Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:22 PM
Ignite Modification Date:
2025-12-24 @ 7:22 PM
NCT ID:
NCT07043803
Eligibility Criteria:
Inclusion Criteria:
1. are 18 years or older
2. have a chart DSM V diagnosis of schizophrenia spectrum or schizoaffective or bipolar disorder or any other mental illness disorder
3. have received ACM and antipsychotic medications for 6 months or more
4. are considered to be clinically stable (by the patient's healthcare team) for 3 months or more
5. the ACM (e.g. benztropine and/or trihexyphenidyl) is being used to treat EPS associated with antipsychotic medications.
6. on an examination using the modified Simpson-Angus Extrapyramidal Symptoms Scale (head dropping and leg pendulousness items are dropped), no single item rated at 3 or 4.
7. able and willing to sign the approved informed consent document.
Exclusion Criteria:
1. patients with ongoing Parkinsonian symptoms who require ACM meds for countering EPS side effects based on the Simpson-Angus Scale score cutoffs.
2. if the clinicians treating the potentially eligible patients consider them to be clinically unstable or if drug-addiction is the focus of treatment and participation in ACM de-prescription protocols is considered risky, the team will defer to the treating clinicians to exclude participants.
3. The same exclusions will apply to those persons undergoing medical procedures and treatments that make participation in this ACM deprescription trial unwise per the treating team.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07043803
Study Brief:
Protocol Section:
NCT07043803