(1)Objectives. The aim of this study was to examine the effects of Rivastigmine on Tardive dyskinesia in patients with schizophrenia.
(2) Design. by chance, double blind, control with placebo
(3) Setting and conduct. 40 schizophrenic patients (DSM IV-TR) who were hospitalized in Razi hospital were divided in two equal groups by chance. Then one group was taken Rivastigmine and the other one placebo in a double blind method. At the beginning and at the end of study (8 weeks) the patients were assessed by Abnormal Involuntary Movement Scale (AIMS). The results were analyzed with covariance method.
(4) Participants including major eligibility criteria. 40 schizophrenic patients (DSM IV-TR) who were hospitalized in Razi hospital and had stable mental status and general medical conditions were divided in two equal groups by chance. (with age range between 18 to 65 years).
(5)Intervention. One group was taken Rivastigmine and the other one placebo in a double blind method.
(6) main outcome measures (variables).
Primary outcome measure: Tardive dyskinesia symptoms
Primary outcome time point: At baseline and after eight weeks follow-up
Primary outcome method of measurement: Abnormal Involuntary Movement Scale (AIMS)
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012092910964N1
Registration date:2013-01-08, 1391/10/19
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-01-08, 1391/10/19
Registrant information
Name
Amirabbas Jahanian
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2228 0765
Email address
amirabbasjahanian@yahoo.com
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2011-10-23, 1390/08/01
Expected recruitment end date
2012-02-04, 1390/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of Rivastigmine on reducing the symptoms of Tardive dyskinesia in patients with Schizophrenia
Public title
The effectiveness of Rivastigmine on treatment of Tardive dyskinesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age range between 18 to 65 years, Spent at least one year of treatment with antipsychotics, to have a stable condition of the patient for at least one month prior to study entry.
Exclusion criteria: Organic brain disease, Any neurological disorders, Having a chronic health problem, Change in the amount or type of antipsychotic medication or tranquilizers were used during the last 6 months so that might affect the patient's motor symptoms, Patients with mental retardation, Patients with thyroid disorders, Diabetes, and Substance Abusers.
Age
From 18 years old to 65 years old
Gender
Male
Phase
2-3
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
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of University of Social Welfare and Rehabilitation
Street address
University of Social Welfare and Rehabilitation, Koodakyar str.,Daneshjoo blvd.,Evin str., Tehran.
City
Tehran
Postal code
1985713834
Approval date
2011-04-21, 1390/02/01
Ethics committee reference number
900148
Health conditions studied
1
Description of health condition studied
Tardive dyskinesia
ICD-10 code
G24.0
ICD-10 code description
Drug-induced dystonia
Primary outcomes
1
Description
Tardive dyskinesia symptoms
Timepoint
At baseline and after eight weeks follow-up
Method of measurement
Abnormal Involuntary Movement Scale (AIMS)
Secondary outcomes
empty
Intervention groups
1
Description
in intervention group: Rivastigmine,1.5 mg capsules, twice a day, in 4 weeks.
Category
Treatment - Drugs
2
Description
in control group: sugar,1.5 mg capsules, twice a day, in 4 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi hospital
Full name of responsible person
Dr. Amirabbas Jahanian
Street address
Razi hospital, Amin abad, Shahr rey.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Vice chancellor for research, University of Social Welfare and Rehabilitation Sciences
Street address
University of Social Welfare and Rehabilitation Sciences, Koodakyar str., Daneshjoo blvd., Evin str., Tehran.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of Social Welfare and Rehabilitation 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
Name of organization / entity
University of Social Welfare and Rehabilitation
Full name of responsible person
Dr.Amirabbas Jahanian
Position
psychiatric / board
Other areas of specialty/work
Street address
University of Social Welfare and Rehabilitation, Koodakyar str., Daneshjoo blvd., Evin str., Tehran.
City
Tehran
Postal code
1985713834
Phone
+98 21 2228 0765
Fax
Email
azadeh_yaraghchi@yahoo.com; Iran
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Dr.Omid Rezaei
Position
psychiatric / board
Other areas of specialty/work
Street address
University of Social Welfare and Rehabilitation Sciences, Koodakyar str., Daneshjoo blvd., Evin str., Tehran.
City
Tehran
Postal code
1985713834
Phone
+98 21 8899 3455
Fax
Email
dr.rezaei@uswr.ac.ir; Iran
Web page address
Person responsible for updating data
Contact
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Dr. Amirabbas Jahanian
Position
psychiatric / board
Other areas of specialty/work
Street address
University of Social Welfare and Rehabilitation Sciences, Koodakyar str., Daneshjoo blvd., Evin str., Tehran.
City
Tehran
Postal code
1985713834
Phone
+98 21 2228 0765
Fax
Email
azadeh_yaraghchi@yahoo.com; Iran
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)