Evaluation of the effect of vitamin B1 and B6 as an adjunct therapy to improve the symptoms of mania phase of bipolar disorder type I; in a double-blind and placebo-controlled clinical trial
The aim of this study is the evaluation of the effect of vitamin B1 and B6 as supportive treatment in healing up the manic symptoms of bipolar patients, including mood symptoms, cognitional disorder, and sleep disorders.
Design
80 patients will be randomized through the table of random numbers and then they will be separated into three parallel groups in a double-blind study and get vitamin B1, vitamin B6, and placebo beside lithium bicarbonate in each group.
Settings and conduct
This is a double-blinded clinical trial. It will be accomplished in three groups of patients in the manic phase who are admitted to Imam Hossein hospital and medical education center.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Diagnosis of bipolar disorder in the manic phase
Having at least 14 scores in Young-Mania questionnaire
Aged between 18 to 50
Getting a consent letter from the patient's guardian
Exclusion criteria:
Having any serious comorbidity
Existence of any other psychiatric diagnosis in axis I disorders
IQ less than 70
Drug abuse (except nicotine and caffeine )
concurrent Alcohol abuse
Women in reproductive ages without using a safe contraception
Patient with CHF (congestive heart failure) or liver disease
Absence of consent for starting or continuing to participate
Intervention groups
There will be three groups of patients in an 8-week schedule as below:
The first group will be treated with 1.5 mg/kg vitamin B1 plus 900 mg lithium bicarbonate each day,
The second group will be treated with 0.6 mg/kg vitamin B6 plus 900 mg lithium bicarbonate each day,
The third group will be treated with a placebo plus 900 mg lithium bicarbonate each day.
Main outcome variables
The main outcome of this study is the approval of vitamin B1 and B6 as supportive agents alongside the main treatment (mood stabilizers) in the manic phase extensively.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200307046712N1
Registration date:2020-04-06, 1399/01/18
Registration timing:registered_while_recruiting
Last update:2020-04-06, 1399/01/18
Update count:0
Registration date
2020-04-06, 1399/01/18
Registrant information
Name
Shaghayegh Mousavi
Name of organization / entity
Alborz university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 26 3340 1629
Email address
mvishaghayegh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-14, 1398/12/24
Expected recruitment end date
2020-05-13, 1399/02/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of vitamin B1 and B6 as an adjunct therapy to improve the symptoms of mania phase of bipolar disorder type I; in a double-blind and placebo-controlled clinical trial
Public title
Evaluation of the effect of vitamin B1 and B6 in manic patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Having diagnostic criteria of DSM-V for mania phase of patients with bipolar disorder
Having at least 14 scores in Young-Mania questionnaire
Aged between 18 to 50
Getting conscious letter of satisfaction from patient tutor
Exclusion criteria:
Having any neurological, organic, cardiovascular and hepatic disorder according to patientsگ evidences or history
Existence of any other diagnosis in axis I disorders according to DSM-V
IQ less than 70 according to examiner clinical judge
Drug abuse (except nicotine and caffeine )
Alcohol abuse coincidentally
Women in reproductive ages without using a safe contraception
Patient with CHF (congestive heart failure) or liver disease
Absence of satisfaction for starting or continuing participating
Age
From 18 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
67
Randomization (investigator's opinion)
Randomized
Randomization description
Method of randomization: simple
Unit of randomization: individual
Tools used in randomization: table of random numbers
Randomization will be done in the absence of patients' sight.
Blinding (investigator's opinion)
Double blinded
Blinding description
According to double-blinding, all the groups of patients will take their drugs without any knowledge about types of them. Also, the patients' nurse will give these drugs to the them according to the randomization the physician has made, without consciousness about types of them.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Alborz University of Medical Sciences
Street address
Alborz University of Medical Science, Official settlement, North Taleghani boulevard, Taleghani Square, Karaj, Alborz Province
City
KARAJ
Province
Alborz
Postal code
3147734568
Approval date
2020-02-15, 1398/11/26
Ethics committee reference number
IR.ABZUMS.REC.1398.243
Health conditions studied
1
Description of health condition studied
Bipolar disorder
ICD-10 code
F31
ICD-10 code description
Bipolar disorder
Primary outcomes
1
Description
mood symptoms .
Timepoint
In this study, mood symptoms will be assessed in the beginning of and at the end of the 8th week of the clinical trial.
Method of measurement
Mood symptoms will be assessed according to the score of the Young-Mania questionnaire .
Secondary outcomes
1
Description
cognition state
Timepoint
In this study, the cognition state of the patients will be assessed in the beginning and at the end of the 8th week of the clinical trial.
Method of measurement
The cognition state of the patients will be assessed according to the score of the Minimal Mental State Exam (MMSE).
2
Description
the sleep state.
Timepoint
In this study, the sleep state of the patients will be assessed in the beginning and at the end of the 8th week of the clinical trial.
Method of measurement
The sleep state pf the patients will be assessed according to the score of Pittsburgh Sleep Quality Questionnaire Index(PSQI).
Intervention groups
1
Description
First intervention group: This group will take 1.5 mg/kg vitamin B1 plus 900 mg lithium bicarbonate.
Category
Treatment - Drugs
2
Description
Second international group: This group will take 0.6 mg/kg vitamin B6 plus 900 mg lithium bicarbonate.
Category
Treatment - Drugs
3
Description
Control group: This group will take one placebo plus 900 mg lithium bicarbonate each day. The placebo will be made in the laboratory of the Alborz University of Medical Science.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein Hospital
Full name of responsible person
Atefe Zandifar
Street address
Imam Hossein Hospital, Mansoorbakht Street, Mohammad Shahr, Alborz province
City
Mohammadshahr
Province
Alborz
Postal code
3147734568
Phone
+98 26 3419 3000
Fax
+98 26 3419 3203
Email
zandifaratefe@gmail.com
Web page address
http://emamhossein.abzums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Alborz University of Medical Science
Full name of responsible person
The assistant of research and technology of Alborz University of Medical Sciensce; Dr Noorisepehr
Street address
Alborz University of Medical Science, Official settlement, North Taleghani boulevard, Taleghani Square, Karaj, Alborz Province
City
Karaj
Province
Alborz
Postal code
3147734568
Phone
+98 26 3255 8920
Fax
Email
zandifaratefe@gmail.com
Web page address
https://abzums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Alborz University of Medical Science
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
Alborz university of medical sciences
Full name of responsible person
Shaghayegh Mousavi
Position
Intern of medicine
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
528,120 AVE,ERAM BOULEVARD
City
KARAJ
Province
Alborz
Postal code
3185746957
Phone
+98 26 3340 1629
Fax
Email
mvishaghayegh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Alborz university of medical sciences
Full name of responsible person
Atefe Zandifar
Position
Psychiatrist
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Alborz University of Medical Science, Official settlement, North Taleghani boulevard, Taleghani Square, Karaj, Alborz Province
City
KARAJ
Province
Alborz
Postal code
3147734568
Phone
+98 26 3255 8920
Fax
Email
zandifaratefe@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Alborz university of medical sciences
Full name of responsible person
Shaghayegh Mousavi
Position
Intern of medicine
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
528,120 AVE,ERAM BOULEVARD
City
KARAJ
Province
Alborz
Postal code
3185746957
Phone
+98 26 3340 1629
Fax
Email
mvishaghayegh@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
The data won,t be released until the publication of the study.