XEN1101 for Major Depressive Disorder
- Registration Number
- NCT04827901
- Lead Sponsor
- James Murrough
- Brief Summary
This project is designed to examine the neuronal KCNQ2/3 potassium (K+) channel subtype as a novel treatment target for mood disorders through the administration of the KCNQ-selective channel opener XEN1101 (Xenon Pharmaceuticals).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description XEN1101 XEN1101 Subjects will take two 10 mg capsules of XEN1101 daily for 8 weeks for a total daily dose of 20 mg. Placebo Placebo Subjects will take a matching placebo daily for eight weeks.
- Primary Outcome Measures
Name Time Method Change in activation within the reward circuit by fMRI Baseline (week 0), End of treatment (week 8) The change in activation within the bilateral ventral striatum (VS) from baseline (week 0) to end of treatment (week 8) as measured by fMRI during an Incentive Flanker Task.
- Secondary Outcome Measures
Name Time Method Change in Montgomery-Åsberg Depression Rating Scale Score Baseline (week 0), End of treatment (week 8) 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, higher score indicating poorer health outcomes. The MADRS provides a measure of the overall level of depression.
Change in Quick Inventory of Depressive Symptomatology, Self-Report [QIDS-SR] Score Baseline (week 0), End of treatment (week 8) 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).
Change in Temporal Experience of Pleasure Scale Baseline (week 0), End of treatment (week 8) 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. Total scores range is 16-108. Lower scores indicate greater levels of anhedonia.
Change in Snaith-Hamilton Pleasure Scale (SHAPS) Baseline (week 0), End of treatment (week 8) 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.
Change in Clinical Global Impression Scale Baseline (week 0), End of treatment (week 8) 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".
The degree of 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".
Trial Locations
- Locations (2)
Icahn School of Medicine at Mount Sinai
🇺🇸New York, New York, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States