Objectives: The purpose of this study is to evaluate the efficacy of vitamin B6 in
the treatment of acute neuroleptic-induced akathisia
Design:a 5-day double-blind, randomized trial. 51 adult inpatients who meet the
DSM- IV-TR criteria for akathisia participate in the trial.
Setting snd conduct: Patients who have a Baseline Barnes Akathisia Scale (BAS) score of at least 2 will be allocated into three groups. 17 patients will receive vitamin B6
1200 mg/day and 17 participants will receive vitamin B6 600 mg per day
and remaining 17 participants will receive propranolol 40 mg per day.
Patients were assessed by a psychiatrist at baseline and each day up to 5
days after the medication started and he will be blind about grouping.medications will be prescribebed in similar formulations. Akathisia severity will be assessed by Barnes Akathisia Scale (BAS) .
Participants: 51 adult patients who have a Baseline Barnes Akathisia Scale (BAS) score of at least 2 will be eligible . patients who have received betablocker or their anticholinergic has been changed will be excluded
Intervention: Vitamine B6 versus placebo
duration of intervention: 5 days
Main outcome measures: patients' score in Barnes Akathisia Scale(BAS)
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201111042935N6
Registration date:2012-02-18, 1390/11/29
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-02-18, 1390/11/29
Registrant information
Name
Farzin Rezaei
Name of organization / entity
Kurdistan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 87 1356 1822
Email address
farrezaei@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research,Kurdistan University of Medical Sciences
Expected recruitment start date
2012-02-20, 1390/12/01
Expected recruitment end date
2013-05-22, 1392/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Vitamin B6 versus propranolol in patients with neuroleptic -induced Akathisia : َA randomized-double blind study
Public title
Vitamin B6 in the treatment of akathisia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:being hospitalized ;receiving neuroleptic
medication; Presence of akathisia based on DSM-IV criteria; Baseline
Barnes Akathisia Scale (BAS) score of at least 2
Exclusion criteria: any hepatic or renal
disease; change in the dose of anticholinergic drugs within 5 days
before the trial; receiving any beta-blocker medication during the study
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
51
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kurdistan University of Medical Sciences
Street address
No 1, Pasdaran Blvd.Kurdistan University of Medical Sciences, Sanandaj
City
Sanandaj
Postal code
Approval date
2011-10-15, 1390/07/23
Ethics committee reference number
20183
Health conditions studied
1
Description of health condition studied
medication-induced acute akathisia
ICD-10 code
G25
ICD-10 code description
Other extrapyramidal and movement disorders
Primary outcomes
1
Description
severity of akathisia
Timepoint
baseline and every day up to 5 days
Method of measurement
Barnes Akathisia Scale (BAS)
Secondary outcomes
empty
Intervention groups
1
Description
vitamin B6 600 mg per day for 5 days
Category
Treatment - Drugs
2
Description
vitamin B6 1200 mg per day for 5 days
Category
Treatment - Drugs
3
Description
propranolol 40 mg per day for 5 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Qods Hospital
Full name of responsible person
Narges Shams Alizadeh
Street address
No2, Pasdaran Blvd., Qods Hospital, Sanandaj
City
Sanandaj
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Kurdistan University of Medical Sciences
Full name of responsible person
Dr Ataollah Heydari
Street address
No1, Pasdaran Blvd, Kurdistan university of Medical Sciences, Deputy of research, Sanandaj
City
Sanandaj
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Kurdistan 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
Kurdistan University of Medical Sciences
Full name of responsible person
Dr. Narges Shams Alizadeh
Position
Assistant professor of psychiatry
Other areas of specialty/work
Street address
No2, Qods Hospital, Pasdaran Blvd.
City
Sanandaj
Postal code
Phone
+98 87 1666 0025
Fax
Email
nshamsalizadeh@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kurdistan University of Medical Sciences
Full name of responsible person
Dr, Farzin Rezaei
Position
Assistant professor of psychiatry
Other areas of specialty/work
Street address
No 3, Koohpayeh alley, Mobarakabad street, Sanandaj
City
Sanandaj
Postal code
Phone
+98 87 1666 0025
Fax
Email
frrezaie@yahoo,com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kurdistan University of Medical Sciences
Full name of responsible person
Dr. Farzin Rezaei
Position
Assistant professor of psychiatry
Other areas of specialty/work
Street address
No 3, Koohpayeh Alley, Mobarakabad street, Sanandaj
City
Sanandaj
Postal code
Phone
+98 37 1356 2246
Fax
+98 87 1666 1340
Email
frrezaie@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)