The objective of this study is to compare efficacy of ECT with and without concurrent sodium valproate therapy in manic patients. Patients hospitalized in Farshchian hospital during manic episode, and are upon sodium valproate therapy, and are going to receive ECT for any reason, will be selected. After obtaining informed consent, these patients will be randomly allocated to either "valproate continuation during ECT" or "valproate cessation during ECT" group. Two groups will be compared regarding symptom severity and illness improvement using YMRS and CGI measures, before ECT and after 2nd, 4th, 6th, and the last session of ECT.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138901161743N3
Registration date:2010-04-20, 1389/01/31
Registration timing:prospective
Last update:
Update count:0
Registration date
2010-04-20, 1389/01/31
Registrant information
Name
Mohammad Haghighi
Name of organization / entity
Research Center for Behavioral Disorders and Substance Abuse, Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1827 4184
Email address
haghighi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Research center for behavioral disorders and substance abuse, Hamadan University of Medical Sciences
Expected recruitment start date
2010-05-22, 1389/03/01
Expected recruitment end date
2011-01-21, 1389/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing efficacy of ECT with and without concurrent sodium valproate therapy in manic patients
Public title
Comparing efficacy of ECT with and without concurrent sodium valproate therapy in manic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: obtaining informed consent, Diagnosis of bipolar I disorder, manic episode, must be confirmed according to DSM IV-TR criteria, Manic episode refractory to pharmacotherapy, receiving therapeutic doses of valproate before ECT for at least 5 days, Serum levels of valproate ≥50 µg/ml, Administration of ECT by attending psychiatrist, age 18-60 years
Exclusion criteria: Uncontrolled physical condition, Pregnant and nursing women, LFT: 3 fold greater than upper normal limits, receiving other anticonvulsant medications, History of epilepsy
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
42
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single 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
Shahid Fahmideh Street
City
Hamadan
Postal code
65178/518
Approval date
2010-03-08, 1388/12/17
Ethics committee reference number
12-10-8-6-5-3-1
Health conditions studied
1
Description of health condition studied
Manic episode of bipolar disorder
ICD-10 code
F31.1 and
ICD-10 code description
Bipolar affective disorder, current episode manic without psychotic symptoms, Bipolar affective disorder, current episode manic with psychotic symptoms
Primary outcomes
1
Description
improvement rate of mania
Timepoint
after second, fourth, sixth and at the end of sessions of ECT
Method of measurement
CGI and YMRS
Secondary outcomes
empty
Intervention groups
1
Description
discontinuation of sudium valproate
Category
Treatment - Drugs
2
Description
continuation of sudium valproate
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Farshchian hospital
Full name of responsible person
Gholamreza Bigdelo
Street address
Farshchian hospital
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research center for behavioral disorders and substance abuse, Hamadan University of Medical Science
Full name of responsible person
Dr. Mohamad Ahmadpanah
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
Research center for behavioral disorders and substance abuse, Hamadan University of Medical Science
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
Research center for behavioral disorders and substance abuse, Hamadan university of medical sciences
Full name of responsible person
Gholamreza Bigdelo
Position
Resident of psychiatry
Other areas of specialty/work
Street address
Farshchian Hospital
City
Hamadan
Postal code
8741-465168
Phone
+98 81 1828 5015
Fax
Email
rbigdelo@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Research center for behavioral disorders and substance abuse, Hamadan university of medical sciences
Full name of responsible person
Dr. Leyla Jahangard
Position
Assistant professor of psychiatry
Other areas of specialty/work
Street address
Farshchian Hospital
City
Hamadan
Postal code
8741-4-65168
Phone
+98 81 1828 5015
Fax
Email
jahangard_li_ps@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)