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A Phase III study to investigate two initial administrations of COMP360 in treatment-resistant depression
EU CTIS ID: 2023-505268-12-00
What this study is testing
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
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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)
You likely can't join if
- Prior or ongoing bipolar disorder, any psychotic disorder, or antisocial personality 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
- 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
See the full eligibility criteria
- 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
- Prior or ongoing bipolar disorder, any psychotic disorder, or antisocial personality 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
- 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
- Psychiatric inpatient within the past six months prior to Screening
- Use of all invasive somatic treatments during the current depressive episode
- 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
- Exhibiting significant suicide risk
- Lifetime exposure to psychedelics with therapeutic intent.
- Depression secondary to a medical or drug-related cause in the opinion of the Investigator
- 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
- Cardiovascular conditions
- Type 1 diabetes mellitus or uncontrolled type 2 diabetes mellitus
- Unstable existing thyroid disease/disorder
- Positive urine drug screens for illicit drugs or drugs of abuse at Screening will be reviewed with participants to determine the pattern of use
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Canada
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Canada; United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.