NCT05895513 · Phase 2 · RECRUITING
Pimavanserin and Aggression and Social Cognition.
This trial tests whether a single 34 mg dose of pimavanserin, a drug that blocks a serotonin receptor, lowers aggressive responses on a lab task in adults with impulsive anger problems. It also looks at hostile thinking. It is a Phase 2 trial, testing early whether it works and is safe, not yet proven or approved for this.
Eligibility criteria
Inclusion Criteria: Participants will have a current (or past) DSM-5 diagnosis of Intermittent Explosive Disorder (IED) or have a Life History of Aggression (LHA) score equal or greater than 12. In addition, all participants must meet the following criteria: 1. Participant is between 21 and 55 years of age and is able to give informed consent. 2. Participant is physically healthy as confirmed by medical history, physical evaluation, ECG, and (in females) has a negative pregnancy test. 3. Two weeks free of anti-psychotic medication. Exclusion Criteria: All subjects with the following are excluded from study: 1. Clinically significant medical condition. 2. Prolonged QT-Interval ( > 0.45 / > 0.47 seconds for males/females). 3. Life history of bipolar disorder / schizophrenia / organic mental syndrome or intellectual disability. 4. Current major depressive disorder with a BDI score > 32. 5. Current alcohol / drug use disorder of greater than mild severity. 6. Current suicidal ideation. 7. Allergy, or other contraindication, to Pimavanserin. 8. Current treatment with opiates or any agents that affect pain threshold. 9. Unwilling/unable to sign informed consent document.
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2025-03-27