Comparison of cognitive impairment and seizure characteristics in manic patients receiving electroconvulsive therapy with or without concurrent treatment with sodium valproate.
After informed consent, we recruit hospitalized patients who are to receive ECT despite sodium valproate treatment.
Diagnosis of manic episode by a psychiatrist and according to DSM-IV-TR and Receiving ECT because of drug resistance are inclusion criteria, while presence of seizure and other medical condition, and receiving of other anticonvulsants are exclusion criteria.
We are studying the impact of concurrent sodium valproate and ECT on seizure characteristics and cognitive side effects.
By continues sampling, we recruit 40 patients and divide them to two groups: continue valproate during ECT (case group), and stop valproate during ECT(control group).
MMSE is measured before the first session, after the third and sixth sessions, and before discharge. ECT device shows seizure threshold and EEG is done for duration of seizure.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201101011743N4
Registration date:2011-08-27, 1390/06/05
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-08-27, 1390/06/05
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
Hamadan univercity of medical sciences
Expected recruitment start date
2010-09-24, 1389/07/02
Expected recruitment end date
2011-11-23, 1390/09/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of cognitive impairment and seizure characteristics in manic patients receiving electroconvulsive therapy with or without concurrent treatment with sodium valproate.
Public title
Comparison of cognitive impairment and seizure characteristics in manic patients receiving electroconvulsive therapy with or without concurrent treatment with sodium valproate.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1. Manic episode based on DSM IV-TR
2. Age between 18 and 60 years
3. Elementary school education (at least)
4. ECT administer by attending physician
Exclusion criteria:
1.Concurrent anticonvulsant therapy (except sodium valproate)
2. Severe cognitive impairment (MMSE ≤ 19) befor the first session of ECT
3.Uncontrolled physical condition
4.Pregnant and nursing women
5. History of epilepsy
6. LFT > 3 fold the normal range
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:
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
Hamadan univercity of medical sciences
Street address
Honarestan street
City
Hamadan
Postal code
65168-4-8741
Approval date
2010-05-19, 1389/02/29
Ethics committee reference number
پ/16/70/7/28614
Health conditions studied
1
Description of health condition studied
Bipolar disorder,Manic episode
ICD-10 code
F30
ICD-10 code description
Manic episode
Primary outcomes
1
Description
Seizure threshold
Timepoint
all session of ECT
Method of measurement
observation
2
Description
Duration of seizure
Timepoint
all session of ECT
Method of measurement
EEG
3
Description
Cognetive side effect
Timepoint
Befor the 1st ECTsession and after 3rd and 6th session
Method of measurement
MMSE
Secondary outcomes
empty
Intervention groups
1
Description
During treatment with ECT that often lasts between 6 to 10 sessions, sodium valproate is continued in the control group.
Category
Treatment - Drugs
2
Description
During treatment with ECT that often lasts between 6 to 10 sessions, sodium valproate is discontinued in the case group.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Farshchian Hospital
Full name of responsible person
Dr. Hassan Hafezian
Street address
Mirzade Eshghi Street, Shariati squar
City
Hamedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan univercity of medical science
Full name of responsible person
Dr Mohammad Haghighi
Street address
Shariati avenue, Shariati cross street
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan univercity 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
Hamedan univercity of medical sciences
Full name of responsible person
Dr Gholamreza Bigdeloo
Position
Resedent of psychiatry
Other areas of specialty/work
Street address
Mirzade Eshghi street, Shariati squar
City
Hamadan
Postal code
65168-4-8741
Phone
+98 82 74184
Fax
+98 81 1828 5015
Email
rbigdelou@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan univercity of medical sciences
Full name of responsible person
Dr Hassan Hafezian
Position
Resident of psychiatry
Other areas of specialty/work
Street address
Mirzade Eshghi street, Shariati squar
City
Hamadan
Postal code
65168-4-8741
Phone
+98 82 74184
Fax
+98 81 1828 5015
Email
hhafezian@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)