Investigating the effect of vitamin B6 as an add-on treatment to lithium compared to placebo on the symptoms of acute mania and the recurrence of mood episodes and suicidal thoughts in patients with bipolar disorder type 1; A double-blind clinical trial
Investigating the effect of vitamin B6 as an adjunctive treatment to lithium in improving sleep disorders in a 24-week follow-up of patients with bipolar disorder type I
Design
A randomized clinical trial with block method using STATA software, with a control group, with parallel design, double-blind, phase 3 and a sample size of 80 people.
Settings and conduct
1- Place of conducting this study: It is in the psychiatry department of Imam Hossein Hospital in Karaj.
2- Study population: people with bipolar disorder type 1
3- Type of blinding: double-blind
4-How to blind: patients do not know the type of treatment. Prescribed medicines are in the form of pills with same shape, color, size, smell, and taste. Completing the final information is the responsibility of the person unaware of the type of treatment. Also, the statistician will be a blind treatment type
Participants/Inclusion and exclusion criteria
Inclusion criteria: having DSM-V diagnostic criteria for bipolar patients in mania phase; their minimum score should be 20 according to Young Mania; Age of 18 to 50 years. Exclusion criteria: suffering from neurological disease; chronic cardiovascular, liver and kidney diseases; IQ less than 70; drug abuse (except nicotine and caffeine); Pregnant and lactating women.
Intervention groups
Intervention group: lithium carbonate tablet 300 mg three times a day along with vitamin B6 tablet, 40 mg for 24 weeks. Control group: lithium carbonate tablet 300 mg three times a day along with placebo for 24 weeks.
Investigating the effect of vitamin B6 as an add-on treatment to lithium compared to placebo on the symptoms of acute mania and the recurrence of mood episodes and suicidal thoughts in patients with bipolar disorder type 1; A double-blind clinical trial
Public title
Investigating of vitamin B6 in Bipolar Mood disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having DSM-V diagnostic criteria for bipolar patients (through a semi-structured interview by a psychiatrist and confirming the diagnosis with a score of at least 20 on the Young Mania scale).
Being at the age of 18 to 65 years old
Exclusion criteria:
Suffering from neurological disease, cardiovascular and liver disease and chronic kidney disease
IQ less than 70
Drug abuse (except nicotine and caffeine)
History of drug sensitivity to lithium carbonate or vitamin B6
Pregnancy and breastfeeding
chronic kidney disease (CKD)
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method used in this study will be the block method, which will be designed by a statistician and STATA software, mainly a randomization list. Then, according to the randomization list, the type of intervention desired for each person will be written on a paper and the paper will be placed in a sealed envelope. The envelopes will be numbered according to the order included in the list. The doctor checks the conditions of the patient to enter the study and if he is eligible, he informs the resident research expert at the hospital. Then the research expert will provide the sealed envelope to the doctor and the doctor will start the desired intervention according to the content inside the envelope.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients do not know the type of treatment. Prescribed medicines are in the form of pills with the same shape ,color, size, smell and taste. Completing the final information is the responsibility of the person who is unaware of the type of treatment. Also, the statistician will be a blind treatment type.
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
Ethics committee unit, Research and Technology Deputy, No. 20, Safarian Alley, Golshahr 45 Meter street
City
Karaj
Province
Alborz
Postal code
3149779453
Approval date
2023-12-18, 1402/09/27
Ethics committee reference number
IR.ABZUMS.REC.1402.269
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
Before and after the intervention (at intervals of weeks 0-4-8-12-18-24-32)
Method of measurement
Young Mania standard questionnaire and brief clinical examination test
2
Description
Improve sleep quality
Timepoint
Before and after the intervention (at intervals of weeks 0-4-8-12-18-24-32)
Method of measurement
Petersburg Sleep Quality Questionnaire
3
Description
Cognitive symptoms
Timepoint
Before and after the intervention (at intervals of weeks 0-4-8-12-18-24-32)
Method of measurement
Mini-Mental State Examination (MMSE)
4
Description
suicidal thoughts
Timepoint
Before and after the intervention (at intervals of weeks 0-4-8-12-18-24-32)
Method of measurement
Beck suicide questionnaire
Secondary outcomes
1
Description
Symptoms of depression
Timepoint
Before and after the intervention (at intervals of weeks 0-4-8-12-18-24-32)
Method of measurement
Beck depression questionnaire
2
Description
Anxiety symptoms
Timepoint
Before and after the intervention (at intervals of weeks 0-4-8-12-18-24-32)
Method of measurement
Beck's anxiety questionnaire
Intervention groups
1
Description
Intervention group: lithium carbonate tablets (300 mg), three times a day along with vitamin B6 (40 mg) a day for 24 weeks.
Category
Treatment - Drugs
2
Description
Control group: lithium carbonate tablets (300 mg), three times a day with a placebo for 24 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein Hospital
Full name of responsible person
Dr. Atefeh Zandifar
Street address
No104; Mansour; Bakht St; Imam Khomeini Blvd
City
Karaj
Province
Alborz
Postal code
3187659348
Phone
+98 26 3620 9056
Email
zandifaratefe@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Razia Lotfi
Street address
Karaj; 45 meters from Golshahr; Safarian Street; Alborz University of Medical Sciences Research and Technology Vice-Chancellor
City
Karaj
Province
Alborz
Postal code
3198764653
Phone
+98 26 3464 3705
Email
Research@abzums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Karaj 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
Karaj University of Medical Sciences
Full name of responsible person
Dr. Atefeh Zandifar
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Karaj; Taleghani Square; North Taleghani Boulevard; Alborz University of Medical Sciences
City
Karaj
Province
Alborz
Postal code
3149779453
Phone
0098 32563328026
Email
zandifaratefe@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Dr. Atefeh Zandifar
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Karaj; Taleghani Square; North Taleghani Boulevard; Alborz University of Medical Sciences
City
Karaj
Province
Alborz
Postal code
3149779453
Phone
0098 32563328026
Email
zandifaratefe@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Dr. Atefeh Zandifar
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Karaj; Taleghani Square; North Taleghani Boulevard; Alborz University of Medical Sciences
City
Karaj
Province
Alborz
Postal code
3149779453
Phone
0098 32563328026
Email
zandifaratefe@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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