In short
Clinical trials are investigating TRAZODONE HYDROCHLORIDE in adults with treatment-resistant depression. These studies look at whether it helps improve depression symptoms and how it performs in research settings, often with other treatments or placebo. The focus is on safety and efficacy in specific patient groups.
Key points
- Clinical trials investigating TRAZODONE HYDROCHLORIDE in the provided data focus on adults with treatment-resistant depression. The main study is a Phase 2 randomized controlled proof-of-concept trial called PSILOTRAZ. It tests a combination approach and compares it with placebo groups, with psychotherapeutic support included. The main result being measured is change in depression symptoms using the MADRS score after 1 month. The trial is authorised and plans to enroll 112 participants.
Trial overview
The available trial data describe one interventional study of TRAZODONE HYDROCHLORIDE in adults with treatment-resistant depression, which means depression that has not improved enough with usual treatment. The study is titled “Efficacy of psilocybin and trazodone combination in treatment-resistant depression: a randomized controlled proof-of-concept study (PSILOTRAZ).”
This study is in Phase 2, so it is looking for early signs that the treatment approach may help and is also monitoring the research process closely. The status is Authorised.
Study design and groups
The study is a randomized controlled proof-of-concept study, which means participants are assigned to groups by chance and the results are compared across groups. The brief summary says the trial is testing a single administration of psilocybin 25 mg plus TRAZODONE HYDROCHLORIDE 30 mg, compared with placebo, with psychotherapeutic support in adult patients with TRD.
The intervention list shows several study arms, including psilocybin 25 mg capsules, TRAZODONE HYDROCHLORIDE oral drops, and placebo versions for comparison. In simple terms, the trial is trying to find out whether the active treatment combination works better than inactive comparison treatments.
Who can participate
The target population in the trial data is adult patients with treatment-resistant depression. No other detailed eligibility rules are provided in the source data, so the main known requirement is having TRD and being an adult.
The study also includes psychotherapeutic support, meaning therapy support is part of the research setting for participants. This tells us the trial is not only testing the study drugs, but also evaluating them in a supported clinical environment.
What is being measured
The primary outcome is the efficacy of the single administration of the psilocybin plus TRAZODONE HYDROCHLORIDE combination at 1 month. Efficacy means how well the treatment works.
Researchers will measure the mean difference in Montgomery-Åsberg Depression Rating Scale (MADRS) scores between baseline and 1 month, comparing the group receiving psilocybin plus TRAZODONE HYDROCHLORIDE with the placebo plus trazodone group. MADRS is a scale used to rate depression severity, so a change in score helps show whether symptoms improve.
Study status and size
The trial is listed as Authorised and plans to enroll 112 participants. This gives a sense of the study size and shows that the research is still in a controlled testing stage rather than routine care.
Only one trial is provided in the source data, so the current clinical trial picture for TRAZODONE HYDROCHLORIDE here is focused on this single Phase 2 depression study.