Clinical TrialBipolar DisorderPsilocybinRecruiting

Acceptability & Safety of Two Sequential Doses of Psilocybin in Bipolar Disorder II Depression

Non-randomised, single-group Phase II trial (n=10) assessing safety and acceptability of up to two 25 mg oral psilocybin administrations with therapeutic support in individuals with Bipolar II depression and suicidal ideation (second dose optional, 4 weeks apart).

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

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Compound research: PsilocybinTopic research: Bipolar DisorderResearch in United States

Detailed Description

This single-group, open-label Phase II study will evaluate the safety, feasibility and acceptability of up to two 25 mg oral psilocybin administrations given 4 weeks apart alongside structured therapeutic support in adults with Bipolar II depression and suicidal ideation (without active plan or intent).

Therapeutic support follows a mindfulness-based CBT approach with five preparatory sessions before the first administration, an optional 60-minute preparation before a second administration, and three integration sessions after each dosing session; additional optional therapy is available during the trial.

Outcomes include measures of suicidality, depressive symptoms, and acute subjective experiences using validated instruments (INQ, MADRS, C-SSRS and others), with safety monitoring via clinical and laboratory assessments.

Study Protocol

Preparation

5 sessions
60 min each

Dosing

2 sessions

Integration

3 sessions

Therapeutic Protocol

mindfulnesscbt

Study Arms & Interventions

Psilocybin 25 mg

experimental

Up to two sequential 25 mg psilocybin administrations with therapeutic support (single-group design).

Interventions

  • Psilocybin25 mg
    via Oral• single dose• 2 doses total

    Two administrations 4 weeks apart; second administration optional.

  • Compound
    via Other• periprocedural

    Therapeutic support: five preparatory sessions before first administration, optional 60-min prep before second, and three integration sessions after each administration; mindfulness-based CBT orientation.

Participants

Ages
25 – 70
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • Must have completed written informed consent
  • Must be at 25 years of age or older at screening (but below age of 70)
  • Confirmed DSM-5 diagnosis of Bipolar II disorder using clinical records and DIAMOND
  • Must meet suicidality criteria per INQ: PB ≥12 and TB ≥36 indicating risk for passive suicidal ideation
  • Must meet depression criteria per MADRS: score 7–34 (mild to moderate)
  • Pass medical exam (physical, history, ECG, blood draw, psychiatric assessments, urine drug test)
  • Willingness to taper relevant medications affecting serotonergic function starting 5 weeks before administration and be off medications for at least 2 weeks prior
  • Willingness to stop allowed medication at least 24 h prior to psilocybin as advised by study physician
  • Ability to complete all protocol assessments and comply with study visits

Exclusion Criteria

  • Exclusion Criteria:
  • Do not read/speak English
  • Active suicidal ideation with intent and/or plan (C-SSRS score 4 or 5)
  • Medically significant suicide attempt in the last 6 months
  • Current or past Bipolar I disorder, psychotic symptoms/disorder, or serious psychiatric comorbidity that impacts safety (e.g., severe SUD, PTSD)
  • First- or second-degree relative with Bipolar I disorder or a psychotic disorder
  • Currently experiencing a hypomanic or mixed episode
  • Any condition judged incompatible with rapport or safe exposure to psilocybin
  • Indication of a personality disorder (e.g., borderline, narcissistic, antisocial) by SCID-PD or clinical judgment

Study Protocol, Arms & Participants

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Study Details

  • Status
    Recruiting
  • Phase
    Phase II
  • Type
    interventional
  • Design
    Non-randomized
  • Target Enrollment10 participants
  • Timeline
    Start: 2025-07-07
    End: 2027-08-01
  • Compound
    Psilocybin
  • Topic
    Bipolar Disorder

Locations

The University of Texas Health Science Center at Houston — Houston, Texas, United States

Recent activity

  • StartedAcceptability & Safety of Two Sequential Doses of Psilocybin in Bipolar Disorder II Depression (NCT06706232, psilocybin)

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