Table of Contents
- Trial overview
- Who is being studied
- What the trial measures
- Trial design and phase
- Key patient terms
Trial overview
This clinical trial is studying Vortioxetine Hydrobromide in people with a recent diagnosis of schizophrenia.[1] The study is described as an interventional trial, which means researchers give a study treatment and then measure the results.[1]
The trial title says it is looking at an already authorized drug for other conditions in people with schizophrenia.[1] The study is authorised and has 37 planned participants.[1]
Who is being studied
The trial focuses on people with schizophrenia and schizophrenia spectrum disorders.[1] The brief summary also says the study is for people with early psychosis, which means the early stage of a psychotic illness.[1]
Psychosis is a mental state where a person may have trouble telling what is real.[1] In this study, the main concern is not only the illness itself, but also cognitive problems linked with early psychosis.[1]
What the trial measures
The main outcome is cognitive functioning improvement, measured by the change in BACS App scores.[1] Cognitive functioning means thinking skills such as memory, attention, and planning.[1]
BACS stands for Brief Assessment of Cognition in Schizophrenia, a test used to check thinking skills in people with schizophrenia.[1] The summary says the score is tracked from baseline to Week 24, with additional time points at Week 26 and Week 50.[1]
The study uses a Composite Z-score, which means several test results are combined into one overall score.[1] This helps researchers see whether thinking skills improve over time.[1]
Trial design and phase
This is a Phase 4 trial.[1] Phase 4 studies usually look at an already authorized treatment in a real-world setting or for another use.[1]
The intervention list includes several antipsychotic drugs, along with Vortioxetine Hydrobromide.[1] The listed medicines are quetiapine, pimozide, chlorpromazine, risperidone, olanzapine, ziprasidone, aripiprazole, thioridazine, and haloperidol.[1]
The study objective is to compare Vortioxetine with treatment as usual in early psychosis, with the main focus on cognition.[1]
Key patient terms
Treatment as usual means the standard care a patient would normally receive outside the study.[1] This gives researchers a way to compare the study treatment with regular care.[1]
Baseline is the first measurement before treatment starts, and Week 24 is the main time point used to check change after treatment.[1] The study also checks later time points at Week 26 and Week 50.[1]
Interventional study means the research team gives a treatment rather than only observing people.[1] In this trial, the goal is to see whether Vortioxetine Hydrobromide can help with cognitive problems in early psychosis.[1]
