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A Phase 3 Double-blind, Placebo-controlled Study (Part A) with an Open-label Extension (Part B) Evaluating DT120 Compared to Placebo in Major Depressive Disorder - Emerge
The study will enroll approximately 140 adult men and women aged 18 to 74 years, inclusive with a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) confirmed primary diagnosis of MDD, a minimum MADRS total score of at least 26 and a CGI-S score of at least 4 at Screening and Baseline without clinically relevant medical or psychiatric history.
The study consists of a 12-week randomized, double-blind, single-dose administration period evaluating DT120 versus placebo, followed by a 40-week extension phase with the opportunity for open-label treatment. During this phase, participants will be monitored and evaluated for potential treatment with DT120 based on pre-specified safety and symptom severity criteria.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 - Placebo | Placebo Comparator | A substance that is designed to have no therapeutic value |
|
| Arm 2 - 100µg DT120 | Experimental | A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Other | A substance that is designed to have no therapeutic value |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Week 6 | The MADRS is used to assess depression severity and to detect changes due to antidepressant treatment. The MADRS includes 10 clinician-completed items. Each of the 10 questions is scored with a range of 0-6 points. An item score of 0 indicates item not present or normal, while an item score of 6 indicates severe or continuous presence of the symptoms. The total possible score is 60, and higher scores represent a more severe condition. | Baseline to Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in the MADRS total score at Week 12, Week 4, Week 2, and Week 1 | The MADRS is used to assess depression severity and to detect changes due to antidepressant treatment. The MADRS includes 10 clinician-completed items. Each of the 10 questions is scored with a range of 0-6 points. An item score of 0 indicates item not present or normal, while an item score of 6 indicates severe or continuous presence of the symptoms. The total possible score is 60, and higher scores represent a more severe condition. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Preferred Research Partner | Fayetteville | Arkansas | 72703 | United States | ||
| Preferred Research Partners, Inc |
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| DT120 |
| Drug |
A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A) |
|
|
| Week 12, Week 4, Week 2, and Week 1 |
| MADRS response (reduction from Baseline score of ≥50%) at each timepoint assessed during the 12-week double-blind period | The MADRS is used to assess depression severity and to detect changes due to antidepressant treatment. The MADRS includes 10 clinician-completed items. Each of the 10 questions is scored with a range of 0-6 points. An item score of 0 indicates item not present or normal, while an item score of 6 indicates severe or continuous presence of the symptoms. The total possible score is 60, and higher scores represent a more severe condition. | Baseline to Week 12 |
| MADRS remission (total score ≤12) at each timepoint assessed during the 12-week double-blind treatment period | The MADRS is used to assess depression severity and to detect changes due to antidepressant treatment. The MADRS includes 10 clinician-completed items. Each of the 10 questions is scored with a range of 0-6 points. An item score of 0 indicates item not present or normal, while an item score of 6 indicates severe or continuous presence of the symptoms. The total possible score is 60, and higher scores represent a more severe condition. | Baseline to Week 12 |
| Clinical Global Impression - Improvement (CGI-I) Scale score at each timepoint assessed during the 12-week double-blind period | The CGI-I scale is used to measure the clinician's assessment of how much the participant's illness has improved or worsened relative to Baseline (Visit 2). The CGI-I comprises one item with 7 possible ratings (1-7 points), where a lower score indicates improvement, and a higher score indicates worsening. | Day 2 to Week 12 |
| Change from Baseline throughout the 12-week double-blind period at each timepoint assessed in Clinical Global Impression - Severity (CGI-S) Scale score | The CGI-S scale assesses the clinician's impression of the participant's current severity of illness relative to the clinician's experience with patients who have the same diagnosis. The CGI-S comprises one item with 7 possible ratings (1-7 points), where a higher score indicates more severe illness. | Baseline to Week 12 |
| Change from Baseline throughout the 12-week double-blind period at each timepoint assessed in Patient Global Impression - Severity (PGI-S) Scale score | The PGI scale is the patient-reported outcome (PRO) counterpart to the CGI scale. The PGI-S comprises one participant-completed item with 5 possible ratings (1-5) where a higher score indicates more severe illness. | Baseline to Week 12 |
