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The Effect of Atomoxetine on Cognitive Symptoms in Schizophrenia Patients

Protocol summary

Study aim
The Effect of Atomoxetine on Cognitive Symptoms in Schizophrenia Patients
Design
A controlled clinical trial with parallel, double-blind, randomized groups was designed on 40 patients with schizophrenia based on case number (even or odd).
Settings and conduct
In this clinical trial, 40 patients with schizophrenia referred to a psychiatric clinic will be randomly divided into two equal groups of atomoxetine and placebo. In the atomoxetine group, patients are given 40 mg of atomoxetine daily for 8 weeks, and in the placebo group, similar tablets in terms of size and color of atomoxetine are prepared from starch and given to patients daily for 8 weeks.
Participants/Inclusion and exclusion criteria
Inclusion criteria: schizophrenia, score of 61 or more on the panss questionnaire; Exclusion criteria: Other neurological disorders, atomoxetine hypersensitivity, complications including angioedema, liver failure, aggression, psychosis, patients receiving ECT in the last 6 weeks, patients taking the antipsychotic drug clozapine
Intervention groups
In the atomoxetine group, patients are given 40 mg of atomoxetine daily for 8 weeks, and in the placebo group, similar tablets in terms of size and color of atomoxetine are prepared from starch and given to patients daily for 8 weeks.
Main outcome variables
Wechsler Short-Term Memory Test

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20211219053452N1
Registration date: 2022-06-25, 1401/04/04
Registration timing: registered_while_recruiting

Last update: 2022-06-25, 1401/04/04
Update count: 0
Registration date
2022-06-25, 1401/04/04
Registrant information
Name
Fatemeh Yousefi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3367 7022
Email address
fatemehyy75@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-21, 1401/02/01
Expected recruitment end date
2022-07-23, 1401/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Atomoxetine on Cognitive Symptoms in Schizophrenia Patients
Public title
The Effect of Atomoxetine on Cognitive Symptoms in Schizophrenia Patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Schizophrenia Get a score of 61 or higher on the panss questionnaire
Exclusion criteria:
Simultaneous presence of other neurological disorders Any allergy to atomoxetine Patients who have received ECT in the last 6 weeks
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
A simple random method based on the patients' record number (odd and even) will be divided into two completely equal groups of atomoxetine and placebo groups (neutral and inert substances such as starch) that have no pharmacological effect on the patient.
Blinding (investigator's opinion)
Double blinded
Blinding description
The researcher and the patient are both unaware of which group they belong to, and the patients, in pairs and individually, are completely equal to the two groups of atomoxetine and the placebo group (a neutral and inert substance like starch in appearance similar to atomoxetine) that has no pharmacological effect on They do not affect the patient and will be divided on the assumption that the drug has a pharmacological or physiological effect on the patient's condition.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Arak University of Medical Sciences
Street address
Alam al-Huda St., Arak University of Medical Sciences
City
Arak
Province
Markazi
Postal code
3819693345
Approval date
2022-04-13, 1401/01/24
Ethics committee reference number
IR.ARAKMU.REC.1401.002

Health conditions studied

1

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

Primary outcomes

1

Description
Wechsler Short-Term Memory Test
Timepoint
Before the intervention and after 8 weeks of treatment
Method of measurement
Wechsler test

Secondary outcomes

1

Description
Short-term memory expansive score, direct visual memory, reverse visual memory, direct auditory memory, auditory reverse memory
Timepoint
Before the intervention and after 8 weeks of treatment
Method of measurement
How to measure short-term memory, direct visual memory, reverse visual memory, direct auditory memory, auditory reverse memory using Wechsler test

Intervention groups

1

Description
Intervention group: Patients are given 40 mg of atomoxetine daily for 8 weeks
Category
Treatment - Drugs

2

Description
Control group: Similar tablets in terms of size and color of atomoxetine are prepared from starch and will be given to patients daily for 8 weeks.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Psychiatric Clinic of Amirkabir Hospital, Arak
Full name of responsible person
ّFatemeh Yousefi
Street address
Hepco St. - Imam Hossein St. - Golzar 11
City
Arak
Province
Markazi
Postal code
3818133150
Phone
+98 86 3367 7022
Email
Fatemehyy75@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Alireza Kamali
Street address
Arak - Basij Square - Arak University of Medical Sciences
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3532
Email
alikamaliir@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Fatemeh Yousefi
Position
General Practitioner
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Hepco St. - Imam Hossein St. - Golzar 11
City
Arak
Province
Markazi
Postal code
3818133150
Phone
+98 86 3367 7022
Email
Fatemehyy75@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Fatemeh Yousefi
Position
General Practitioner
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Hepco St. - Imam Hossein St. - Golzar 11
City
Arak
Province
Markazi
Postal code
3818133150
Phone
+98 86 3367 7022
Email
Fatemehyy75@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Fatemeh Yousefi
Position
General Practice
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Hepco St. - Imam Hossein St. - Golzar 11
City
Arak
Province
Markazi
Postal code
3818133150
Phone
+98 86 3367 7022
Email
Fatemehyy75@gmail.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
All data is potentially shareable after unidentifiable individuals
When the data will become available and for how long
Start the access period immediately after printing the results
To whom data/document is available
Study data will be available to researchers working at academic and scientific institutes
Under which criteria data/document could be used
Any analysis on unidentifiable individual data is allowed.
From where data/document is obtainable
Send your request via email
What processes are involved for a request to access data/document
Documents or data files will be sent to the applicant after receiving the request
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