Clinical Trials Logo
  1. Home
  2. Depressive Disorder, Treatment-Resistant
  3. NCT03756129

Proof of Concept Study Evaluating the Efficacy and Safety of MIJ821 in Patients With Treatment-resistant Depression

Depressive Disorder, Treatment-Resistant Clinical Trial

Official title:
A Multi-center, Randomized, subject-and Investigator Blinded, Placebo-controlled, Active Comparator, Parallel-group Proof of Concept Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of MIJ821 in Patients With Treatment-resistant Depression

Clinical Trial Summary

This study will evaluate 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 will be conducted in the US and in Europe (Spain and Czech Republic). The MIJ821 will be administered via infusion on a weekly or bi-weekly basis. The efficacy will be measured after 24 hours using a specific golden standard scale, the Montgomery-Asberg Depression Rating Scale. The study duration is 6 weeks of treatment plus 1 month of follow up period.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03756129
Study type Interventional
Source Novartis
Contact Novartis Pharmaceuticals
Phone 1-888-669-6682
Email Novartis.email@novartis.com
Status Recruiting
Phase Phase 2
Start date February 8, 2019
Completion date March 13, 2020
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT03207282 - Treatment Resistant Depression in America Latina
Completed NCT02691520 - Epidemiology of Treatment Resistant Depression in Taiwan Phase 4
Completed NCT02452892 - Low Field Magnetic Stimulation (LFMS) in Subjects With Treatment-Resistant Depression (TRD) N/A
Completed NCT02493868 - A Study of Intranasal Esketamine Plus an Oral Antidepressant for Relapse Prevention in Adult Participants With Treatment-resistant Depression Phase 3
Recruiting NCT03283670 - Inhaled Nitrous Oxide for Treatment-Resistant Depression: Optimizing Dosing Strategies Phase 2
Recruiting NCT03004521 - Lithium Versus Quetiapine in Treatment Resistant Depression Phase 4
Recruiting NCT03434041 - A Study to Evaluate the Efficacy, Pharmacokinetics, Safety and Tolerability of Flexible Doses of Intranasal Esketamine Plus an Oral Antidepressant in Adult Participants With Treatment-resistant Depression Phase 3
Not yet recruiting NCT03852160 - 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 Phase 3
Completed NCT02577250 - Ketamine Infusions for PTSD and Treatment-Resistant Depression Phase 1
Recruiting NCT02610712 - Clinical Trial of the Use of Ketamine in Treatment Resistant Depression Phase 4
Recruiting NCT03051256 - Safety, Tolerability, PK Profile, and Symptom Response of a 7-Day Dosing With 25 mg Daily and 50 mg Daily of REL-1017 in Major Depressive Disorder Phase 2
Not yet recruiting NCT03851380 - Improving Brain Stimulation Through Imaging
Recruiting NCT02782104 - A Long-term Safety Study of Intranasal Esketamine in Treatment-resistant Depression Phase 3
Recruiting NCT03626181 - Biomarkers of Theta Burst Stimulation in Major Depressive Disorder N/A
Recruiting NCT02994433 - NMDA Receptor Antagonist Nitrous Oxide Targets Affective Brain Circuits Phase 1
Completed NCT02153502 - 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 Phase 2
Completed NCT01898429 - Deep Brain Stimulation (DBS) for Treatment-Resistant Depression (TRD) N/A
Completed NCT03109002 - An Epidemiology Study of Treatment Resistant Depression in the United States (US)
Recruiting NCT03373253 - Treatment-Resistant Depression Cohort in Europe
Completed NCT01983904 - DBS for Treatment Resistant Depression N/A