A Study to Evaluate the Effectiveness of DT-101 in Patients With Depression
Start Date
12/16/2025
Completion Date
8/1/2027
Summary
The goal of this clinical trial is to learn if DT-101 can treat depression in adults. The effect of DT-101 will be compared to placebo. Subjects will attend the clinic every couple of weeks complete general health checks and complete questionnaires.
Detailed Description
The purpose of this study is to compare DT-101 and placebo in adult participants with MDD. The study will also evaluate how safe and well tolerated the study drug is. The clinical study staff will check participants' suitability to take part in the clinical research study by performing physical and neurological examinations, obtaining blood and urine samples, conducting clinical assessments and reviewing medical and treatment history. These tests and assessments will continue throughout the study with the purpose of checking the participants' ongoing suitability and to collect data to analyze the effect that DT-101 may have on their depression symptoms. Participants will also have blood samples taken to allow analysis of how DT-101 is absorbed and used by the body (PK sampling), some blood samples may be retained in order to perform future research that may be useful when looking at whether genetics affects how a person responds to DT-101 (PGx sampling)
Eligibility Criteria
Age Range: 18 years to 75 years
Interventions
DT-101
DT-101
Placebo
Conditions
Locations
Draig Clinical Site
Bentonville, Arkansas 72712
United States
Draig Clinical Site
Little Rock, Arkansas 72211
United States
Draig Clinical Site
Oceanside, California 92056
United States
Draig Clinical Site
San Diego, California 92103
United States
Draig Clinical Site
Torrance, California 90502
United States
Draig Clinical Site
Miami, Florida 33166
United States
Draig Clinical Site
New Port Richey, Florida 34652
United States
Draig Clinical Site
Orlando, Florida 32803
United States
Draig Clinical Site
Atlanta, Georgia 30331
United States
Draig Clinical Site
Decatur, Georgia 30030
United States
Draig Clinical Site
Gaithersburg, Maryland 20877
United States
Draig Clinical Site
Watertown, Massachusetts 02472
United States
Draig Clinical Site
Flowood, Mississippi 39232
United States
Draig Clinical Site
Las Vegas, Nevada 89102
United States
Draig Clinical Site
Marlton, New Jersey 08009
United States
Draig Clinical Site
New York, New York 10312
United States
Draig Clinical Site
Media, Pennsylvania 19372
United States
Draig Clinical Site
Austin, Texas 78737
United States
Draig Clinical Site
Austin, Texas 78754
United States
Draig Clinical Site
DeSoto, Texas 75115
United States
Draig Clinical Site
Richardson, Texas 75243
United States
Draig Clinical Site
Wichita Falls, Texas 76309
United States
Draig Clinical Site
Bellevue, Washington 98004
United States
Draig Clinical Site
Kazanlak, 6100
Bulgaria
Draig Clinical Site
Pleven, 5980
Bulgaria
Draig Clinical Site
Plovdiv, 4000
Bulgaria
Draig Clinical Site
Sofia, 1606
Bulgaria
Draig Clinical Site
Vratsa, 3000
Bulgaria
Draig Clinical Site
Ostrava, 70868
Czechia
Draig Clinical Site
Prague, 10000
Czechia
Draig Clinical Site
Říčany, 25101
Czechia
Draig Clinical Site
Gdansk, 80-952
Poland
Draig Clinical Site
Katowice, 40-156
Poland
Draig Clinical Site
Poznan, 60-835
Poland
Draig Clinical Site
Chester, CH2 1HX
United Kingdom
Draig Clinical Site
Eastbourne, BN23 5UZ
United Kingdom
Draig Clinical Site
Glasgow, PA1 1JS
United Kingdom
Draig Clinical Site
London, SE5 8AF
United Kingdom
Draig Clinical Site
Nottingham, NG7 2TU
United Kingdom
Draig Clinical Site
Oxford, OX3 7JX
United Kingdom