A Phase III study to investigate two initial administrations of COMP360 in treatment-resistant depression
Key facts
- Where
- Barcelona, Collado Villalba, Sant Boi de Llobregat, Sant Boi De Llobregat (Barcelona), Valladolid és Zamora, SpanyolországSee the 8 sites
- Phase
- 3. fázis
Where in Spanyolország
- Clinica Delos S.L.P.Barcelona, SpanyolországNo longer taking part
- Hospital Clinic de BarcelonaBarcelona, SpanyolországNo longer taking part
- Hospital Universitari Vall d'HebronBarcelona, SpanyolországNo longer taking part
- Hospital Universitario General De VillalbaCollado Villalba, SpanyolországNo longer taking part
- Parc Sanitari Sant Joan de DéuSant Boi de Llobregat, SpanyolországNo longer taking part
- Hospital Benito MenniSant Boi De Llobregat (Barcelona), SpanyolországNo longer taking part
- Hospital Universitario Rio HortegaValladolid, SpanyolországNo longer taking part
- Complejo Asistencial de Zamora. Hospital Provincial de ZamoraZamora, SpanyolországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Compass Pathfinder Limited
- Trial code
- EU 2023-505268-12-00
- Record updated
- 2026. június 29.
- Original description
To investigate the efficacy of two administrations of COMP360 (25 mg compared to 1 mg), administered with psychological support in adult participants with TRD, in improving symptoms of depression at Week 6Read full original descriptionShow less
A Phase III, multicentre, randomised, double-blind, controlled study to investigate the efficacy, safety, and tolerability of two initial administrations of COMP360 in participants with treatment-resistant depression
To investigate the efficacy of two administrations of COMP360 (25 mg compared to 1 mg), administered with psychological support in adult participants with TRD, in improving symptoms of depression at Week 6
Inclusion: Aged ≥18 years at Screening; Major depression without psychotic features; If the current major depressive episode is the participant’s first lifetime episode of depression, the length of the current episode must be ≥6 months and ≤2 years at Screening; MADRS total score ≥20 at Screening and Baseline; TRD, defined as failure to respond to an adequate dose and duration of two, three, or four different pharmacological treatments for the current episode; Successful discontinuation of all prohibited medications at least two weeks prior to the Baseline visit (if applicable); Please refer to the Protocol for the full list of inclusion criteria.
Exclusion: Prior or ongoing bipolar disorder, any psychotic disorder, or antisocial personality disorder; Psychiatric inpatient within the past six months prior to Screening; Use of all non invasive somatic treatments within the past six months prior to Screening; Current enrolment in a psychological therapy programme that will not remain stable; Alcohol or substance use disorder within the 12 months prior to Screening; Depression secondary to a medical or drug-related cause in the opinion of the Investigator; Positive urine drug screens for illicit drugs or drugs of abuse at Screening will be reviewed with participants to determine the pattern of use; Lifetime paranoid, schizoid, schizotypal, histrionic, narcissistic personality disorder, or any ongoing serious psychiatric comorbidity; Borderline personality disorder; Ongoing post-traumatic stress disorder, obsessive-compulsive disorder, or anorexia nervosa; Cardiovascular conditions; Type 1 diabetes mellitus or uncontrolled type 2 diabetes mellitus; Unstable existing thyroid disease/disorder; Clinically significant results on vital signs, ECG, or physical examination at Screening or Baseline, or laboratory tests at Screening; Please refer to the Protocol for the full list of exclusion criteria; Use of all invasive somatic treatments during the current depressive episode; Exhibiting significant suicide risk; Lifetime exposure to psychedelics with therapeutic intent; Exposure to psilocybin, or any other classic psychedelics during the past year or current depressive episode, and agreement not to use psychedelics for the duration of the study follow up; Participants who are pregnant, nursing, or planning a pregnancy.