TrialReader

The Safety and Efficacy of Psilocybin in Participants With Type 2 Bipolar Disorder (BP-II) Depression.

NCT04433845 — Phase 2, Unknown, 15 participants, Sheppard Pratt Health System
ClinicalTrials Daily  ·  Areas  ·  Conditions  ·  Drugs  ·  Sponsors  ·  
RegistryNCT04433845
StatusUnknown
PhasePhase 2
Study typeInterventional; na, single group, masking: none, treatment
Enrollment15 (Actual)
SponsorSheppard Pratt Health System (Other); collaborators: COMPASS Pathways
ConditionsTreatment Resistant Depression
InterventionsPsilocybin (Drug)
Datesstart 2021-03-01, primary completion 2023-01-15 (estimated), completion 2023-04-15 (estimated), first posted 2020-06-16, last updated 2022-10-25
Locations1 site in United States

Related Papers Related Patents Related Grants Related Experts
AI Assistant Save
All trials for Treatment Resistant Depression All trials of Psilocybin

-Summary

The primary objective of this study is to evaluate the efficacy of 25 mg of psilocybin under supportive conditions to adult participants with BP-II, current episode depressed, in improving depressive symptoms.

Expand all sections  ·  Collapse all

+Arms and interventions

ArmTypeInterventionsDescription
PsilocybinExperimentalDrug: Psilocybin25mg of Psilocybin
  • Psilocybin (Drug): Open-label

+Outcome measures

Primary outcomes

  • Montgomery-Asberg Depression Rating Scale (MADRS) [From Baseline (Day -1) to three weeks post-dose.]: MADRS is a clinician-rated scale measuring depression severity, consisting of 10 items, each scored from 0 (normal) to 6 (severe), for a total possible score of 60; higher scores denote greater severity. Response = >50% decrease and Remission =< 10 actual score

+Eligibility

Sex: All, ages: 18 Years to 65 Years

Inclusion Criteria:

* Diagnosis of Type 2 Bipolar Disorder (BP-II) Depression

Exclusion Criteria:

* Comorbidities

+Locations (1)

FacilityCityCountryStatus
Sheppard PrattBaltimore, MarylandUnited States

+Publications

  • Results publication: Aaronson ST, van der Vaart A, Miller T, LaPratt J, Swartz K, Shoultz A, Lauterbach M, Sackeim HA, Suppes T. Single-Dose Synthetic Psilocybin With Psychotherapy for Treatment-Resistant Bipolar Type II Major Depressive Episodes: A Nonrandomized Open-Label Trial. JAMA Psychiatry. 2024 Jun 1;81(6):555-562. doi: 10.1001/jamapsychiatry.2023.4685. PMID 38055270

+Investigators

My Notes