Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruiting
Participants planned
120
Countries
1
Sites
1
Prolonged grief disorder
The primary objective of this trial is to determine whether scores on the revised prolonged grief disorder scale will be reduced significantly after the PEX010 dosing session.
Key facts
- Sponsor
- Linkopings Universitet
- Participant type
- Healthy volunteers, Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Psychiatry and Psychology [F] - Mental Disorders [F03]
- Trial duration
- 17 Jul 2025 → ongoing
- Decision date (initial)
- 2025-02-10
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
The primary objective of this trial is to determine whether scores on the revised prolonged grief disorder scale will be reduced significantly after the PEX010 dosing session.
Secondary objectives 1
- The secondary objective of this trial is to evaluate if self-touch has the potential to reduce PG-R scores (further).
Conditions and MedDRA coding
Prolonged grief disorder
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- The subject has given their written consent to participate in the trial.
- PG13-R score 30 or higher
- Good health as determined by medical history, ECG, and clinical assessment of lab tests. Lab tests will include electrolytes (sodium, potassium, chloride, magnesium, calcium, phosphate), GFR, creatinine, glucose, complete blood count, hemoglobin, MCV, white blood cells, platelets, TSH, liver panel including total bilirubin, ALP, AST, ALT, GGT. The final decision will be according to the judgment of a study physician.
Exclusion criteria 4
- Any clinically significant medical condition as determined by medical history and lab tests, including CNS, cardiovascular disorders including uncontrolled hypertension (greater than 165/95), respiratory, gastrointestinal, hepatic, renal, endocrine, or reproductive disorders, as assessed by the Principal Investigator (PI) or designee, after appropriate consultation if needed.
- Any current clinically significant psychiatric problems including a diagnosis of substance dependence other than nicotine during the past year (defined in DSM-5 terms as Substance Use Disorder, Moderate or Severe;), as assessed by PI or designee.
- History of psychotic experiences or suicidality, or family history (first degree relatives) of psychosis.
- History of bipolar disorder or family history (first degree relatives) of bipolar disorder.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Score on PG13-R
Secondary endpoints 1
- Score on PG13-R
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
PEX010 Psilocybin Capsules (1mg psilocybin)
PRD11531716 · Product
- Active substance
- Dry Extract From Psilocybe Cubensis (15-25:1), Extraction Solvent: Methanol
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL
- Max daily dose
- 1 mg milligram(s)
- Max total dose
- 1 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- REGION OESTERGOETLAND
- Paediatric formulation
- No
- Orphan designation
- No
PEX010 Psilocybin Capsules (25 mg psilocybin)
PRD11531717 · Product
- Active substance
- Dry Extract From Psilocybe Cubensis (15-25:1), Extraction Solvent: Methanol
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL
- Max daily dose
- 25 mg milligram(s)
- Max total dose
- 25 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- REGION OESTERGOETLAND
- Paediatric formulation
- No
- Orphan designation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Linkopings Universitet
- Sponsor organisation
- Linkopings Universitet
- Address
- Sandbacksgatan 7, Linkopings Domkyrkofors. Linkopings Domkyrkofors.
- City
- Linkoping
- Postcode
- 582 25
- Country
- Sweden
Scientific contact point
- Organisation
- Linkopings Universitet
- Contact name
- Rebecca Böhme
Public contact point
- Organisation
- Linkopings Universitet
- Contact name
- Rebecca Böhme
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Sweden | Ongoing, recruiting | 120 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Sweden | 2025-07-17 | 2025-11-07 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 68 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_protocol_PGD-psi_2024-518218-24-00 | 2 |
| Protocol (for publication) | D4_1-01 MMS | 1 |
