Treatment Resistant DepressionPhase 2NCT07183748
Psilocybin Microdosing With Psychotherapy for Treatment-Resistant Depression
A Phase 2 study testing Psilocybin (drug) in people with Treatment Resistant Depression, run by Beersheva Mental Health Center at 1 site in Israel.
Trial 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 who have not responded to previous pharmacological or long-term psychological interventions. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Treatment Resistant Depression
- What is being tested?
- Psilocybin (drug)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Dec 2025to 1 Jun 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
Mental Health Center Beer Sheva
Beersheba
Dr. Arbel, +972506576691, oded.arbel@pbsh.health.gov.il
About this study
Official title: A Double-blind, Phase II Feasibility Study to Assess the Safety and Efficacy of Psilocybin Microdosing Combined With Psychotherapy in Treatment-resistant Depression
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 who have not responded to previous pharmacological or long-term psychological interventions.
Read more
Hypothesis:
Compared to baseline, the group that begins with psilocybin will exhibit a more rapid reduction in depressive symptoms after six weeks, compared to the group that begins with placebo and receives only psychotherapy. Following the crossover between conditions, the placebo-first group will also show an accelerated reduction in these measures after the subsequent six weeks.
Alternative hypothesis: No difference will be observed between groups in the rate of symptom reduction.
Objective:
To examine biological markers that may mediate potential improvements in depressive symptoms among participants receiving psilocybin microdosing compared to placebo.
Hypothesis:
Compared to baseline, six weeks of active psilocybin dosing will result in decreased levels of cortisol and inflammatory markers, and increased levels of oxytocin and BDNF in saliva.
Objective:
To assess psychological factors that may mediate potential improvements in depressive symptoms among participants receiving psilocybin microdosing compared to placebo.
Hypothesis:
Compared to baseline, six weeks of active psilocybin dosing will lead to increased cognitive flexibility, greater self-compassion, and enhanced present-moment awareness.
Objective:
To explore a subpopulation of women experiencing premenstrual symptom exacerbation (PMS) and the potential for improvement in depressive symptoms in the days preceding menstruation, if any.
Hypothesis:
Among women with worsened premenstrual symptoms, psilocybin will reduce premenstrual symptoms, specifically depressive symptoms, compared to baseline.
- Conditions
- Treatment Resistant Depression
- Being tested
- Psilocybin (drug), Placebo
- Medical subject headings
- Depressive Disorder, Treatment-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psilocybin (drug)Drug
0.4 grams
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Not described Receives: Drug: Psilocybin (drug) |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beck Depression Inventory -II (BDI-II) change from baseline
depression symptoms, will be measured by the Beck Depression Inventory
Measured: Baseline, Weeks 2, 4, 6, 8, 10, 12, and 24
Columbia Suicide Severity Rating Scale (C-SSRS)
A standardized questionnaire that assesses suicidal ideation and behavior, including severity and intensity of thoughts, and history of suicide attempts.
Measured: Baseline, Weeks 2, 4, 6, 8, 10, 12, and 24
Mindful Attention Awareness Scale (MAAS
A self-report questionnaire that measures the frequency of mindful states in day-to-day life, focusing on present-moment awareness and attention.
Measured: Baseline, Weeks 2, 4, 6, 8, 10, 12, and 24
Five Facet Mindfulness Questionnaire (FFMQ)
A self-report measure that assesses five aspects of mindfulness: observing, describing, acting with awareness, non-judging, and non-reactivity.
Measured: Baseline, Weeks 2, 4, 6, 8, 10, 12, and 24
Self-Compassion Scale, Neff, 2003b
self-report questionnaire that measures levels of self-compassion across dimensions such as self-kindness, common humanity, and mindfulness.
Measured: Baseline, Weeks 2, 4, 6, 8, 10, 12, and 24
The Quality of Life Enjoyment & Satisfaction Questionnaire (Q-LESQ-SF) .
A self-report measure that evaluates an individual's degree of enjoyment and satisfaction in various areas of daily functioning and overall quality of life.
