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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to week 6
Awards & highlights

Study Summary

This trial will test a new drug, ixekizumab, for patients with treatment-resistant depression.

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.Check my eligibility
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.See study design
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.

Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Montgomery-Åsberg Depression Rating Scale Score
Secondary outcome measures
Change in Clinical Global Impression Scale
Change in Quick Inventory of Depressive Symptomatology, Self-Report [QIDS-SR] Score
Change in Snaith-Hamilton Pleasure Scale (SHAPS)
+3 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: IxekizumabActive Control1 Intervention
Ixekizumab 160 mg (two 80 mg injections) at Week 0, followed by 80 mg at Weeks 2 and 4 via subcutaneous route.
Group II: PlaceboPlacebo Group1 Intervention
Matching saline placebo at Week 0 (two injections), followed by one injection at Weeks 2 and 4 via subcutaneous route.

Find a Location

Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiLead Sponsor
860 Previous Clinical Trials
524,448 Total Patients Enrolled
34 Trials studying Depression
4,341 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, Placebo
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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this experiment actively seeking new participants?

"According to the clinicaltrials.gov, this research is actively seeking participants. It was first published on August 27th 2021 with a recent update occurring November 16th 2021."

Answered by AI

Are geriatric participants being considered for this research?

"This research is open to any person aged 18 and over, up until the age of 65."

Answered by AI

How many individuals have been included in this clinical investigation?

"Indeed, clinicaltrials.gov indicates that this medical trial is actively investigating volunteers; the preliminary post was published on August 27 2021 and it has been recently updated on November 16th 2021. The research necessitates 28 individuals from a single healthcare facility."

Answered by AI

Has Ixekizumab been proven to be dependable for patients?

"Given its Phase 2 status, our team at Power believe ixekizumab is moderately safe and assigned it a score of 2. This drug has been studied for safety but not yet confirmed on efficacy."

Answered by AI

Who is eligible to partake in this trial?

"This medical research is searching for 28 people afflicted with melancholia aged 18 to 65. To be eligible, potential participants must have a Quick Inventory of Depressive Symptoms - Clinician Administered (QIDS-C) score ≥ 14, meet the DSM-5 criteria for Major Depressive Disorder [MDD], and been on stable dosages of antidepressant medication for more than 4 weeks prior to randomization; further they must demonstrate an ability to comply with the requirements set out by their primary investigator."

Answered by AI

Who else is applying?

What site did they apply to?
Icahn School of Medicine at Mount Sinai
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Targeting IL-17A for Treatment-Resistant Depression
James Murrough 2021. "Targeting IL-17A for Treatment-Resistant Depression". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04979910.
All > Mdd
~4 spots leftby Oct 2024
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