Obsessive-Compulsive DisorderPhase 1NCT06258031
PsilOCD: A Pharmacological-Challenge Feasibility Study
A Phase 1 study testing Psilocybin (COMP360) in people with Obsessive-Compulsive Disorder, run by Imperial College London at 1 site in United Kingdom.
Trial summary
The purpose of this study is to assess the impact of psilocybin on cognitive inflexibility and neural plasticity in a cohort of people with obsessive-compulsive disorder (OCD). Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Obsessive-Compulsive Disorder
- What is being tested?
- Psilocybin (COMP360)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 Oct 2022to 24 Jul 2024
- Phase
- Phase 1
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 20 to 65 years;
- Any gender;
- A primary diagnosis of OCD (based on the Mini-International Neuropsychiatric Interview (M.I.N.I.));
- Has met diagnostic criteria for OCD for at least 12 months;
- Willing to comply with protocol and associated lifestyle restrictions;
- Adequate understanding of the English language to give informed consent and participate in the study;
- Participant can attend visits as an outpatient;
- Comfortable using a computer, access to internet from home, and willing to participate in some of the study visits via video-link.
Who cannot join
- Current or past history of dependent (according to ICD10 criteria) substance use (not including nicotine and/or caffeine), Tourette's syndrome, autism spectrum disorder, epilepsy, organic mental disorder, or a personality disorder apart from obsessive-compulsive personality disorder;
- Current or past history of psychosis or mania in themselves or a first-degree relative;
- Unstable physical health;
- Significantly abnormal clinical test result;
- Heavy smoker, or unable to attend the dosing days (including the subsequent recovery part) without a smoking break;
- Unwillingness to allow their GP or mental health practitioners to be informed of their participation (or, to allow study team access to Summary Care Record).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PsilOCD: Evaluating the Effects of the 5-HT2A Agonist Psilocybin on the Neurocognitive and Clinical Correlates of Compulsivity (A Pharmacological-Challenge Feasibility Study)
The purpose of this study is to assess the impact of psilocybin on cognitive inflexibility and neural plasticity in a cohort of people with obsessive-compulsive disorder (OCD).
Read the detailed description
This mechanistic study will utilise a within-subjects design, administering up to 10mg of psilocybin to participants with OCD (DSM-5 criteria) on two separate instances spaced four weeks apart. To ensure consistency and participant safety, dosing will occur under medical supervision with psychological support from two experienced therapists. Before and after each session, participants will engage in virtual preparation and integration sessions led by their therapists. Cognitive tasks will be administered in the days following each dosing session. Additionally, acute post-dosing EEG recordings will be conducted, and blood samples will be taken after each dosing session. OCD symptoms will also be assessed seven times throughout the trial by an external blinded psychiatrist, serving as a secondary outcome. Collectively, these measures aim to evaluate changes in cognitive inflexibility, decision-making abilities, neuroplasticity (peripheral blood markers and EEG measures), inflammation (peripheral blood markers), and symptomatology following each dosing session.
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- Psilocybin (COMP360)
- Medical subject headings
- Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psilocybin (COMP360)Drug
Also called O-phosphoryl-4-hydroxy-N,N-dimethyltryptamine
Up to 10mg on two occasions
| Study group | Role | What they receive |
|---|---|---|
| All participants | Experimental | Up to 10mg of psilocybin on two separate dosing days (separated by 4 weeks) Receives: Drug: Psilocybin (COMP360) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intradimensional-extradimensional (ID-ED) set shift
Scores on this neurocognitive task administered as part of the Cambridge Neuropsychological Test Automated Battery (CANTAB). ID-ED performance is an established measure of cognitive inflexibility in OCD (Chamberlain et al., Am J Psychiatry, 2007), with worse scores corresponding to decreased flexibility.
Measured: 4 weeks
The visual long-term potentiation (vLTP) electroencephalogram (EEG) paradigm (acute quantified changes in neuroplasticity in the visual system).
We will assess acute changes in homosynaptic neuroplasticity using the visual long-term potentiation (vLYTP) EEG paradigm. In this paradigm, we induce neural plasticity in the occipital cortex by exposing participants to visual stimuli of varying frequencies. This task specifically quantifies homosynaptic plasticity because it triggers changes in neighbouring neurons within the occipital cortex.
