Major Depressive DisorderPhase 3NCT06941844
A Phase 3 Trial of DT120 for Major Depressive Disorder (Emerge)
A Phase 3 study testing DT120 in people with Major Depressive Disorder, run by Definium Therapeutics US, Inc. at 22 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 - Emerge 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
- 149 participants
- Where
- 22 sitesUnited States
- Study dates
- 14 Apr 2025to Feb 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
22 sites in 1 country.
22 sites in 1 country
United States22 sites
Austin Clinical Trial Partners
Austin, Texas, 78737
Sheppard Pratt
Baltimore, Maryland, 21204
Memory Clinic, Inc
Bennington, Vermont, 05201
Cenexel HRI
Berlin, New Jersey, 08053
Adams Clinical Boston
Boston, Massachusetts, 02116
Neuro-Behavioral Clinical Research
Canton, Ohio, 44720
Uptown Research Institute (URI), LLC
Chicago, Illinois, 60640
University of Cincinnati
Cincinnati, Ohio, 45219
University of Missouri
Columbia, Missouri, 65212
Mountain View Clinical Research, Inc
Denver, Colorado, 80209
CNS, LLC (Jacksonville)
Jacksonville, Florida, 32256
Kadima Neuropsychiatry Institute
La Jolla, California, 92037
Preferred Research Partners, Inc
Little Rock, Arkansas, 72211
CNS, LLC (Memphis)
Memphis, Tennessee, 38119
Cedar Clinical Research
Murray, Utah, 84020
Adams Clinical Harlem
New York, New York, 10029
Columbia - New York State Psychiatric Institute
New York, New York, 10032
CNS, LLC (Orlando)
Orlando, Florida, 32801
Charter Research
Orlando, Florida, 32803
Adams Clinical Philadelphia
Philadelphia, Pennsylvania, 19104
Psychedelic Science Institute
Santa Monica, California, 90404
Adams Clinical
Watertown, Massachusetts, 02472
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 - Emerge
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
Read the detailed description
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.
- 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, LSD D-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 - 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 (26)
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
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
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.
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
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
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.
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 posted24 Apr 2025
- Study start14 Apr 2025
- Primary completion20 May 2026
- Study completionFeb 2027 (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
- 149 participants (actual)
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
- NCT06941844
- Sponsor's protocol ID
- MM120-310
- Status last verified
- Jul 2026
- First submitted
- 16 Apr 2025
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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 - Emerge
- ClinicalTrials.gov ID
- NCT06941844
- Acronym / sponsor ID
- MM120-310
- Conditions
- Major Depressive Disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 149 participants (actual)
- Lead sponsor
- Definium Therapeutics US, Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Apr 2025 (actual)
- Primary completion
- 20 May 2026 (actual)
- Study completion
- Feb 2027 (estimated)
- First posted
- 24 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 - Placebo | Placebo comparator | Other: PlaceboA substance that is designed to have no therapeutic value |
| Arm 2 - 100µg DT120 | Experimental | Drug: DT120A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A) |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboA substance that is designed to have no therapeutic value | Other | Arm 1 - Placebo |
| DT120Also: MM120, lysergide tartrate, LSD D-TartrateA psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A) | Drug | Arm 2 - 100µg DT120 |
Primary outcome
Change from Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Week 6
Time frame: Baseline to 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.
26 secondary outcomes
Change from Baseline in the MADRS total score at Week 12, Week 4, Week 2, and Week 1
Time frame: 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
Time frame: Baseline to Week 12
MADRS remission (total score ≤12) at each timepoint assessed during the 12-week double-blind treatment period
Time frame: Baseline to Week 12
Clinical Global Impression - Improvement (CGI-I) Scale score at each timepoint assessed during the 12-week double-blind period
Time frame: 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
Time frame: 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
Time frame: Baseline to Week 12
Change from Baseline throughout the 12-week double-blind period at each timepoint assessed in MADRS-6
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: Baseline to Week 12
Percent of men and women with normal and abnormal sexual functioning at each timepoint assessed during the double-blind period
Time frame: 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
Time frame: Day 1 to Week 52
Time to first treatment or lack of efficacy in the open-label period (Part B)
Time frame: Day 1 to Week 52
Need for DT120 treatment as assessed by the average number of DT120 treatments during the study
Time frame: Day 1 to Week 52
MADRS response (reduction from Baseline score of ≥50%) at each timepoint assessed during the 40-week open-label period
Time frame: 40-week open label period
MADRS remission (total score ≤12) at each timepoint assessed during the 40-week open-label period
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline to Week 52
Change from Double-blind Baseline throughout the 40-week open-label period at each timepoint assessed in WPAI-SHP
Time frame: Baseline to Week 52
Change from Double-blind Baseline throughout the 40-week open-label period at each timepoint assessed in EQ-5D-5L
Time frame: Baseline to Week 52
CSFQ-14 total score at each timepoint assessed during the open-label period
Time frame: 40 week open label period
Percent men and women with normal and abnormal sexual functioning at each timepoint assessed during the open-label period
Time frame: 40 week open label period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing DT120 in people with Major Depressive Disorder, run by Definium Therapeutics US, Inc. at 22 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Week 6 (time frame: Baseline to Week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.