This five week randomized control clinical trial includes 60 in-patients with bipolar mood disorder- type I with manic phase. The patients are randomly allocated either into lithium+olanzapine or aripiprazole+lithium groups. Young Mania Rating Scale is used to measure the clinical symptoms. Assessment will be occurred at baseline, week 1, week 3, and week 5.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201305213930N25
Registration date:2014-11-18, 1393/08/27
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-11-18, 1393/08/27
Registrant information
Name
Ahmad Ghanizadeh
Name of organization / entity
Research Center for Psychiatry and Behavioral Sciences, Shiraz University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1627 3070
Email address
ghanizad@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2013-09-12, 1392/06/21
Expected recruitment end date
2015-02-02, 1393/11/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A head to head comparison of aripiprazole versus olanzaoine as adjvants to lithium for treating manic or mixed episodes in bipolar I disorder
Public title
A head to head comparison of aripiprazole versus olanzaoine as adjvants to lithium for treating manic or mixed episodes in bipolar disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients from both gender aged 16 to 65 years old with bipolar mood disorder-type I- manic phase.
Exclusion criteria: sever uncontrolled medical conditions such as hypothyroidism; positive history of allergy to one of the medications.
Age
From 16 years old to 65 years old
Gender
Both
Phase
3
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
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sceinces
Street address
Shiraz University of Medical Sceinces
City
Shiraz
Postal code
--
Approval date
2013-08-11, 1392/05/20
Ethics committee reference number
CT-P-92-5542
Health conditions studied
1
Description of health condition studied
Bipolar mood disorder manic or mixed phase
ICD-10 code
F30
ICD-10 code description
Manic episode
Primary outcomes
1
Description
clinical symptoms of mania
Timepoint
baseline, week 1, week 3, and week 3
Method of measurement
Interview, Young Mania Rating Scale
Secondary outcomes
empty
Intervention groups
1
Description
Lithium (up to 1200mg/day)+Olanzapine (25mg/day)
Category
Treatment - Drugs
2
Description
Lithium (up to 1200mg/day)+Aripiprazole ( up to 25mg/day)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Research Center for Psychiatry and Behavioral Sciences, Shiraz University of Medical Sciences
Full name of responsible person
Ahmad Ghanizadeh
Street address
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shiraz University of Medical Sciences
Full name of responsible person
Basi Hashemi
Street address
Vice-chancellery of Research Affairs, Shiraz University of Medical sciences, Zand Street
City
Shiraz
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, Shiraz 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
Shiraz University of Medical sciences
Full name of responsible person
Ahmad Ghanizadeh
Position
MD
Other areas of specialty/work
Street address
Hafez Hospital
City
Shiraz
Postal code
Phone
+98 71 3627 3070
Fax
Email
ghanizad@sina.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical sciences
Full name of responsible person
AHmad Ghanizadeh
Position
MD
Other areas of specialty/work
Street address
Hafez Hospital
City
Shiraz
Postal code
Phone
+98 71 3627 3070
Fax
Email
ghanizad@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)