The effect of deloxitin on the negative symptoms of schizophrenia
Design
Two arm parallel group randomised trial with blinded postoperative care and outcome assessment
Settings and conduct
In this double-blind randomized clinical trial study, 44 patients with schizophrenia with negative symptoms were recruited based on a structured clinical interview and DSM-IV basis at the Qods Hospital in Sanandaj or in outpatient clinics or centers. Patients in the intervention group were given 30 mg doloxetine in the first week and 60 mg daily in the second week to 7 weeks in addition to standard treatment. The positive and negative syndrome scale (PANSS) scale was evaluated at the beginning of the study, at week 4 and at the end of week 8. The drug and placebo are not recognizable, so a double-blind study is performed
Participants/Inclusion and exclusion criteria
Patients with schizophrenia؛Patients with prominent negative symptoms؛No severe depression in patients
Intervention groups
Patients in the intervention group were given 30 mg doloxetine in the first week and 60 mg daily in the second week until the 7th week. In the control group, the same dose was given to the control group.
Main outcome variables
Negative symptoms, positive symptoms, severity of psychiatric disorder, depression
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191218045795N2
Registration date:2020-04-04, 1399/01/16
Registration timing:retrospective
Last update:2020-04-04, 1399/01/16
Update count:0
Registration date
2020-04-04, 1399/01/16
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
2019-09-23, 1398/07/01
Expected recruitment end date
2020-02-04, 1398/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of Duloxetine adjuantive treatment on Negative Symptoms of Schizophrenia
Public title
The effect of Deluxitine on the negative symptoms of schizophrenia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with schizophrenia
Patients with prominent negative symptoms
Exclusion criteria:
major depression
Age
From 18 years old to 59 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be randomly assigned to the intervention and control groups using block randomization
The patients will be randomly assigned to the intervention and control groups using block randomization
Arrangement of the randomization process: 1) Determining the volume of each block (quadruple blocks) 2) Preparing the list of the blocks and assigning a number (between 1 and 6 ) to each of them 3)Choosing random numbers between 1 and 6 4) Defining the treatment assignment list
Blinding (investigator's opinion)
Double blinded
Blinding description
The physician who will examine the patients will not be aware of the intervention. Therefore, the trial will be run as double blind.
Placebo
Used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of kordestan University of Medical Sciences
Street address
Niro entezami Blvd,Qods hospital
City
Sanandaj
Province
Kurdistan
Postal code
6617713141
Approval date
2018-09-25, 1397/07/03
Ethics committee reference number
IR.MUK.REC.1397.143
Health conditions studied
1
Description of health condition studied
Negative symptom
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Comparison of the positive and negative symptoms of schizophrenia
Timepoint
At baseline, 2, 4 and 8 weeks later
Method of measurement
Questionnaire for comparing positive and negative symptoms
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Deloxitin powder, manufactured by Dana Gostar Pharmaceuticals and weighed with 10 mg precision scales, is poured into the empty capsules. Patients receive 30 mg of deluxitine and antipsychotic capsules daily for one week, and from the second week, they are given two capsules of 60 mg daily, lasting for 7 weeks.
Category
Treatment - Drugs
2
Description
Control group: The control group received placebo, which is completely uniform, colorless and odorless with the drug. Patients were given placebo for one week and two capsules for the second week and continued for 7 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Qods hospital
Full name of responsible person
Narges Shams alizadeh
Street address
Niro entezami Blvd
City
Sanandaj
Province
Kurdistan
Postal code
6617713141
Phone
+98 87 3328 5910
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
Ebrahim Qadere
Street address
Abidar Ave
City
Sanandaj
Province
Kurdistan
Postal code
6618634683
Phone
+98 87 3366 4653
Email
ebrahimghaderi@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
2
Sponsor
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Ebrahim Qadere
Street address
Abidar
City
Sanjesh
Province
Kurdistan
Postal code
6618634683
Phone
+98 87 3366 4653
Email
ebrahimghaderi@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
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Niro entezami blvd
City
Sanjesh
Province
Kurdistan
Postal code
6617713141
Phone
+98 87 3366 0026
Email
n.shamsalizadeh@muk.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Narges ShamsAlizadeh
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Niro entezami Blvd
City
Sanandaj
Province
Kurdistan
Postal code
6617713141
Phone
+98 87 3366 0026
Email
n.shamsalizadeh@muk.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Narges Shams-alizadeh
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
No.11,pasdaran Blvd
City
Sanandaj
Province
Kurdistan
Postal code
66644166451
Phone
+98 87 3366 0025
Email
n.shamsalizadeh@muk.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be 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