|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
IRCT |
|
Last refreshed on:
|
27 April 2013 |
|
Main ID: |
IRCT201107143930N7 |
|
Date of registration:
|
2011-08-09 |
|
Primary sponsor: |
|
|
Public title:
|
Concomitant psychotropic medication and electroconvulsive therapy on Schizophrenia
|
|
Scientific title:
|
The effect of concomitant psychotropic medication and electroconvulsive therapy on Schizophrenia -
|
|
Date of first enrolment:
|
2011-07-14 |
|
Target sample size:
|
60 |
|
Recruitment status: |
Complete |
|
URL:
|
http://www.irct.ir/searchresult.php?id=3930&number=7 |
|
Study type:
|
interventional |
|
Study design:
|
Randomization: randomized. Blinding: Double blind. Placebo: used. Assignment: Parallel. Purpose: Treatment. Other design features: .
|
|
|
Countries of recruitment
|
|
Iran, Islamic Republic Of
| | | | | | | |
|
Contacts
|
|
Name:
|
|
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
|
|
Name:
|
Ahmad Ghanizadeh
|
|
Address:
|
Hafez Hospital, Chamran Street
Shiraz
Iran, Islamic Republic Of |
|
Telephone:
|
00987116273070 |
|
Email:
|
ghanizad@sina.tums.ac.ir |
|
Affiliation:
|
Shiraz University of Medical sciences |
| |
|
Key inclusion & exclusion criteria
|
Inclusion 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.
Exclusion criteria:
Age minimum:
18
Age maximum:
65
Gender:
Both male and female
|
|
Health Condition(s) or Problem(s) studied
|
schizophrenia
Schizophrenia
|
|
Intervention(s)
|
|
Intervention 1: Olanzapn (5 to 20 mg/day) or respredone (1 to 6 mg/day). Intervention 2: Placebo.
|
|
Primary Outcome(s)
|
|
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 Outcome(s)
|
|
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
|
|
Source(s) of Monetary Support
|
|
Shiraz University of Medical Sciences
|
|