Major Depressive DisorderPhase 3NCT07592689
A Phase 3 Trial of DT120 for Major Depressive Disorder (Ascend)
A Phase 3 study testing DT120 in people with Major Depressive Disorder, run by Definium Therapeutics US, Inc. at 30 sites in United States.
Trial summary
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 - Ascend Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- DT120
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 165 participants
- Where
- 30 sitesUnited States
- Study dates
- 10 May 2026to Jun 2028
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of MDD per DSM-5
- Male or female aged 18 to 74
- Currently experiencing a major depressive episode (MDE) of ≥8 weeks and ≤24 months duration
- MADRS Total Score ≥26
- CGI-S Score ≥4
Who cannot join
- Certain psychiatric disorders (other than major depressive disorder)
- First degree relative with or lifetime history of a psychotic disorder or bipolar disorder
- Current diagnosis of alcohol or substance use disorder (excluding nicotine and caffeine
- Any clinically significant unstable illness
Trial locations and contacts
30 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Definium Therapeutics Clinical Trials Info Requests contact
30 sites in 1 country
United States30 sites, 28 recruiting
- Recruiting
CenExel - Atlanta Center for Medical Research
Atlanta, Georgia, 30331
Denniel Brown, 404-881-5800, d.brown@cenexel.com
- Recruiting
Austin Clinical Trial Partners
Austin, Texas, 78737
Cara Fonken, 512-521-0595, cfonken@austinCTP.com
- Recruiting
Memory Clinic Inc.
Bennington, Vermont, 05201
Cynthia Murphy, PhD, 413-281-0576, research@memorydoc.org
- Active, not recruiting
Adams Clinical Boston
Boston, Massachusetts, 02116
- Recruiting
Adams Clinical Watertown
Boston, Massachusetts, 02472
Harrison Gillman, 617-744-8542, hgillman@adamsclinical.com
- Recruiting
Uptown Research Institute
Chicago, Illinois, 60640
Chloe Rzeppa, 773-989-8313 ext. x113, crzeppa@uptownresearch.com
- Not yet recruiting
Cleveland Clinic
Cleveland, Ohio, 44113
Katelyn Schwesinger, 440-728-6025, schwesk@ccf.org
- Recruiting
CenExel - iResearch Atlanta
Decatur, Georgia, 30030
Branden Freeman, 404-537-1281, b.freeman@cenexel.com
- Recruiting
Mountain View Clinical Research, Inc
Denver, Colorado, 80209
Jessica Bryant, 720-941-8894, jessica@mtnresearch.com
- Recruiting
Cedar Clinical Research
Draper, Utah, 84020
Kye Cutrubus, 801-369-4219, kye.cutrubus@numinusnetwork.com
- Recruiting
Clinical Neuroscience Solutions, LLC (Jacksonville)
Jacksonville, Florida, 32256
Susan Angel, 904-218-5757, sangel@cnshealthcare.com
- Recruiting
Redbird Research
Las Vegas, Nevada, 89119
Pam Pioquinto, 702-577-2000, pamela@redbird-research.com
- Recruiting
Preferred Research Partners, Inc.
