Evaluation of therapeutic effect of valproate with aripiprazol versus valproate with risperidone in patients with bipolar I Disorder most recent manic or mixed episode
The main objective of this study is to compare the effect of combination therapy of valproate with aripiprazole or risperidone .The effect of this combination on weight as a secondary objective will be.The study population is patients with Bipolar I Disorder.case selection with interviews based on diagnostic criteria revised text of the Diagnostic and Statistical Manual of mental disorder(DSM IV-TR) by a psychiatrist and consider the inclusion and exclusion criteria will be enrolled in the study.The most important criterion for inclusion, will be Yang scale more than 17.The sample size based on the statistical power of 80% and 95% confidence intervals will be 40 people.Patients will be randomly assigned to two groups.Researchers and patients will not inform from drug and group types .20 patients in a group valproate with aripiprazole and 20 in the other group will receive valproate with risperidone.n weeks 3 and 6 based on measurements of Yang's scores and weight datas will be collected.During the study patients visit every week and will be monitored physically and mentally.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201510222166N2
Registration date:2016-03-29, 1395/01/10
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-03-29, 1395/01/10
Registrant information
Name
ALI Nazeri Astane
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2289 0100
Email address
a.nazeri@uswr.ac.ir
Recruitment status
Recruitment complete
Funding source
University of Social Walfare and Rehabilitation Science
Expected recruitment start date
2015-10-23, 1394/08/01
Expected recruitment end date
2015-12-21, 1394/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of therapeutic effect of valproate with aripiprazol versus valproate with risperidone in patients with bipolar I Disorder most recent manic or mixed episode
Public title
Aripiprazole effect in the treatment of mania
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria :diagnosis of bipolar disorder in mania or mixed episode based on DSM-IV- TR ;patients with YMRS >OR=17. Exclusion criteria : pregnant women ;breastfeeding women; debilitating physical and neurological illness; sever liver disease; severe kidney disease
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
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
University of Social Welfare and Rehabilitation Sciences
before intervention, after the 3 weeks and 6 weeks trial
Method of measurement
yung mania rating scaie (YMRS)
Secondary outcomes
1
Description
Weight
Timepoint
before intervention , after the 3 and 6 weeks trial
Method of measurement
balance
Intervention groups
1
Description
this study is drug intervention trial. cases divided randomly two groups.one group will receive valproate 15 mg/kg combind with aripiprazole 30 mg daily.
Category
Treatment - Drugs
2
Description
patients will receive randomly valprate 15 mg/kg and risperidone 6mg/kg in second group.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
RAZI PSYCHIATRY HOSPITAL
Full name of responsible person
Nazeri Astaneh ALI
Street address
tehran - shahr rey-shahid rastegar blvd- razi psychiatry hospital
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
mr.ADL AKBAR
Street address
Tehran - evin-daneshjoo blvd - koodakiar st
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of Social Welfare and Rehabilitation 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
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Dieji Bahman
Position
psychiathry resident
Other areas of specialty/work
Street address
Tehran - evin - daneshjoo blvd - koodakiare st
City
Tehran
Postal code
Phone
+98 21 2218 0006
Fax
Email
dr.dieji@gmail .com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Nazeri Astane ALI
Position
ATTENDING OF PSYCHIATRY GROOP
Other areas of specialty/work
Street address
Tehran - Evin - daneshjoo blvd - koodakiare st
City
Tehran
Postal code
Phone
+98 21 2218 0140
Fax
Email
a.nazeri@uswr.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Dieji Bahman
Position
psychiatry resident
Other areas of specialty/work
Street address
Tehran - Evin - daneshjoo blvd - koodakiare st
City
Tehran
Postal code
Phone
+98 21 2218 0006
Fax
Email
dr,dieji@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)