XEN1101 for Major Depressive Disorder
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|ClinicalTrials.gov Identifier: NCT04827901|
Recruitment Status : Recruiting
First Posted : April 1, 2021
Last Update Posted : November 10, 2022
|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Disorder||Drug: XEN1101 Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||This is a phase II, randomized, parallel-arm, placebo-controlled clinical trial were 60 patients with major depressive disorder will be randomized in 1:1 fashion to XEN1101 (N=30) or matching placebo (N=30).|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Proof of Concept Randomized Controlled Trial of XEN1101 for the Treatment of Major Depressive Disorder|
|Actual Study Start Date :||October 19, 2021|
|Estimated Primary Completion Date :||January 2024|
|Estimated Study Completion Date :||February 2024|
Active Comparator: XEN1101
Subjects will take two 10 mg capsules of XEN1101 daily for 8 weeks for a total daily dose of 20 mg.
two 10 mg capsules
Placebo Comparator: Placebo
Subjects will take a matching placebo daily for eight weeks.
- Change in activation within the reward circuit by fMRI [ Time Frame: 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.
- Change in Montgomery-Åsberg Depression Rating Scale Score [ Time Frame: 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 [ Time Frame: 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 Snaith-Hamilton Pleasure Scale (SHAPS) [ Time Frame: 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 Temporal Experience of Pleasure Scale [ Time Frame: 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 Clinical Global Impression Scale [ Time Frame: 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".
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04827901
|Contact: Sara Hameed, B.A.||firstname.lastname@example.org|
|Contact: Amelia Karimemail@example.com|
|United States, New York|
|Icahn School of Medicine at Mount Sinai||Recruiting|
|New York, New York, United States, 10029|
|Contact: Sara Hameed, B.A. 212-585-4622 firstname.lastname@example.org|
|Contact: Amelia Karim 212-585-4621 email@example.com|
|Principal Investigator: James W Murrough, MD, PhD|
|United States, Texas|
|Baylor College of Medicine||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Tabish Iqbal 713-798-4095 firstname.lastname@example.org|
|Principal Investigator: Sanjay Mathew, MD|
|Principal Investigator:||James W Murrough, MD, PhD||Icahn School of Medicine at Mount Sinai|