In short
Clinical trials investigating RIVASTIGMINE are studying whether it can reduce cognitive side-effects after ECT and support treatment planning in people with depression. These studies also look at how well EEG and clinical features can predict ECT response. The focus is on adults with depression in an interventional Phase 3 trial.
Key points
- Clinical trial data for RIVASTIGMINE focus on people with depression who are receiving ECT. The main study asks whether RIVASTIGMINE can reduce cognitive side-effects, especially problems with memory and thinking. The trial is Phase 3 and includes 100 participants. It also studies whether EEG and clinical features can predict who will respond to ECT and who may have side-effects. The study used placebo comparison and measured both cognitive outcomes and prediction accuracy.
Trial overview
The trial titled Prediction of ECT treatment response and reduction of Cognitive Side-effects using EEG and Rivastigmine studied people with depression. It was an interventional Phase 3 study with 100 enrolled participants and a completed status.
The study looked at two goals: reducing cognitive side-effects after ECT and improving the ability to predict who would respond to ECT. ECT means electroconvulsive therapy, a treatment used in severe depression.
Study design and treatment groups
The trial compared RIVASTIGMINE with placebo using transdermal use, which means the treatment was given through the skin with an adhesive plaster. The source lists two active doses, 9.5 mg and 4.6 mg, and matching placebo plasters that contained 0 mg of rivastigmin.
This design helped researchers compare changes in thinking and memory between the RIVASTIGMINE group and the placebo group.
Who participated
The target population was people with depression. The source does not provide more detailed entry rules, such as age limits, severity rules, or other medical conditions required for participation.
Because the study focused on ECT, the participants were people for whom ECT was being considered or used as part of care in the research setting.
What the trial measured
The main outcome was whether there was no change in the RIVASTIGMINE group on cognitive and memory-related measures, compared with an effect in the placebo group. In simple terms, the researchers wanted to see if RIVASTIGMINE could prevent or reduce worsening in thinking and memory after ECT.
The trial also measured whether a classification algorithm could accurately predict ECT response and side-effects at a statistically significant level. A classification algorithm is a rule-based or computer-based method that sorts people into groups, such as likely responder or non-responder.
Another part of the study used EEG, which is a test that records brain activity, to help build the prediction method for ECT response.
Why this study matters
The study aimed to improve the acceptability and tolerability of ECT by reducing its cognitive side-effects. Better memory and thinking outcomes could make ECT easier to use for people with chronic severe depression.
The researchers also wanted to avoid giving ECT to people who are unlikely to benefit, because this could expose them to risks without enough chance of improvement. In this way, the trial combined a treatment question with a prediction question: can RIVASTIGMINE help after ECT, and can EEG plus clinical data better forecast ECT results?