Little Rock, Arkansas, 72211
Stacy Tierney, 501-553-9987 ext. x111, stierney@preferredresearchpartners.com
- Recruiting
K2 Medical Research (Maitland)
Maitland, Florida, 32751
Vanessa Carrillo, 407-676-5252, vanessa.carrillo@k2med.com
- Active, not recruiting
Adams Clinical Harlem
New York, New York, 10029
- Recruiting
Coastal Carolina Research
North Charleston, South Carolina, 29405
Brandy Dreyer, 843-856-3784, brandy.dreyer@coastalcarolinaresearch.com
- Recruiting
ATP Clinical Research Orange County
Orange, California, 92866
Raissa Rebollar, 949-354-5353, raissar@pnsoc.com
- Recruiting
Inner Space Research
Orem, Utah, 84058
Yohan Paitrault, 801-871-5516, yohan@innerspaceresearch.com
- Recruiting
Clinical Neuroscience Solutions, LLC (Orlando)
Orlando, Florida, 32801
Chanel Adams, 407-425-5100 ext. x204, cadams@cnshealthcare.com
- Not yet recruiting
Charter Research
Orlando, Florida, 32803
Sarahi Monsalve, 407-337-1000, sarahi.monsalve@charterresearch.com
- Recruiting
Adams Clinical Philadelphia
Philadelphia, Pennsylvania, 19104
Elizabeth Huang, 267-207-2511, ehuang@adamsclinical.com
- Recruiting
Kadima Neuropsychiatry Institute
San Diego, California, 92037
Alexiss Rivas, 858-412-4130, alexissr@kadimanp.com
- Not yet recruiting
UCSF Department of Neurology
San Francisco, California, 94158
Jennifer Mitchell, 510-985-3522, LSDForDepression@ucsf.edu
- Recruiting
Psychedelic Science Institute
Santa Monica, California, 90404
Ashley Ramos, 310-378-0303, trialadmin@psychedelicsci.com
- Recruiting
CenExel - iResearch Savannah
Savannah, Georgia, 31405
Katie McCants, 912-744-0800, k.mccants@cenexel.com
- Not yet recruiting
Seattle Neuropsychiatric Treatment Center
Seattle, Washington, 98104
Libby Kell, 206-467-6300 ext. 5, libby.kell@seattlentc.com
- Recruiting
Arch Clinical Trials, LLC
St Louis, Missouri, 63141
Erica Ehrhardt, 314-282-3521, eehrhardt@archclinicaltrials.com
- Recruiting
K2 Medical Research (Tampa)
Tampa, Florida, 33607
Karina Perez, 813-800-5252, karina.perez@k2med.com
- Not yet recruiting
VA Portland Healthcare System
Vancouver, Washington, 98661
Bianca Watt, 503-781-1205, bianca.watt@va.gov
- Recruiting
Vitalix Clinical
Worcester, Massachusetts, 01608
Rajvi Patel, 413-363-5206, rpatel@vitalixclinical.com
About this study
Official title: A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled, 12-Week Study (Part A) With a 40-Week Open-label Extension (Part B) Evaluating the Efficacy and Safety of Oral DT120 Compared to Placebo in the Treatment of Adults With Major Depressive Disorder - Ascend
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 - Ascend
Read the detailed description
The study will enroll approximately 165 participants 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 (EP) with opportunity for open-label treatment during which participants will be monitored and evaluated for potential retreatment with DT120 based on pre-specified safety and symptom severity criteria.
- Conditions
- Major Depressive Disorder
- Being tested
- Placebo, DT120
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboOther
A substance that is designed to have no therapeutic value
DT120Drug
Also called MM120, lysergide tartrate
A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A)
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 - Placebo | Placebo comparator | A substance that is designed to have no therapeutic value Receives: Other: Placebo |
| Arm 2 - 50µg DT120 | Sham comparator | A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A) Receives: Drug: DT120 |
| Arm 3 - 100µg DT120 | Experimental | A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A) Receives: Drug: DT120 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to Week 6
Secondary outcomes (27)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 1 to Week 52
Need for DT120 treatment as assessed by the average number of DT120 treatments received
Average number of treatments assessed from first dose in the double-blind period through completion of the open label extension.
Measured: 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.
Measured: Day 1 to Week 52
Single dose durability as assessed by time to event where moderate or worse MDD symptoms resurfaced
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.
Measured: 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.
Measured: 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 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Baseline to Week 52
Change from Baseline in the Changes in Sexual Functioning Questionnaire (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 27 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.
Measured: 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.
Measured: 40 week open label period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2026
- Study start10 May 2026
- Primary completionSep 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 165 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Definium Therapeutics US, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07592689
- Sponsor's protocol ID
- MM120-311
- Status last verified
- Jul 2026
- First submitted
- 12 May 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No