1. Home
  2. Approved trials
  3. » فارسی

The assessment of folic Acid and vitamin B6 effects add-in sodium valproate in bipolar mood Disorder in Acute phase of mania

Protocol summary

Summary
1)Purposes of trial: Investigation of adjunct treatment of folic acid and vitamin B6 to sodium valproate in acute mania disorder and their comparisons with eachother. 2) Study design :randomized ,double blind ,control with placebo , unicentral ,first step of trial 3) Trial method: Admitted patients in Mashhad Ebne Sina’s hospital with diagnosis of bipolar mood disorder type I with recent mania episode with included criteria and without exclusion criteria of study, divide randomly in 3 groups a,b and c ,then will treat and compare in two basic and maintenance steps that will describe in detail at follow. 4)Participants :Inclusion criteria: 1)patients age between 18 to 45 years old according to birth certificate.2) Diagnosis of bipolar mood disorder I with recent episode of mania.3) Filling out informed consent. Exclusion criteria:1)Suicidal or homicidal idea.2)Have the positive pregnancy test. 5)Interventions: Case group 1: folic acid ,oral tab 5mg,once a day ,for six weeks /Case group 2:vitamin B6,oral tab 40mg,towice a day, for six weeks /Control group :placebo ,oral tab ,for six weeks 6)Main outcome varieties: severity of mania ,cognitive scale.both of tests will evaluate at baseline and end of the third and sixth weeks.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201112188106N1
Registration date: 2012-01-14, 1390/10/24
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-01-14, 1390/10/24
Registrant information
Name
Alireza Ebrahimi
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1883 1993
Email address
ebrahimia871@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2011-04-04, 1390/01/15
Expected recruitment end date
2011-06-22, 1390/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The assessment of folic Acid and vitamin B6 effects add-in sodium valproate in bipolar mood Disorder in Acute phase of mania
Public title
The assessment of folic Acid and vitamin B6 effects in bipolar patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:1)Patients age between 18 to 45 years old according to birth certificate.2)Diagnosis of bipolar mood disorder I with recent episode of mania according to DSM IV TR diagnosis criteria.3)Roling out diagnosis of schizophrenia,delirium,anorexia nervosa,bulimia,autism,substance abuse(at least during 3 months ago ),mental retardation,adhd.4)Absence of psychiatric hospitalization history during 3 months ago.5)Absence of seizure history6)Absence of severe allergy history.7)Filling out informed consent.8)Absence of allergic history to sodium valproate. Exclusion criteria:1)Patients who evaluate at risk of suicide or homicide according to psychiatric diagnosis.2)Female patients are doubted for pregnancy, should test serum pregnancy test and will exclude from study if it is positive.3)Patients who take other drugs such as antimanic drugs that could not be able to stop them in two weeks before study or during it.
Age
From 18 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 43
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Mashhad University of Medical Sciences
Street address
University Research Affairs-Research Vice-Mashhad University of Medical Science.Mashhad
City
Mashhad
Postal code
Approval date
2011-03-12, 1389/12/21
Ethics committee reference number
89827

Health conditions studied

1

Description of health condition studied
Bipolar disorder
ICD-10 code
F31.9
ICD-10 code description
Bipolar affective disorder, unspecified

Primary outcomes

1

Description
Severity of mania
Timepoint
Baseline,End of the third week,End of the six week
Method of measurement
Jung Mania Rating Scale(YMRS)

2

Description
Cognitive scale
Timepoint
Baseline,End of the third week,End of the six week
Method of measurement
Mini Mental State Examination (MMSE)

Secondary outcomes

empty

Intervention groups

1

Description
Case group 1: folic acid,oral tab 5mg,once a day,for six weeks
Category
Treatment - Drugs

2

Description
Case group 2:vitamin B6,oral tab 40mg,towice a day, for six weeks
Category
Treatment - Drugs

3

Description
Control group:placebo,oral tab,once a day,for six weeks
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Ebne Sina's Hospital
Full name of responsible person
alireza ebrahimi
Street address
Ebne Sina Psychiatric Hospital,before Bou Ali square,Horre Ameli Bolvard,Mashhad
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr.Jalil Tavakol Afshari
Street address
The Vice Chancellor for Research.Mashhad University of Medical Sciences.Mashhad
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Alireza Ebrahimi
Position
Assistant Community of Psychiatry
Other areas of specialty/work
Street address
Ebne Sina Psychiatric Hospital,before Bou Ali square,Horre Ameli Bolvard,Mashhad
City
Mashhad
Postal code
Phone
+98 51 1883 1993
Fax
Email
ebrahimia871@mums.ac.ir/alireza.ebrahimi37@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Ali Talaei
Position
Assistant Professor
Other areas of specialty/work
Street address
Ebne Sina Psychiatric Hospital,before Bou Ali Square,Horre Ameli Bolvard,Mashhad
City
Mashhad
Postal code
Phone
+98 51 1761 4021
Fax
Email
TalaeiA@mums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Alireza Ebrahimi
Position
MD
Other areas of specialty/work
Street address
City
Mashhad
Postal code
Phone
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...