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Currently receiving treatment with no more than three psychotropic medications (e.g., antidepressants, anti-anxiety medications, stimulants, antipsychotics, and mood stabilizers).*

Study 204 is double-blind, which means that neither the participants nor the researchers know which treatment the participants are receiving. Participants will be randomly selected to receive either zatolmilast (the investigational study drug) or placebo (a pill that does not include active drug) for 13 weeks. Approximately two of three participants will receive zatolmilast and one of three participants will receive placebo.

Don’t see a site near you? Travel support to and from sites for study participant and his caregiver may be covered by Tetra Therapeutics, a Shionogi Group Company, and may include travel and lodging arrangements and reimbursement for expenses such as meals (limitations may apply). Contact medinfo@shionogi.com or 1-800-849-9707 if you have any questions.

†Participants with a history of seizure, who are currently receiving treatment, must be seizure-free for 3 months prior to screening, or for 2 years if not on treatment.

*Participants must be at a stable dose and dosing regimen for at least 4 weeks prior to screening. Dosing must remain stable throughout the 13-week study.

Travel to and from sites for study participant and his caregiver may be covered by Tetra Therapeutics, a Shionogi Group Company, and may include travel and lodging arrangements and reimbursement for expenses such as meals (limitations may apply).

Zatolmilast is an investigational drug. Safety and efficacy have not been established. There is no guarantee that zatolmilast will be approved by any health authority.

Before eligibility can be determined, a participant must attend a screening session (for approximately 4-6 hours) at a clinic. The screening session will take place approximately 2-4 weeks before the study begins (Day 1).

Participants may continue with psychotropic medications*, behavioral/non-pharmacological treatments* and anti-epileptic medications† throughout the 13-week study.

In-person safety and efficacy (~ 4-6 hours); determine eligibility for continuation to Study 302, the open-label extension

This is a subset of the full eligibility criteria. A comprehensive list of eligibility criteria will be discussed during a participant’s screening visit.

Participants in Study 204 will be eligible to enroll in Study 302, an up to two-year, open-label extension, after completing Week 13.