Last updated: March 23, 2023
Sponsor: Adams Clinical
Overall Status: Active - Recruiting
Phase
N/A
Condition
Depression
Affective Disorders
Depression (Major/severe)
Treatment
N/AClinical Study ID
NCT04748276
TRAIT-MDD-107
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Participant has signed an ICF prior to any study-specific procedures being performed.
- Participant is male or female of age ≥ 18 years old.
- Participant has a diagnosis of MDD as confirmed by the MINI semi-structured diagnosticinterview and ≥ 14 HAM-D total score.
- Participant is in good physical health and, in the opinion of the investigator, is asuitable candidate for treatment with an ADT.
Exclusion
Exclusion Criteria:
- Participant is pregnant, breast-feeding, or planning to become pregnant.
- A history or presence of a clinically significant hepatic, renal, gastrointestinal,cardiovascular, endocrine, respiratory, immunologic, hematologic, dermatologic, orneurologic abnormality, which in the opinion of the investigator may impactparticipant safety or study results.
- Participant has a history of any psychiatric condition other than MDD, which in theopinion of the investigator is primary, or any other psychiatric or neurologicdisorder or symptom that could pose undue risk to the participant or compromise thestudy.
- Any participant who represents an acute suicidal risk in the opinion of theinvestigator.
- Moderate or severe substance use disorder within 90 days prior to screen, according toDSM-5 criteria that in the opinion of the investigator could pose undue risk to theparticipant, or compromise the study.
- Any condition that, in the opinion of the investigator, makes the participantunsuitable for the study.
Study Design
Total Participants: 400
Study Start date:
January 02, 2019
Estimated Completion Date:
December 31, 2023
Connect with a study center
Adams Clinical
Watertown, Massachusetts 02472
United StatesActive - Recruiting
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