The Efficacy of Trazadone on Acute Neuroleptic-Induced Akathisia:
Design
double blind, randomised controlled trial
Settings and conduct
Patient on antipsychotic medication in Qods hospital
Participants/Inclusion and exclusion criteria
inclusio :currently on antipsychotic medication;
a score of at least 2(mild akathisia) on the global subscale of theBarnes Akathisia Rating Scale (BARS)
exclusion:taking betablocker, cyproheptadin ,miancerin,B6
suiccidal thought
severe akathisia ,global score of BARS >5
Intervention groups
In the intervention group, Trazodon 5 mg/d was prescribed . Similarly, the control group ,received the placebo once daily for 5 day
Main outcome variables
akathisia,BARS score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191218045795N1
Registration date:2020-02-08, 1398/11/19
Registration timing:retrospective
Last update:2020-02-08, 1398/11/19
Update count:0
Registration date
2020-02-08, 1398/11/19
Registrant information
Name
Narges Shams alizadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 87 3366 8821
Email address
n.shamsalizadeh@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-03, 1397/11/14
Expected recruitment end date
2019-07-14, 1398/04/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of trazodone on neuroleptic-induced acute akathisia
Public title
The effect of trazodone on neuroleptic -induced acute akathisia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
currently onantipsychotic medication;
a score of at least 2(mild akathisia) on the global subscale of theBarnes Akathisia Rating Scale (BARS)
Exclusion criteria:
taking betablocker, cyproheptadin ,miancerin,B6
suiccidal thought
severe akathisia ,global score of BARS >5
Age
From 20 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
4 - block allocationrandom
Blinding (investigator's opinion)
Double blinded
Blinding description
placebo was made of inert substances designed to have no effect. In this study, except for the pharmacist who prepared the medication and placebo, all the other people including psychiatrists, patients, and researchers
were blind to the study groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
IR.MUK.REC.1397.310
Street address
Pasdran Blv
City
Sanandaj
Province
Kurdistan
Postal code
6617978743
Approval date
2018-12-24, 1397/10/03
Ethics committee reference number
IR.MUK.REC.1397.310
Health conditions studied
1
Description of health condition studied
akathisia
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
BARS akathisia score
Timepoint
before intervention and 5 day after intervention
Method of measurement
BARS akathisia questionaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group taking trazodon 50 mg\day for 5 day.preparations were available in identical capsules.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Qods hospital
Full name of responsible person
Zahra asadi
Street address
Entezam Blv
City
Sanandaj
Province
Kurdistan
Postal code
6617978743
Phone
+98 87 3366 0025
Email
nshamsalizadeh@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Ibrahim Ghaderi
Street address
Pasdaran Blvd
City
Sanandaj
Province
Kurdistan
Postal code
6617978743
Phone
+98 87 3366 4957
Email
nshamsalizadeh@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sanandaj 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
Sanandaj University of Medical Sciences
Full name of responsible person
narges shams-alizadeh
Position
associated profesor
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Pasdaran Blvd
City
Sanandaj
Province
Kurdistan
Postal code
6617978743
Phone
009833664957
Email
nshamsalizadeh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
narges shams-alizadeh
Position
associated professor
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Pasdaran Blvd
City
Sannandaj
Province
Kurdistan
Postal code
6617978743
Phone
0098664957
Email
nshamsalizadeh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
narges shams-alizadeh
Position
associated professor
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
pasdaran Blvd sanandaj
City
sanandaj
Province
Kurdistan
Postal code
6617978743
Phone
0098664957
Email
nshamsalizadeh@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
participant individual data
When the data will become available and for how long
6 months after publication
To whom data/document is available
people working in academic institutions
Under which criteria data/document could be used
researcher working on academic institution
From where data/document is obtainable
email : nshamsalizadeh@yahoo.com
What processes are involved for a request to access data/document