Measured: 8 weeks
Secondary outcomes (11)
Clinical measures of compulsivity of relevance to OCD including Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
Assess OCD symptoms over the study's duration (with higher scores corresponding to worse symptoms in all scales mentioned)
Measured: 8 weeks
Cognitive measure: Reversal learning task (administered as part of the Cambridge Neuropsychological Test Automated Battery (CANTAB))
Assesses ability to adapt to changing contingencies; higher scores indicate better cognitive flexibility
Measured: 4 weeks
Cognitive measure: Information-seeking task
It tests participants' confidence and ability to make decisions involving uncertainty by monitoring their tendency to seek extra information (recently developed by Lion Schulz and colleagues, 2020)
Measured: 4 weeks
Cognitive measure: Visuospatial memory paired-associates learning task (administered as part of the Cambridge Neuropsychological Test Automated Battery (CANTAB))
Serves as a control task; higher scores indicate better visuospatial memory faculties
Measured: 4 weeks
Measures of the acute psychological effects of psilocybin including the Emotional Breakthrough Inventory
Higher scores correspond to greater subjective emotional changes elicited by the acute psilocybin experience
Measured: 4 weeks
Measures of depression symptoms including the Montgomery-Åsberg Depression Rating Scale (MADRS)
Higher scores correspond to worse depressive symptoms
Measured: 8 weeks
Measures of anxiety symptoms including the State-Trait Anxiety Inventory (STAI)
Higher scores correspond to worse anxiety-related symptoms
Measured: 8 weeks
Acute plasma serum concentration of Brain-Derived Neurotrophic Factor (BDNF)
BDNF concentration (pg/mL) serves as a biomarker with significant functions in brain health, neuroplasticity, and the regulation of inflammation.
Measured: 4 weeks
Oura: heart-rate variability
Participants will be given an Oura ring to keep track of heart-rate variability (HRV) throughout the duration of the study (participants will not be able to see their own data).
Measured: 8 weeks
Oura: sleep stages
Oura rings will also measure the number of minutes/hours spent in each sleep stage (awake, light, deep, and rapid eye movement (REM))
Measured: 8 weeks
Oura: REM sleep
Examines acute changes in neuroplasticity. Participants detect subtle colour changes while listening to sound sequences, triggering an EEG signal increase in the auditory cortex. This measures the brain's ability to induce repetition suppression across consecutive trials, reflecting its capacity to adapt to expected sound sequences over time.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2024
- Study start28 Oct 2022
- Primary completion28 Jun 2024
- Study completion24 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obsessive-Compulsive DisorderStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Two different, fixed doses of psilocybin (Dose A = 10mg - x, Dose B = 10mg - y) are given on two separate dosing days to all patients.
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Professor David Nutt, Principal investigator, Imperial College LondonDr David Erritzoe, Principal investigator, Imperial College LondonDr Luca Pellegrini, Principal investigator, University of Hertfordshire/Imperial College LondonProfessor Naomi Fineberg, Principal investigator, University of Hertfordshire
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06258031
- Sponsor's protocol ID
- 298206
- Status last verified
- Nov 2024
- First submitted
- 8 Jan 2024
- Last updated
- 6 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PsilOCD: Evaluating the Effects of the 5-HT2A Agonist Psilocybin on the Neurocognitive and Clinical Correlates of Compulsivity (A Pharmacological-Challenge Feasibility Study)
- ClinicalTrials.gov ID
- NCT06258031
- Acronym / sponsor ID
- 298206
- Conditions
- Obsessive-Compulsive Disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 28 Oct 2022 (actual)
- Primary completion
- 28 Jun 2024 (actual)
- Study completion
- 24 Jul 2024 (actual)
- First posted
- 14 Feb 2024 (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.
The purpose of this study is to assess the impact of psilocybin on cognitive inflexibility and neural plasticity in a cohort of people with obsessive-compulsive disorder (OCD).
