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 @ 10:36 PM
Ignite Modification Date:
2025-12-24 @ 10:36 PM
NCT ID:
NCT02221635
Eligibility Criteria:
Inclusion Criteria:
* DSM-IV (Diagnostic and Statistical Manual of Mental Disorders-IV)diagnosis of schizoaffective disorder
* Experiencing an acute exacerbation of psychotic symptoms
* A score of \>=4 on at least 3 of the following 7 PANSS items: Delusions (P1), Hallucinatory behavior (P3), Excitement (P4), Hostility (P7), Tension (G4), Uncooperativeness (G8), and Poor Impulse Control (G14)
* A score of \>=16 on YMRS and/or a score of \>=16 on the HAM-D-21
* Healthy based on physical examinations, electrocardiogram (ECG), laboratory tests, medical history, and vital signs measurements
Exclusion Criteria:
* A primary active mental illness diagnosis other than schizoaffective disorder
* Have attempted suicide within 12 months or are at imminent risk of suicide or violent behavior
* Subjects with first episode of psychosis
* Received electroconvulsive therapy in the past 3 months
* History of hypersensitivity to or intolerance of paliperidone, risperidone, or 20% Intralipid (placebo)
* Received long-acting antipsychotic medication within 2 injection cycles
* Received therapy with clozapine within 3 months
* A history of neuroleptic malignant syndrome
* Previous history of lack of response to antipsychotic medication
* Subjects receiving therapy with antidepressants or mood stabilizers that has been initiated and/or changed in dose \<30 days prior to screening
* Receiving therapy with carbamazepine
* Receiving therapy with monoamine oxidase inhibitors
* Pregnant, breast-feeding, or planning to become pregnant
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02221635
Study Brief:
Protocol Section:
NCT02221635