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| Name | Class |
|---|---|
| Anne and Don Fizer Foundation | UNKNOWN |
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The purpose of the study is to assess the safety and acceptability of up to two sequential administrations of 25 mg psilocybin with additional therapeutic support in decreasing suicidality in patients with Bipolar Disorder (BD II) depression.
This study aims to determine whether psilocybin paired with psychotherapy is a safe, feasible, and acceptable treatment for Bipolar II (BD II) depression, specifically, individuals experiencing suicidal ideation (without having an active plan or intention to act). The design is a non-randomized clinical trial, where patients will receive up to 2 doses of 25mg psilocybin in the context of psychological support informed by mindfulness-based CBT and typical elements of psychedelic treatments (e.g., preparation, intention setting, integration). The investigators will measure suicidality, depression, and acute experiences using validated questionnaires at multiple time points in the study. If this study shows psilocybin to be a feasible, acceptable, and safe treatment option, this would have huge implications for improving outcomes because highly effective treatment for suicidality in patients with Bipolar Disorder is still lacking.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Psilocybin with therapeutic support | Experimental | Up to two sequential administrations of 25 mg psilocybin with additional therapeutic support. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Psilocybin | Drug | Two sequential administrations of 25 mg psilocybin, 4 weeks apart. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility as Assessed by Number of Participants who Complete the Trial (Overall Retention) | This is assessed by number of participants who complete the trial, that is, the number of participants who complete the first dose and follow-up visits up to 3 weeks after the first dose. | from baseline to 3 weeks after first administration session |
| Feasibility as Assessed by Number of Therapy Sessions Attended | from baseline to 3 weeks after first administration session | |
| Feasibility as Assessed by Number of Assessments Completed | from baseline to 3 weeks after first administration session | |
| Acceptability of Two Dosing Sessions as Assessed by Number of Participants who Choose to Participate in a Second Administration Session | 11 weeks after first administration session | |
| Acceptability as Assessed by Number of Therapy Sessions Attended | from baseline to 11 weeks after first administration session | |
| Acceptability as Assessed by Number of Assessments Completed | from baseline to 11 weeks after first administration session | |
| Score on the Thwarted Belongingness (TB) Items of the Interpersonal Needs Questionnaire (INQ-15) | The Thwarted Belongingness (TB) section of the INQ-15 has a total score range from 9 to 63, with a higher score indicating greater TB. | baseline, 3 weeks after first administration session |
| Score on the Perceived Burdensomeness (PB) Items of the Interpersonal Needs Questionnaire (INQ-15) |
| Measure | Description | Time Frame |
|---|---|---|
| Score on the Montgomery-Åsberg Depression Rating Scale (MADRS) | The total score on the MADRS ranges from 0 to 60, with a higher score indicating a greater depression. | baseline, 3 weeks after first administration session |
| Score on the Quick Inventory of Depressive Symptomatology (QIDS-SR16) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Thomas Meyer, PhD | Contact | 713-486-2643 | thomas.d.meyer@uth.tmc.edu | |
| Lauren Vale, MA | Contact | 713-486-2643 | lauren.n.vale@uth.tmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Thomas Meyer, PhD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Recruiting | Houston | Texas | 77006 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38055270 | Background | 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. | |
| 36001306 |
