Clinical TrialTreatment-Resistant Depression (TRD)PsilocybinUnknown status

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

Open-label, single-group Phase II study (n=15 actual) evaluating a single 25 mg dose of psilocybin with supportive therapy in adults with BP-II current depressive episode.

Target Enrollment
15 participants
Study Type
Phase II interventional
Design
Non-randomized

Detailed Description

Open-label, single-group Phase II trial administering a single 25 mg oral dose of psilocybin with supportive psychotherapy to adults with bipolar II depression; primary objective is change in depressive symptoms.

Actual enrollment listed as 15. Outcomes include efficacy on depressive symptoms; safety and tolerability monitored under supportive conditions.

Study Protocol

Preparation

sessions

Dosing

1 sessions

Integration

sessions

Therapeutic Protocol

Manualized psychotherapy included

Study Arms & Interventions

Psilocybin

experimental

Open-label single-group administration of 25 mg psilocybin.

Interventions

  • Psilocybin25 mg
    via Oral• single dose• 1 doses total

    Open-label single 25 mg dose; supportive psychotherapy provided.

Participants

Ages
18 – 65
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • Diagnosis of Type 2 Bipolar Disorder (BP-II) Depression

Exclusion Criteria

  • Exclusion Criteria:
  • Comorbidities

Study Details

Locations

Sheppard Pratt — Baltimore, Maryland, United States

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