Treatment Resistant DisordersPhase 2NCT05243329
Investigating the Therapeutic Effects of Psilocybin in Treatment-Resistant Post-Traumatic Stress Disorder
A Phase 2 study testing Psilocybin in people with Treatment Resistant Disorders and Post Traumatic Stress Disorder, run by Halucenex Life Sciences Inc. at 1 site in Canada.
Trial summary
Post-traumatic stress disorder (PTSD) is a complex disorder expressed as a variety of neurobiological symptoms, including anxiety, re-experiencing, hyperarousal, and avoidance symptoms, along with comorbidities such as anxiety, depression, and increased risk for self-medicating substance abuse. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Treatment Resistant Disorders, Post Traumatic Stress Disorder
- What is being tested?
- Psilocybin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 3 Oct 2022to 30 Dec 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- After signing and dating the informed consent documents, subject eligibility will be assessed. Subjects must meet the following criteria to be eligible for enrollment into the study.
- Subjects must be ≥18 and ≤70 years of age.
- Subjects must meet the Diagnostic \& Statistical Manual of Mental Disorders - Version V (DSM-V) criteria for TR-PTSD.
- Subjects must have treatment-resistant PTSD symptoms, defined as a CAPS score of ≥30 (signifying moderate to severe symptoms) following at least 3 months of prior SSRI or serotonin-norepinephrine reuptake inhibitor (SNRI) treatment in addition to at least 4 months of psychotherapy (adapted from Mithoefer et al, 2011).
- Subjects must be able to communicate in English.
Who cannot join
- Subjects meeting any of the following criteria will not be eligible for participation in the study:
- Pregnant individuals and those of childbearing age not using effective contraception (e.g., oral contraceptive pill, injection, implant, patch, vaginal ring, intrauterine coil, intrauterine device, tubal ligation, or barrier method).
- Uncontrolled hypertension or BP ≥140/90 mmHg over 2 days, with at least 4 BP assessments completed.
- In the clinical judgement of the investigator, any hazard-posing medical, emotional, or significant character disorder or condition rendering unsuitability for the study. For example, poorly controlled diabetes, severe cardiovascular disease, seizure disorders, sleep apnea disorders (suspected or ineffectively treated), untrustworthiness, suicidality, etc.
- Any use of methamphetamines or any injection drug abuse in the past 30 days and/or a positive test for drugs of abuse (e.g., cocaine, amphetamines, opiates, benzodiazepines, etc.).
- Any other significant substance use disorder that may interfere with study objectives including consuming >5 cups of caffeinated coffee a day or inability, without discomfort, to refrain from smoking cigarettes or cannabis, or consuming alcohol for 7 hours.
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- Blood draw or needle phobia.
- Suicidal attempt or active ideation deemed to present risk of suicide as judged by study clinical staff in past 30 days..
- BMI <14 or >42 or the Qualified investigator deems the patient sufficiently healthy to participate.
- Current or previously diagnosed schizophrenia spectrum or other psychotic disorders, including schizophrenia, schizoaffective disorder, schizotypal disorder, schizophreniform disorder or brief psychotic disorder; current or previous history of bipolar disorder, or obsessive-compulsive disorder.
- Any uncontrolled eating disorder (e.g., purging or anorexia or worsening of directionally undesirable weight change of 5 kg in past 30 days).
- Subjects with a diagnosis of DSM-5 personality disorder which has a major impact on the subject's current psychiatric status
- Use of any investigational drug, hallucinogen, or ketamine/esketamine within the past 30 days, or plan to use during the study.
Trial locations and contacts
1 site in 1 country.
About this study
Post-traumatic stress disorder (PTSD) is a complex disorder expressed as a variety of neurobiological symptoms, including anxiety, re-experiencing, hyperarousal, and avoidance symptoms, along with comorbidities such as anxiety, depression, and increased risk for self-medicating substance abuse. Currently, there are only two approved medications in the United States (US) for PTSD, paroxetine and sertraline.
Psychedelic medications, including psilocybin, have recently received breakthrough designation by the US Food and Drug Administration (FDA) for other psychiatric indications. Although no formal clinical trials have yet investigated psychedelic substances for the treatment of PTSD, the available evidence warrants such an investigation. The present study aims to investigate the effect of psilocybin on treatment-resistant PTSD.
