The effect of Melatonin in Schizophrenia treatment
- Conditions
- Schizophrenia.Schizophrenia
- Registration Number
- IRCT20230619058537N1
- Lead Sponsor
- Ahvaz University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 66
Patients admitted in the Psychiatric department of Ahvaz Golestan Hospital, who are in the age range of 16 to 65 years
Diagnosis of schizophrenia based on DSM-5 criteria
Informed consent of the patients or their guardian to participate in a research project
Schizophrenic patients treated with risperidone
Taking typical and atypical antipsychotic drugs, except for Risperidone, antidepressants, Sodium valproate, and Lithium.
Presence of comorbid psychiatric disorder (bipolar-psychotic, obsessive-compulsive disorder, post-traumatic stress disorder, eating disorder)
Current or past diagnosis (last 6 months) of severe personality disorders that compromise the participant's ability to meet the requirements.
Use of narcotic drugs or alcohol in the last 12 months, except for nicotine and caffeine
Presence of mental retardation or other neurological cognitive disorders such as dementia, delirium, head trauma, seizures, obstructive sleep apnea.
History of ECT in the past 6 months
In case of serious complications, the patient will be excluded from the study.
Hypersensitivity to Melatonin or any of the ingredients in the placebo
Use of Clozapine or previous use of Melatonin based on medical history obtained
Pregnancy , lactating women
Diagnosing the depressive episode of schizophrenia based on the Calgary questionnaire
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cognitive symptoms of schizophrenia. Timepoint: First, 4 and 6 weeks after the study. Method of measurement: Wechsler Memory Questionnaire, Cognitive impairment investigation via review of auditory verbal learning, Digit symbol substitution test, Fluency test.
- Secondary Outcome Measures
Name Time Method Sleep-wake disorders. Timepoint: First, 4 and 6 weeks after the start of the study. Method of measurement: Pittsburgh Sleep Quality Questionnaire.