Aim: This double blind study will be done to assess the effect of valproate sodium oral and intravenous loading dose on treatment of patients with acute mania episode. Sample: 60 patients will be selected according to diagnostic and statistical Manual IV –TR criteria and divided into two experiment and control group randomly. Groups will be matched on age, sex, marriage status, educational level, mania type and its episode and severity. We will use psychological test as a pre and post test: Clinical Global Impression Scale and Young mania rating scale. Intervention: 20mg /kg intravenous valproate sodium (injection) plus placebo tablet in experimental Group; valproate sodium tablet orally plus placebo (injection) in control group. Valproate sodium Plasma level will be measured in 1, 3 and 7 days after injection.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201108087260N1
Registration date:2011-10-25, 1390/08/03
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-10-25, 1390/08/03
Registrant information
Name
Mehdi Sharifmehr
Name of organization / entity
Hamadan university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1828 5011
Email address
m.sharifmehr@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Research center for behavioral disorders and substances abuse & Vice chancellor for research, Hamadan university of medical sciences
Expected recruitment start date
2011-09-14, 1390/06/23
Expected recruitment end date
2012-09-12, 1391/06/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study: the effect of valproate sodium oral and intravenous loading dose on treatment of patients with acute mania
Public title
The effect of valproate sodium on treatment of patients with mania
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients who are in acute mania episode. Exclusion criteria: patients with other psychiatric disorders.
Age
From 18 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
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
Hamadan university of medical sciences
Street address
Farshchian hospital, Shariati street, Pastor cross road
City
Hamadan
Postal code
518/65178
Approval date
2011-05-30, 1390/03/09
Ethics committee reference number
785/9/35/16/پ/د
Health conditions studied
1
Description of health condition studied
bipolarity- mania episode
ICD-10 code
F30
ICD-10 code description
Manic episode
Primary outcomes
1
Description
plasma level
Timepoint
one, three and seven days after injection
Method of measurement
measure of plasma level
Secondary outcomes
empty
Intervention groups
1
Description
Control group: 20mg/kg of valproate sodium tablet plus placebo for injection
Category
Treatment - Drugs
2
Description
Experiment group: 20mg/kg intravenous valproate sodium and placebo as a tablet
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Research institute for behavioral disorders and substances abuse, Farshchian Hospital
Full name of responsible person
Dr. Ali Ghaleiha
Street address
Farshchian hospital , Shariati squire, Mirzadeh Eshghi street
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor of research and technology & Research institute for behavioral disorder and substanc
Full name of responsible person
Dr. Ali Ghaleiha
Street address
Farshchian hospital
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor of research and technology & Research institute for behavioral disorder and substanc
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
Hamadan university of medical sciences
Full name of responsible person
Dr. Mehdi Sharifmehr
Position
resident of psychiatry
Other areas of specialty/work
Street address
Psychiatry group, Farshchian hospital, Hamadan university of medical sciences
City
Hamadan
Postal code
65178/518
Phone
+98 81 1828 5015
Fax
+98 81 1828 5015
Email
m.sharifmehr@umsha.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamadan university of medical science
Full name of responsible person
Dr. Mehdi Sharifmehr
Position
Resident of psychiatry
Other areas of specialty/work
Street address
Psychiatry group, Hamadan university of medical science
City
Hamadan
Postal code
65178/518
Phone
+98 81 1828 5015
Fax
+98 81 1828 5015
Email
m.sharifmehr@umsha.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamadan university of medical science
Full name of responsible person
Dr Mehdi Sharifmehr
Position
Resident of Psychiatry
Other areas of specialty/work
Street address
Hamadan university of medical sciences
City
Hamadan
Postal code
65178/518
Phone
+98 81 1828 5015
Fax
+98 81 1828 5015
Email
m.sharifmehr@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)