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RIVASTIGMINE

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.

Table of Contents

Trial overview

The trial titled Prediction of ECT treatment response and reduction of Cognitive Side-effects using EEG and Rivastigmine studied people with depression.[1] It was an interventional Phase 3 study with 100 enrolled participants and a completed status.[1]

The study looked at two goals: reducing cognitive side-effects after ECT and improving the ability to predict who would respond to ECT.[1] ECT means electroconvulsive therapy, a treatment used in severe depression.[1]

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.[1] The source lists two active doses, 9.5 mg and 4.6 mg, and matching placebo plasters that contained 0 mg of rivastigmin.[1]

This design helped researchers compare changes in thinking and memory between the RIVASTIGMINE group and the placebo group.[1]

Who participated

The target population was people with depression.[1] 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.[1]

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.[1] In simple terms, the researchers wanted to see if RIVASTIGMINE could prevent or reduce worsening in thinking and memory after ECT.[1]

The trial also measured whether a classification algorithm could accurately predict ECT response and side-effects at a statistically significant level.[1] A classification algorithm is a rule-based or computer-based method that sorts people into groups, such as likely responder or non-responder.[1]

Another part of the study used EEG, which is a test that records brain activity, to help build the prediction method for ECT response.[1]

Why this study matters

The study aimed to improve the acceptability and tolerability of ECT by reducing its cognitive side-effects.[1] Better memory and thinking outcomes could make ECT easier to use for people with chronic severe depression.[1]

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.[1] 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?[1]

Trial ID Phase Condition Studied Status Enrollment
2024-518047-37-01 Phase 3 Depression Completed 100

FAQ

  • What are the RIVASTIGMINE trials studying? The trial is studying whether RIVASTIGMINE can help reduce cognitive side-effects after ECT. It is also testing whether EEG and clinical data can predict who will respond to ECT.
  • Who can take part in these trials? The trial is for people with depression. The source does not give more detailed participation rules, such as age limits or other eligibility criteria.
  • What phase is the RIVASTIGMINE trial? The study is a Phase 3 trial. This means it is testing the treatment in a larger group to see how well it works and how it performs in real patients.
  • What outcomes are being measured? The trial measures changes in cognition and memory, especially whether there is less decline in the RIVASTIGMINE group than in the placebo group. It also measures how accurate prediction algorithms are for ECT response and side-effects.
  • Is this trial completed? Yes, the trial status is completed. That means the planned study activities have been finished.

Ongoing Clinical Trials on RIVASTIGMINE

  • Study on Improving ECT Response and Reducing Cognitive Side Effects in Depression Patients Using Rivastigmine

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands

Glossary

  • ECT: Electroconvulsive therapy, a treatment used for severe depression. The trial studies whether RIVASTIGMINE can reduce memory and thinking problems after this treatment.
  • Cognition: Mental abilities such as thinking, attention, and learning. The trial checks whether these abilities change after treatment.
  • Memory-related measures: Tests or scores that look at memory function. The trial compares these measures between RIVASTIGMINE and placebo groups.
  • Placebo: A treatment that looks like the study drug but has no active medicine. It is used to compare results fairly.
  • Phase 3: A later stage of clinical research that studies a treatment in a larger group of patients.
  • Interventional study: A study where researchers give a treatment and then measure the results.
  • EEG: Electroencephalography, a test that records brain activity. The trial uses EEG to help predict who may respond to ECT.
  • Prediction algorithm: A set of rules or a computer method used to estimate an outcome, such as ECT response or side-effects.
  • Treatment response: How well a person improves after treatment. In this trial, it means response to ECT.
  • Side-effects: Unwanted effects from treatment. This trial looks at cognitive side-effects after ECT.

References