Read the detailed description
Post-traumatic stress disorder (PTSD) is a complex disorder expressed as a variety of neurobiological symptoms, including anxiety, re-experiencing, hyperarousal, and avoidance symptoms, along with comorbidities such as anxiety, depression, and increased risk for self-medicating substance abuse. Currently, there are only two approved medications in the United States (US) for PTSD, paroxetine and sertraline. These selective serotonin reuptake inhibitors (SSRIs) have limited efficacy. Furthermore, there is a lack of efficacious pharmacotherapy for treatment-resistant PTSD; PTSD remains a chronic and sometimes debilitating condition. New research into other treatment options for PTSD are warranted.
Psychedelic medications, including psilocybin, have recently received breakthrough designation by the US Food and Drug Administration (FDA) for other psychiatric indications. Psilocybin has received breakthrough designation for treatment of depression. Research on psilocybin has shown that it facilitates fear extinction in mice and promotes neuroplasticity, increasing neurogenesis, spinogenesis and synaptogenesis. These properties may contribute to antidepressive and anxiolytic effects. Psilocybin also reduces activity in the amygdala during threat responses; decreased amygdala reactivity is correlated with positive mood. This is particularly relevant since individuals with PTSD showed increased reactivity in the amygdala, which may increase the ability to process traumatic memories. Although no formal clinical trials have yet investigated psychedelic substances for the treatment of PTSD, the available evidence warrants such an investigation. The present study aims to investigate the effect of psilocybin on treatment-resistant PTSD.
- Being tested
- Psilocybin
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsilocybinDrug
10 mg or 25 mg oral aqueous psilocybin solution
| Study group | Role | What they receive |
|---|---|---|
| Psilocybin treatment for treatment-resistant PTSD | Experimental | Experimental Treatment:
Experimental: Psilocybin
10mg (low dose) on Day 7
25mg (high dose) on Day 14
10mg dose (optional top-up low dose) at Month 7
Treatment Description:
Drug: Psilocybin drug product suspension
Psilocybin is manufactured as a bulk API powder. The psilocybin drug product suspension is prepared by a compounding pharmacist at the clinic site. The psilocybin drug product suspension will be mixed in a glass with water to produce the psilocybin solution for oral consumption. Subjects will be instructed to orally consume the study medication in the glass in its entirety.
Psilocybin will be administered in the following doses and at the following time points for this study:
* 1 mL of 10mg/mL (low dose) on Day 7 (10 mg)
* 2.5 mL of 10 mg/mL (high dose) on Day 14 (25 mg)
* [Optional dose] 1 mL of 10mg/mL (low dose) on Month 7/Day 210 (10 mg) Receives: Drug: Psilocybin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary efficacy of psilocybin using the 11-Dimension Altered States of Consciousness (11D-ASC) will assess
This is a 42 item questionnaire assessing patient-rated subjective intensity of psilocybin's effects
Measured: Day 14
PTSD symptom severity as measured by the Clinician-Administered PTSD Scale (CAPS-5)
Total CAPS-5 Scores range from 0-80. Higher scores indicate greater symptom severity.
Measured: Screening to 12 months follow up
PTSD symptom severity as measured by the Posttraumatic Checklist for the DSM-5 (PCL-5)
Total PCL-5 Scores range from 0-80. Higher scores indicate greater symptom severity.
Measured: Screening to 12 months follow up
Subjective distress caused by traumatic events as measured by the Impact of Events Scale Revised (IES-R).
The IES-R is a 22-item self-report measure where respondents are asked to identify a specific stressful life event and then indicate how much they were distressed or bothered during the past seven days by each "difficulty" listed. Items are rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely"). The IES-R yields a total score (ranging from 0 to 88).
Measured: Screening to 12 months follow up
Symptoms of Psychopathology as measured by the Symptom Checklist 90-R (SC90-R).
The 90 items in the SC90-R are assessed by the subject using a 5-point rating scale.
Measured: Screening to 12 months follow up
Symptom severity, treatment response, and the efficacy of treatment studies of patients with mental disorders as measured by the Clinical Global Impression - Improvement (CGI-I)/ Clinical Global Impression - Severity (CGI-S).
The CGI-S scale is a 7-point, clinician-rated scale (ranging from 1 to 7, with 1 indicating a "normal state" and 7 indicating "among the most extremely ill patients").
Measured: Day 22
Secondary outcomes (7)
Anxiety as measured by the Beck Anxiety Inventory (BAI).
The BAI is a 21-item self-report inventor. Total BAI Scores range from 0-63; higher scores indicate more severe anxiety.
Measured: Up to 12 month follow up
Anxiety as measured by the State Trait Anxiety Inventory - Trait Version (STAI-T).
The STAI-T scale consists of 20 items on a 4-point scale; Higher scores indicate greater anxiety.
