This is a double blind randomized control clinical trial about the safety and efficacy of concomitant Electroconvulsive therapy and atypical antipsychotics in 45 patients with bipolar mood disorder. The sample will be randomly allocated to one the two groups in ratio of 2:1. The first group will receive ECT plus olanzapine (5 to 10mg/day, PO, generally in 2 doses) and the second group will receive ECT plus placebo. Young Mania Rating Scale (YMRS) is used to assess clinical efficacy on mania symptoms. The cognitive functions of the patients before and after taking ECT are assessed using a modified version of Mini Mental Status Evaluation (MMSE).All the patients require to be applied electroconvulsive therapy be treating psychiatrist. Lack of written informed consent is an exclusive criterion.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201107143930N8
Registration date:2011-08-17, 1390/05/26
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-08-17, 1390/05/26
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
2011-07-07, 1390/04/16
Expected recruitment end date
2011-11-07, 1390/08/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy of electroconvulsive therapy plus olanzapine on patients with bipolar mood disorder
Public title
Electroconvulsive therapy plus olanzapine on patients with bipolar mood disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusive criteria: age range of 17 to 60 years; None of them has contraindications for ECT taking and/or olanzapine under study. Exclusion criteria: pregnant and lactating women; clinically estimated mental retardation, and refusal of the patient or her or his legal representative for participation in the study.
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Vice-chancellery of Research Affairs, Shiraz University of Medical sciences, Zand Street
City
Shiraz
Postal code
Approval date
2011-07-14, 1390/04/23
Ethics committee reference number
CT-90-2976
Health conditions studied
1
Description of health condition studied
Bipolar Mood disorder
ICD-10 code
F30-F39
ICD-10 code description
Bipolar affective disorder- Manic episode
Primary outcomes
1
Description
Young Mania Rating Scale
Timepoint
4 weeks
Method of measurement
Interview
Secondary outcomes
1
Description
Mini Mental Status Evaluation
Timepoint
before intervention, after every session of ECT
Method of measurement
Interview
Intervention groups
1
Description
ٍECT + olanzapine (5 to 10mg/day, PO, generally in 2 doses)
Category
Treatment - Drugs
2
Description
ECT + Placebo
Category
Placebo
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
Gholam Reza Hatam
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
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, Chamran Street
City
Shiraz
Postal code
Phone
+98 71 1627 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)