DT120 for Depression
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment called DT120 for individuals with major depressive disorder (MDD). Researchers aim to determine if DT120, which affects the brain's serotonin system, can improve depression symptoms. Participants will receive either a low dose of DT120, a higher dose, or a placebo (a harmless pill with no effect). Those diagnosed with MDD who have experienced a major depressive episode for over two months but less than two years might find this trial suitable. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that DT120, a treatment under study for major depressive disorder, appears safe. DT120 is a carefully formulated version of LSD used in controlled medical settings.
Earlier studies have demonstrated positive effects of DT120 on anxiety and depression symptoms. The treatment involves just one dose, linked to long-lasting relief. Importantly, these studies have not reported any major unwanted side effects, suggesting patients tolerate the treatment well.
The treatment is now in the final phase of trials, which usually indicates it has already proven safe in earlier studies. This phase focuses on confirming its safety and effectiveness in larger groups of people.
Overall, the evidence so far indicates that DT120 is safe, with no major safety concerns reported in previous research.12345Why do researchers think this study treatment might be promising for depression?
Unlike the standard treatments for depression, which often include selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs), DT120 is unique because it acts as an agonist at the serotonin 2A receptor (5-HT2A). This distinct mechanism of action offers a new way to potentially alleviate depressive symptoms by directly targeting a different pathway in the brain. Researchers are excited because this could provide faster relief and benefit patients who don't respond well to existing medications. Additionally, the study explores different dosages, with the 50µg and 100µg arms, to optimize effectiveness and safety, offering hope for tailored treatment options.
What evidence suggests that DT120 might be an effective treatment for depression?
Research has shown that DT120, a medical-grade form of LSD, can significantly alleviate depression. In earlier studies, patients who took DT120 experienced quick and lasting relief from anxiety, with 48% achieving complete symptom relief after 12 weeks. DT120 primarily activates the serotonin 2A receptor in the brain, which is believed to improve mood and manage emotions. This trial will explore different dosages of DT120, including 50µg and 100µg, to assess its potential for long-term benefits with just one dose. These findings suggest that DT120 could be a promising option for individuals with major depressive disorder.12367
Are You a Good Fit for This Trial?
This trial is for adults diagnosed with major depressive disorder (depression). Participants should generally be in stable health and able to follow study procedures. People with certain other mental health conditions or serious medical issues may not be eligible.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
12-week randomized, double-blind, single-dose administration period evaluating DT120 versus placebo
Open-label Extension
40-week open-label treatment where participants are monitored and evaluated for potential retreatment with DT120
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- DT120
Trial Overview
The study compares a new medication called DT120 to a placebo (inactive pill) in people with depression. At first, neither participants nor doctors know who gets which treatment. Later, all can receive DT120 in an open-label phase.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Placebo Group
A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A)
A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A)
A substance that is designed to have no therapeutic value
Find a Clinic Near You
Who Is Running the Clinical Trial?
Definium Therapeutics US, Inc.
Lead Sponsor
Citations
Definium Therapeutics Announces First Patient Dosed in ...
The primary endpoint of Ascend is the change from baseline on the Montgomery-Åsberg Depression Rating Scale (MADRS) at Week 6 between DT120 ODT ...
A Phase 3 Trial of DT120 for Major Depressive Disorder ...
A phase of research to describe clinical trials that gather more information about a drug's safety and effectiveness by studying different populations and ...
3.
psychiatrictimes.com
psychiatrictimes.com/view/the-latest-data-on-psychedelic-dt120-odt-with-daniel-r-karlin-md-maThe Latest Data on Psychedelic DT120 ODT With Daniel R. ...
DT120, a pharmaceutical-grade formulation of LSD, shows rapid, lasting anxiety relief—single dose, no therapy—with 48% remission at 12 weeks.
Major depressive disorder: Validated treatments and future ...
This article explores effective and valid therapies for treating depression by addressing current and future research topics for different treatment categories.
Definium Therapeutics Teases Phase III DT120 Data for ...
DT120, an orally disintegrating LSD tablet, is in three Phase III trials (two for GAD, one for MDD) with Breakthrough Therapy designation; ...
DT120 ODT | LSD Therapy for Depression and Anxiety
In clinical trials, DT120 has shown positive effects in reducing symptoms of anxiety and depression after just a single administration. These effects can be ...
DT120 (lysergide D-tartrate) to treat generalized anxiety ...
If effective and safe, DT120 could provide a one-time, long-lasting treatment option for GAD. In a phase 3 clinical trial, DT120 is administered ...
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