This is a double blind randomized control clinical trial about the safety and efficacy of concomitant Electroconvulsive therapy and atypical antipsychotics in patients with schizophrenia. The sample includes 60 patients with schizophrenia randomly allocated to one of the groups. The Positive and Negative Syndrome Scale (PANSS) is used for assessment of treatment efficacy. Need to receive electroconvulsive therapy (ECT) determined by psychiatrist is an inclusion criteria. Patient or caregivers who do not provide written informed consent are excluded. Patients with serious medical conditions are not included.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201107143930N7
Registration date:2011-08-09, 1390/05/18
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-08-09, 1390/05/18
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
2011-07-14, 1390/04/23
Expected recruitment end date
2012-11-14, 1391/08/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of concomitant psychotropic medication and electroconvulsive therapy on Schizophrenia
Public title
Concomitant psychotropic medication and electroconvulsive therapy on Schizophrenia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusive criteria: Diagnosed schizophrenia in accordance with DSM-IV, needs to be applied electroconvulsive therapy (ECT) determined by psychiatrist; providing written informed consent.
Exclusion Criteria: Patient who does not volunteer himself or herself, Serious neurological or medical damage such as epilepsy, diabetes, cardiac disease or autistic disorder.
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:
60
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
2011-09-29, 1390/07/07
Ethics committee reference number
CT-90-2974
Health conditions studied
1
Description of health condition studied
schizophrenia
ICD-10 code
F20
ICD-10 code description
Schizophrenia
Primary outcomes
1
Description
The Positive and Negative Syndrome Scale for schizophrenia (PANSS)
Timepoint
before first ECT session and about 4 weeks after the last session of ECT
Method of measurement
Interview
Secondary outcomes
1
Description
a modified version of Mini Mental Status Evaluation
Timepoint
before first ECT session, after every session of ECT, and about 4 weeks after the last session of ECT
Method of measurement
interview
Intervention groups
1
Description
Olanzapn (5 to 20 mg/day) or respredone (1 to 6 mg/day)
Category
Treatment - Drugs
2
Description
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
Hafez hospital, Chamran Street
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)