A Phase 3 Trial of DT120 for Major Depressive Disorder (Ascend)
ConditionMajor Depressive Disorder
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-74
SponsorDefinium Therapeutics US, Inc.
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
Placebo
Other interventionA substance that is designed to have no therapeutic value
DT120
DrugA psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A)
Treatment groups
165 Participants
are divided into 3 treatment groupsGroup A: Arm 1 - PlaceboPlacebo comparator 1 intervention
Group B: Arm 2 - 50µg DT120Sham comparator 1 intervention
Group C: Arm 3 - 100µg DT120Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline to Week 6Secondary outcomes
1
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.
Time frame
Week 12, Week 4, Week 2, and Week 12
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.
Time frame
Baseline to Week 123
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.
Time frame
Baseline to Week 124
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.
Time frame
Day 2 to Week 12Sponsors and contacts
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Source ClinicalTrials.gov