Measured: Baseline, Weeks 2, 4, 6, 8, 10, 12, and 24
Premenstrual symptoms screening tool: PSST, Steiner
A screening questionnaire that identifies premenstrual syndrome (PMS) and premenstrual dysphoric disorder (PMDD) based on the severity and impact of symptoms.
Measured: Baseline, Weeks 2, 4, 6, 8, 10, 12, and 24
Cognitive Flexibility Scale
A self-report questionnaire that measures an individual's ability to adapt thinking and behavior in response to changing situations and demands.
Measured: Baseline, Weeks 2, 4, 6, 8, 10, 12, and 24
Connectedness Scale
A self-report questionnaire that assesses an individual's sense of connection to others, community, and the broader world.
Measured: Baseline, Weeks 2, 4, 6, 8, 10, 12, and 24
SETS 2012
A self-report questionnaire that measures patients' expectations regarding the effectiveness and outcomes of a treatment.
Measured: Baseline, Weeks 2, 4, 6, 8, 10, 12, and 24
Treatment Guess Questionnaire
A brief measure where participants indicate which treatment condition they believe they received, used to assess blinding integrity.
Measured: Baseline, Weeks 2, 4, 6, 8, 10, 12, and 24
Change from Baseline in Systolic Blood Pressure
Systolic blood pressure measured in the seated position after 5 minutes of rest Unit of Measure: mmHg
Measured: Baseline, Weeks 2, 4, 6, 8, 10, 12, 24
Change from Baseline in Diastolic Blood Pressure
Diastolic blood pressure measured in the seated position after 5 minutes of rest. Unit of Measure: mmHg
Measured: Baseline, Weeks 2, 4, 6, 8, 10, 12, 24
Change from Baseline in Heart Rate
Resting heart rate by pulse/monitor. Resting heart rate by pulse/monitor
Measured: Baseline, Weeks 2, 4, 6, 8, 10, 12, 24
Change from Baseline in Body Temperature
Oral/tympanic temperature per site SOP. Unit of Measure: °C
Measured: Baseline, Weeks 2, 4, 6, 8, 10, 12, 24
Change from Baseline in Salivary concentration
Morning salivary collected per SOP, Unit of Measure: [ng/mL / nmol/L]
Measured: Baseline, Weeks 2, 4, 6, 8, 10, 12, 24
Participants with treatment-emergent clinically significant laboratory abnormalities
Proportion of participants with any new or worsening clinically significant abnormality in hematology or clinical chemistry panels, per site reference ranges and PI judgment (or per predefined thresholds). Unit of Measure: % participants
Measured: Baseline, Weeks 2, 4, 6, 8, 10, 12, 24
Emotional Go-No-Go
In this task, participants respond to certain stimuli with a motor action, while in others, they must withhold a response. Previous findings indicate impaired inhibition in patients with depression, as shown in classic response inhibition tasks using faces with negative or neutral expressions.
Measured: On 6, 12, and 24 weeks FU.
2 Task Switching
A cognitive task that measures mental flexibility and executive control by requiring participants to alternate between different tasks or rules, assessing their ability to shift attention and adapt to changing demands.
Measured: On 6,12, and 24 weeks FU.
ONE-BACK
A working memory task in which participants view a sequence of stimuli and must indicate whether the current stimulus is the same as the one immediately preceding it, assessing attention and short-term memory.
Measured: On 6,12, and 24 weeks FU.
Item & Associative recognition
A memory task that assesses the ability to recognize previously presented items and to recall the associations between them, measuring both item memory and relational/associative memory processes.
Measured: On 6,12, and 24 weeks FU.
Qualitative interview
A semi-structured interview designed to capture participants' experiences, perceptions, and expectations in their own words. According to the protocol, approximately one-third of the patients will be randomly selected to participate.
