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Targeting IL-17A for Treatment-Resistant Depression
Phase 2 trial testing Ixekizumab in Major Depressive Disorder in 7 participants. Completed in 12 April 2024.
| Lead sponsor | Icahn School of Medicine at Mount Sinai |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 7 |
| Start date | 27 August 2021 |
| Primary completion | 12 April 2024 |
| Estimated completion | 12 April 2024 |
| Sites | 1 location across United States |
Icahn School of Medicine at Mount Sinai
Adults 18 to 70, any sex, with Major Depressive Disorder. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The safety and feasibility of using ixekizumab in patients with TRD will be assessed by the completion of treatment measured as the receipt of all three Ixekizumab injections (160 mg at week 0, 80 mg at weeks 2 and 4). Drop-out rates will be calculated.
| Group | Value | 95% CI |
|---|---|---|
| Ixekizumab | 0 |
The incidence and frequency of all anticipated and unanticipated serious and non-serious adverse events
| Group | Value | 95% CI |
|---|---|---|
| Ixekizumab | 8 |
Response rate at week 6 as compared to baseline, defined as \>=50% MADRS total score improvement. The Montgomery-Åsberg Depression Rating Scale (MADARS) is a 10-item instrument used for the evaluation of depressive symptoms in adults and for the assessment of any changes to those symptoms. Each of the 10 items is rated on a scale of 0 to 6, with differing descriptors for each item. These individual item scores are added together to form a total score, which can range between 0 and 60 points. The MADRS provides a measure of the overall level of depression. Higher score indicates poorer health
| Group | Value | 95% CI |
|---|---|---|
| Ixekizumab | 28.57 | ± 6.55 |
| Group | Value | 95% CI |
|---|---|---|
| Ixekizumab | 23.86 | ± 10.07 |
Remission rate at week 6 as compared to baseline, defined as MADRS total score of \<=10.. The Montgomery-Åsberg Depression Rating Scale (MADARS) is a 10-item instrument used for the evaluation of depressive symptoms in adults and for the assessment of any changes to those symptoms. Each of the 10 items is rated on a scale of 0 to 6, with differing descriptors for each item. These individual item scores are added together to form a total score, which can range between 0 and 60 points. The MADRS provides a measure of the overall level of depression. Higher score indicates poorer health outcome.
| Group | Value | 95% CI |
|---|---|---|
| Ixekizumab | 28.57 | ± 6.55 |
| Group | Value | 95% CI |
|---|---|---|
| Ixekizumab | 23.86 | ± 10.07 |
The Quick Inventory of Depressive Symptomatology, Self-Report (QIDS-SR) is a 16-item self-rated instrument designed to assess the severity of depressive symptoms. The 16 items cover the nine symptom domains of major depression and are rated on a scale of 0-3. Total score ranges from 0 to 27, with ranges of 0-5 (normal), 6-10 (mild), 11-15 (moderate), 16-20 (moderate to severe), and 21+ (severe). Higher score indicates poorer health outcome.
| Group | Value | 95% CI |
|---|---|---|
| Ixekizumab | 13.57 | ± 4.04 |
| Group | Value | 95% CI |
|---|---|---|
| Ixekizumab | 11.57 | ± 5.50 |
The Snaith-Hamilton Pleasure Scale (SHAPS) is a well-validated 14-item self-report questionnaire commonly used to assess anhedonia. Each item on the SHAPS is worded so that higher scores indicate greater pleasure capacity. A total score can be derived by summing the responses to each item. Items answered with "strongly agree" are coded as "1", while a "strongly disagree" response was assigned a score of "4." Total scores on the SHAPS can range from 14 to 56, with higher scores corresponding to higher levels of anhedonia.
| Group | Value | 95% CI |
|---|---|---|
| Ixekizumab | 35.29 | ± 11.43 |
| Group | Value | 95% CI |
|---|---|---|
| Ixekizumab | 33.14 | ± 12.23 |
The Temporal Experience of Pleasure Scale (TEPS) is an 18-item self-report measurement of anhedonia which consists of a series of statements that must be rated according to how accurate they are for the individual. The scale produces a sub-score that differentiates the role of anticipatory pleasure ('wanting') and is derived of 10 items. Subscales scores from 9-54. Total scores range is 16-108. Lower scores indicate greater levels of anhedonia.
| Group | Value | 95% CI |
|---|---|---|
| Ixekizumab | 57.71 | ± 21.78 |
| Group | Value | 95% CI |
|---|---|---|
| Ixekizumab | 63.14 | ± 24.59 |
This is a widely administered clinician rated scale that assesses the subject overall illness severity and the degree of improvement from the initial assessment. Illness severity is rated on a 1-7 scale where 1 corresponds to "Normal, Not at All Ill", 2 is "Borderline Mentally Ill", the anchor for 3 is "Mildly Ill", the anchor for 4 is "Moderately Ill", 5 is "Markedly Ill", 6 is "Severely Ill", and 7 is "Among the Most Extremely Ill Patients". Illness improvement is rated on a 1-7 scale where 1 corresponds to "Very Much Improved", 2 is "Much Improved", the anchor for 3 is "Minimally Improved"
| Group | Value | 95% CI |
|---|---|---|
| Ixekizumab | 3.43 | ± 1.51 |
| Group | Value | 95% CI |
|---|---|---|
| Ixekizumab | 3.57 | ± 0.98 |
| Group | Value | 95% CI |
|---|---|---|
| Ixekizumab | 4.71 | ± 0.49 |
| Group | Value | 95% CI |
|---|---|---|
| Ixekizumab | 4.29 | ± 0.76 |
The Columbia-Suicide Severity Rating Scale (C-SSRS) is a comprehensive, semi-structured interview that uniquely measures the full spectrum of suicidality including passive and active suicidal ideation, suicidal intent as well as suicidal behaviors. Full range from 0 to 9, with higher score indicating higher suicidal ideation severity.
| Group | Value | 95% CI |
|---|---|---|
| Ixekizumab | 0.86 | ± 1.21 |
| Group | Value | 95% CI |
|---|---|---|
| Ixekizumab | 0.57 | ± 1.13 |
The Hamilton Anxiety Rating Scale (HAM-A) is a scale of assessments of anxiety states. The scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where \<17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Higher score indicates poorer health outcomes.
| Group | Value | 95% CI |
|---|---|---|
| Ixekizumab | 19.00 | ± 5.57 |
| Group | Value | 95% CI |
|---|---|---|
| Ixekizumab | 14.86 | ± 7.01 |
Time frame: 6 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Ixekizumab |
|---|---|---|
| Headache | Nervous system disorders | — |
| Nausea | Gastrointestinal disorders | — |
| Tinnitus | Nervous system disorders | — |
| Myalgia | Musculoskeletal and connective tissue disorders | — |
| Hot Flashes | Nervous system disorders | — |
| Bloating | Gastrointestinal disorders | — |
| Palpitation | Cardiac disorders | — |
| Skin Lesion | Skin and subcutaneous tissue disorders | — |
Data from ClinicalTrials.gov NCT04979910 adverse events section.
The proposed study aims to test ixekizumab, a monoclonal antibody (mAb) against interleukin 17A (IL-17A), in patients with treatment-resistant depression (TRD).
3 peer-reviewed publications reference this trial (live from Europe PMC):
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