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The effect of Melatonin in Schizophrenia treatment

Investigating the effect of Melatonin on the cognitive symptoms of patients with Schizophrenia treated with Risperidone: a randomized double-blind clinical trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20230619058537N1
Enrollment
66
Registered
2023-07-09
Start date
2023-06-25
Completion date
Unknown
Last updated
2023-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia. Schizophrenia

Interventions

Intervention 1: Intervention group: In addition to the second-generation antipsychotic drug (risperidone) that they have already taken, the patients receive two 3 mg melatonin tablets at the same time

Sponsors

Ahvaz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
16 Years to 65 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Sleep-wake disorders. Timepoint: First, 4 and 6 weeks after the start of the study. Method of measurement: Pittsburgh Sleep Quality Questionnaire.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactBehrouzian Forouzan

Ahvaz University of Medical Sciences

behrouzian-f@ajums.ac.ir+98 61 3374 3038

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026