The study is performed on hospitalized patients in Sanandaj Qods Hospital who receive ECT.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Hospitalization in Qods Hospital ; Age between 18 and 60 years ; Signing informed consent form by patient or his legal guardian ; Number of sessions of ECT between 6 to 12 sessions and Exclusion criteria : Having alcohol dependence in the past 3 months except nicotine and caffeine ; Mental retardation ; Causes of delirium and dementia and cognitive impairment ; History of thiamine use in the previous 3 months and History of allergy to thiamine.
Intervention groups
The intervention group received a capsule containing 100 mg of thiamine twice daily and the control group received a placebo capsule twice daily during the ECT.
Main outcome variables
Wechsler test and MMSE scores
General information
Reason for update
Acronym
Sanandaj Thiamine study
IRCT registration information
IRCT registration number:IRCT20191218045795N4
Registration date:2020-05-03, 1399/02/14
Registration timing:registered_while_recruiting
Last update:2020-05-03, 1399/02/14
Update count:0
Registration date
2020-05-03, 1399/02/14
Registrant information
Name
Narges Shams alizadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 87 3366 8821
Email address
n.shamsalizadeh@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-29, 1398/12/10
Expected recruitment end date
2021-09-01, 1400/06/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of Thiamine on Cognitive Performance of Paitients Under Electro-Convulsive Therapy: A Randomized Double Blind Clinical Trial.
Public title
Efficacy of Thiamine in Amnisia due to Electro Convulsive Therapy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients candicate for ECT ; Age between 18-60 years old.
The Patient or his or her legal guardian must sign the informed consent form.
The number of Electro Convulsive Therapy sessions ; must be between 2-12 sessions.
Exclusion criteria:
Alcohol and substance dependence except Caffeine and Nicotine in past 3 months.
Proven Intelligent Disability or diagnosed with assistant.
History of Delirium, Dementia and Cognitive Disorders.
History of Thiamine consumption from 3 months before the visit.
History of Thiamine sensitivity.
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
The random assignment of patients is done by the resident implementing the plan using pre-determined envelopes. The random allocation list is provided to the pharmacist by the block method provided by the methodological consultant. Required drugs are embedded in envelopes and numbered. Can be arranged in order to be given to patients. The drugs will be administered in two groups and will be similar in appearance. Wounded Patients who are evaluating outcomes, being a patient psychiatrist, will not be aware of grouping.
Quadratic random blocking is also used for random allocation as follows:
The 4-way random blocking method is as follows and its blocks include:
AABB
1 For Group A patients
And for Group B patients
BABA BBAA ABAB AABB ABBA BAAB BABA
BABA ABBA BBAA AABB BABA ABAB BAAB
BBAA
2
ABAB
3
BABA
4
ABBA
5
BAAB
6
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients (participants) and outcome assessors, project researchers, patient therapist psychiatrists, and nurse staff who give medication were kept blind in the study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of kurdistan University of Medical Sciences
Street address
Pasdaran blv,Sanandaj
City
Sanandaj
Province
Kurdistan
Postal code
6617978743
Approval date
2020-03-15, 1398/12/25
Ethics committee reference number
IR.MUK.REC.1398.308
Health conditions studied
1
Description of health condition studied
Schizophrenia,Schizoaffective,Mood dosorders and Obsessive-compulsive disorders