Status:
RECRUITING
Psilocybin Microdosing With Psychotherapy for Treatment-Resistant Depression
Lead Sponsor:
Beersheva Mental Health Center
Collaborating Sponsors:
MSICS PHARMA LTD
Conditions:
Treatment Resistant Depression
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
Objective: To assess the safety and efficacy of a six-week microdosing regimen of psilocybin combined with short-term, experience-based psychotherapy in patients with treatment-resistant depression w...
Eligibility Criteria
Inclusion
- Age range between 18-65 years.
- Diagnosis of treatment-resistant major depression as defined by the DSM-IV criteria (309.81) (ASA 1994) and determined by the BDI (BDI-II, 1996).
- Willingness to discontinue psychiatric medication starting two weeks prior to the beginning of the study and throughout its duration, as well as to cease the use of drugs and licensed cannabis, and to suspend psychotherapy for the duration of the study. Participants also commit not to initiate psychiatric medication or psychotherapy during the study without consulting the research team. All under supervision within a day treatment framework.
- Abstinence from drugs and other psychiatric medications.
- Negative pregnancy test for women, and use of contraception by both men and women during the study period.
- Willingness to sign a confidentiality waiver allowing the research team to consult with the participant's treating physician.
- Willingness to provide the contact information of a close and relevant person in case suicidal ideation arises.
- Commitment to participate in all stages of the study, including follow-up assessments.
- Willingness not to participate in another study during the current study period.
Exclusion
- Investigators and their immediate family members are not permitted to participate in the study. Immediate family is defined as the investigator's spouse, parent, child, grandparent, or grandchild.
- Pregnant women, breastfeeding women, or women of childbearing age who are not using medically approved contraceptive methods (e.g., condoms).
- Men who are sexually active and may cause pregnancy but are unwilling to use contraception.
- Significant unstable physical illness (including cardiac, hepatic, renal, respiratory, endocrinological, neurological, or hematological conditions), based on the investigator's judgment.
- Psychotic spectrum disorders.
- Bipolar disorder.
- Post-traumatic disorder involving dissociative symptoms.
- Uncontrolled anxiety disorder.
- Chronic perceptual disorder (HPPD).
- Head injury or cognitive impairment (including intellectual disability or dementia).
- Severe suicidal risk or aggressive behavior toward others, as assessed by the investigator and standardized depression/suicide assessment questionnaires.
- History of chronic benzodiazepine use (at least 4 mg lorazepam daily for over two years), or signs and symptoms of benzodiazepine use within two weeks prior to randomization.
- Alcohol and/or substance abuse within the past 6 months, based on the clinical judgment of the investigator.
- Any active addiction (substance use disorder).
- Current or past epilepsy.
- Individuals with focal or generalized encephalopathy (e.g., tumor, stroke, meningitis, encephalitis), or head trauma that may be epileptogenic.
Key Trial Info
Start Date :
December 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2028
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT07183748
Start Date
December 1 2025
End Date
June 1 2028
Last Update
November 19 2025
Active Locations (1)
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1
Mental Health Center Beer Sheva
Beersheba, Israel