- |||||||||| psilocybin (COMP360) / Compass Pathways
Trial completion date, Trial initiation date, Trial primary completion date: PSILOBSD: Psilocybin rTMS for Treatment Resistant Depression (clinicaltrials.gov) - Jul 24, 2024
P2, N=100, Not yet recruiting,
Trial completion date: May 2027 --> May 2028 | Initiation date: Jun 2024 --> Sep 2024 | Trial primary completion date: Mar 2027 --> Mar 2028
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Trial initiation date: PSILOBSD: Psilocybin rTMS for Treatment Resistant Depression (clinicaltrials.gov) - Apr 4, 2024
P2, N=100, Not yet recruiting,
Trial completion date: May 2027 --> May 2028 | Initiation date: Jun 2024 --> Sep 2024 | Trial primary completion date: Mar 2027 --> Mar 2028 Initiation date: Jan 2024 --> Jun 2024
- |||||||||| psilocybin (COMP360) / Compass Pathways
Trial completion date, Trial primary completion date: PSILAUT: Psilocybin in Adults With and Without Autism Spectrum Disorder (clinicaltrials.gov) - Mar 5, 2024
P=N/A, N=70, Recruiting,
Initiation date: Jan 2024 --> Jun 2024 Trial completion date: Dec 2024 --> Sep 2025 | Trial primary completion date: Dec 2024 --> Sep 2025
- |||||||||| psilocybin (COMP360) / Compass Pathways
Journal: Assessing expectancy and suggestibility in a trial of escitalopram v. psilocybin for depression. (Pubmed Central) - Jan 22, 2024
P2
Overall, our results suggest that psychedelic therapy may be less vulnerable to expectancy biases than previously suspected. The relationship between baseline trait suggestibility and response to psilocybin therapy implies that highly suggestible individuals may be primed for response to this treatment.
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Preclinical, Journal: Rapid-acting antidepressant drugs modulate affective bias in rats. (Pubmed Central) - Jan 14, 2024
The relearning effects of ketamine were dependent on protein synthesis localized to the rat medial prefrontal cortex and could be modulated by cue reactivation, consistent with experience-dependent neural plasticity. These findings suggest a neuropsychological mechanism that may explain both the acute and sustained effects of RAADs, potentially linking their effects on neural plasticity with affective bias modulation in a rodent model.
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Journal: Psychological Support for Psilocybin Treatment: Reply to Letters on Our Commentary. (Pubmed Central) - Jan 6, 2024
These findings suggest a neuropsychological mechanism that may explain both the acute and sustained effects of RAADs, potentially linking their effects on neural plasticity with affective bias modulation in a rodent model. No abstract available
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Clinical data, Journal: Psilocybin therapy for treatment resistant depression: prediction of clinical outcome by natural language processing. (Pubmed Central) - Aug 22, 2023
A machine learning algorithm using NLP and EBI accurately predicts long-term patient response, allowing rapid prognostication of personalized response to psilocybin treatment and insight into therapeutic model optimization. Further research is required to understand if language data from earlier stages in the therapeutic process hold similar predictive power.
- |||||||||| psilocybin (COMP360) / Compass Pathways
Journal: Psilocybin for treatment resistant depression in patients taking a concomitant SSRI medication. (Pubmed Central) - Jul 14, 2023
This phase II, exploratory, international, fixed-dose, open-label study explored the safety, tolerability, and efficacy of a synthetic form of psilocybin (investigational drug COMP360) adjunct to a selective serotonin reuptake inhibitor in participants with TRD...Both response and remission were evident in 8 (42.1%) participants. Larger, comparator-controlled trials are necessary to understand if this paradigm can optimize treatment-outcome where antidepressant drug withdrawal would be problematic.
- |||||||||| psilocybin (COMP360) / Compass Pathways
Journal: A Bayesian Reanalysis of a Trial of Psilocybin versus Escitalopram for Depression. (Pubmed Central) - Jun 20, 2023
P2
The present results provide a more precise and nuanced interpretation to previously reported results from this trial, and support the need for further research into the relative efficacy of psilocybin therapy for depression with respect to current leading treatments. NCT03429075.
- |||||||||| psilocybin (COMP360) / Compass Pathways
Safety of COMP360 (Synthetic Psilocybin) in Bipolar Type II Depression (Regency Ballroom D) - Jun 15, 2023 - Abstract #ISBD2023ISBD_444;
At 12 weeks 10 of 12 (83.3%) met both remission and response criteria. Conclusions In this small, open-label pilot study, most subjects reported significant improvement in chronic depressive symptoms with durability lasting for the three months they were followed post dosing and no evidence for safety concerns.
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An Open Label Study of COMP360 (Synthetic Psilocybin) in Bipolar Type II Depression (Crystal Ballroom AB) - Jun 15, 2023 - Abstract #ISBD2023ISBD_237;
No subject showed evidence of mania or hypomania by YMRS score at any visit after dosing. Conclusions Further exploration into the efficacy of psychedelic therapy within this poorly served psychiatrically ill population is warranted.
- |||||||||| psilocybin (COMP360) / Compass Pathways
Trial completion date, Trial primary completion date: The Safety and Tolerability of COMP360 in Participants With Post-traumatic Stress Disorder (clinicaltrials.gov) - Jun 13, 2023
P2, N=20, Recruiting,
Conclusions Further exploration into the efficacy of psychedelic therapy within this poorly served psychiatrically ill population is warranted. Trial completion date: Aug 2023 --> Apr 2024 | Trial primary completion date: Jun 2023 --> Dec 2023
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An Open Label Study of Synthetic Psilocybin in Bipolar Type II Depression (Sapphire AB) - Apr 29, 2023 - Abstract #SOBP2023SOBP_119;
Methods Fourteen adults with bipolar II depression and at least two treatment failures were dosed with a single 25mg dose of synthetic psilocybin (COMP360) after withdrawal from psychotropic medication at least two weeks before dosing...Conclusions Most subjects reported significant improvement in chronic depressive symptoms without hypomania or suicidality and durability lasting for three months follow-up. Further studies are warranted.