Detailed description
This mechanistic study will utilise a within-subjects design, administering up to 10mg of psilocybin to participants with OCD (DSM-5 criteria) on two separate instances spaced four weeks apart. To ensure consistency and participant safety, dosing will occur under medical supervision with psychological support from two experienced therapists. Before and after each session, participants will engage in virtual preparation and integration sessions led by their therapists. Cognitive tasks will be administered in the days following each dosing session. Additionally, acute post-dosing EEG recordings will be conducted, and blood samples will be taken after each dosing session. OCD symptoms will also be assessed seven times throughout the trial by an external blinded psychiatrist, serving as a secondary outcome. Collectively, these measures aim to evaluate changes in cognitive inflexibility, decision-making abilities, neuroplasticity (peripheral blood markers and EEG measures), inflammation (peripheral blood markers), and symptomatology following each dosing session.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Two different, fixed doses of psilocybin (Dose A = 10mg - x, Dose B = 10mg - y) are given on two separate dosing days to all patients.
| Arm | Type | Receives |
|---|---|---|
| All participants | Experimental | Drug: Psilocybin (COMP360)Up to 10mg of psilocybin on two separate dosing days (separated by 4 weeks) |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Aged 20 to 65 years;
- Any gender;
- A primary diagnosis of OCD (based on the Mini-International Neuropsychiatric Interview (M.I.N.I.));
- Has met diagnostic criteria for OCD for at least 12 months;
- Willing to comply with protocol and associated lifestyle restrictions;
Key exclusion criteria (6 listed)
- Current or past history of dependent (according to ICD10 criteria) substance use (not including nicotine and/or caffeine), Tourette's syndrome, autism spectrum disorder, epilepsy, organic mental disorder, or a personality disorder apart from obsessive-compulsive personality disorder;
- Current or past history of psychosis or mania in themselves or a first-degree relative;
- Unstable physical health;
- Significantly abnormal clinical test result;
- Heavy smoker, or unable to attend the dosing days (including the subsequent recovery part) without a smoking break;
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 (COMP360)Also: O-phosphoryl-4-hydroxy-N,N-dimethyltryptamineUp to 10mg on two occasions | Drug | All participants |
Primary outcome
Intradimensional-extradimensional (ID-ED) set shift
Time frame: 4 weeks
Scores on this neurocognitive task administered as part of the Cambridge Neuropsychological Test Automated Battery (CANTAB). ID-ED performance is an established measure of cognitive inflexibility in OCD (Chamberlain et al., Am J Psychiatry, 2007), with worse scores corresponding to decreased flexibility.
The visual long-term potentiation (vLTP) electroencephalogram (EEG) paradigm (acute quantified changes in neuroplasticity in the visual system).
Time frame: 8 weeks
We will assess acute changes in homosynaptic neuroplasticity using the visual long-term potentiation (vLYTP) EEG paradigm. In this paradigm, we induce neural plasticity in the occipital cortex by exposing participants to visual stimuli of varying frequencies. This task specifically quantifies homosynaptic plasticity because it triggers changes in neighbouring neurons within the occipital cortex.
11 secondary outcomes
Clinical measures of compulsivity of relevance to OCD including Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
Time frame: 8 weeks
Cognitive measure: Reversal learning task (administered as part of the Cambridge Neuropsychological Test Automated Battery (CANTAB))
Time frame: 4 weeks
Cognitive measure: Information-seeking task
Time frame: 4 weeks
Cognitive measure: Visuospatial memory paired-associates learning task (administered as part of the Cambridge Neuropsychological Test Automated Battery (CANTAB))
Time frame: 4 weeks
Measures of the acute psychological effects of psilocybin including the Emotional Breakthrough Inventory
Time frame: 4 weeks
Measures of depression symptoms including the Montgomery-Åsberg Depression Rating Scale (MADRS)
Time frame: 8 weeks
Measures of anxiety symptoms including the State-Trait Anxiety Inventory (STAI)
Time frame: 8 weeks
Acute plasma serum concentration of Brain-Derived Neurotrophic Factor (BDNF)
Time frame: 4 weeks
Oura: heart-rate variability
Time frame: 8 weeks
Oura: sleep stages
Time frame: 8 weeks
Oura: REM sleep
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2024.
- 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.
Professor David Nutt principal investigator
Imperial College London
Dr David Erritzoe principal investigator
Imperial College London
Dr Luca Pellegrini principal investigator
University of Hertfordshire/Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Psilocybin (COMP360) in people with Obsessive-Compulsive Disorder, run by Imperial College London at 1 site in United Kingdom.
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 8 inclusion and 6 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: finished, as of the sponsor's last update on 6 Nov 2024. 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 United Kingdom. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Intradimensional-extradimensional (ID-ED) set shift (time frame: 4 weeks). The study lists 2 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 6 Nov 2024.