An Overview of Psychedelic Clinical Trials and Drug Development Pipeline
The Revival of Psychedelic Research
The resurgence of interest in psychedelic research can be traced back to the early 21st century. Advocacy groups such as the Multidisciplinary Association for Psychedelic Studies (MAPS) played a crucial role in championing the therapeutic potential of these substances. Breakthroughs in psychopharmacology and a series of controlled studies demonstrated that psychedelics could be safely administered in clinical settings, paving the way for modern clinical trials.
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Current Status of Psychedelic Clinical Trials
To provide a comprehensive update on the status of hallucinogens in the drug pipeline, we reviewed data from ClinicalTrials.gov. Our focus was on completed phase 2 trials and phase 3 trials that are either completed, active, or currently recruiting patients. Here, we delve into the specifics of some of the most promising substances being studied.
For a deeper dive on this story, go to Psychiatry Advisor.
Ketamine
Ketamine was the first psychedelic to be legalized for medical use in the United States as an anesthetic. The FDA approved a nasal spray containing esketamine (the S+ enantiomer of ketamine) in 2019 for treatment-resistant depression (TRD) and major depressive disorder (MDD) with acute suicidal ideation or behavior. Unlike esketamine, ketamine is not FDA-approved for any psychiatric disorder.
- Completed Phase 2 Trials: 54 in total, including 39 for depressive disorders, 9 for substance use, 6 for suicidality, 5 for PTSD, 4 for OCD, 3 for bipolar disorder, and 1 for postpartum depression.
- Phase 3 Trials: 24 completed, 9 recruiting, and 1 active but not recruiting. These include trials for depressive disorders (23), suicidality (8), substance use (3), PTSD (2), and postpartum depression (1).
Ketamine, especially in IV form, shows rapid antidepressant effects and is being evaluated among both adults and adolescents. It has demonstrated noninferiority to electroconvulsive therapy (ECT) in treating TRD, with improved quality of life scores. Ketamine has also shown significant improvements in PTSD symptom severity when used with prolonged exposure therapy. Ongoing research aims to replicate and confirm these results.
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MDMA
MDMA has been primarily evaluated for PTSD treatment, with significant efficacy demonstrated. ClinicalTrials.gov lists 12 completed phase 2 trials and 6 phase 3 trials (3 completed, 1 active, 2 recruiting).
- Completed Phase 2 Trials: 12 in total.
- Phase 3 Trials: 3 completed, 1 active, and 2 recruiting. Primary indications include PTSD and anxiety disorders.
In phase 3 trials for PTSD, MDMA combined with psychotherapy has shown that a significant percentage of patients no longer meet the criteria for PTSD after treatment. MDMA has also been effective in reducing anxiety related to life-threatening illnesses and social anxiety in adults with autism spectrum disorder.
Estimated Status Changes:
- FDA approval for PTSD treatment is anticipated within the next 6 months, with potential approval for anxiety disorders following within 3-5 years.
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Psilocybin
Psilocybin has been evaluated in 12 completed phase 2 trials, with 5 phase 3 trials currently recruiting. The primary focus has been on depressive disorders, but also includes anxiety, anorexia, and body dysmorphia.
- Completed Phase 2 Trials: 12 in total, with 9 for depressive disorders, 2 for anxiety, 1 for anorexia, and 1 for body dysmorphia.
- Phase 3 Trials: 5 currently recruiting.
Psilocybin has shown promise in treating depressive disorders, with significant responses observed in clinical trials. A proprietary psilocybin analog, CYB003, has received Breakthrough Therapy designation from the FDA for MDD treatment, showing robust and sustained improvements in depressive symptoms.
Estimated Status Changes:
- FDA approval for depressive disorders could occur within the next 1-2 years, with broader psychiatric applications potentially following within 4-6 years.
LSD
LSD has been investigated in 5 completed phase 2 studies for anxiety, ADHD, and depression. A tartrate salt form of LSD, MM120, received Breakthrough Therapy designation from the FDA for treating generalized anxiety disorder (GAD).
- Completed Phase 2 Trials: 5 in total, with 3 for anxiety, 1 for ADHD, and 1 for depression.
MM120 demonstrated significant improvements in anxiety symptoms at a 100 µg dose, with sustained clinical response and remission rates.
Estimated Status Changes:
- FDA approval for GAD treatment could be seen within the next 3-5 years, with potential future applications for ADHD and depression as further data becomes available.
Overall, the development of psychedelic therapies for mental health shows significant promise. Continued research and clinical trials will be crucial in confirming these preliminary findings and expanding the therapeutic applications of these substances.
Conclusion: A Promising Path Forward
The journey of hallucinogens from stigmatized substances to potential game-changers in mental health treatment. And it is a testament to the power of scientific research and advocacy. It is essential to approach their integration into clinical practice with caution, ensuring that safety and efficacy remain paramount. The future of mental health treatment is bright, and hallucinogens may well play a pivotal role in shaping it.
