A Study to Evaluate the Effectiveness of DT-101 in Patients With Depression
NCT ID: NCT07300969
Last Updated: 2026-02-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
300 participants
INTERVENTIONAL
2025-12-16
2027-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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DT-101 A
DT-101
DT-101 A
DT-101 B
DT-101
DT-101 B
Placebo
Placebo
Placebo
Interventions
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DT-101
DT-101 A
DT-101
DT-101 B
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
* Male or female (assigned at birth, inclusive of all gender identities) participant must be 18 to 75 years of age, inclusive at the time of signing the informed consent.
* Has recurrent depression (defined as at least one prior episode excluding the current one), as diagnosed by DSM 5-TR (Diagnostic and Statistical Manual of Mental Disorders, 2022).
Exclusion Criteria
* Unstable medical condition or unstable chronic disease.
* Significant neurological abnormality.
* History of moderate or severe alcohol or drug use disorder as per DSM-5-TR in the 6 months prior to Screening.
* History of seizure.
* In the investigator's opinion, the participant is not capable of adhering to the protocol requirements.
18 Years
75 Years
ALL
No
Sponsors
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Draig Therapeutics Ltd
INDUSTRY
Responsible Party
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Locations
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Draig Clinical Site
Bentonville, Arkansas, United States
Draig Clinical Site
Little Rock, Arkansas, United States
Draig Clinical Site
Oceanside, California, United States
Draig Clinical Site
San Diego, California, United States
Draig Clinical Site
Torrance, California, United States
Draig Clinical Site
Miami, Florida, United States
Draig Clinical Site
New Port Richey, Florida, United States
Draig Clinical Site
Atlanta, Georgia, United States
Draig Clinical Site
Decatur, Georgia, United States
Draig Clinical Site
Gaithersburg, Maryland, United States
Draig Clinical Site
Watertown, Massachusetts, United States
Draig Clinical Site
Flowood, Mississippi, United States
Draig Clinical Site
Las Vegas, Nevada, United States
Draig Clinical Site
Marlton, New Jersey, United States
Draig Clinical Site
New York, New York, United States
Draig Clinical Site
Media, Pennsylvania, United States
Draig Clinical Site
Austin, Texas, United States
Draig Clinical Site
DeSoto, Texas, United States
Draig Clinical Site
Richardson, Texas, United States
Draig Clinical Site
Bellevue, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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DT-101/201
Identifier Type: -
Identifier Source: org_study_id
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