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 @ 9:42 PM
Ignite Modification Date:
2025-12-24 @ 9:42 PM
NCT ID:
NCT00791232
Eligibility Criteria:
Inclusion Criteria:
* Willingness to spend 2 weeks as an in-patient during the washout and treatment period
* Currently treated with oral risperidone antipsychotic monotherapy for at least 1 month prior to screening
* DSM-IV diagnosis of schizophrenia (Patients with a diagnosis of schizophrenia \[paranoid type (295.30), disorganized type (295.10), catatonic type (295.20), undifferentiated type (295.90), or residual type (295.60)\] as defined by DSM-IV criteria
* Absence of acute exacerbation for a minimum of 6 months prior to screening
* Female patients must be postmenopausal for at least 1 year, surgically sterile, or practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization) before screening and throughout the study, and have a negative urine pregnancy test at screening and baseline
* The patient is otherwise healthy on the basis of a physical examination, medical history, electrocardiogram, and the results of blood biochemistry and hematology tests and a urinalysis performed within 30 days of the start of the treatment period. If the results of the biochemistry or hematology tests or the urinalysis testing are not within the laboratory's reference ranges, the patient may be included only on condition that the investigator judges that the deviations are not clinically significant.
Exclusion Criteria:
* Involuntarily committed in-patients
* Patients who have received long-acting depot antipsychotic medication (discontinued RISPERDAL CONSTA for less than 10 weeks or discontinued other depots for less than 2 cycles)
* Any significant history of cardiovascular disease: atrial fibrillation or flutter, second and third degree heart block and equivalent, resting supraventricular tachycardia (\>100 beats per minute), unstable atherosclerotic heart disease, valvular abnormality
* Body Mass Index \> = 35 kg/m2 or a history of or current hypertension
* Use of disallowed concomitant therapy or patients likely to require prohibited concomitant therapy during participation in the study
* Patients with a pacemaker
* Concomitant disease of the central nervous system that would bias the study evaluations, e.g.
* stroke, brain tumor, Parkinson's disease, significant brain trauma, Alzheimer's disease, epilepsy, multiple sclerosis, currently-treated migraine
* A DSM-IV Axis I diagnosis other than schizophrenia or with a DSM-IV diagnosis of substance dependence within 6 months prior to screening evaluation (nicotine and caffeine dependence are not exclusionary)
* Diabetes mellitus and/or repeated fasting blood glucose value during the washout period \>126 mg/dl and /or HbA1C \> 7. 5%, hypothalamo-hypophyse dysfunction, Cushing, Addison, thyrotoxicosis, or Anemia (as defined by hematocrit \< 30%)
* Suicidal or homicidal ideation
* Positive drug screen at screening and at baseline
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00791232
Study Brief:
Protocol Section:
NCT00791232