Determining the effectiveness of cyproheptadine in the treatment of acute akathisia caused by neuroleptics
Design
Clinical trial with a control group, with parallel groups, double-blind, validated, phase 3 on 50 patients, 4 random blocks method is used for validation.
Settings and conduct
The study will be conducted on patients hospitalized in Sanandaj Quds Hospital and the psychosomatic department of Kausar Hospital who were taking antipsychotics, so that they are divided into two intervention and control groups, cyproheptadine is prescribed to the intervention group and placebo to the intervention group. Blinding is done in such a way that only the co-designer of the plan knows which patient will receive the drug and which placebo, and the patient and the doctor do not know about the groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Get antipsychotic, A minimum score of 2 on the akathisia scale is obvious
Exclusion criteria: Get betablocker, cyproheptadine ,miancerin, Vitamin B6, suicided thought severe, Severe akathisia(score higher than 5 in BARS)
Intervention groups
Intervention and control group
Intervention group: The intervention is cyproheptadine, which is prepared by a pharmacologist in the form of capsules.
Control group: placebo capsule, which is completely similar to the original drug in terms of shape, color and smell.
Main outcome variables
Akathisia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191218045795N7
Registration date:2023-02-25, 1401/12/06
Registration timing:prospective
Last update:2023-02-25, 1401/12/06
Update count:0
Registration date
2023-02-25, 1401/12/06
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
2023-03-21, 1402/01/01
Expected recruitment end date
2023-08-23, 1402/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of cyproheptadine in the treatment of acute akathisia caused by neuroleptics
Public title
The effectiveness of cyproheptadine in the treatment of acute akathisia caused by neuroleptics
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Get antipsychotic
A minimum score of 2 on the akathisia scale BARS
Exclusion criteria:
Receiving beta blocker, mianserin, cyproheptadine, vitamin B6
Suiccidal thoughtsevere
Severe akathisia (score higher than 5 in BARS)
Age
From 20 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:
50
Randomization (investigator's opinion)
Randomized
Randomization description
4 - block allocationrandom
Patients are placed in two groups A and B by the assistant using the randomized block method. For this randomization, pre-prepared cans and medicines are made by the pharmacist and based on the patients in the order provided by the statistical consultant. The patient and the outcome researcher are unaware of which of the two groups is receiving the medication or placebo.
Random allocation method:
Individuals are assigned to the intervention and control groups using the method of forming 4 random blocks as follows.
AABB, ABAB, BBAA, BABA
A: Intervention Group
B: Control Group
Up to 48 people are randomized using the formation of 4 random blocks and random selection from the sequence of these blocks. For the remaining two people, each of them will be placed in one of the intervention and control groups using the lottery method.
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
Ethics Committee of Kurdistan University of Medical Sciences
Street address
No.1, Pasdaran Street, Sanandaj, Kurdistan, Iran, Kurdistan University of Medical Sciences
City
Sanandaj
Province
Kurdistan
Postal code
6617913141
Approval date
2022-11-08, 1401/08/17
Ethics committee reference number
IR.MUK.REC.1401.340
Health conditions studied
1
Description of health condition studied
Akathisia
ICD-10 code
G25.71
ICD-10 code description
Drug induced akathisia
Primary outcomes
1
Description
BARS akathisia score
Timepoint
At the beginning of the study (before the start of the intervention) and 5 days after the start of cyproheptadine
Method of measurement
BARS akathisia questionaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention in this study is Cyproheptadine. First, Cyproheptadine powder (manufactured by Tekaje-Iran ) which is prepared by a pharmacologist, is poured into empty capsules in the amount of 4 mg with empty scales. Cyproheptadine is easily poured from The gastrointestinal tract is absorbed and reaches the maximum blood level within two hours. Extensively metabolized in the liver, the most important biotransformation pathways of this drug are demethylation and oxidation. The capsules are then given to the patients in the intervention group by a trained nurse for 4 days at 9 pm.
Category
Treatment - Drugs
2
Description
Control group: Placebo is prepared based on the color of the requested powder (including flour, starch and pigment) and in the amount of 15 mg in the same capsules where the drug was poured, and it is completely the same shape, color and smell of Cyproheptadine. It also has no effect on acacia.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Qods hospital
Full name of responsible person
Narges Shamsalizadeh
Street address
No.1, Pasdaran Street, Sanandaj, Kurdistan, Iran, Kurdistan University of Medical Sciences
City
Sanandaj
Province
Kurdistan
Postal code
6617794795
Phone
+98 87 3366 0025
Email
n.shamsalizadeh@muk.ac.ir
2
Recruitment center
Name of recruitment center
Kwsar hospital
Full name of responsible person
Narges Shamsalizadeh
Street address
No.1, Pasdaran Street, Sanandaj, Kurdistan, Iran, Kurdistan University of Medical Sciences
City
Sanandaj
Province
Kurdistan
Postal code
6617794795
Phone
+98 87 3366 0025
Email
n.shamsalizadeh@muk.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Afshin Malaki
Street address
No.1, Pasdaran Street, Sanandaj, Kurdistan, Iran, Kurdistan University of Medical Sciences
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 Shamsalizadeh
Position
Associated profesor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
No.1, Pasdaran Street, Sanandaj, Kurdistan, Iran, Kurdistan University of Medical Sciences
City
Sanandaj
Province
Kurdistan
Postal code
6617978743
Phone
+98 87 3366 4957
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 Shamsalizadeh
Position
Associated professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
No.1, Pasdaran Street, Sanandaj, Kurdistan, Iran, Kurdistan University of Medical Sciences
City
Sanandaj
Province
Kurdistan
Postal code
6617978743
Phone
+98 87 3366 4957
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 Shamsalizadeh
Position
Associated professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
No.1, Pasdaran Street, Sanandaj, Kurdistan, Iran, Kurdistan University of Medical Sciences
City
Sanandaj
Province
Kurdistan
Postal code
6617978743
Phone
+98 87 3366 4957
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
Nshamsalizadeh@yahoo.com
What processes are involved for a request to access data/document
The application must be sent by the applicant to the research vice-chancellor of the University of Medical Sciences, if approved by the relevant vice-chancellor, the files will be sent via email.