Clinical trials: Treatment-Resistant Depression
Depression Severe
Brain Stimulation for Severe Depression
Chronic intracalvarial cortical stimulation is a minimally invasive method involving the neurosurgical placement of an electrode above the inner table of the skull.
- Trial name
- NCT05393622
- Testing
- INTRACALVARIAL PREFRONTAL CORTICAL STIMULATION (IpCS) IN SEVERE TREATMENT-RESISTANT DEPRESSION
- Where
- 2 sites in United States
- Volunteers
- 20 people
- Sponsor
- Inner Cosmos 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 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
Depression
RESIST : Administration of MAP4343 in Antidepressant Non-Responders Patients Experiencing a Major Depressive Episode
The study is a phase II, double-blind, randomized, placebo controlled, parallel, multicentric study in 110 patients with drug resistant depression.
- Trial name
- NCT03870776
- Testing
- MAP4343
- Where
- 10 sites in France
- Volunteers
- 126 people
- Sponsor
- Mapreg
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
Long Term Follow Up Study to COMP 001 And COMP 003 Trials (P-TRD LTFU)
The primary objective of this study is to assess the long-term efficacy of psilocybin with respect to use of new antidepressant treatment, hospitalisations for depression, suicidality, and depressive severity rated using the…
- Trial name
- NCT04519957
- Where
- 8 sites in United States, Czechia and 3 more
- Volunteers
- 66 people
- Sponsor
- COMPASS Pathways
Treatment-resistant Depression
A Long-term, Safety and Efficacy Study of Intranasal Esketamine in Treatment-resistant Depression
The purpose of this open-label, multicenter study is to assess the long term safety and efficacy of intranasal esketamine plus an oral antidepressant in participants with treatment-resistant depression (TRD).
- Trial name
- SUSTAIN-2 (NCT02497287)
- Testing
- Esketamine (Intranasal Spray), Duloxetine (Oral Antidepressant), Escitalopram (Oral Antidepressant)
- Where
- 109 sites in United States, Argentina and 19 more
- Volunteers
- 802 people
- Sponsor
- Janssen Research & Development, LLC
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
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, 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
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 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
An Open-Label Study to Evaluate the Safety, Tolerability and Pharmacodynamics of BPL-003 in Patients With Treatment Resistant Depression
An open-label, multi-centre, Phase 2a study to evaluate the safety, tolerability, and pharmacodynamics of one and two doses of intranasal BPL-003 combined with psychological support, in patients with treatment resistant…
- Trial name
- NCT05660642
- Testing
- BPL-003
- Where
- 3 sites in United Kingdom
- Volunteers
- 72 people
- Sponsor
- Beckley Psytech Limited
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
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
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
Depressive Disorder, Major
A Long-Term Extension Study for Participants With Treatment-resistant Major Depressive Disorder Who Are Continuing Esketamine Nasal Spray Treatment
The primary purpose of this study is to assess the long-term safety and tolerability of esketamine nasal spray in combination with a selective serotonin reuptake inhibitor/serotonin-norepinephrine reuptake inhibitor (SSRI/SNRI)…
- Trial name
- ESCAPE-LTE (NCT04829318)
- Testing
- Esketamine, SSRI/SNRI
- Where
- 59 sites in Argentina, Belgium and 12 more
- Volunteers
- 183 people
- Sponsor
- Janssen-Cilag Ltd.
Depression
A Study to Evaluate the Efficacy, Safety and Tolerability of Fixed Doses of Intranasal Esketamine in Japanese Participants With Treatment Resistant Depression
The purpose of this study is to evaluate the efficacy of fixed dosed intranasal esketamine compared to intranasal placebo, as an add-on to an oral antidepressant in Japanese participants with treatment-resistant depression (TRD)…
- Trial name
- NCT02918318
- Testing
- Intranasal esketamine (28 mg), Intranasal esketamine (56 mg), Intranasal esketamine (84 mg)
- Where
- 43 sites in Japan
- Volunteers
- 202 people
- Sponsor
- Janssen Pharmaceutical K.K.
Treatment-resistant Depression
A Study to Evaluate the Efficacy, 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 compare the efficacy and safety of switching treatment-resistant depression (TRD) subjects from a prior antidepressant treatment (to which they have not responded) to either intranasal esketamine…
- Trial name
- TRANSFORM-2 (NCT02418585)
- Testing
- Esketamine, Duloxetine (Oral Antidepressant), Escitalopram (Oral antidepressant)
- Where
- 48 sites in United States, Czechia and 3 more
- Volunteers
- 236 people
- Sponsor
- Janssen Research & Development, LLC
Treatment Resistant Depressive Disorder
A Study To Evaluate The Safety, Tolerability And Pharmacokinetics of HS-10345 In Treatment-Resistant Depression
The purpose of this study is to assess the safety, tolerability and pharmacokinetics of intranasal HS-10345 (84mg) compared with placebo in participants with treatment-resistant depression (TRD).
- Trial name
- NCT05196971
- Testing
- HS-10345 84mg
- Where
- China
- Volunteers
- 12 people
- Sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.