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TRAZODONE HYDROCHLORIDE

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.

Table of Contents

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.[1] The study is titled “Efficacy of psilocybin and trazodone combination in treatment-resistant depression: a randomized controlled proof-of-concept study (PSILOTRAZ).”[1]

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.[1] The status is Authorised.[1]

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.[1] 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.[1]

The intervention list shows several study arms, including psilocybin 25 mg capsules, TRAZODONE HYDROCHLORIDE oral drops, and placebo versions for comparison.[1] In simple terms, the trial is trying to find out whether the active treatment combination works better than inactive comparison treatments.[1]

Who can participate

The target population in the trial data is adult patients with treatment-resistant depression.[1] No other detailed eligibility rules are provided in the source data, so the main known requirement is having TRD and being an adult.[1]

The study also includes psychotherapeutic support, meaning therapy support is part of the research setting for participants.[1] This tells us the trial is not only testing the study drugs, but also evaluating them in a supported clinical environment.[1]

What is being measured

The primary outcome is the efficacy of the single administration of the psilocybin plus TRAZODONE HYDROCHLORIDE combination at 1 month.[1] Efficacy means how well the treatment works.[1]

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.[1] MADRS is a scale used to rate depression severity, so a change in score helps show whether symptoms improve.[1]

Study status and size

The trial is listed as Authorised and plans to enroll 112 participants.[1] This gives a sense of the study size and shows that the research is still in a controlled testing stage rather than routine care.[1]

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.[1]

Trial ID Phase Condition studied Status Enrollment
2024-512911-34-00 Phase 2 Treatment-resistant depression Authorised 112

FAQ

  • What is being studied in TRAZODONE HYDROCHLORIDE trials? The trial data show TRAZODONE HYDROCHLORIDE being studied as part of a combination treatment for treatment-resistant depression. The main goal is to see whether this study approach improves depression symptoms.
  • Who can take part in these trials? The trial is for adult patients with treatment-resistant depression. This means people whose depression has been hard to treat with usual care.
  • What phase is the TRAZODONE HYDROCHLORIDE trial? The study is a Phase 2 trial. Phase 2 studies usually look more closely at whether a treatment may work and continue to watch safety.
  • What is the main outcome being measured? The main outcome is the change in depression symptoms using the Montgomery-Åsberg Depression Rating Scale, also called MADRS. Researchers compare scores at baseline and after 1 month.
  • Is TRAZODONE HYDROCHLORIDE being tested alone? In the trial data, TRAZODONE HYDROCHLORIDE is tested in combination with psilocybin and compared with placebo groups. The study also includes psychotherapeutic support.

Ongoing Clinical Trials on TRAZODONE HYDROCHLORIDE

  • Study on Psilocybin and Trazodone for Adults with Treatment-Resistant Depression

    Not yet recruiting

    2 1 1
    Investigated drugs:
    France

Glossary

  • Treatment-resistant depression: Depression that has not improved enough with usual treatments.
  • Adult patients: People who are 18 years old or older.
  • Phase 2: An early clinical trial phase that checks whether a treatment may work and continues to monitor safety.
  • Interventional study: A trial where researchers give a treatment and then measure its effects.
  • Randomized controlled trial: A study where participants are placed into groups by chance and compared with a control group.
  • Proof-of-concept study: A study designed to see if an idea or treatment approach shows early signs of working.
  • Placebo: A look-alike treatment with no active study drug, used for comparison.
  • Psychotherapeutic support: Therapy support given during the study to help guide and monitor participants.
  • Montgomery-Åsberg Depression Rating Scale (MADRS): A score used by researchers to measure how severe depression symptoms are.
  • Baseline: The starting point before treatment begins.
  • Primary outcome: The main result the researchers want to measure.

References

  1. https://clinicaltrials.gov/study/2024-512911-34-00