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:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2025-12-25 @ 3:32 AM
NCT ID:
NCT00772005
Eligibility Criteria:
Key Inclusion Criteria:
* The patient has a diagnosis of schizophrenia according to the DSM-IV-TR criteria and the patient has been clinically stable in a nonacute phase of their illness.
* Documentation that the patient has received treatment with olanzapine, oral risperidone, or paliperidone for schizophrenia for at least 6 weeks prior to the screening visit and has been on a stable dose of that antipsychotic medication for at least 4 weeks prior to the screening visit.
* The patient is in good health (except for the diagnosis of schizophrenia) as judged by the investigator.
* Women of childbearing potential (not surgically sterile or 2 years postmenopausal) must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the study and for 30 days after participation in the study. Acceptable methods of contraception include barrier method with spermicide, intrauterine device (IUD), steroidal contraceptive (oral, transdermal, implanted, and injected) in conjunction with a barrier method, or documented abstinence.
* The patient has a PANSS negative symptom score of 15 or more at the screening and baseline visits.
Key Exclusion Criteria:
* The patient has a severity rating of moderate or worse on any item of the PANSS positive symptom subscale.
* The patient has any Axis I disorder according to DSM-IV-TR criteria, including schizoaffective disorder, apart from schizophrenia and nicotine dependence, or any Axis II disorder that would interfere with the conduct of the study.
* The patient has moderate to severe depressive symptoms, as indicated by the CDSS.
* The patient has current active suicidal ideation, is at imminent risk of self-harm, or has a history of significant suicidal ideation or suicide attempt at any time in the past that causes concern at present.
* The patient has tardive dyskinesia, akathisia, moderate or worse level of extrapyramidal symptoms, or any other clinically significant movement disorder.
* The patient has a history of any cutaneous drug reaction or drug hypersensitivity reaction, a history of any clinically significant hypersensitivity reaction, or has a history of multiple clinically relevant allergies.
* The patient is a pregnant or lactating woman.
* The patient has previously received modafinil or armodafinil, or the patient has a known sensitivity to any ingredients in the study drug tablets.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00772005
Study Brief:
Protocol Section:
NCT00772005