Also known as: TRD
Compass Pathways said COMP360 for treatment-resistant depression retains FDA Breakthrough Therapy designation as it advances in phase 3. A Trump executive order also directs faster federal review of psychedelic drugs with breakthrough status.
A pooled analysis of five randomized trials found intranasal esketamine improved MADRS scores in adults with TRD in both sexes. Females showed greater improvement and higher odds of treatment-response toward trial end.
Psyence Biomedical dosed the first patient in a Phase IIb study of NPX-5 in Adjustment Disorder among cancer patients receiving palliative care. The randomized, double-blind trial is running across five Australian sites.
NRx said the FDA issued a positive review letter on its preservative-free ketamine ANDA, requesting only minor administrative changes. The company also received FDA guidance outlining a path to an NDA for NRX-100 using clinical trial data and real-world evidence.
Compass Pathways reported positive late-stage COMP360 psilocybin data in treatment-resistant depression and plans FDA talks ahead of a filing between October and December. The update lifted shares across several psychedelics developers.
A 34-person trial found that a single 21.5mg intravenous dose of DMT with psychotherapy produced rapid antidepressant effects lasting three to six months. Separate brain-scan research across five psychedelics found a shared pattern of weaker within-network links and stronger communication between brain networks.
NRx Pharmaceuticals said an FDA Type C meeting indicated a path to an NDA for NRX-100, using clinical trial results and real-world ketamine data from more than 65,000 patients.
NRx said the FDA outlined a path for a New Drug Application for NRX-100, a preservative-free ketamine formulation for depression with suicidality. The company plans to submit the NDA by June 2026 and said no additional nonclinical or bridging studies would be required.
The FDA approved milsaperidone for bipolar I disorder and schizophrenia, while COMP360 psilocybin met its primary endpoint in a second phase 3 trial for treatment-resistant depression. Phase 2a data showed intravenous DMT (SPL026) significantly reduced depressive symptoms in major depressive disorder patients.
Clinical trials show psychedelic substances like psilocybin, LSD and MDMA combined with therapy can effectively treat depression, anxiety and addiction. Several substances are in Phase III trials, with esketamine already approved for treatment-resistant depression. Research suggests these treatments may work with fewer doses than traditional medications.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07528157 |
Early Brainwave Biomarkers for Personalized Neuromodulation in Treatment-resistant Depression |
NOT_YET_RECRUITING | NA |
| NCT07512284 |
Mindfulness Engaged Neurostimulation for Depression (MEND II) |
RECRUITING | PHASE2 |
| NCT07499583 |
Psilocybin Assisted Psychotherapy for Treatment Resistant Depression and Co-occurring Substance Use Disorder |
NOT_YET_RECRUITING | PHASE1/PHASE2 |
| NCT07474974 |
ipRGC as a Potential Biomarker for Predicting Transcranial Magnetic Stimulation Treatment Response in Major Depressive Disorder |
NOT_YET_RECRUITING | NA |
| NCT07310381 |
Vagus Nerve Stimulation (VNS) Electroencephalogram (EEG) Protocol Supplement |
NOT_YET_RECRUITING | NA |
| NCT07262008 |
Sustained Mood Improvement With Laughing Gas Exposure |
NOT_YET_RECRUITING | PHASE3 |
| NCT07227103 |
A Randomized, Double-Blind Controlled Comparison of NRX-101 vs. Placebo for Adults Being Treated With Transcranial Magnetic Stimulation for Treatment Resistant Depression |
NOT_YET_RECRUITING | PHASE2/PHASE3 |
| NCT07189689 |
Mental Health Mission Mood Disorder Cohort Study |
NOT_YET_RECRUITING | |
| NCT07188753 |
Randomized Controlled Trial Testing the Efficacy of Transcranial Magnetic Stimulation by Accelerated & High-dose Theta-burst, Functional Imaging Guided, in the Treatment of Depression in Elderly Subjects With Cognitive Impairment |
NOT_YET_RECRUITING | NA |
| NCT07183748 |
Psilocybin Microdosing With Psychotherapy for Treatment-Resistant Depression |
RECRUITING | PHASE2 |