- |||||||||| psilocybin (COMP360) / Compass Pathways
Journal: Unblinding and demand characteristics in the treatment of depression. (Pubmed Central) - Mar 14, 2023
We highlight the importance of exploring blinding as a mechanism, confirming dose-related outcomes, and dissociating unblinding effects from efficacy. Unblinding does not necessarily invalidate the subjective experience of sustained recovery from depression.
- |||||||||| psilocybin (COMP360) / Compass Pathways
Improvement in Depression Symptoms Measured by Montgomery- (08. Room Passy) - Mar 2, 2023 - Abstract #EPA2023EPA_292;
Three weeks after dosing, psilocybin 25 A single administration of COMP360 psilocybin therapy rapidly and dose-relatedly improved symptoms of depressed mood and anhedonia
- |||||||||| psilocybin (COMP360) / Compass Pathways
Journal: Psilocybin for Treatment-Resistant Depression. Reply. (Pubmed Central) - Feb 27, 2023
A single administration of COMP360 psilocybin therapy rapidly and dose-relatedly improved symptoms of depressed mood and anhedonia No abstract available
- |||||||||| psilocybin (COMP360) / Compass Pathways
Journal: Optimizing outcomes in psilocybin therapy: Considerations in participant evaluation and preparation. (Pubmed Central) - Feb 27, 2023
This paper proposes that readiness assessment includes both intrapersonal and interpersonal factors in order to improve safety, patient care, and treatment outcomes. While at the present time a reliable and valid instrument has not been developed, we propose that three specific areas of focus - patient presentation, therapeutic alliance, and patient safety - may be used to establish a patient's readiness for psilocybin therapy, thus increasing therapy optimization and personalization.
- |||||||||| psilocybin (COMP360) / Compass Pathways
New P2 trial: A Phase II, Multicentre, Randomised, Double-blind, Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Efficacy of COMP360 in Participants With Major Depressive Disorder With One Prior Treatment Failure (clinicaltrials.gov) - Feb 17, 2023
P2, N=102, Recruiting,
- |||||||||| psilocybin (COMP360) / Compass Pathways
Improvement in Depression Symptoms Measured by Montgomery- (Rock Creek Ballroom) - Feb 11, 2023 - Abstract #ADAA2023ADAA_341;
Greater improvement in the 25mg arm was apparent from Day 2 and remained to Week 12 (Lassitude remained to Week 6 only). On the QIDS-SR16, the item with the largest difference in mean CFB at Week 3 in the 25mg arm was in Feeling Sad and remained evident through to Week 12 (mean (SD) -1.1 (1.08)).
- |||||||||| psilocybin (COMP360) / Compass Pathways
Journal: Single-Dose Psilocybin for a Treatment-Resistant Episode of Major Depression. (Pubmed Central) - Nov 9, 2022
P2
Larger and longer trials, including comparison with existing treatments, are required to determine the efficacy and safety of psilocybin for this disorder. (Funded by COMPASS Pathfinder; EudraCT number, 2017-003288-36; ClinicalTrials.gov number, NCT03775200.).
- |||||||||| psilocybin (COMP360) / Compass Pathways
Trial completion: Safety and Efficacy of Psilocybin for Body Dysmorphic Disorder (clinicaltrials.gov) - Nov 4, 2022
P2, N=12, Completed,
(Funded by COMPASS Pathfinder; EudraCT number, 2017-003288-36; ClinicalTrials.gov number, NCT03775200.). Active, not recruiting --> Completed
- |||||||||| psilocybin (COMP360) / Compass Pathways
An Open Label Study of COMP360 (Synthetic Psilocybin) in Bipolar Type II Depression (Grand Saguaro) - Oct 31, 2022 - Abstract #ACNP2022ACNP_442;
P2
The relative improvement was notably greater in treatment-resistant depression patients with bipolar II disorder versus patients with major depression. Further exploration into the efficacy of psychedelic therapy within this poorly served psychiatrically ill population is warranted.
- |||||||||| psilocybin (COMP360) / Compass Pathways
Enrollment change, Trial completion date, Trial primary completion date: An Open Label Study of the Safety and Efficacy of Psilocybin in Participants With Treatment-Resistant Depression (P-TRD) (clinicaltrials.gov) - Oct 25, 2022
P2, N=27, Recruiting,
These results are supportive of continued investigation into the use of psychedelic therapy in even the most treatment resistant patients who have not benefitted from even the most aggressive treatment interventions. N=15 --> 27 | Trial completion date: Apr 2022 --> Oct 2023 | Trial primary completion date: Apr 2022 --> Oct 2023
- |||||||||| psilocybin (COMP360) / Compass Pathways
Enrollment closed, Trial completion date, Trial primary completion date: The Safety and Efficacy of Psilocybin in Participants With Type 2 Bipolar Disorder (BP-II) Depression. (clinicaltrials.gov) - Oct 25, 2022
P2, N=15, Active, not recruiting,
N=15 --> 27 | Trial completion date: Apr 2022 --> Oct 2023 | Trial primary completion date: Apr 2022 --> Oct 2023 Recruiting --> Active, not recruiting | Trial completion date: Aug 2022 --> Apr 2023 | Trial primary completion date: Aug 2022 --> Jan 2023
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