Measured: Up to 6 month follow up
Depression as measured by the Beck Depression Inventory (BDI).
The BDI is a 21-item, self-report rating inventory with each item scored on a scale value of 0 to 3; higher total scores indicating more severe depression symptoms.
Measured: Up to 12 month follow up
Depression as measured by the Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR).
The QIDS-SR contains 16 items, with each item scored from 0 to 3.
Measured: Up to 12 month follow up
Impairments in daily living as measured by the Sheehan Disability Scale (SDS).
This is a 3-item, clinician administered questionnaire with all items rated on an 11-point continuum, with higher scores indicating more severe impairment. (0 meaning "no impairment" to 10 meaning "most severe").
Measured: Up to 12 month follow up
Body Mass Index (BMI)
Measure of body mass based on height and weight
Measured: Up to 12 month follow up
Trauma Related Nightmare Survey
trauma-focused survey to track sleep and nightmare-related information
Measured: Up to 12 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2022
- Study start3 Oct 2022
- Primary completion30 Oct 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment Resistant DisordersStudies 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Halucenex Life Sciences Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- KGK Science Inc.
- Responsible party
- Sponsor
- Investigators
- Lisa Batten, PhD, Study director, Halucenex Life SciencesPaige Stevens, MD, Principal investigator, Contracted
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05243329
- Sponsor's protocol ID
- 22HLCPP01/HCX-2020-001
- Status last verified
- Jun 2023
- First submitted
- 15 Dec 2021
- Last updated
- 29 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Therapeutic Effects of Psilocybin in Treatment-Resistant Post-Traumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT05243329
- Acronym / sponsor ID
- 22HLCPP01/HCX-2020-001
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Halucenex Life Sciences Inc.Industry (pharma, biotech, devices)
- Collaborators
- KGK Science Inc.
- Study start
- 3 Oct 2022 (actual)
- Primary completion
- 30 Oct 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 17 Feb 2022 (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.
Post-traumatic stress disorder (PTSD) is a complex disorder expressed as a variety of neurobiological symptoms, including anxiety, re-experiencing, hyperarousal, and avoidance symptoms, along with comorbidities such as anxiety, depression, and increased risk for self-medicating substance abuse. Currently, there are only two approved medications in the United States (US) for PTSD, paroxetine and sertraline.
Psychedelic medications, including psilocybin, have recently received breakthrough designation by the US Food and Drug Administration (FDA) for other psychiatric indications. Although no formal clinical trials have yet investigated psychedelic substances for the treatment of PTSD, the available evidence warrants such an investigation. The present study aims to investigate the effect of psilocybin on treatment-resistant PTSD.
Detailed description
Post-traumatic stress disorder (PTSD) is a complex disorder expressed as a variety of neurobiological symptoms, including anxiety, re-experiencing, hyperarousal, and avoidance symptoms, along with comorbidities such as anxiety, depression, and increased risk for self-medicating substance abuse. Currently, there are only two approved medications in the United States (US) for PTSD, paroxetine and sertraline. These selective serotonin reuptake inhibitors (SSRIs) have limited efficacy. Furthermore, there is a lack of efficacious pharmacotherapy for treatment-resistant PTSD; PTSD remains a chronic and sometimes debilitating condition. New research into other treatment options for PTSD are warranted.
Psychedelic medications, including psilocybin, have recently received breakthrough designation by the US Food and Drug Administration (FDA) for other psychiatric indications. Psilocybin has received breakthrough designation for treatment of depression. Research on psilocybin has shown that it facilitates fear extinction in mice and promotes neuroplasticity, increasing neurogenesis, spinogenesis and synaptogenesis. These properties may contribute to antidepressive and anxiolytic effects. Psilocybin also reduces activity in the amygdala during threat responses; decreased amygdala reactivity is correlated with positive mood. This is particularly relevant since individuals with PTSD showed increased reactivity in the amygdala, which may increase the ability to process traumatic memories. Although no formal clinical trials have yet investigated psychedelic substances for the treatment of PTSD, the available evidence warrants such an investigation. The present study aims to investigate the effect of psilocybin on treatment-resistant PTSD.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Psilocybin treatment for treatment-resistant PTSD | Experimental | Drug: PsilocybinExperimental Treatment: Experimental: Psilocybin 10mg (low dose) on Day 7 25mg (high dose) on Day 14 10mg dose (optional top-up low dose) at Month 7 Treatment Description: Drug: Psilocybin drug product suspension Psilocybin is manufactured as a bulk API powder. The psilocybin drug product suspension is prepared by a compounding pharmacist at the clinic site. The psilocybin drug product suspension will be mixed in a glass with water to produce the psilocybin solution for oral consumption. Subjects will be instructed to orally consume the study medication in the glass in its entirety. Psilocybin will be administered in the following doses and at the following time points for this study: * 1 mL of 10mg/mL (low dose) on Day 7 (10 mg) * 2.5 mL of 10 mg/mL (high dose) on Day 14 (25 mg) * [Optional dose] 1 mL of 10mg/mL (low dose) on Month 7/Day 210 (10 mg) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- After signing and dating the informed consent documents, subject eligibility will be assessed. Subjects must meet the following criteria to be eligible for enrollment into the study.
