Determination of the Effect of Simultaneous Use of Folic Acid and Sodium Valproate in the Treatment of Acute Mania
Design
A placebo controlled, double blind randomized clinical trial with parallel groups with 60 patients.
Settings and conduct
Since the study is designed blind, therapists and prescribing nurses and also data analyzer do not know the type of medication prescribed for the patients.
Participants/Inclusion and exclusion criteria
Inclusion criteria: diagnosis of type 1 bipolar disorder in the Mania episode based on DSM-V diagnostic criteria.
Exclusion criteria: the presence of anemia, History of ADHD, history of admission to psychiatric hospital during the past three months, positive pregnancy test in women, receiving other medications such as anti-mania treatment during two weeks prior to the study or During the study, a history of sensitivity to sodium valproate.
Intervention groups
A sample of 60 patients was selected and randomly divided into two groups of case and control (each group was 30 patients).The case group will be treated with sodium valproate and folic acid and the control group will be treated with placebo and sodium valproate.
Main outcome variables
Acute mania improvement (using Young Mania Rating Scale score and short mental state test 1 score)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180103038196N2
Registration date:2018-06-07, 1397/03/17
Registration timing:retrospective
Last update:2018-06-07, 1397/03/17
Update count:0
Registration date
2018-06-07, 1397/03/17
Registrant information
Name
Amir Hossein Salimi Kordasiabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 912 361 5549
Email address
hosseininejad.s.mohsen@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-20, 1396/12/01
Expected recruitment end date
2018-04-21, 1397/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Compare Effectiveness of Adding Folic Acid to Sodium Valproate in Treating patients with Acute Mania
Public title
Efficacy of Adding Folic Acid to Sodium Valproate on patients with Acute Mania
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Being at the age of 18 to 50 years
Diagnosis of type 1 bipolar disorder, being in mania episode based on diagnostic criteria DSM-5 (By a semi-structured interview by a psychiatrist and diagnosis based on minimum score 20 from the Young Mania Rating Scale)
Exclusion criteria:
Intolerance to increase the dose of the drug over a specified period of time.
Presence of anemia
Abnormal folic acid levels
Changing the diagnosis and rejection of the initial diagnosis during the course of treatment
History of ADHD
psychiatric diagnosis combined with medication and other diseases
history of admission to the psychiatric hospital during the past three months,
Positive pregnancy test in women
receive other medications, such as anti-mania treatments, two weeks prior to study or during the study
history of sodium valproate sensitivity
Age
From 18 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
A sample of 60 patients was selected based on the inclusion criteria and randomly divided into two groups of intervention and control (each group was 30 patients). Patients will be matched for age and sex.
Blinding (investigator's opinion)
Double blinded
Blinding description
Therapists and prescribing nurses and also data analyzer did not know the type of medication prescribed for patients. Therefore the study was double blind.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of golestan University of Medical Sciences
Street address
Falsafi compelex, 5th kilometer, Gorgan- sari road.
City
Gorgan
Province
Golestan
Postal code
4934174515
Approval date
2017-10-24, 1396/08/02
Ethics committee reference number
IR.GOUMS.REC.1396.82
Health conditions studied
1
Description of health condition studied
Acute Mania
ICD-10 code
F31.1
ICD-10 code description
Bipolar disorder, current episode manic without psychotic features
Primary outcomes
1
Description
Improvement of acute mania based on the results of the used tests
Timepoint
The beginning of the study (before the intervention) and 3 and 6 weeks after the intervention
Method of measurement
Young Mania Rating Scale and Mini-Mental State Examination 1
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: patients receiving folic acid + sodium valproate .Sodium valproate starts at 400 mg per day and will increase up to maximum of 20 mg per kg per day or the highest dose that the patient can withstand. In addition sodium valproate, the group will receive one tablet of folic acid 5 milligrams a day.
Category
Treatment - Drugs
2
Description
Control group: patients receiving placebo + sodium valproate . Sodium valproate starts at 400 mg per day and will increase up to a maximum of 20 mg per kg per day or the highest dose that the patient can withstand.In addition to sodium valproate, the control group will receive one placebo tablet
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Panje Azar Hospital
Full name of responsible person
Dr Peyman Rad
Street address
Panje Azar hospital , Panje Azar avenue, Gorgan
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 2142 1651
Email
info@goums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Dr Peyman Rad
Street address
Falsafi Complex, 5th Kilometer of Gorgan -Sari Road, Gorgan
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3242 1651
Email
info@goums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gorgan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
ِِDr Peyman Rad
Position
assistant
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Azar 10, 5 Azar Ave,Gorgan
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3242 1651
Email
salimia92@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Dr Peyman Rad
Position
assistant
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Azar10 , Panje Azar avenue, Gorgan
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3242 1651
Email
salimia92@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
َAmir Hossein Salimi
Position
medical doctor
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Danesh 1,Danesh avenue, Gorgan
City
Gogan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3242 1651
Email
salimia92@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All data is shareable
When the data will become available and for how long
from 2018
To whom data/document is available
Professors and people studying at medical universities
Under which criteria data/document could be used
All data is shareable
From where data/document is obtainable
salimia92@gmail.com
What processes are involved for a request to access data/document