Objective: The objective of the present study was to compare the efficacy of oxcarbazepine and sodium valproate in the treatment of acute phase of mania.This research is a prospective double blind and randomized clinical trial. The sample included admitted patients in Ebne-sina hospital with Diagnosis of bipolar disorder in acute phase of mania who met the inclusion criteria. Patients were randomly allocated in two groups taking oxcarbazepine (maximum 900 to 2400 mg per day) and sodium valproate(maximum 20-30 mg/kg/day). The study consisted 3-14 days of base line phase and 4weeks of double blind clinical trial. Assessment was done by using Minimal Status Examination (MMSE), Young Mania Rating Scale (YMRS), and Clinical Global Impression-scale (CGI-S) at baseline, After 3 and 6 weeks .adverse effects of drugs were evaluated at weeks3 and 6.
For eligibility in the study patients had to be 18 to 60 years of age and with DSM- IV- TR axis I diagnosis of BMD-I in acute manic episode.
Exclusion criteria included a primary diagnosis of Schizophrenia, delirium, anorexia nervosa, bulimia, autism, substance abuse, mental retardation and ADHD in recent 3 months.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201012055280N2
Registration date:2011-02-18, 1389/11/29
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-02-18, 1389/11/29
Registrant information
Name
Raheleh Nejati
Name of organization / entity
Mashhad University of Medical Scinces, Ibn-e- Sina Psychiatric Hospital
Country
Iran (Islamic Republic of)
Phone
+98 51 3711 2540
Email address
nejatir2@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancecellor for Research, Mashhad University of Medical Sciences
Expected recruitment start date
2009-07-04, 1388/04/13
Expected recruitment end date
2010-05-03, 1389/02/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Therapeutic Efficacy of Oxcarbazepine and Sodium Valproate in Acute Mania
Public title
Therapeutic Efficacy of Oxcarbazepine and Sodium Valproate in Acute Mania
Purpose
Treatment
Inclusion/Exclusion criteria
For eligibility in the study patients had to be 18 to 60 years of age and with DSM- IV- TR axis I diagnosis of BMD-I in acute manic episode.
Exclusion criteria included a primary diagnosis of Schizophrenia, delirium, anorexia nervosa, bulimia, autism, substance abuse, mental retardation and ADHD in recent 3 months. Other exclusion criteria were a history of epilepsy, a history of psychogenic polydipsia, a history of symptomatic hyponatremia and patients who were taking other antimanic medications during the study prior or within one week before it. Patients were required to be free of psychotropic drugs with exceptions of diphenhydramin or lorazapam for control of agitation and aggression. Risperidone 2-4 mg/day was prescribed for all of patients.
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
48
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 Mashhad University of Medical Sciences
Street address
Daneshgah street, Ghoreishi building
City
Mashhad
Postal code
Approval date
2009-06-30, 1388/04/09
Ethics committee reference number
T2259
Health conditions studied
1
Description of health condition studied
acute mania
ICD-10 code
F30.1
ICD-10 code description
Mania without psychotic symptoms
Primary outcomes
1
Description
Change of mood
Timepoint
base line,weeks 3,6
Method of measurement
Young Mania rating scale
Secondary outcomes
1
Description
Clinical Global Impression Scale
Timepoint
base line ,weeks 3 and 6
Method of measurement
change of scores
Intervention groups
1
Description
In the first group, during the 2 weeks titration phase, the Oxcarpazepine was started by 300 mg and increased every 2 days to a maximum dose of 900 to 2400 mg per days or the highest tolerated dose.
Category
Treatment - Drugs
2
Description
In the second group, Na Valporate was initiated by 600 mg/day and increased to a 20-36 mg/day or the highest tolerated dose for patients.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ibn-e-Sina psychiatric Hospital
Full name of responsible person
Dr. Ali Talaei
Street address
Ibn-e-Sina psychiatric Hospital, Horre ameli avenue,boo Ali square
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Scinces
Full name of responsible person
Mashhad University of Medical Scinces
Street address
Daneshgah Street, Ghoreishi Building
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 Scinces
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
Psychiatry and Behavioral Sciences Research Center, Ibn-e-Sina Hospital, Mashhad University of Medic
Full name of responsible person
Dr. Ali Talaei
Position
Assistant Professor of Psychiatry
Other areas of specialty/work
Street address
Ibn-e-Sina psychiatric Hospital, Horre Ameli avenue, Boo Ali square
City
Mashhad
Postal code
Phone
+98 51 3711 2540
Fax
+98 51 1712 4184
Email
talaeia@mums.ac.ir , alitalaei@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Psychiatry and Behavioral Sciences Research Center, Ibn-e-sina Hospital Mashhad University of Medica
Full name of responsible person
Dr Atefeh Soltanifar
Position
Assistant Professor / Child and Adolescent Psychiatrist
Other areas of specialty/work
Street address
Ibn-e-Sina psychiatric Hospital, Horre Ameli avenue, Boo Ali square
City
Mashhad
Postal code
Phone
+98 51 1711 2721
Fax
+98 51 1712 4184
Email
soltanifara@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Psychiatry and Behavioral Sciences Research Center, Ibn-e-Sina Hospital Mashhad, University of Medic
Full name of responsible person
Dr Atefeh Soltanifar
Position
Assistant Professor, Child and Adolescent Psychiatrist,
Other areas of specialty/work
Street address
Ibn-e-Sina psychiatric Hospital, Horre Ameli avenue, Boo Ali square
City
Mashhad
Postal code
Phone
+98 51 1711 2721
Fax
+98 51 1712 4184
Email
soltanifara@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)