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Monoclonal Antibodies

Ixekizumab for Treatment-Resistant Depression

Phase 2
Recruiting
Led By James W Murrough, MD, PhD
Research Sponsored by Icahn School of Medicine at Mount Sinai
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants must meet DSM-5 criteria for Major Depressive Disorder (MDD) in a current major depressive episode (MDE) as determined by a study psychiatrist and confirmed using the Structured Clinical Interview for DSM-5 Research Version (SCID-5-RV)
Men and women, age 18-70 years
Must not have
Diagnosis of a major neurocognitive disorder
Any contraindication to MRI or gadolinium including claustrophobia, any trauma or surgery which may have left magnetic material in the body, magnetic implants or pacemakers, inability to lie still for 1 hour or more, any known allergy to gadolinium
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial tests ixekizumab, a medication that blocks a specific protein, in adults whose depression hasn't improved with other treatments. By reducing inflammation, it may help alleviate their symptoms.

Who is the study for?
Adults aged 18-65 with treatment-resistant depression, on stable antidepressant doses for over 4 weeks, and have had at least two adequate treatment trials. Participants must not be at risk of self-harm or substance abuse, pregnant or breastfeeding, and willing to use contraception.
What is being tested?
The trial is testing Ixekizumab, an antibody targeting IL-17A, against a placebo in patients who haven't responded well to standard depression treatments. It's designed to see if this new approach can help where other treatments haven't.
What are the potential side effects?
Ixekizumab may cause side effects such as infections due to immune system suppression, allergic reactions at the injection site, and possibly others that are common with monoclonal antibodies.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with Major Depressive Disorder and am currently experiencing a major depressive episode.
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I am between 18 and 70 years old.
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I have been on the same dose of antidepressant for more than 4 weeks.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with a significant memory or thinking problem.
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I can undergo an MRI without any health risks or physical limitations.
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I do not have any unstable illnesses affecting my organs or immune system.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Drop-out Rate
Number of anticipated and unanticipated Adverse events
Secondary study objectives
Change in Clinical Global Impression Scale
Change in Montgomery-Åsberg Depression Rating Scale Score - remission rate
Change in Montgomery-Åsberg Depression Rating Scale Score - response rate
+5 more

Side effects data

From 2019 Phase 4 trial • 566 Patients • NCT03151551
1%
Upper respiratory tract infection
1%
Nasopharyngitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Adalimumab Follow-up
Ixekizumab Follow-up
Ixekizumab
Adalimumab

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: IxekizumabExperimental Treatment1 Intervention
Ixekizumab 160 mg (two 80 mg injections) at Week 0, followed by 80 mg at Weeks 2 and 4 via subcutaneous route.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ixekizumab
2020
Completed Phase 4
~6560

Find a Location

Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiLead Sponsor
904 Previous Clinical Trials
541,801 Total Patients Enrolled
38 Trials studying Depression
6,042 Patients Enrolled for Depression
James W Murrough, MD, PhDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
1 Previous Clinical Trials
60 Total Patients Enrolled
1 Trials studying Depression
60 Patients Enrolled for Depression

Media Library

Ixekizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04979910 — Phase 2
Depression Research Study Groups: Ixekizumab
Depression Clinical Trial 2023: Ixekizumab Highlights & Side Effects. Trial Name: NCT04979910 — Phase 2
Ixekizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04979910 — Phase 2
~7 spots leftby Oct 2026
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