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 @ 9:08 PM
Ignite Modification Date:
2025-12-24 @ 9:08 PM
NCT ID:
NCT06838104
Eligibility Criteria:
Inclusion Criteria:
* Patients aged between 18 to 50 years.
* Patients diagnosed with schizophrenia according to DSM-5 criteria, exhibiting both positive negative symptoms.
* Patients who score less than 6 on the Calgary Depression Scale for Schizophrenia (CDSS), indicating no significant depressive episode, will be considered eligible.
Exclusion Criteria:
* Patients with a known hypersensitivity or allergy to melatonin or any of its excipients.
* Patients with a current or past diagnosis of major depressive disorder, bipolar disorder, or obsessive-compulsive disorder, unless these are in full remission and do not require active pharmacological treatment.
* Patients with any unstable or serious medical condition (e.g., cardiovascular, hepatic, renal, or respiratory diseases) that could interfere with the study outcomes or pose additional risk to the patient.
* Married women of reproductive age, unless they use a reliable non-hormonal contraception method.
* Patients with neurological disorders, such as epilepsy, Parkinson's disease, or traumatic brain injury, which may mimic psychiatric symptoms.
* Use of antiepileptic, antihypertensive, anticoagulant, or anti-platelet drugs.
* Use of inhibitors or stimulants of hepatic isoenzymes that metabolize melatonin or olanzapine (e.g., omeprazole, rifampin, fluvoxamine, ciprofloxacin, carbamazepine, modafinil).
* History of addictive disorders.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT06838104
Study Brief:
Protocol Section:
NCT06838104