A Phase III study to investigate two initial administrations of COMP360 in treatment-resistant depression

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Compass Pathfinder Limited

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Psychiatry and Psychology [F] - Mental Disorders [F03]

Trial duration

9 Feb 2024 → ongoing

Decision date (initial)

2024-07-25

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Others, Safety

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

Conditions and MedDRA coding

Treatment-resistant depression

Study design 3 periods

Regulatory references

Scientific advice from competent authorities

Medicines Evaluation Board, Federal Institute For Drugs And Medical Devices, Medical Products Agency

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Aged ≥18 years at Screening
2. Major depression without psychotic features
3. 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
4. MADRS total score ≥20 at Screening and Baseline
5. TRD, defined as failure to respond to an adequate dose and duration of two, three, or four different pharmacological treatments for the current episode
6. Successful discontinuation of all prohibited medications at least two weeks prior to the Baseline visit (if applicable)
7. Please refer to the Protocol for the full list of inclusion criteria

Exclusion criteria 20

1. Prior or ongoing bipolar disorder, any psychotic disorder, or antisocial personality disorder
2. Exhibiting significant suicide risk
3. Depression secondary to a medical or drug-related cause in the opinion of the Investigator
4. 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
5. Participants who are pregnant, nursing, or planning a pregnancy
6. Cardiovascular conditions
7. Type 1 diabetes mellitus or uncontrolled type 2 diabetes mellitus
8. Unstable existing thyroid disease/disorder
9. Positive urine drug screens for illicit drugs or drugs of abuse at Screening will be reviewed with participants to determine the pattern of use
10. Clinically significant results on vital signs, ECG, or physical examination at Screening or Baseline, or laboratory tests at Screening
11. Please refer to the Protocol for the full list of exclusion criteria
12. Lifetime paranoid, schizoid, schizotypal, histrionic, narcissistic personality disorder, or any ongoing serious psychiatric comorbidity
13. Borderline personality disorder
14. Ongoing post-traumatic stress disorder, obsessive-compulsive disorder, or anorexia nervosa
15. Psychiatric inpatient within the past six months prior to Screening
16. Use of all invasive somatic treatments during the current depressive episode
17. Use of all non invasive somatic treatments within the past six months prior to Screening
18. Current enrolment in a psychological therapy programme that will not remain stable
19. Alcohol or substance use disorder within the 12 months prior to Screening
20. Lifetime exposure to psychedelics with therapeutic intent.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. COMP360 25 mg versus COMP360 1 mg for the change from baseline in MADRS total score at Week 6

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 3

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Compass Pathfinder Limited

Sponsor organisation

Compass Pathfinder Limited

Address

3rd Floor, 1 Ashley Road 1 Ashley Road

City

Altrincham

Postcode

WA14 2DT

Country

United Kingdom

Scientific contact point

Organisation

Compass Pathfinder Limited

Contact name

Clinical Operations

Public contact point

Organisation

Compass Pathfinder Limited

Contact name

Clinical Operations

Third parties 6

Locations

9 EU/EEA countries · 36 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Corrective measures 3 · Art. 77 CTR

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 64 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

16 submissions — initial application plus substantial / non-substantial modifications