Psilocybin for Bipolar Disorder
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether psilocybin, a compound in certain mushrooms, can safely reduce suicidal thoughts in individuals with Bipolar Disorder II experiencing depression. Participants will receive up to two doses of psilocybin with therapeutic support to assess its impact on mental health. Ideal candidates for this trial include those diagnosed with Bipolar Disorder II, experiencing mild to moderate depression, and having ongoing thoughts of being a burden or feeling disconnected from others. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group.
Do I have to stop taking my current medications for the trial?
Yes, you will need to taper off mood stabilizers and other relevant medications starting 5 weeks before the psilocybin administration and be off them for at least 2 weeks prior. You must also stop certain allowed medications at least 24 hours before taking psilocybin, as advised by the study physician.
Is there any evidence suggesting that psilocybin is likely to be safe for humans?
Research has shown that psilocybin, the active ingredient in "magic mushrooms," is under study for its safety and potential benefits in treating bipolar disorder, particularly bipolar II depression. In one study, individuals with bipolar II disorder who took psilocybin reported noticeable symptom relief. Another study examined psilocybin's safety by assessing changes in depression severity after treatment.
While these results are encouraging, the overall safety of psilocybin for treating bipolar disorder remains under investigation. Some studies suggest psilocybin might be safe, but further research is necessary to confirm this. The current research phase primarily tests safety and side effects. Therefore, despite some positive evidence, continued study is crucial to fully understand psilocybin's safety for individuals with bipolar disorder.12345Why do researchers think this study treatment might be promising for Bipolar Disorder?
Most treatments for bipolar disorder involve mood stabilizers or antipsychotics, which work by balancing neurotransmitters like dopamine and serotonin. However, psilocybin is unique because it’s a psychedelic compound that targets serotonin receptors in a novel way, potentially offering rapid mood enhancement. Researchers are excited because psilocybin may provide faster relief from mood swings compared to traditional medications, which often take weeks to become effective. Additionally, the therapeutic support accompanying psilocybin treatment could help integrate the experience, potentially leading to more profound, lasting improvements in mood and mental health.
What evidence suggests that psilocybin might be an effective treatment for bipolar disorder?
Research has shown that psilocybin, administered with therapeutic support, may help treat depression in people with Bipolar II Disorder. One study found that many patients experienced relief from their depression. In another trial, 80% of participants saw their depression disappear without worsening symptoms like mania or suicidal thoughts. The results also indicated fewer days with depression and more days without mental health issues. These findings suggest that psilocybin, when used with therapy, could effectively reduce depression in bipolar disorder.13467
Who Is on the Research Team?
Thomas Meyer, PhD
Principal Investigator
The University of Texas Health Science Center, Houston
Are You a Good Fit for This Trial?
This trial is for individuals with Bipolar Disorder II who are experiencing depression and may have suicidal thoughts. Participants must be stable on their current medications and in good physical health to handle the psilocybin treatment.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive up to two sequential doses of 25 mg psilocybin with therapeutic support
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Psilocybin
Psilocybin is already approved in United States, European Union for the following indications:
- Treatment-resistant depression (TRD) under Breakthrough Therapy designation
- Treatment-resistant depression (TRD) under PRIME designation
Find a Clinic Near You
Who Is Running the Clinical Trial?
The University of Texas Health Science Center, Houston
Lead Sponsor
Anne and Don Fizer Foundation
Collaborator