Determining the effectiveness of tetrabenazine in the treatment of tardive dyskinesia in psychiatric patients
Design
A clinical trial has a control group with parallel groups.
Settings and conduct
A study on the treatment of drug complications among tardive dyskinesia patients. They will take medicine for two months.
Participants/Inclusion and exclusion criteria
Patients with mood or psychotic disorders who suffer from tardive dyskinesia and have no history of neurological diseases such as epilepsy, Parkinson's and heart diseases.
Intervention groups
Two groups of 14 people will be selected. Tetrabenazine was prescribed to one group and placebo to the other group.
Main outcome variables
Elimination of dyskinesis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240308061212N1
Registration date:2024-05-03, 1403/02/14
Registration timing:registered_while_recruiting
Last update:2024-05-03, 1403/02/14
Update count:0
Registration date
2024-05-03, 1403/02/14
Registrant information
Name
Golnaz Moghaddampour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3354 4004
Email address
gmoghaddampour@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-08, 1403/01/20
Expected recruitment end date
2024-09-20, 1403/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of tetrabenazine in the treatment of tardive dyskinesia in psychiatric patients
Public title
Investigating the therapeutic effect of tetrabenazine in psychiatric patients with drug complications
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having a diagnosis of tardive dyskinesia disorder
Having at least one diagnosis of mood or psychotic disorders
Having the ability to give informed consent
Having a minimum age of 18 years and a maximum age of 65 years
Exclusion criteria:
History of neurological diseases such as epilepsy, Parkinson's, stroke and ischemic cardiac problems
History of tetrabenazine allergy
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
28
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done as a simple randomization, so that 28 numbers will be randomized in the table by the Random Number Generator software, the first 14 numbers will enter the intervention group and the next 14 numbers will enter the control group. Patients are numbered in the order of entering the study and enter their study group according to the randomized list.
Blinding (investigator's opinion)
Double blinded
Blinding description
The participants will be unaware of the intervention group, the control group will receive the intervention in the form of a placebo, the main drug and the placebo will be delivered to the groups in a special numbered envelope. The main researcher and the person evaluating drug effects and drug side effects will also be blinded to the intervention and control groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Zanjan University of Medical Sciences
Street address
Zanjan University of Medical Sciences , Azadi Square, Zanjan
City
Zanjan
Province
Zanjan
Postal code
4515613191
Approval date
2024-01-16, 1402/10/26
Ethics committee reference number
IR.ZUMS.REC.1402.254
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
AIMS test scores
Timepoint
The AIMS test will be conducted at the beginning and the 8th week of the study
Method of measurement
AIMS Movement Disorders Test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The treatment plan is to start tetrabenazine with a dose of 12.5 mg per day for the case group and increase the dose to 25 mg in the second week and then increase the dose to 50 mg in the third week.
Category
Treatment - Drugs
2
Description
Control group: In the control group, the placebo will be used in the form of empty capsules.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital, Zanjan University of Medical Sciences
Full name of responsible person
Golnaz Moghaddampour
Street address
Shahid Beheshti Hospital, Ark sq, Zanjan
City
Zanjan
Province
Zanjan
Postal code
4513615788
Phone
+98 24 3354 4001
Email
beheshti @zums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr. Hossein Mostafavi
Street address
Zanjan University of Medical Sciences , Azadi Square, Zanjan
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3315 6141
Email
Research@zums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Golnaz Moghaddampour
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Shahid Beheshti hospital, Ark sq, Zanjan
City
Zanjan
Province
Zanjan
Postal code
4513615788
Phone
+98 24 3354 4001
Email
gmoghaddampour@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Golnaz Moghaddampour
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Shahid Beheshti hospital, Ark sq, Zanjan
City
Zanjan
Province
Zanjan
Postal code
4513615788
Phone
+98 24 3354 4001
Email
gmoghaddampour@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Golnaz Moghaddampour
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Shahid Beheshti hospital, Ark sq, Zanjan
City
Zanjan
Province
Zanjan
Postal code
4513615788
Phone
+98 24 3354 4001
Email
gmoghaddampour@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The data file of participants can be shared after de-identifying people
When the data will become available and for how long
Access will be possible 6 months after the results are published
To whom data/document is available
Researchers working in academic institutions and scientific journals
Under which criteria data/document could be used
Statistical reanalysis
From where data/document is obtainable
Dr. Ahmad Zolghadriha - Ahmad_zolghadriha@yahoo.com- 09123810175
Golnaz Moghadampour - 09144075793- gmoghaddampour@gmail,com
What processes are involved for a request to access data/document