A Phase 3 Trial of DT120 for Major Depressive Disorder (Ascend)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Placebo, DT120.
- Who it may be relevant to
- Registry conditions: Major Depressive Disorder. Basic parameters: 18 years — 74 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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 - Ascend
Overview
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
Detailed description
The study will enroll approximately 165 participants 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 (EP) with opportunity for open-label treatment during which participants will be monitored and evaluated for potential retreatment with DT120 based on pre-specified safety and symptom severity criteria.
Interventions
- Other Placebo
A substance that is designed to have no therapeutic value - Drug DT120
A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A)
Primary outcome measures
- Change from Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Week 6 [Time frame: Baseline to Week 6]
Secondary outcome measures (12)
- 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]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
United States · 30 centers
- Preferred Research Partners, Inc. — Little Rock
- ATP Clinical Research Orange County — Orange
- Kadima Neuropsychiatry Institute — San Diego
- UCSF Department of Neurology — San Francisco
- Psychedelic Science Institute — Santa Monica
- Mountain View Clinical Research, Inc — Denver
- Clinical Neuroscience Solutions, LLC (Jacksonville) — Jacksonville
- K2 Medical Research (Maitland) — Maitland
- … and 22 more centers
Identifiers
NCT: NCT07592689 · MM120-311