BridgeMD
New treatment option for Treatment Resistant Depression
Official title Imaging the Effects of Serotonin 2A Receptor Modulation on Synaptic Density in Treatment-resistant Depression (SYNVEST)
ClinicalTrials.gov ID: NCT06512220
What this study is testing
What is Psilocybin 25 mg?
Psilocybin 25 mg is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for treatment resistant depression.
Also referred to as PEX010.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Limit: 5000 characters. Psilocybin, the chemical component of "magic mushrooms", has been administered with psychotherapy in several randomized clinical trials (RCTs) showing large and sustained antidepressant effects.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Adults 18 to 65 years old;
- Must be deemed to have capacity to provide informed consent;
- Must sign and date the informed consent form;
- Stated willingness to comply with all study procedures;
- Ability to read and communicate in English, such that their literacy and comprehension is sufficient for understanding the consent form and study...
You likely can't join if
- Pregnant as assessed by a urine pregnancy test at Screening (V1) or individual's that intend to become pregnant during the study or are breastfeeding;
- Treatment with another investigational drug or other intervention within 30 days of Screening (V1);
- Have initiated psychotherapy in the preceding 12 weeks prior to Screening (V1);
- Have a DSM-5 diagnosis of substance use disorder (use of tobacco is permitted) within the preceding 6 months;
- Have active suicidal ideation with intent and plan as determined by item 3 of the HamD-17;
- Any DSM-5 lifetime diagnosis of a schizophrenia-spectrum disorder; obsessive-compulsive disorder, psychotic disorder (unless substance induced or due...
See the full eligibility criteria
- Adults 18 to 65 years old;
- Must be deemed to have capacity to provide informed consent;
- Must sign and date the informed consent form;
- Stated willingness to comply with all study procedures;
- Ability to read and communicate in English, such that their literacy and comprehension is sufficient for understanding the consent form and study questionnaires, as evaluated by study staff obtaining consent;
- Primary DSM-5 diagnosis of non-psychotic MDD, single or recurrent, based on the Structured Clinical Interview for DSM-5 (SCID-5) administered at the first screening visit;
- Participants diagnosed with treatment-resistant depression defined as individuals with a baseline HamD-17 score \> 14 and that have not responded to two or more separate trials of antidepressants at an adequate dosage...
- Ability to take oral medication;
- Individuals who are capable of becoming pregnant: use of highly effective contraception for at least 3 months prior to screening and agreement to use such a method during study participation;
- Individuals who are willing to taper off current antidepressant and antipsychotic medications for a minimum of 2-weeks (or more depending on the medication) prior to Baseline (V2) and whose physician confirms that it is...
- Agreement to adhere to Lifestyle Considerations (section 4.5) throughout study duration.
- Pregnant as assessed by a urine pregnancy test at Screening (V1) or individual's that intend to become pregnant during the study or are breastfeeding;
- Treatment with another investigational drug or other intervention within 30 days of Screening (V1);
- Have initiated psychotherapy in the preceding 12 weeks prior to Screening (V1);
- Have a DSM-5 diagnosis of substance use disorder (use of tobacco is permitted) within the preceding 6 months;
- Have active suicidal ideation with intent and plan as determined by item 3 of the HamD-17;
- Any DSM-5 lifetime diagnosis of a schizophrenia-spectrum disorder; obsessive-compulsive disorder, psychotic disorder (unless substance induced or due to a medical condition), bipolar I or II disorder, paranoid...
- Any first-degree relative with a diagnosis of schizophrenia-spectrum disorder; psychotic disorder (unless substance-induced or due to a medical condition); or bipolar I disorder as determined by the family medical...
- Presence of a relative or absolute contraindication to psilocybin, including a drug allergy, recent stroke history, uncontrolled hypertension, low or labile blood pressure, recent myocardial infarction, cardiac...
- Presence of baseline prolonged QTc or Torsade de Pointes as measured by the ECG or a history of long QTc syndrome or related risk factors;
- History of allergy or contraindication to risperidone
- Current or past traumatic brain injury or other neurological/neurodegenerative disorder
- Unable or unwilling to undergo PET or MRI scanning (e.g. claustrophobia, pacemaker);
- Blood disorders, disorders of coagulation, or ongoing use of anticoagulant medication
- Any disability that may prevent the participant from completing study requirements (e.g., non-correctable clinically significant sensory impairment such as not hearing well enough to communicate with study personnel...
- Participant exceeds the annual or lifetime amount of radiation
- Any other clinically significant physical illness including chronic infectious diseases or any other major concurrent illness that, in the opinion of the investigator, may interfere with the interpretation of the study...
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
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 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Ontario, Canada. 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 ClinicalTrials.gov; the study team decides eligibility.