In short
Colloidal silicon dioxide is a chemical substance, a form of silica, used as an inactive ingredient (excipient) in medicines. In the clinical trial data provided, it is listed as a component of a placebo tablet in a Phase 3 study for major depressive disorder with insomnia. The trial enrolled 134 participants.
Key points
- Colloidal silicon dioxide is a form of silica, also known as silicon dioxide.
- It is used in medicines as an excipient — a non-medicinal ingredient that helps with manufacturing and stability.
- In the registered trial, it is part of the placebo tablet, not the active drug being tested.
- The trial is a Phase 3 study in patients with major depressive disorder and insomnia.
- The study aims to measure improvement in insomnia severity using the Insomnia Severity Index (ISI).
- The trial is currently authorised and plans to enroll 134 participants.
What is colloidal silicon dioxide?
Colloidal silicon dioxide is a chemically synthesised substance, a form of silica. It is also known as silicon dioxide or silica. In the European Union clinical trial registry, it is recorded under the name COLLOIDAL SILICON DIOXIDE. The substance is authorised as a medicine in some records, though the specific authorisation details are not provided in the data. In the trial listed, colloidal silicon dioxide appears as a component of the placebo tablet, meaning it is an inactive ingredient rather than the active medicine being investigated.
How does colloidal silicon dioxide work?
Colloidal silicon dioxide does not have a medicinal effect on the body. It is classified as a mineral and is used for non-medicinal purposes in pharmaceutical products. According to a Canadian health product database, it serves roles such as an anticaking agent, glidant, disintegrant, and flow enhancer. These functions help in the manufacturing of tablets and capsules, ensuring that powders flow evenly and that tablets break apart correctly after swallowing. It is not intended to treat or prevent any disease.
Which conditions is it used or studied for?
- Major depressive disorder with insomnia — the registered trial investigates the active substance daridorexant in patients with a major depressive episode and moderate to severe insomnia. Colloidal silicon dioxide is part of the placebo arm of this study.
Colloidal silicon dioxide itself is not studied as a treatment for any condition. It is included in the trial record because it is an ingredient in the placebo tablets given to some participants.
How is colloidal silicon dioxide given?
In the registered trial, colloidal silicon dioxide is given orally as part of a tablet. The record lists a quantity of 3000 micrograms per tablet. It is one of several inactive ingredients in the placebo tablet, which also includes microcrystalline cellulose, croscarmellose sodium, and magnesium stearate. The substance is used in oral pharmaceutical forms as a manufacturing aid.
What do the clinical trials show?
Only one clinical trial involving colloidal silicon dioxide is listed in the provided data. This trial is a Phase 3 interventional study. Its status is authorised, meaning the trial has received approval to proceed. The planned enrollment is 134 participants.
The study evaluates the efficacy and safety of daridorexant, an active drug, in patients with major depressive disorder and insomnia. Colloidal silicon dioxide is not the substance being tested for efficacy; it is part of the placebo formulation used for comparison.
The main outcome measured is the improvement in insomnia severity, assessed using the Insomnia Severity Index (ISI) at 3 months. The ISI is a questionnaire that measures how severe a person's insomnia symptoms are.