Measured: Baseline, 6 weeks, and 24 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2025
- Study start1 Dec 2025 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment Resistant DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beersheva Mental Health Center
- Sponsor type
- Other government
- Collaborators
- MSICS PHARMA LTD
- Responsible party
- Principal investigator, ODED ARBEL, Beersheva Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07183748
- Sponsor's protocol ID
- MHC-5-22
- Status last verified
- Aug 2025
- First submitted
- 15 Jun 2025
- Last updated
- 19 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Phase II Feasibility Study to Assess the Safety and Efficacy of Psilocybin Microdosing Combined With Psychotherapy in Treatment-resistant Depression
- ClinicalTrials.gov ID
- NCT07183748
- Acronym / sponsor ID
- MHC-5-22
- Conditions
- Treatment Resistant Depression
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Beersheva Mental Health CenterOther government
- Collaborators
- MSICS PHARMA LTD
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 19 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 who have not responded to previous pharmacological or long-term psychological interventions.
Hypothesis:
Compared to baseline, the group that begins with psilocybin will exhibit a more rapid reduction in depressive symptoms after six weeks, compared to the group that begins with placebo and receives only psychotherapy. Following the crossover between conditions, the placebo-first group will also show an accelerated reduction in these measures after the subsequent six weeks.
Alternative hypothesis: No difference will be observed between groups in the rate of symptom reduction.
Objective:
To examine biological markers that may mediate potential improvements in depressive symptoms among participants receiving psilocybin microdosing compared to placebo.
Hypothesis:
Compared to baseline, six weeks of active psilocybin dosing will result in decreased levels of cortisol and inflammatory markers, and increased levels of oxytocin and BDNF in saliva.
Objective:
To assess psychological factors that may mediate potential improvements in depressive symptoms among participants receiving psilocybin microdosing compared to placebo.
Hypothesis:
Compared to baseline, six weeks of active psilocybin dosing will lead to increased cognitive flexibility, greater self-compassion, and enhanced present-moment awareness.
Objective:
To explore a subpopulation of women experiencing premenstrual symptom exacerbation (PMS) and the potential for improvement in depressive symptoms in the days preceding menstruation, if any.
Hypothesis:
Among women with worsened premenstrual symptoms, psilocybin will reduce premenstrual symptoms, specifically depressive symptoms, compared to baseline.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: Psilocybin (drug) |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psilocybin (drug)0.4 grams | Drug | Treatment |
| PlaceboPlacebo | Other | Placebo |
Primary outcome
Beck Depression Inventory -II (BDI-II) change from baseline
Time frame: Baseline, Weeks 2, 4, 6, 8, 10, 12, and 24
depression symptoms, will be measured by the Beck Depression Inventory
Columbia Suicide Severity Rating Scale (C-SSRS)
Time frame: Baseline, Weeks 2, 4, 6, 8, 10, 12, and 24
A standardized questionnaire that assesses suicidal ideation and behavior, including severity and intensity of thoughts, and history of suicide attempts.
Mindful Attention Awareness Scale (MAAS
Time frame: Baseline, Weeks 2, 4, 6, 8, 10, 12, and 24
A self-report questionnaire that measures the frequency of mindful states in day-to-day life, focusing on present-moment awareness and attention.
Five Facet Mindfulness Questionnaire (FFMQ)
Time frame: Baseline, Weeks 2, 4, 6, 8, 10, 12, and 24
A self-report measure that assesses five aspects of mindfulness: observing, describing, acting with awareness, non-judging, and non-reactivity.
Self-Compassion Scale, Neff, 2003b
Time frame: Baseline, Weeks 2, 4, 6, 8, 10, 12, and 24
self-report questionnaire that measures levels of self-compassion across dimensions such as self-kindness, common humanity, and mindfulness.
The Quality of Life Enjoyment & Satisfaction Questionnaire (Q-LESQ-SF) .
Time frame: Baseline, Weeks 2, 4, 6, 8, 10, 12, and 24
A self-report measure that evaluates an individual's degree of enjoyment and satisfaction in various areas of daily functioning and overall quality of life.
