Targeting IL-17A for Treatment-Resistant Depression

  • STATUS
    Recruiting
  • End date
    Oct 27, 2023
  • participants needed
    28
  • sponsor
    Icahn School of Medicine at Mount Sinai
Updated on 27 November 2021

Summary

The proposed study aims to test ixekizumab, a monoclonal antibody (mAb) against interleukin 17A (IL-17A), in patients with treatment-resistant depression (TRD).

Description

In the proposed study n=28 adult individuals with TRD will be treated with either ixekizumab or placebo for 4 weeks. Participants will complete screening procedures, body fluid analyses and brain imaging before and after treatment with ixekizumab or placebo.

Details
Condition Major depression, Endogenous depression, major depressive disorders, major depressive disorder
Treatment Placebo, Ixekizumab
Clinical Study IdentifierNCT04979910
SponsorIcahn School of Medicine at Mount Sinai
Last Modified on27 November 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Written informed consent (and assent when applicable) obtained from subject
Ability for subject to comply with the requirements of the study as determined by the PI
Men and women, age 18-65 years
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)
Participants have had 2 adequate trials of antidepressants/augmentation strategies during current episode. (Refer to ATRQ Guidelines for Completion for guidelines on dose/duration required for a trial to be considered adequate.)
Patients must be on a stable dose of antidepressant medication for >4 weeks prior to randomization
CRP level 2mg/L at screening
Quick Inventory of Depressive Symptoms - Clinician Administered (QIDS-C) score 14
If female of childbearing potential, must agree to use of a medically accepted form of contraception, or else agree to abstinence until 6 months after the last dose of study drug
Male patients, if heterosexually active with a partner who is female of childbearing potential, pregnant, or breastfeeding, must agree to barrier contraception for the treatment period and for at least 6 months after the last dose of study drug. Female partners of male participants must use at least one form of highly effective contraception starting at least one cycle prior to male patient study drug initiation until 6 months after the last dose of study drug

Exclusion Criteria

A primary psychiatric diagnosis other than MDD as defined by DSM-5; [comorbid anxiety disorders (including agoraphobia, generalized anxiety disorder, social anxiety disorder and panic disorder) and posttraumatic stress disorder (PTSD) are allowed]
Has a history of schizophrenia or other psychotic disorder, major depressive disorder with psychotic features, or bipolar I or II disorder
Diagnosis of a major neurocognitive disorder
Meets criteria for a moderate or severe substance use disorder within the past 6 months, with the exception of nicotine use disorder
The patient is pregnant or breastfeeding
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
Positive urine toxicology screen for illicit drugs at the time of screening
Serious and imminent risk of self-harm or violence as determined by the PI
History of suicide attempt in the past 2 years or screening CSSRS Ideation Score >2 in the past month
Clinically significant abnormalities of laboratory tests or physical examination
Any unstable medical illnesses including hepatic, renal, gastroenterological, respiratory, cardiovascular (including ischemic heart disease); endocrinologic, neurologic (including history of severe head injury), immunologic, or hematologic disease
Presence of TB as assessed by Quantiferon Gold test at screening
Concomitant treatments with other biologics or other immune-suppressant agents; PRN use of NSAIDs is permissible
Female participants who are pregnant, breastfeeding, or may become pregnant, or unwilling to practice birth control during participation in the study or the 6 months following
Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data
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