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 @ 11:33 PM
Ignite Modification Date:
2025-12-24 @ 11:33 PM
NCT ID:
NCT00594256
Eligibility Criteria:
Inclusion Criteria:
* Patients aged 18-45 with a DSM-IV diagnosis of schizophrenia and insomnia related to schizophrenia, confirmed by a structured interview (SCID).
Exclusion Criteria:
* Lack of capacity to give informed consent (capacity is determined by a licensed member of the treatment team).
* Unstable medical illness.
* Diagnosis of restless leg syndrome, a seizure disorder, uncontrolled hypertension, unstable cardiac illness, or obstructive sleep apnea.
* Pregnancy or lack of adequate birth control.
* History of substance dependence disorder.
* Current treatment with valproic acid.
* Succinic semialdehyde dehydrogenase deficiency (SSADH).
* Persistent need for treatment with benzodiazepines, barbiturates, opiates or other sedative hypnotics.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT00594256
Study Brief:
Protocol Section:
NCT00594256