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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 Generalized Anxiety Disorder - Voyage
The study will enroll up to 200 participants aged 18 to 74 years, inclusive with a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) confirmed primary diagnosis of GAD and a minimum HAM-A total score of at least 20 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 Hamilton Anxiety Rating Scale (HAM-A) total score at Week 12 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in HAM-A total score at Week 8, Week 4, Week 2, and Week 1 | 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. | Week 8, Week 4, Week 2, and Week 1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lighthouse Psychiatry | Gilbert | Arizona | 85234 | United States | ||
| Scottsdale Research Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41730563 | Derived | Jacobs E, Zahid Z, Hinkle J, Nayak S, Yaden DB. Psychedelic medicine: mechanisms, evidence, and translation to practice. BMJ. 2026 Feb 23;392:e081723. doi: 10.1136/bmj-2024-081723. |
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This study is double-blinded, which means that both the participants and the treating clinicians will be masked to treatment allocation, meaning neither party will know which participants are receiving the active drug and which are receiving the placebo. The placebo tablet is identical looking to the active drug
| DT120 |
| Drug |
A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A) |
|
|
| HAM-A response (reduction from Baseline score of ≥50%) at each timepoint assessed during the 12-week double-blind period | 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 |
| HAM-A remission (total score ≤7) at each timepoint assessed during the 12-week double-blind treatment period | 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 |
| 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 - Montgomery-Åsberg Depression Rating Scale (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 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 HAM-A 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 |
| HAM-A response (reduction from Baseline score of ≥50%) at each timepoint assessed during the 40-week open-label period | 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. | 40 week open label period |
| HAM-A remission (total score ≤7) at each timepoint assessed during the 40-week open-label period | 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. | 40 week open label period |
| 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 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 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 |
| Scottsdale |
| Arizona |
| 85022 |
| United States |
| Kadima Neuropsychiatry Institute | La Jolla | California | 92037 | United States |
| UCSF Department of Neurology | San Francisco | California | 94158 | United States |
| Psychedelic Science Institute | Santa Monica | California | 90404 | United States |
| Mountain View | Denver | Colorado | 80209 | United States |
| Clinical Neuroscience Solutions Inc. | Jacksonville | Florida | 32256 | United States |
| Segal Trials | Lauderhill | Florida | 33319 | United States |
| Atlanta Center for Medical Research | Atlanta | Georgia | 30331 | United States |
| iResearch Atlanta | Decatur | Georgia | 30030 | United States |
| CenExel iResearch, LLC | Savannah | Georgia | 31405 | United States |
| Uptown Research Institute | Chicago | Illinois | 60640 | United States |
| Adams Clinical Boston | Boston | Massachusetts | 02116 | United States |
| Adams Clinical Watertown | Watertown | Massachusetts | 02472 | United States |
| Hassman Research Institute | Marlton | New Jersey | 08053 | United States |
| Spectrum Neuroscience and Treatment Institute | New York | New York | 10021 | United States |
| Adams Clinical Harlem | New York | New York | 10029 | United States |
| New York State Psychiatric Institute (NYSPI) | New York | New York | 10032 | United States |
| Adams Clinical Bronx | The Bronx | New York | 10461 | United States |
| Cleveland Clinic Lutheran Hospital | Cleveland | Ohio | 44113 | United States |
| Summit Headlands LLC | Portland | Oregon | 97210 | United States |
| Scranton Medical Institute | Moosic | Pennsylvania | 18507 | United States |
| Adams Clinical Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| Coastal Carolina Research Center | North Charleston | South Carolina | 29405 | United States |
| Clinical Neuroscience Solutions, Inc. | Memphis | Tennessee | 38119 | United States |
| University of Texas at Austin | Austin | Texas | 78712 | United States |
| Austin Clinical Trial Partners | Austin | Texas | 78737 | United States |
| BioBehavioral Research of Austin | Austin | Texas | 78759 | United States |
| FutureSearch Trials of Dallas, LLC | Dallas | Texas | 75231 | United States |
| Adams Clinical Dallas | DeSoto | Texas | 75115 | United States |
| Cedar Clinical Research | Draper | Utah | 84020 | United States |
| Inner Space Research | Orem | Utah | 84058 | United States |
| Memory Clinic Inc. | Bennington | Vermont | 05201 | United States |
| Seattle Neuropsychiatric Treatment Center | Seattle | Washington | 98104 | United States |
| ID | Term |
|---|---|
| D000098647 | Generalized Anxiety Disorder |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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