| Protocol (for publication) | D4_1-01E MMS | 1 |
| Protocol (for publication) | D4_1-02 MINI - Mini Internationell Neuropsykiatrisk Intervju | 1 |
| Protocol (for publication) | D4_1-02E MINI | 1 |
| Protocol (for publication) | D4_1-03 AUDIT | 1 |
| Protocol (for publication) | D4_1-03E AUDIT | 1 |
| Protocol (for publication) | D4_1-04 DUDIT version 2-2 | 1 |
| Protocol (for publication) | D4_1-04E DUDIT-English-version | 1 |
| Protocol (for publication) | D4_1-05 MMSE-NR3_vers-1-61 | 1 |
| Protocol (for publication) | D4_1-05E MMSE-NR3_english | 1 |
| Protocol (for publication) | D4_2-01 MR-formular | 1 |
| Protocol (for publication) | D4_2-01E MR-form-english | 1 |
| Protocol (for publication) | D4_2-02 TMS_safety_english | 1 |
| Protocol (for publication) | D4_2-02E TMS_safety_english | 1 |
| Protocol (for publication) | D4_3-01 ITSS | 1 |
| Protocol (for publication) | D4_3-01E ITSS | 1 |
| Protocol (for publication) | D4_3-02 CDS | 1 |
| Protocol (for publication) | D4_3-02E CDS | 1 |
| Protocol (for publication) | D4_3-03 GSES | 1 |
| Protocol (for publication) | D4_3-03E GSES_English | 1 |
| Protocol (for publication) | D4_3-04 SCCS | 1 |
| Protocol (for publication) | D4_3-04E Self-Concept_Clarity | 1 |
| Protocol (for publication) | D4_3-05 PHQ-9_svensk | 1 |
| Protocol (for publication) | D4_3-05E PHQ-9 | 1 |
| Protocol (for publication) | D4_3-06 PGI | 1 |
| Protocol (for publication) | D4_3-06E PGI | 1 |
| Protocol (for publication) | D4_3-07 GMRI | 1 |
| Protocol (for publication) | D4_3-07E GMRI | 1 |
| Protocol (for publication) | D4_4-01 MADRS-Sjalvskattning | 1 |
| Protocol (for publication) | D4_4-01E MADR-S | 1 |
| Protocol (for publication) | D4_4-02 GAD-7 svenska | 1 |
| Protocol (for publication) | D4_4-02E GAD-7 | 1 |
| Protocol (for publication) | D4_4-03 PDI_plus_svenska | 1 |
| Protocol (for publication) | D4_4-03E PDI | 1 |
| Protocol (for publication) | D4_4-04 RQ | 1 |
| Protocol (for publication) | D4_4-04E RQ | 1 |
| Protocol (for publication) | D4_4-05 NEO-FFI-3 | 1 |
| Protocol (for publication) | D4_4-05E neo-ff1_english | 1 |
| Protocol (for publication) | D4_4-06 EMA | 1 |
| Protocol (for publication) | D4_4-06E EMA_english | 1 |
| Protocol (for publication) | D4_5-01 Treatment Expectation | 1 |
| Protocol (for publication) | D4_5-01E Treatment expectation | 1 |
| Protocol (for publication) | D4_5-02 Treatment Expectation-T | 1 |
| Protocol (for publication) | D4_5-02E Treatment expectation-T | 1 |
| Protocol (for publication) | D4_5-03 Tillaggsfragor | 1 |
| Protocol (for publication) | D4_5-03E Additional questions | 1 |
| Protocol (for publication) | D4_5-04 Monitor skattningsformular | 1 |
| Protocol (for publication) | D4_5-04E 5D_ASC | 1 |
| Protocol (for publication) | D4_5-05 5D-ASC FINAL | 1 |
| Protocol (for publication) | D4_5-05E Monitor rating scale | 1 |
| Protocol (for publication) | D4_5-06 PIQ sv | 1 |
| Protocol (for publication) | D4_5-06E PIQ | 1 |
| Protocol (for publication) | D4_5-07 CEQ | 1 |
| Protocol (for publication) | D4_5-07E CEQ | 1 |
| Protocol (for publication) | D4_5-08 Treatment Evaluation | 1 |
| Protocol (for publication) | D4_5-08E Treatment evaluation | 1 |
| Protocol (for publication) | D4_5-09 Treatment Evaluation-T | 1 |
| Protocol (for publication) | D4_5-09E Treatment evaluation-T | 1 |
| Protocol (for publication) | D4_Bilageforteckning_CTIS | 1 |
| Protocol (for publication) | D4_E-pg-13 | 1 |
| Protocol (for publication) | D4_pg-13_revised_swedish | 1 |
| Recruitment arrangements (for publication) | K1_forfarande_rekryt_samtycke_2024-518218-24-00 | 1 |
| Subject information and informed consent form (for publication) | L1_Forskningspersonsinformation_sorg_2024-518218-24-00 | 2 |
| Subject information and informed consent form (for publication) | L1_Forskningspersonsinformation_sorg_2024-518218-24-00_ENG | 2 |
| Subject information and informed consent form (for publication) | L2_annons_2024-518218-24-00 | 2 |
| Subject information and informed consent form (for publication) | L2_annons_2024-518218-24-00_ENG | 2 |
| Synopsis of the protocol (for publication) | D1_protocol_synopsis_2024_518218_24-00_SV | 2 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-11-05 | Sweden | Acceptable 2025-02-07
|
2025-02-10 |