Evaluation of the effect of vitamin B6 as adjunctive therapy in ameliorating symptoms of acute mania in patients with bipolar disorder Type 1 hospitalized in Roozbeh Hospital; a double-blind placebo-controlled clinical trial
the effect of vitamin B6 as adjunctive therapy in ameliorating the symptoms of mania in patients with bipolar I disorder hospitalized in Roozbeh Hospital
Design
A randomized, double-blind, placebo-controlled clinical trial
Settings and conduct
Fifty patients with bipolar disorder at Roozbeh Hospital will be treated with placebo and double-blind placebo-controlled intervention with vitamin B6 adjuvant therapy. The therapist and the patient are blind and do not know the type of medication.
Participants/Inclusion and exclusion criteria
Inclusion: 18-65 years old, diagnosis of type 1 bipolar disorder in early mania based on DSM-V diagnostic criteria (by semi-structured interview by psychiatrist and confirmation of diagnosis with score of at least 20 from Young's Maniac Scale), Possible consent Presence of the patient's legal guardian
Exclusion: no psychosis in the patient, no history of drug sensitivity to lithium carbonate or vitamin B6, no diagnosis of schizophrenia, delirium, anorexia neurosis, bulimia neurosis, autism, substance abuse (at least 3 months ago), retardation, mental retardation Type 2 bipolar disorder.
Intervention groups
Fifty patients with type 1 bipolar disorder in the mania phase are randomly divided into two groups. One group is treated with standard lithium carbonate and vitamin B6 and the other group is treated with standard lithium carbonate and placebo for 6 weeks. Mania symptoms improve and cognitive symptoms and brain map.
Main outcome variables
Mania Symptoms (Young Mania Questionnaire)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200317046801N1
Registration date:2020-03-27, 1399/01/08
Registration timing:retrospective
Last update:2020-03-27, 1399/01/08
Update count:0
Registration date
2020-03-27, 1399/01/08
Registrant information
Name
Rahim Badrfam
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5541 9151
Email address
rbadrfam@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-01, 1398/08/10
Expected recruitment end date
2020-02-18, 1398/11/29
Actual recruitment start date
2019-11-01, 1398/08/10
Actual recruitment end date
2020-02-18, 1398/11/29
Trial completion date
2020-06-20, 1399/03/31
Scientific title
Evaluation of the effect of vitamin B6 as adjunctive therapy in ameliorating symptoms of acute mania in patients with bipolar disorder Type 1 hospitalized in Roozbeh Hospital; a double-blind placebo-controlled clinical trial
Public title
The effect of vitamin B6 in bipolar patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Subjects aged 18 to 65 years old
Diagnosis of type 1 bipolar disorder in early-onset mania based on DSM-V diagnostic criteria (by semi-structured interview by a psychiatrist and confirmation of diagnosis with a score of at least 20 on the Young Mania Scale).
Consent of the possibility of being present on the patient's legal guardian
Exclusion criteria:
Absence of psychosis in patients
A history of drug sensitivity to lithium carbonate or vitamin B6
Absence of diagnoses of schizophrenia, delirium, anorexia neurosis, bulimia neurosis, autism, substance abuse (at least 3 months ago), retardation Bipolar type 2 seizures (Existence of suicide due to lack of suicide risk factor for use of evaluated drugs as well as weekly weekly medications and low weekly prescription drugs are not included in the plan).
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:
50
Actual sample size reached:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is simple and individual, is a random tool of random numbers and how to construct a random sequence. In order to prevent selection bias, the researchers employ a randomization method as well as hiding random allocation to report it correctly. These researchers can gain valid results by better understanding this method and its proper implementation....
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants, lead investigator, healthcare personnel (physicians, nurses, physiotherapists, etc.) responsible for patient care, data collection and outcome assessors, and the Data Safety and Monitoring Committee Those who draft the article are not aware of any type of prescription drug.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
North Kargar Ave.Lashgar Road.Rozbeh Hospital
City
Tehran
Province
Tehran
Postal code
1333715914
Approval date
2019-03-07, 1397/12/16
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1397.935
Health conditions studied
1
Description of health condition studied
BIPOLAR DISORDER
ICD-10 code
F31
ICD-10 code description
Bipolar mood disorder
Primary outcomes
1
Description
Mania Symptoms by Young Mania Questionnaire
Timepoint
Baseline and weeks 3, 4, and 8 after vitamin B6 start
Method of measurement
Yang Mania questionnaire
Secondary outcomes
1
Description
Sleep quality
Timepoint
Baseline and weeks 3, 4, and 8 after vitamin B6 start
Method of measurement
Petersburg questionnaire
2
Description
Nutrition and appetite status
Timepoint
Baseline and weeks 3, 4, and 8 after vitamin B6 start
Method of measurement
Appetite Rating Scale
3
Description
Mini mental status
Timepoint
Baseline and weeks 3, 4, and 8 after vitamin B6 start
Method of measurement
Mini mental status examination
4
Description
Brain Mapping
Timepoint
Baseline and week , 8 after vitamin B6 start
Method of measurement
QEEG | Quantitative Electroencephalogram Test
Intervention groups
1
Description
Fifty Patients with type 1 bipolar disorder in the mania phase are randomly divided into two groups. 25patients in the intervention group receive standard lithium carbonate and vitamin B 6medication treatment, and they will be evaluated for improvement of mania symptoms, cognitive symptoms, and brain map within 8 weeks.
Category
Treatment - Drugs
2
Description
25 patients in the control group receive standard lithium carbonate and placebo treatment and are treated for 8 weeks for improvement in manic and cognitive symptoms and brain map.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Roozbeh Hospital
Full name of responsible person
Rahim Badrfam
Street address
Rozbeh Hospital, South Kargar Ave.
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 9151
Email
rbadrfam@gmail.com
2
Recruitment center
Name of recruitment center
Psychiatry and Psychology Research Center of Tehran University of Medical Sciences
Full name of responsible person
Mohammadreza Mohammadi
Street address
Rozbeh Hospital, South Kargar Ave.
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5542 2001
Email
mohammadimr@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Ali Sahraeian
Street address
Vice Chancellor for Research and Technology, Sixth Floor, Qods Ave., Keshavarz Boulevard, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417653911
Phone
+98 21 8163 3686
Email
vcr@tums.ac.ir
Grant name
Vice chancellor for research, Tehran University of Medical Sciences
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Rahim Badrfam
Position
Rezidrnt
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Rozbeh Hospital, South Kargar Ave.
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 9151
Email
rbadrfam@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Rahim Badrfam
Position
Rezident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Rozbeh Hospital, South Kargar Ave.
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 9151
Email
rbadrfam@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Rahim Badrfam
Position
Rezident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Rozbeh Hospital, South Kargar Ave.
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 9151
Email
rbadrfam@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
After the article is published, all the results will be made available to those interested