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