- Subjects must be ≥18 and ≤70 years of age.
- Subjects must meet the Diagnostic \& Statistical Manual of Mental Disorders - Version V (DSM-V) criteria for TR-PTSD.
- Subjects must have treatment-resistant PTSD symptoms, defined as a CAPS score of ≥30 (signifying moderate to severe symptoms) following at least 3 months of prior SSRI or serotonin-norepinephrine reuptake inhibitor (SNRI) treatment in addition to at least 4 months of psychotherapy (adapted from Mithoefer et al, 2011).
- Subjects must be able to communicate in English.
Key exclusion criteria (13 listed)
- Subjects meeting any of the following criteria will not be eligible for participation in the study:
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 |
|---|---|---|
| Psilocybin10 mg or 25 mg oral aqueous psilocybin solution | Drug | Psilocybin treatment for treatment-resistant PTSD |
Primary outcome
Primary efficacy of psilocybin using the 11-Dimension Altered States of Consciousness (11D-ASC) will assess
Time frame: Day 14
This is a 42 item questionnaire assessing patient-rated subjective intensity of psilocybin's effects
PTSD symptom severity as measured by the Clinician-Administered PTSD Scale (CAPS-5)
Time frame: Screening to 12 months follow up
Total CAPS-5 Scores range from 0-80. Higher scores indicate greater symptom severity.
PTSD symptom severity as measured by the Posttraumatic Checklist for the DSM-5 (PCL-5)
Time frame: Screening to 12 months follow up
Total PCL-5 Scores range from 0-80. Higher scores indicate greater symptom severity.
Subjective distress caused by traumatic events as measured by the Impact of Events Scale Revised (IES-R).
Time frame: Screening to 12 months follow up
The IES-R is a 22-item self-report measure where respondents are asked to identify a specific stressful life event and then indicate how much they were distressed or bothered during the past seven days by each "difficulty" listed. Items are rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely"). The IES-R yields a total score (ranging from 0 to 88).
Symptoms of Psychopathology as measured by the Symptom Checklist 90-R (SC90-R).
Time frame: Screening to 12 months follow up
The 90 items in the SC90-R are assessed by the subject using a 5-point rating scale.
Symptom severity, treatment response, and the efficacy of treatment studies of patients with mental disorders as measured by the Clinical Global Impression - Improvement (CGI-I)/ Clinical Global Impression - Severity (CGI-S).
Time frame: Day 22
The CGI-S scale is a 7-point, clinician-rated scale (ranging from 1 to 7, with 1 indicating a "normal state" and 7 indicating "among the most extremely ill patients").
7 secondary outcomes
Anxiety as measured by the Beck Anxiety Inventory (BAI).
Time frame: Up to 12 month follow up
Anxiety as measured by the State Trait Anxiety Inventory - Trait Version (STAI-T).
Time frame: Up to 6 month follow up
Depression as measured by the Beck Depression Inventory (BDI).
Time frame: Up to 12 month follow up
Depression as measured by the Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR).
Time frame: Up to 12 month follow up
Impairments in daily living as measured by the Sheehan Disability Scale (SDS).
Time frame: Up to 12 month follow up
Body Mass Index (BMI)
Time frame: Up to 12 month follow up
Trauma Related Nightmare Survey
Time frame: Up to 12 month follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Lisa Batten, PhD study director
Halucenex Life Sciences
Paige Stevens, MD principal investigator
Contracted
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 in people with Treatment Resistant Disorders and Post Traumatic Stress Disorder, run by Halucenex Life Sciences Inc. at 1 site in Canada.
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 5 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 29 Jun 2023. 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 Canada. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary efficacy of psilocybin using the 11-Dimension Altered States of Consciousness (11D-ASC) will assess (time frame: Day 14). The study lists 6 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 29 Jun 2023.