patients With Treatment Resistant Depression Who Receive VNS Therapy at Different Doses
This is a postmarket medical device study. The objective of this study is to compare the safety and effectiveness of Vagus Nerve Stimulation (VNS) Therapy administered at different amounts of electrical charge for the treatment…
- Trial name
- NCT00305565
- Testing
- VNS Therapy
- Where
- 26 sites in United States
- Volunteers
- 331 people
- Sponsor
- Cyberonics, 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.
Major Depressive Disorder
The Study of Olanzapine Plus Fluoxetine in Combination for Treatment of Treatment Resistant Depression
The purposes of this study are to determine: Whether olanzapine plus fluoxetine in combination will help patients with treatment-resistant major depression.
- Trial name
- NCT00035321
- Testing
- Olanzapine, Fluoxetine
- Where
- 33 sites in United States, Canada
- Volunteers
- 600 people
- Sponsor
- Eli Lilly and Company