Premenstrual symptoms screening tool: PSST, Steiner
Time frame: Baseline, Weeks 2, 4, 6, 8, 10, 12, and 24
A screening questionnaire that identifies premenstrual syndrome (PMS) and premenstrual dysphoric disorder (PMDD) based on the severity and impact of symptoms.
Cognitive Flexibility Scale
Time frame: Baseline, Weeks 2, 4, 6, 8, 10, 12, and 24
A self-report questionnaire that measures an individual's ability to adapt thinking and behavior in response to changing situations and demands.
Connectedness Scale
Time frame: Baseline, Weeks 2, 4, 6, 8, 10, 12, and 24
A self-report questionnaire that assesses an individual's sense of connection to others, community, and the broader world.
SETS 2012
Time frame: Baseline, Weeks 2, 4, 6, 8, 10, 12, and 24
A self-report questionnaire that measures patients' expectations regarding the effectiveness and outcomes of a treatment.
Treatment Guess Questionnaire
Time frame: Baseline, Weeks 2, 4, 6, 8, 10, 12, and 24
A brief measure where participants indicate which treatment condition they believe they received, used to assess blinding integrity.
Change from Baseline in Systolic Blood Pressure
Time frame: Baseline, Weeks 2, 4, 6, 8, 10, 12, 24
Systolic blood pressure measured in the seated position after 5 minutes of rest Unit of Measure: mmHg
Change from Baseline in Diastolic Blood Pressure
Time frame: Baseline, Weeks 2, 4, 6, 8, 10, 12, 24
Diastolic blood pressure measured in the seated position after 5 minutes of rest. Unit of Measure: mmHg
Change from Baseline in Heart Rate
Time frame: Baseline, Weeks 2, 4, 6, 8, 10, 12, 24
Resting heart rate by pulse/monitor. Resting heart rate by pulse/monitor
Change from Baseline in Body Temperature
Time frame: Baseline, Weeks 2, 4, 6, 8, 10, 12, 24
Oral/tympanic temperature per site SOP. Unit of Measure: °C
Change from Baseline in Salivary concentration
Time frame: Baseline, Weeks 2, 4, 6, 8, 10, 12, 24
Morning salivary collected per SOP, Unit of Measure: [ng/mL / nmol/L]
Participants with treatment-emergent clinically significant laboratory abnormalities
Time frame: Baseline, Weeks 2, 4, 6, 8, 10, 12, 24
Proportion of participants with any new or worsening clinically significant abnormality in hematology or clinical chemistry panels, per site reference ranges and PI judgment (or per predefined thresholds). Unit of Measure: % participants
Emotional Go-No-Go
Time frame: On 6, 12, and 24 weeks FU.
In this task, participants respond to certain stimuli with a motor action, while in others, they must withhold a response. Previous findings indicate impaired inhibition in patients with depression, as shown in classic response inhibition tasks using faces with negative or neutral expressions.
2 Task Switching
Time frame: On 6,12, and 24 weeks FU.
A cognitive task that measures mental flexibility and executive control by requiring participants to alternate between different tasks or rules, assessing their ability to shift attention and adapt to changing demands.
ONE-BACK
Time frame: On 6,12, and 24 weeks FU.
A working memory task in which participants view a sequence of stimuli and must indicate whether the current stimulus is the same as the one immediately preceding it, assessing attention and short-term memory.
Item & Associative recognition
Time frame: On 6,12, and 24 weeks FU.
A memory task that assesses the ability to recognize previously presented items and to recall the associations between them, measuring both item memory and relational/associative memory processes.
Qualitative interview
Time frame: Baseline, 6 weeks, and 24 weeks.
A semi-structured interview designed to capture participants' experiences, perceptions, and expectations in their own words. According to the protocol, approximately one-third of the patients will be randomly selected to participate.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Psilocybin (drug) in people with Treatment Resistant Depression, run by Beersheva Mental Health Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Oded Arbel, MD (+972506576691, oded.arbel@pbsh.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Beck Depression Inventory -II (BDI-II) change from baseline (time frame: Baseline, Weeks 2, 4, 6, 8, 10, 12, and 24). The study lists 22 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.