Clinical Trials Logo
  1. Home
  2. Treatment Resistant Depression
  3. NCT05454410

Study of Efficacy, Safety, Tolerability and Pharmacokinetics of MIJ821 in Participants With Treatment- Resistant Depression (TRD)

Treatment-Resistant Depression Clinical Trial

Official title:
A Randomized, Double-blind, Placebo-controlled, Parallel-group Trial to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Single Subcutaneous MIJ821 Injection in Addition to Standard of Care in Participants With Treatment-resistant Depression

Clinical Trial Summary

The main purpose of this study is 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 depression (TRD)

Clinical Trial Description

Approximately 56 participants will be randomized in a total of 20-25 centers worldwide. The trial consists of screening period of up to 28 days. On Day 1, eligible participants will be randomized to one of the treatment arms (low, medium or high dose of MIJ821) or placebo and receive study treatment administered as a single subcutaneous injection. Participant will remain at the clinic for at least 4 hours after administration of study treatment for safety observation including assessment of local tolerability by visual inspection of the injection area. Post-dose clinic visits will occur 24 hours post dose (Day 2), Days 8, 15, 22 and 29 to evaluate efficacy and safety. Efficacy assessments will include the Montgomery-Asberg Depression Scale (MADRS) and other clinical outcome assessments (COAs). Safety assessments include laboratory tests, ECGs, vital signs and physical examinations. In addition phone calls will be conducted 3 days after each on-site clinic visit with the exception of End-of-study (EOS) visit. EOS visit will be completed on site on Day 29. The total duration of the study is approximately 8 weeks (56 days), including screening. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05454410
Study type Interventional
Source Novartis
Contact
Status Completed
Phase Phase 2
Start date March 13, 2023
Completion date November 28, 2023
View Details
See also
  Status Clinical Trial Phase
Completed NCT02497287 - A Long-term, Safety and Efficacy Study of Intranasal Esketamine in Treatment-resistant Depression Phase 3
Recruiting NCT03653858 - Efficacy Study of Deep Brain Stimulation in Patients With Treatment Resistant Major Depression N/A
Recruiting NCT02462551 - Focal Electrically Administered Seizure Therapy for the Treatment of Depression N/A
Recruiting NCT01868802 - Ketamine for Treatment-resistant Depression: A Multicentric Clinical Trial in Mexican Population Phase 2
Recruiting NCT05377177 - Cortical Inhibition as a Biomarker of Response in a Comparison of Bilateral Versus Unilateral Accelerated Theta Burst Stimulation for Suicidal Ideation in Treatment-Resistant Depression -COMBAT-SI N/A
Completed NCT05095792 - Effect of Ketamine on Neurological Activity as Measured by Electroencephalogram (EEG)
Recruiting NCT06372834 - Adjuvant Accelerated piTBS for Reducing Suicidal Ideation in TRD Patients: A Randomized, Sham-controlled Trial N/A
Active, not recruiting NCT03701724 - Cost-utility Analysis of Maintenance rTMS for Treatment-resistant Depression N/A
Recruiting NCT05800860 - A Trial of GH001 in Patients With Treatment-resistant Depression Phase 2
Completed NCT01945047 - Action of Ketamine in Treatment-Resistant Depression Phase 2/Phase 3
Recruiting NCT05045378 - Low-dose Ketamine Infusion Among Adolescents With Treatment-resistant Depression Phase 4
Recruiting NCT05422417 - Dorsomedial Prefrontal Neuromodulation in Treatment-resistant Depression N/A
Recruiting NCT05842291 - pBFS Guided High-dose rTMS Therapy for Treatment-Resistant Depression N/A
Recruiting NCT04821271 - Antidepressant Effects of TS-161 in Treatment-Resistant Depression Phase 2
Active, not recruiting NCT04670081 - Efficacy and Safety of Psilocybin in Treatment-Resistant Major Depression Phase 2
Terminated NCT01598324 - Functional and Neurochemical Correlates of Treatment Response in Major Depressive Disorder N/A
Recruiting NCT05710237 - Does Psilocybin Require Psychedelic Effects to Treat Depression? Phase 2
Completed NCT03329391 - Psychosocial Characteristics and Non-pharmacological Intervention of Patients With Treatment-resistant Depression N/A
Not yet recruiting NCT05661383 - Olfactory and Brain Stimulations in Treatment-resistant Depression N/A
Recruiting NCT05607654 - The Mechanisms of Underlying Accelerated Repetitive Transcranial Magnetic Stimulation for Treatment-resistant Depression N/A