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| Name | Class |
|---|---|
| MSICS PHARMA LTD | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Psilocybin (drug) | Drug | 0.4 grams |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Beck Depression Inventory -II (BDI-II) change from baseline | depression symptoms, will be measured by the Beck Depression Inventory | 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. | 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. | 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. | 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. | 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. | Baseline, Weeks 2, 4, 6, 8, 10, 12, and 24 |
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Inclusion Criteria:
Exclusion Criteria:
Men who are sexually active and may cause pregnancy but are unwilling to use contraception.
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Oded Arbel, MD | Contact | +972506576691 | oded.arbel@pbsh.health.gov.il |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mental Health Center Beer Sheva | Recruiting | Beersheba | Israel |
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| ID | Term |
|---|---|
| D061218 | Depressive Disorder, Treatment-Resistant |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D011562 | Psilocybin |
| D004364 | Pharmaceutical Preparations |
| ID | Term |
|---|---|
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
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| Other |
Placebo |
|
| 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. | 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. | 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. | 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. | 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. | 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 | 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 | 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 | 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 | 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] | 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 | 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. | 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. | 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. | 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. | 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. | Baseline, 6 weeks, and 24 weeks. |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D014363 | Tryptamines |
| D054836 | Indolizidines |
| D007212 | Indolizines |