Bioavailability Comparison of Trazodone Hydrochloride Tablets in Major Depressive Disorder with and without Anxiety: A Randomized, Crossover Study

The primary objective of this study is to compare the **bioavailability** of 150 mg and 300 mg trazodone hydrochloride tablets formulated with a new polymer against the existing 150 mg and 300 mg trazodone hydrochloride Contramid® tablets, both produced by Angelini Pharma S.p.A., at steady-state. This comparison is clinically relevant as it aims to evaluate the potential differences in drug absorption and efficacy, which could impact the therapeutic management of patients with **Major Depressive Disorders** with and without anxiety. The study also includes healthy volunteers, although the therapeutic indication is not being studied in this group.

The clinical trial involves participants diagnosed with **Major Depressive Disorders** with and without anxiety, as well as healthy volunteers for whom the therapeutic indication is not studied. The study population includes both male and female subjects, encompassing age ranges from 18 to 64 years. The trial population was selected to include a vulnerable population, although specific selection criteria are not provided. The sponsor has not disclosed the total number of participants involved in the study. No specific lifestyle considerations such as diet, physical activity, or habits have been detailed in the available data.

The clinical trial is designed as a **randomized**, two-way, crossover study involving two parallel groups. The primary aim is to compare the **bioavailability** of 150 mg and 300 mg trazodone hydrochloride tablets formulated with a new polymer against the existing 150 mg and 300 mg trazodone hydrochloride Contramid® tablets at steady-state. The study targets individuals with **Major Depressive Disorders** with and without anxiety, as well as healthy volunteers, although the therapeutic indication is not being studied in the latter group. The trial is categorized as a Phase 2 study and is expected to commence recruitment on May 6, 2024, with an estimated completion date of July 11, 2024.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to assess eligibility based on predefined criteria. Following successful screening, participants will be randomized into one of the two treatment groups. The study will include multiple follow-up visits to monitor the participants' response to the treatment and ensure safety. These visits will be scheduled at regular intervals throughout the trial duration. The end-of-study visit will mark the conclusion of the participant's involvement, during which final assessments will be conducted to evaluate the primary and secondary endpoints of the study.

The expected length of participant involvement will span the entire trial duration, from the initial screening to the end-of-study visit. However, certain conditions may necessitate early termination from the study, such as adverse events, non-compliance with study protocols, or withdrawal of consent by the participant. The trial is structured to maintain scientific rigor and ensure the reliability of the data collected, adhering to ethical standards and regulatory requirements throughout its execution.

The clinical trial documentation does not provide specific details regarding the **experimental medication** used in the study. Information such as the name, pharmaceutical form, dosage, route, and frequency of administration is not available. Additionally, there is no data on whether the medication is a **paediatric formulation** or if it is classified as an **orphan drug**. The maximum daily dose, total dose, and treatment period are also unspecified.

Details about any **non-experimental treatments** used in the study, such as standard-of-care therapy, placebo, or comparator treatment, are not provided. There is no information on the administration of other medicinal products or their role in the trial.

Additional relevant information about drug administration, dosing schedules, and participant compliance monitoring is not included in the available data. The documentation lacks specifics on the **product's authorization status**, pharmaceutical form, and the origin of the active substances.

The clinical trial is designed to assess efficacy in a Phase 2 study. The trial is scheduled to begin recruitment on May 6, 2024, with an estimated end date of July 11, 2024. The efficacy assessment will be conducted through a series of planned evaluations, although specific parameters or endpoints for efficacy evaluation are not detailed in the provided data. The trial will follow a structured timeline to ensure systematic data collection and analysis. The methods and tools for measuring efficacy, as well as the specific timepoints for these assessments, are not specified in the available information. The trial will adhere to rigorous standards typical of Phase 2 studies to ensure the reliability and validity of the efficacy data collected.