| Change from Baseline throughout the 12-week double-blind period at each timepoint assessed in MADRS-6 | The MADRS-6 is a subscale of the 10-item MADRS and evaluates the core symptoms of depression: apparent sadness, reported sadness, inner tension, lassitude, inability to feel, and pessimistic thought. | Baseline to Week 12 |
| Change from Baseline throughout the 12-week double-blind period at each timepoint assessed in Hamilton Anxiety Rating Scale (HAM-A) | The HAM-A consists of the following 14 items that encompass both psychological and somatic symptoms of 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. | Baseline to Week 12 |
| Change from Baseline throughout the 12-week double-blind period at each timepoint assessed in - Work Productivity and Activity Impairment Specific Health Problem Questionnaire (WPAI-SHP) | The WPAI-SHP is a 6-item questionnaire, with a recall period of the past 7 days. The WPAI measures impairments in both paid work and unpaid work. It measures absenteeism, presenteeism as well as impairment in unpaid activity because of the health problem under study. | Baseline to Week 12 |
| Change from Baseline throughout the 12-week double-blind period at each timepoint assessed in - EuroQol-5 Dimensions - 5 Levels (EQ-5D-5L) | The EuroQol 5 Dimension 5 Level (EQ-5D-5L) is a self-reported outcome measure used to evaluate health outcomes over a wide range of health conditions and treatments. The EQ-5D consists of the EQ-5D descriptive system and the EQ visual analogue scale (VAS). | Baseline to Week 12 |
| Change from Baseline in the Changes in Sexual Functioning Questionnaire (CSFQ-14) total score at each timepoint assessed during the double-blind period | The CSFQ-14 is a structured self-reported questionnaire designed to measure illness- and medication-related changes in sexual functioning that consists of 14 items measuring sexual functioning as a total score (14 items). There is a male and female version of the CSFQ-14 scale and a total score of less than 47 for men and less than 41 for women indicates sexual dysfunction. Lower scores are associated with worsened sexual functioning. | Baseline to Week 12 |
| Percent of men and women with normal and abnormal sexual functioning at each timepoint assessed during the double-blind period | The CSFQ-14 is a structured self-reported questionnaire designed to measure illness- and medication-related changes in sexual functioning that consists of 14 items measuring sexual functioning as a total score (14 items). There is a male and female version of the CSFQ-14 scale and a total score of less than 47 for men and less than 41 for women indicates sexual dysfunction. Lower scores are associated with worsened sexual functioning. | Baseline to Week 12 |
| Percent of participants requiring one, two, three, four, or five doses of DT120 during the 52-week study (Part A and Part B) as assessed by participants meeting protocol-specified retreatment criteria during the 40-week open-label period | Percent of participants requiring one, two, three, four, or five doses of DT120 during the 52-week study (Part A and Part B) as assessed by participants meeting protocol-specified retreatment criteria during the 40-week open-label period. | Day 1 to Week 52 |
| Time to first treatment or lack of efficacy in the open-label period (Part B) | Measured as time from first dosing in the Double-blind period to participant meeting MADRS criteria for re-dose or meeting criteria for lack of efficacy. | Day 1 to Week 52 |
| Need for DT120 treatment as assessed by the average number of DT120 treatments during the study | Average number of treatments assessed from first dose in the double-blind period through completion of the open label extension. | Day 1 to Week 52 |
| MADRS response (reduction from Baseline score of ≥50%) at each timepoint assessed during the 40-week open-label period | The MADRS is used to assess depression severity and to detect changes due to antidepressant treatment. The MADRS includes 10 clinician-completed items. Each of the 10 questions is scored with a range of 0-6 points. An item score of 0 indicates item not present or normal, while an item score of 6 indicates severe or continuous presence of the symptoms. The total possible score is 60, and higher scores represent a more severe condition. | 40-week open label period |
| MADRS remission (total score ≤12) at each timepoint assessed during the 40-week open-label period | The MADRS is used to assess depression severity and to detect changes due to antidepressant treatment. The MADRS includes 10 clinician-completed items. Each of the 10 questions is scored with a range of 0-6 points. An item score | 40-week open label period |
| Change from Double-blind Baseline throughout the 40-week open-label period at each timepoint assessed in MADRS total score | The MADRS is used to assess depression severity and to detect changes due to antidepressant treatment. The MADRS includes 10 clinician-completed items. Each of the 10 questions is scored with a range of 0-6 points. An item score of 0 indicates item not present or normal, while an item score of 6 indicates severe or continuous presence of the symptoms. The total possible score is 60, and higher scores represent a more severe condition. | Baseline to Week 52 |
