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The proposed study aims to test ixekizumab, a monoclonal antibody (mAb) against interleukin 17A (IL-17A), in patients with treatment-resistant depression (TRD).
In the proposed study n=20 adult individuals with TRD will be treated with ixekizumab for 4 weeks. Participants will complete screening procedures, body fluid analyses and brain imaging before and after treatment with ixekizumab.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ixekizumab | Experimental | Ixekizumab 160 mg (two 80 mg injections) at Week 0, followed by 80 mg at Weeks 2 and 4 via subcutaneous route. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ixekizumab | Drug | a monoclonal antibody (mAb) against interleukin 17A (IL-17A) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Dropped-out | 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. | 6 weeks |
| Number of Anticipated and Unanticipated Adverse Events | The incidence and frequency of all anticipated and unanticipated serious and non-serious adverse events | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Montgomery-Åsberg Depression Rating Scale Score - Response Rate | 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 outcome. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James W Murrough, MD, PhD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Icahn School of Medicine at Mount Sinai | New York | New York | 10025 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ixekizumab | Ixekizumab 160 mg (two 80 mg injections) at Week 0, followed by 80 mg at Weeks 2 and 4 via subcutaneous route. Ixekizumab: a monoclonal antibody (mAb) against interleukin 17A (IL-17A) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ixekizumab | Ixekizumab 160 mg (two 80 mg injections) at Week 0, followed by 80 mg at Weeks 2 and 4 via subcutaneous route. Ixekizumab: a monoclonal antibody (mAb) against interleukin 17A (IL-17A) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Who Dropped-out | 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. | Posted | Count of Participants | Participants | 6 weeks |
|
|
6 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ixekizumab | Ixekizumab 160 mg (two 80 mg injections) at Week 0, followed by 80 mg at Weeks 2 and 4 via subcutaneous route. Ixekizumab: a monoclonal antibody (mAb) against interleukin 17A (IL-17A) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Esther Lee | Icahn School of Medicine at Mount Sinai | 212-585-6133 | esther.lee@mssm.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 3, 2024 | Apr 14, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 3, 2024 | Apr 14, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D003863 | Depression |
| D061218 | Depressive Disorder, Treatment-Resistant |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
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| ID | Term |
|---|---|
| C549079 | ixekizumab |
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This trial is a phase II, open-label trial where n=20 patients with treatment resistant depression will be treated with ixekizumab for 4 weeks and will undergo brain scans before and after the treatment period.
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| Baseline and 6 weeks |
| Change in Montgomery-Åsberg Depression Rating Scale Score - Remission Rate | 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. | Baseline and 6 weeks |
| Change in Quick Inventory of Depressive Symptomatology, Self-Report [QIDS-SR] Score | 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. | Baseline and 6 weeks |
| Change in Snaith-Hamilton Pleasure Scale (SHAPS) | 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. | Up to Week 6 |
| Change in Temporal Experience of Pleasure Scale | 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. | Baseline and 6 weeks |
| Change in Clinical Global Impression Scale | 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", the anchor for 4 is "No Change", 5 is "Minimally Worse", 6 is "Much Worse", and 7 is "Very Much Worse". | Baseline and 6 weeks |
| Change in The Columbia-Suicide Severity Rating Scale (C-SSRS) | 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. | Baseline and 6 weeks |
| Change in The Hamilton Anxiety Rating Scale (HAM-A) | 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. | Baseline and 6 weeks |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| Primary | Number of Anticipated and Unanticipated Adverse Events | The incidence and frequency of all anticipated and unanticipated serious and non-serious adverse events | Posted | Number | events | 6 weeks |
|
|
|
| Secondary | Change in Montgomery-Åsberg Depression Rating Scale Score - Response Rate | 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 outcome. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 6 weeks |
|
|
|
| Secondary | Change in Montgomery-Åsberg Depression Rating Scale Score - Remission Rate | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 6 weeks |
|
|
|
| Secondary | Change in Quick Inventory of Depressive Symptomatology, Self-Report [QIDS-SR] Score | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 6 weeks |
|
|
|
| Secondary | Change in Snaith-Hamilton Pleasure Scale (SHAPS) | 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. | Posted | Mean | Standard Deviation | score on a scale | Up to Week 6 |
|
|
|
| Secondary | Change in Temporal Experience of Pleasure Scale | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 6 weeks |
|
|
|
| Secondary | Change in Clinical Global Impression Scale | 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", the anchor for 4 is "No Change", 5 is "Minimally Worse", 6 is "Much Worse", and 7 is "Very Much Worse". | Posted | Mean | Standard Deviation | score on a scale | Baseline and 6 weeks |
|
|
|
| Secondary | Change in The Columbia-Suicide Severity Rating Scale (C-SSRS) | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 6 weeks |
|
|
|
| Secondary | Change in The Hamilton Anxiety Rating Scale (HAM-A) | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 6 weeks |
|
|
|
| 0 |
| 7 |
| 0 |
| 7 |
| 4 |
| 7 |
| Nausea | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
|
| Tinnitus | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
|
| Hot Flashes | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
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| Bloating | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
|
| Palpitation | Cardiac disorders | MedDRA (13.0) | Systematic Assessment |
|
| Skin Lesion | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Systematic Assessment |
|
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| D001519 |
| Behavior |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Title | Measurements |
|---|---|
|
| 6 weeks - Severity |
|