Effect of Melatonin on Cognitive Performance Impairment

Phase 3

Recruiting

Conditions: Bipolar.
Bipolar disorder

Registration Number: IRCT20220516054879N5

Lead Sponsor: Gerash University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 46

Inclusion Criteria

Patients over 18 years of age who are diagnosed with bipolar according to Diagnostic and Statistical Manual of Mental Disorders V (DSM-V) criteria and based on the diagnosis of a psychiatrist, and at the beginning of ECT treatment, refer to Rasht Shafa Hospital.

Exclusion Criteria

Schizophrenia
Drug Abusers
Psychiatric diseases with other mental illnesses
Bradyarrhythmia
Liver or kidney failure
History of seizures
Drug or alcohol use
History of asthma or bronchospasm
History of allergy to melatonin
Pregnancy
Breastfeeding
Currently uncontrolled hypertension
Active peptic ulcer
Receiving nitroglycerin
History of severe skin disease such as Steven Johnson.

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary measurable outcome in this study is the evaluation of cognitive disorders caused by electroshock therapy in bipolar patients treated with melatonin by the Mini-Mental State Examination questionnaire, which is evaluated before and after 12 sessions of electroshock therapy. Timepoint: Before and after 12 sessions of electroshock therapy. Method of measurement: Mini-Mental State Examination questionnaire.

Secondary Outcome Measures

Name	Time	Method
The examination of changes in systolic and diastolic blood pressure. Timepoint: Before and after each session. Method of measurement: The blood pressure of the patients are checked and measured by the doctor and the researcher every time the patient visits.;Check heart rate changes. Timepoint: Before and after each session. Method of measurement: The heart rate of the patients is checked and measured by the doctor and the researcher every time the patient visits.;Investigation of possible drug side effects. Timepoint: Before and after each session. Method of measurement: Patients are examined by doctors and researchers at each visit.