In short
Croscarmellose sodium is a polymer-based substance used as an inactive ingredient (excipient) in oral tablets. In the clinical trial record provided, it appears as a placebo component in a Phase 3 study of daridorexant for major depressive disorder with insomnia, which enrolled 134 participants. The trial is authorised but not yet reporting results.
Key points
- Croscarmellose sodium is a polymer-based excipient, not an active drug.
- It is given orally as part of a tablet formulation.
- In the listed trial it serves as a placebo component, not the tested medicine.
- The trial is a Phase 3 study in major depressive disorder with insomnia.
- The study plans to enrol 134 participants.
- The primary measure is the Insomnia Severity Index (ISI) at 3 months.
What is croscarmellose sodium?
Croscarmellose sodium is a polymer-based substance of natural origin, derived from cellulose. It is not an active medicine but an excipient: an inactive ingredient added to tablets to help them dissolve and release the active drug. In the registry records for the trial listed on this page, it appears under the product name croscarmellose sodium. The substance is authorised as a medicine component, although the authorisation record does not specify a holder or number in the provided data. In the clinical trial described here, croscarmellose sodium is not the medicine being tested; it is part of the placebo arm.
How does croscarmellose sodium work?
Croscarmellose sodium works as a disintegrant. When a tablet reaches the stomach or intestine, croscarmellose sodium absorbs water and swells, causing the tablet to break apart. This helps the active drug dissolve and become available to the body. The substance has no pharmacological effect of its own, which is why it can be used in placebo formulations.
Which conditions is it used or studied for?
Croscarmellose sodium itself is not used to treat any condition. It appears in the trial record as part of a placebo for a study in one condition:
- Major depressive disorder with insomnia — a mental health condition where people have both a major depressive episode and moderate to severe difficulty sleeping. The trial tests whether the active drug daridorexant improves insomnia in these patients.
How is croscarmellose sodium given?
Croscarmellose sodium is given orally, as part of a tablet. In the trial record, the oral formulation contains croscarmellose sodium at a dose of 7500 micrograms per tablet, alongside other inactive ingredients: microcrystalline cellulose (138300 micrograms), colloidal silicon dioxide (3000 micrograms), and magnesium stearate (1200 micrograms). These amounts describe the composition of the tablet, not a therapeutic dose.
What do the clinical trials show?
One clinical trial record is available for this substance. The trial is a Phase 3 interventional study, the most advanced phase before regulatory submission, and is currently authorised, meaning it has received approval to proceed but has not reported results.
The study enrols 134 participants with major depressive episode and moderate to severe insomnia disorder. Its primary outcome is improvement in insomnia severity, measured by the Insomnia Severity Index (ISI) — a questionnaire where patients rate the severity of their sleep problems — at 3 months.
Croscarmellose sodium appears in this trial only as a placebo component. The active medicine being tested is daridorexant, given as a 50 mg oral dose. The placebo arm exists so that researchers can compare the effect of daridorexant against a tablet that looks the same but contains no active drug.
What side effects are known?
The registry record for this trial does not report side effects for croscarmellose sodium. As an inactive excipient used in small amounts, it is generally regarded as safe, but no side-effect data specific to this substance are provided in the source material for this page.