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 @ 6:33 PM
Ignite Modification Date:
2025-12-24 @ 6:33 PM
NCT ID:
NCT03075657
Eligibility Criteria:
Inclusion Criteria:
* All adult patients of either sex with age range 18-65 years with the clinical diagnosis of schizophrenia. (DSM-V)
* Treatment naïve patients or patients who had not taken any treatment for at least 4 weeks before inclusion.
* Legal guardian of patients consenting to participate in the study by signing the informed consent form.
Exclusion Criteria:
* Schizoaffective disorder or schizophrenia with somatoform disorders.
* Highly agitated patients who need immediate treatment.
* Patients who are already under treatment for the presenting conditions.
* Patients with comorbid substance abuse or history of organicity
* Patients with known history of dementia, obstructive sleep apnoea syndrome, diabetes mellitus.
* Pregnant and nursing women.
* History of allergy or hypersensitivity to ramelteon.
* Legal guardian of patients not willing to participate in the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03075657
Study Brief:
Protocol Section:
NCT03075657