| Change from Double-blind Baseline throughout the 40-week open-label period at each timepoint assessed in Clinical Global Impression - Severity (CGI-S) Scale score | The CGI-S scale assesses the clinician's impression of the participant's current severity of illness relative to the clinician's experience with patients who have the same diagnosis. The CGI-S comprises one item with 7 possible ratings (1-7 points), where a higher score indicates more severe illness. | Baseline to Week 52 |
| Change from Double-blind Baseline throughout the 40-week open-label period at each timepoint assessed in Patient Global Impression - Severity (PGI-S) Scale score | The PGI scale is the patient-reported outcome (PRO) counterpart to the CGI scale. The PGI-S comprises one participant-completed item with 5 possible ratings (1-5) where a higher score indicates more severe illness. | Baseline to Week 52 |
| Change from Double-blind Baseline throughout the 40-week open-label period at each timepoint assessed in MADRS-6 total score | The MADRS-6 is a subscale of the 10-item MADRS and evaluates the core symptoms of depression: apparent sadness, reported sadness, inner tension, lassitude, inability to feel, and pessimistic thought. | Baseline to Week 52 |
| Change from Double-blind Baseline throughout the 40-week open-label period at each timepoint assessed in HAM-A total score | The HAM-A consists of the following 14 items that encompass both psychological and somatic symptoms of 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. | Baseline to Week 52 |
| Change from Double-blind Baseline throughout the 40-week open-label period at each timepoint assessed in WPAI-SHP | The WPAI-SHP is a 6-item questionnaire, with a recall period of the past 7 days. The WPAI measures impairments in both paid work and unpaid work. It measures absenteeism, presenteeism as well as impairment in unpaid activity because of the health problem under study. | Baseline to Week 52 |
| Change from Double-blind Baseline throughout the 40-week open-label period at each timepoint assessed in EQ-5D-5L | The EuroQol 5 Dimension 5 Level (EQ-5D-5L) is a self-reported outcome measure used to evaluate health outcomes over a wide range of health conditions and treatments. The EQ-5D consists of the EQ-5D descriptive system and the EQ visual analogue scale (VAS). | Baseline to Week 52 |
| CSFQ-14 total score at each timepoint assessed during the open-label period | The CSFQ-14 is a structured self-reported questionnaire designed to measure illness- and medication-related changes in sexual functioning that consists of 14 items measuring sexual functioning as a total score (14 items). There is a male and female version of the CSFQ-14 scale and a total score of less than 47 for men and less than 41 for women indicates sexual dysfunction. Lower scores are associated with worsened sexual functioning. | 40 week open label period |
| Percent men and women with normal and abnormal sexual functioning at each timepoint assessed during the open-label period | The CSFQ-14 is a structured self-reported questionnaire designed to measure illness- and medication-related changes in sexual functioning that consists of 14 items measuring sexual functioning as a total score (14 items). There is a male and female version of the CSFQ-14 scale and a total score of less than 47 for men and less than 41 for women indicates sexual dysfunction. Lower scores are associated with worsened sexual functioning. | 40 week open label period |
| Little Rock |
| Arkansas |
| 72211 |
| United States |
| Kadima Neuropsychiatry Institute | La Jolla | California | 92037 | United States |
| Psychedelic Science Institute | Santa Monica | California | 90404 | United States |
| Mountain View Clinical Research, Inc | Denver | Colorado | 80209 | United States |
| Clinical Neuroscience Solutions, Inc | Jacksonville | Florida | 32256 | United States |
| Clinical Neuroscience Solutions, Inc | Orlando | Florida | 32801 | United States |
| Charter Research | Orlando | Florida | 32803 | United States |
| Uptown Research | Chicago | Illinois | 60640 | United States |
| Sheppard Pratt | Baltimore | Maryland | 21204 | United States |
| Adams Clinical Boston | Boston | Massachusetts | 02116 | United States |
| Adams Clinical | Watertown | Massachusetts | 02472 | United States |
| University of Missouri | Columbia | Missouri | 65212 | United States |
| Cenexel HRI | Berlin | New Jersey | 08053 | United States |
| Adams Clinical Harlem | New York | New York | 10029 | United States |
| Columbia - New York State Psychiatric Institute | New York | New York | 10032 | United States |
| Neuro-Behavioral Clinical Research | Canton | Ohio | 44720 | United States |
| University of Cincinnati | Cincinnati | Ohio | 45219 | United States |
| Adams Clinical Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| Clinical Neuroscience Solutions, Inc | Memphis | Tennessee | 38119 | United States |
| Dell Medical School, University of Texas at Austin | Austin | Texas | 78712 | United States |
| Austin Clinical Trial Partners | Austin | Texas | 78737 | United States |
| FutureSearch Trials of Dallas | Dallas | Texas | 75231 | United States |
| Cedar Clinical Research | Murray | Utah | 84020 | United States |
| Memory Clinic, Inc | Bennington | Vermont | 05201 | United States |
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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