Comparing the Effects of Melatonin and Placebo on Cognitive Side Effects of Electroconvulsive Therapy (ECT) in Patients with Mood Disorders: a randomized clinical trial
The aim of present study was to evaluate the effect of Melatonin on prevention of cognitive dysfunction after treatment of mood disorder in patients with electroconvulsive therapy (ECT). In this phase three, single center, randomized double-blind clinical trial, 40 patients with mood disorders admitted to psychiatry ward, who were candidate of ECT therapy, were included the study. Patients with mood disorder who were between 18 and 65 years of age were included and patients with history of substance abuse and previous ECT were excluded from the study. Patients were randomly allocated to two groups using random number table. Intervention group received Melatonin pill (one tablet (3mg) per day,) and control group received placebo pills (one tablet per day) for 4 weeks. Melatonin and placebo pills were identical in appearance and physicians as well as the patients were not aware of the type of pill. Patients were evaluated by mini-mental status examination (MMSE) questionnaire before and after the end of all ECT sessions and also 6 months after intervention. Change in mental status, measured by MMSE questionnaire, was compared between the groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015103124793N1
Registration date:2016-12-20, 1395/09/30
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-12-20, 1395/09/30
Registrant information
Name
Taleb Badri
Name of organization / entity
Baqiyatallah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8126 1001
Email address
dr_badri@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Anesthesiology Research Center, Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2015-11-22, 1394/09/01
Expected recruitment end date
2016-05-21, 1395/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the Effects of Melatonin and Placebo on Cognitive Side Effects of Electroconvulsive Therapy (ECT) in Patients with Mood Disorders: a randomized clinical trial
Public title
Effects of Melatonin on Cognitive Dysfunction After Electroconvulsive Therapy (ECT)
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: affective disorders lead to hospitalization in psychiatric wards; age 18 to 65 years; having informed consent.
Exclusion criteria: substance abuse; schizophrenia; previous treatment with electroconvulsive therapy; having psychosis
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
patients were randomly allocated to two intervention and control group using random number table
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical Sciences, Daneshjoo Blvd, Velenjak, Tehran-Iran
City
Tehran
Postal code
198571151
Approval date
2015-11-19, 1394/08/28
Ethics committee reference number
IR.SBMU.RAM.REC.1394.323
Health conditions studied
1
Description of health condition studied
Mood Disorders
ICD-10 code
F30-F39
ICD-10 code description
Mood [affective] disorders
Primary outcomes
1
Description
Patients' mental status
Timepoint
pretreatment, after finishing ECT sessions, 4 weeks after finishing all sessions
Method of measurement
Mini-mental Status Examination Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Melatonine, 3 mg tablet, orally, once a day, for a period of 4 weeks
Category
Treatment - Drugs
2
Description
Placebo tablet, orally, once a day, for a period of 4 weeks