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Evaluating the effect of agomelatine on positive and negative symptoms of schizophrenic patients admitted to the psychiatry ward of Golestan hospital

Protocol summary

Study aim
Evaluating the effect of agomelatine on positive and negative symptoms of schizophrenic patients admitted to the psychiatry ward of Golestan Hospital
Design
A clinical trial with a control group, with parallel groups, double-blind, randomized, phase 1-2 on 22 patients. The patients were randomized by random permutation blocks with a block size of 6 (using the table related to random permutations).
Settings and conduct
This study will be conducted in the psychiatry department of Ahvaz Golestan Hospital in a blinded manner, where the treating psychiatrist, nurse student evaluator and patients are not aware of the intervention and control groups. In addition to prescription antipsychotic treatment, patients will receive agomelatine tablets (Tadbir Kalai Jam Pharmaceutical Company) (one 25 mg tablet 30 minutes before bedtime) in the intervention group and placebo tablets in the control group.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients diagnosed with schizophrenia according to DSM-5 criteria, Calgary Schizophrenia Depression Score (CDSS), positive symptom subscale score of PANSS. Conditions of non-entry: use of typical antipsychotic drugs and antidepressants, sodium valproate, lithium, and benzodiazepines, presence of accompanying psychiatric disorders such as schizoaffective or other psychotic disorders.
Intervention groups
Intervention group: prescription antipsychotic treatment with agomelatine tablets (Tadbir Kalai Jam Pharmaceutical Company), in the form of one 25 mg tablet 30 minutes before bedtime. Control group: Prescription antipsychotic treatment, and placebo tablets, which are similar to agomelatine tablets in terms of shape, smell, taste, size and colour, will be received in the same way as the intervention group.
Main outcome variables
5-DSM, CDSS, PANSS

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240805062662N1
Registration date: 2024-08-31, 1403/06/10
Registration timing: prospective

Last update: 2024-08-31, 1403/06/10
Update count: 0
Registration date
2024-08-31, 1403/06/10
Registrant information
Name
Tahereh Amirshekari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 917 368 7265
Email address
amirshekari.t@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-09-05, 1403/06/15
Expected recruitment end date
2024-10-06, 1403/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of agomelatine on positive and negative symptoms of schizophrenic patients admitted to the psychiatry ward of Golestan hospital
Public title
The effect of agomelatine on positive and negative symptoms of schizophrenic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients diagnosed with schizophrenia based on DSM-5 criteria Calgary Schizophrenia Depression Score (CDSS) ≤ 18 PANSS positive symptoms subscale score is greater than 7 and less than or equal to 28. PANSS negative symptoms subscale score greater than or equal to 24 and at least 2 of the 3 main symptoms (emotional boredom, passive/indifferent social withdrawal and lack of spontaneity and fluency in conversation) have ≥ 4 points.
Exclusion criteria:
Taking typical antipsychotic drugs, antidepressants, sodium valproate, lithium, and benzodiazepines The presence of accompanying psychiatric disorders such as schizoaffective or other psychotic disorders, bipolar disorder, anxiety disorders such as panic disorder or obsessive-compulsive disorder, post-traumatic stress disorder, eating disorder Current or past (past 6 months) diagnosis of severe personality disorders that would compromise the participant's ability to perform the study requirements. Hypersensitivity to agomelatine or any of the ingredients of the placebo
Age
From 18 years old to 65 years old
Gender
Both
Phase
1-2
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 22
Randomization (investigator's opinion)
Randomized
Randomization description
To the patients randomly and by the method of randomized permutation blocks with a block size of 6 (using the table related to random permutations). A statistician will prepare a random list. The interventions used in this research will be placed in sealed envelopes according to the randomized list by someone outside the study according to the corresponding codes, and then each patient who will enter the study; will be assigned
Blinding (investigator's opinion)
Double blinded
Blinding description
The treating psychiatrist, nurse student evaluator and patients are not aware of the intervention and control group.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Ground floor, Vice-Chancellor for Research and Technology, Ahvaz Jundishapur University of Medical Sciences, University City, Golestan street, Ahvaz, Iran.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2024-05-25, 1403/03/05
Ethics committee reference number
IR.AJUMS.REC.1403.097

Health conditions studied

1

Description of health condition studied
Schizophrenia
ICD-10 code
F20
ICD-10 code description
Schizophrenia

Primary outcomes

1

Description
5-DSM
Timepoint
Before the intervention, 2 and 4 weeks after the intervention
Method of measurement
Interview

2

Description
CDSS
Timepoint
Before the intervention, 2 and 4 weeks after the intervention
Method of measurement
Interview

3

Description
PANSS
Timepoint
Before the intervention, 2 and 4 weeks after the intervention
Method of measurement
Interview

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In addition to the prescribed antipsychotic treatment that they were already taking, patients receive agomelatine tablets (Tadbir Kalaye Jam Pharmaceutical Company) in the form of one 25 mg tablet 30 minutes before going to sleep.
Category
Treatment - Drugs

2

Description
Control group: In addition to prescribed antipsychotic treatment, patients receive placebo tablets, which are similar to agomelatine tablets in terms of shape, smell, taste, size, and color, and are prepared by the Faculty of Pharmacy of Ahvaz University, in the same way as the intervention group.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Psychiatry Department of Golestan Hospital
Full name of responsible person
Tahereh Amirshekari
Street address
Psychiatry Department of Golestan Hospital, Golestan Steet, Ahvaz, Iran.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 917 368 7265
Email
amirshekari.t@ajums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mehrnoosh Zakerkish
Street address
Ahvaz Jandishapur University of Medical Sciences, Golestan street, Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3311 0000
Email
itc@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Tahereh Amirshekari
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Psychiatry Department of Golestan Hospital, Golestan Steet, Ahvaz, Iran.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 917 368 7265
Fax
Email
amirshekari.t@ajums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Tahereh Amirshekari
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Psychiatry Department of Golestan Hospital, Golestan Steet, Ahvaz, Iran.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 917 368 7265
Fax
Email
amirshekari.t@ajums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Tahereh Amirshekari
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Psychiatry Department of Golestan Hospital, Golestan Steet, Ahvaz, Iran.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 917 368 7265
Fax
Email
amirshekari.t@ajums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
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