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

Official Summary

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 Requirements

• Minimum Age: 18 Years
• Maximum Age: 74 Years

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: TRIPLE
• Enrollment: 165 participants

Study Arms

• Arm 1 - Placebo (PLACEBO_COMPARATOR)
  A substance that is designed to have no therapeutic value
• Arm 2 - 50µg DT120 (SHAM_COMPARATOR)
  A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A)
• Arm 3 - 100µg DT120 (EXPERIMENTAL)
  A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A)

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 Outcomes

• Change from Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Week 6 (Baseline to Week 6)

Secondary Outcomes

• Change from Baseline in the MADRS total score at Week 12, Week 4, Week 2, and Week 1 (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 (Baseline to Week 12)
• MADRS remission (total score ≤10) at each timepoint assessed during the 12-week double-blind treatment period (Baseline to Week 12)
• Clinical Global Impression - Improvement (CGI-I) Scale score at each timepoint assessed during the 12-week double-blind period (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 (Baseline to Week 12)

Eligibility Criteria

Inclusion Criteria:

1. Diagnosis of MDD per DSM-5
2. Male or female aged 18 to 74
3. Currently experiencing a major depressive episode (MDE) of ≥8 weeks and ≤24 months duration
4. MADRS Total Score ≥26
5. CGI-S Score ≥4

Exclusion Criteria:

1. Certain psychiatric disorders (other than major depressive disorder)
2. First degree relative with or lifetime history of a psychotic disorder or bipolar disorder
3. Current diagnosis of alcohol or substance use disorder (excluding nicotine and caffeine
4. Any clinically significant unstable illness

Trial Locations

• Lighthouse Psychiatry, Gilbert, Arizona, United States
• Preferred Research Partners, Inc., Little Rock, Arkansas, United States
• UCSF Department of Neurology, San Francisco, California, United States
• Psychedelic Science Institute, Santa Monica, California, United States
• Mountain View Clinical Research, Inc, Denver, Colorado, United States
• Charter Research, Orlando, Florida, United States
• CenExel Atlanta, Atlanta, Georgia, United States
• CenExel Decatur, Decatur, Georgia, United States
• CenExel Savannah, Savannah, Georgia, United States
• Uptown Research Institute, Chicago, Illinois, United States
• ...and 8 more locations

Contact Information

• Definium Therapeutics Clinical Trials Info Requests — CONTACT
  Phone: 1-332-282-0479
  Email: clinicaltrials@definiumtx.com

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