Clinical trials: Treatment Resistant Major 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
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
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.
Healthy
A Multiple Ascending Dose Study of BCI-838 in Healthy Volunteers
This study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of BCI-838 and its metabolite BCI-632 in healthy male and female subjects.
- Trial name
- NCT01548703
- Testing
- BCI-838
- Where
- Netherlands
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- BrainCells 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
Depressive Disorder, Major
A Clinical Trial for the Treatment of Depression With Repetitive Transcranial Magnetic Stimulation (rTMS)
The purpose of this study is to determine whether the Cervel Neurotech rTMS device is safe and effective in the treatment of depression in people who do not get better with antidepressant medications or cannot take antidepressant…
- Trial name
- NCT01909232
- Testing
- Active Cervel Neurotech Multi-Coil Transcranial Magnetic Stimulator, Inactive Cervel Neurotech Multi-Coil Transcranial Magnetic Stimulator
- Where
- 6 sites in United States
- Volunteers
- 92 people
- Sponsor
- Cervel Neurotech, Inc.
Treatment Resistant Depression
A Study to Assess the Efficacy, Safety and Tolerability of VLS-01 Buccal Film, Compared to Placebo in Patients With Treatment Resistant Depression (ELUMINA)
This Phase 2 study (protocol number VLS-01-203) will determine the efficacy, safety, and tolerability of short-term treatment with a VLS-01 transmucosal buccal film (VLS-01-BU) in patients with treatment resistant Major…
- Trial name
- NCT06524830
- Testing
- VLS-01-203 BU
- Where
- 48 sites in United States, Australia and 2 more
- Volunteers
- 142 people
- Sponsor
- atai Therapeutics, Inc.
Major Depressive Disorder (MDD)
Regulated Stimulation for Optimized Network Activity and Therapeutic Equilibrium - Maintenance
The objective of this study is to evaluate the safety, tolerability, and preliminary efficacy of the Motif XCS System when used as indicated for treatment-resistant depression (TRD).
- Trial name
- RESONATE-M (NCT07684794)
- Testing
- Motif XCS System
- Volunteers
- 10 people
- Sponsor
- Motif Neurotech, Inc.
Major Depressive Disorder
Regulated Stimulation for Optimized Network Activity and Therapeutic Equilibrium
The objective of this study is to evaluate the safety, tolerability, and preliminary efficacy of the Motif eXternally powered Cortical Stimulation (XCS) System when used as indicated for treatment-resistant depression (TRD).
- Trial name
- RESONATE (NCT07594483)
- Testing
- Motif XCS System
- Where
- 3 sites in United States
- Volunteers
- 20 people
- Sponsor
- Motif Neurotech, Inc.
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.
Major Depressive Disorder
A Study of the Efficacy of Intravenous Esketamine in Adult Patients With Treatment-Resistant Depression
The purpose of this study is to assess the efficacy of esketamine compared with placebo in improving symptoms of depression in patients with treatment resistant depression.
- Trial name
- NCT01640080
- Testing
- Esketamine
- Where
- 9 sites in Belgium, Germany and 1 more
- Volunteers
- 30 people
- Sponsor
- Janssen Research & Development, LLC
Major Depressive Disorder
Pilot Study in Multi-Coil Repetitive Transcranial Magnetic Stimulation (rTMS) for Treatment Resistant Depression
The purpose of this study is to assess the efficacy of a Deep Shaped-Field repetitive transcranial magnetic stimulation (DSF-rTMS) system in the treatment of depression.
- Trial name
- NCT01431001
- Testing
- Cervel Neurotech Deep Shaped-Field repetitive transcranial magnetic stimulator (DSF-rTMS)
- Where
- 4 sites in United States, Australia
- Volunteers
- 40 people
- Sponsor
- Cervel Neurotech, Inc.
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 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
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
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
Major Depressive Disorder
Open Label Optimization Study
The goal of this observational study is to demonstrate effectiveness in the treatment of Major Depressive Disorder The primary objective is to assess the effectiveness in the treatment of Major Depressive Disorder using the CGI-I…
- Trial name
- OLO (NCT05819021)
- Testing
- SAINT® Neuromodulation System (NMS)
- Where
- 7 sites in United States
- Volunteers
- 1,000 people
- Sponsor
- Magnus Medical
Depressive Disorder, Treatment-Resistant
Efficacy, Safety, and Tolerability Study of AVP-786 as an Adjunctive Therapy in Patients With Major Depressive Disorder With an Inadequate Response to Antidepressant Treatment
The objectives of this 10-week study are to evaluate the efficacy, safety, and tolerability of AVP 786 as an adjunctive therapy compared with placebo in patients with major depressive disorder (MDD) who have shown an inadequate…
- Trial name
- NCT02153502
- Testing
- AVP-786 (d6-dextromethorphan hydrobromide and quinidine sulfate combination)
- Where
- 32 sites in United States
- Volunteers
- 206 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Major Depressive Disorder, Treatment Resistant Depression
Open-Label Safety Study of AXS-05 in Subjects With Depression
An open-label, long-term, safety study of AXS-05 in patients with major depressive disorder (MDD), including treatment resistant depression.
- Conditions
- Major Depressive Disorder, Treatment Resistant Depression, Depression
- Trial name
- NCT04039022
- Testing
- AXS-05 (dextromethorphan and bupropion) oral tablets
- Where
- 51 sites in United States
- Volunteers
- 876 people
- Sponsor
- Axsome Therapeutics, 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.