Clinical trials: Treatment-resistant Depression
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
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, Major
A Long-term Comparison of Esketamine Nasal Spray Versus Quetiapine Extended Release, Both in Combination With a Selective Serotonin Reuptake Inhibitor/Serotonin-Norepinephrine Reuptake Inhibitor, in Participants With Treatment Resistant Major Depressive Disorder
The primary purpose of this study is to evaluate the efficacy of flexibly dosed esketamine nasal spray compared with quetiapine extended-release (XR), both in combination with a continuing selective serotonin reuptake…
- Trial name
- ESCAPE-TRD (NCT04338321)
- Testing
- Esketamine 28 mg, Esketamine 56 mg, Esketamine 84 mg
- Where
- 171 sites in Argentina, Austria and 22 more
- Volunteers
- 676 people
- Sponsor
- Janssen-Cilag International NV
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
Treatment Resistant Depression
Phase 2 Study of NV-5138 in Adults With Treatment Resistant Depression
This study will evaluate the efficacy and safety of NV-5138 in adults with TRD
- Trial name
- NCT05066672
- Testing
- NV-5138
- Where
- United States
- Volunteers
- 250 people
- Sponsor
- Navitor 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
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.
Unipolar Depression, Treatment Resistant Depression
Home-administered tDCS for Treatment of Depression
This study will determine the safety and efficacy of home administered tDCS in adults with unipolar depression. The device used to administer tDCS will be the Soterix Medical 1X1 mini-CT.
- Trial name
- NCT04781127
- Testing
- Soterix Medical mini-CT tDCS stimulator
- Where
- United States
- Volunteers
- 50 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
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.
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.
Treatment Resistant Depression
Linear Asymmetric rTMS in Adolescent Treatment-Resistant Depression: Tolerability of Treatment Durations Ranging From Ten Days to One Day
This is a pilot interventional study to investigate the acceptability, tolerability, and side effect profile for varying numbers of treatment sessions/day of a new rTMS treatment in adolescents with treatment-resistant depression…
- Trial name
- NCT03986658
- Testing
- Linear Asymmetric rTMS System
- Where
- Canada
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- NeuroQore Inc.
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
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
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
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
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.