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| Therapeutic Support | Behavioral | Five preparatory in-person psychotherapy sessions will be offered before the first administration session during weeks 1, 2, 3, 4, and 5. The optional second administration session will be preceded by a shorter 60 min preparatory session the day before. Each administration session will be followed by 3 integration sessions and will adopt a Mindfulness-based CBT approach (M-CBT), in which a therapist will help the participant to process their experience and how to translate this into actual changes in everyday life. If participants prefer more psychological support after the second administration session, they will be offered additional, optional therapy sessions for the duration of the trial regardless if they opted for a second administration session or not. |
|
The Perceived Burdensomeness (PB) section of the INQ-15 has a total score range from 6 to 42, with a higher score indicating greater PB. |
| baseline, 3 weeks after first administration session |
| Score on the Columbia-Suicide Severity Rating Scale (C-SSRS) | The total score on the C-SSRS ranges from 0-5, with 5 indicating the highest level of suicidal ideation. | baseline, 3 weeks after first administration session |
Total score on the QIDS-SR16 ranges from 0 to 27, where higher scores indicate a higher occurence of depressive symptoms. |
| baseline, 3 weeks after first administration session |
| Score on the Young Mania Rating Scale (YMRS) | The total score on the YMRS ranges from 0 to 60, with higher scores indicating greater severity of mania. | baseline, 3 weeks after first administration session |
| Psychiatric Symptoms as Assessed by Score on the Brief Psychiatric Rating Scale (positive symptom subscale) (BPRS+) | The total score on the BPRS+ ranges from 4 to 28, with higher scores indicating a higher severity of psychopathology. | baseline, 3 weeks after first administration session |
| Score on the Altman Self-Rating Mania Scale (ASRM) | The total score on the ASRM ranges from 5-25, with higher scores indicating more severity of mania. | baseline, 3 weeks after first administration session |
| Bogenschutz MP, Ross S, Bhatt S, Baron T, Forcehimes AA, Laska E, Mennenga SE, O'Donnell K, Owens LT, Podrebarac S, Rotrosen J, Tonigan JS, Worth L. Percentage of Heavy Drinking Days Following Psilocybin-Assisted Psychotherapy vs Placebo in the Treatment of Adult Patients With Alcohol Use Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2022 Oct 1;79(10):953-962. doi: 10.1001/jamapsychiatry.2022.2096. |
| 29119217 | Background | Carhart-Harris RL, Bolstridge M, Day CMJ, Rucker J, Watts R, Erritzoe DE, Kaelen M, Giribaldi B, Bloomfield M, Pilling S, Rickard JA, Forbes B, Feilding A, Taylor D, Curran HV, Nutt DJ. Psilocybin with psychological support for treatment-resistant depression: six-month follow-up. Psychopharmacology (Berl). 2018 Feb;235(2):399-408. doi: 10.1007/s00213-017-4771-x. Epub 2017 Nov 8. |
| 33146667 | Background | Davis AK, Barrett FS, May DG, Cosimano MP, Sepeda ND, Johnson MW, Finan PH, Griffiths RR. Effects of Psilocybin-Assisted Therapy on Major Depressive Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2021 May 1;78(5):481-489. doi: 10.1001/jamapsychiatry.2020.3285. |
| 36322843 | Background | Goodwin GM, Aaronson ST, Alvarez O, Arden PC, Baker A, Bennett JC, Bird C, Blom RE, Brennan C, Brusch D, Burke L, Campbell-Coker K, Carhart-Harris R, Cattell J, Daniel A, DeBattista C, Dunlop BW, Eisen K, Feifel D, Forbes M, Haumann HM, Hellerstein DJ, Hoppe AI, Husain MI, Jelen LA, Kamphuis J, Kawasaki J, Kelly JR, Key RE, Kishon R, Knatz Peck S, Knight G, Koolen MHB, Lean M, Licht RW, Maples-Keller JL, Mars J, Marwood L, McElhiney MC, Miller TL, Mirow A, Mistry S, Mletzko-Crowe T, Modlin LN, Nielsen RE, Nielson EM, Offerhaus SR, O'Keane V, Palenicek T, Printz D, Rademaker MC, van Reemst A, Reinholdt F, Repantis D, Rucker J, Rudow S, Ruffell S, Rush AJ, Schoevers RA, Seynaeve M, Shao S, Soares JC, Somers M, Stansfield SC, Sterling D, Strockis A, Tsai J, Visser L, Wahba M, Williams S, Young AH, Ywema P, Zisook S, Malievskaia E. Single-Dose Psilocybin for a Treatment-Resistant Episode of Major Depression. N Engl J Med. 2022 Nov 3;387(18):1637-1648. doi: 10.1056/NEJMoa2206443. |
| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| D059020 | Suicidal Ideation |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D013405 | Suicide |
| D016728 | Self-Injurious Behavior |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D011562 | Psilocybin |
| D012657 | Self-Help Groups |
| ID | Term |
|---|---|
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D014363 | Tryptamines |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D009938 | Organizations |
| D004472 | Health Care Economics and Organizations |
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