The effect of N-acetylcysteine in patients with generalized anxiety disorder
Design
Clinical trial with control group, with parallel groups, not blind, randomized, phase 3, on 100 patients. Accidental block randomization
Settings and conduct
Patients with Generalized Anxiety Disorder refer to Razi Hospital
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with GAD disorder diagnosed by a psychiatrist based on DSM-V criteria and spit-zer questionnaire.
Non-inclusion criteria: Patients with hepatic encephalopathy, asthma, gastric hemorrhage and fluid overload; Taking anticonvulsant drugs; Other Mental disorders such as autism, seizures and chronic diseases; Pregnant and lactating women; Inability to understand and sign consent form
Intervention groups
Intervention group:Includes 50 patients who receive N-acetylcysteine in addition to routine treatment for 2 months.
Control group: Includes 50 patients who receive only routine treatment of the disease prescribed by a psychiatrist.
Main outcome variables
Anxiety score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150706023083N5
Registration date:2020-08-09, 1399/05/19
Registration timing:registered_while_recruiting
Last update:2020-08-09, 1399/05/19
Update count:0
Registration date
2020-08-09, 1399/05/19
Registrant information
Name
Haleh Rezaee
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3337 2250
Email address
rezaeeha@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-05, 1399/04/15
Expected recruitment end date
2021-07-06, 1400/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of N-acetylcysteine and standard treatment on anxiety score in patients with generalized anxiety disorder
Public title
The effect of N-acetylcysteine in GAD
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with GAD disorder at the discretion of a psychiatrist based on DSM-V criteria and Spit-zer questionnaire
Exclusion criteria:
Patients with hepatic encephalopathy , asthma, gastric hemorrhage and fluid overload
Taking anticonvulsant drugs
Other Mental disorders such as autism, seizures and chronic diseases
Pregnant and lactating women
Inability to understand and sign consent
Age
From 17 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done using block of size 4.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committe of Tabriz University of Medical Science
Street address
No 20, Safa avenue, Besaat street, Mirdamad
City
Tabriz
Province
East Azarbaijan
Postal code
5166956547
Approval date
2020-06-22, 1399/04/02
Ethics committee reference number
IR.TBZMED.REC.1399.301
Health conditions studied
1
Description of health condition studied
Generalized anxiety disorder
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder
Primary outcomes
1
Description
Anxiety score
Timepoint
On arrival and after 2, 4, 6, 8 weeks after receiving medicine
Method of measurement
Spit-Zer Anxiety Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Including 50 patients who, in addition to receiving standard treatment for anxiety disorder, receive N-acetylcysteine for 2 months at a daily dose of 600 mg .
Category
Treatment - Drugs
2
Description
Control group: Includes 50 patients who receive only standard treatment for the disease.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Outpatient Clinic of Razi Hospital
Full name of responsible person
Dr Zahra Moosavi
Street address
Sheykh Mohammad Khiyabani Ave., Bakeri blvd., Elgoli, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5167846184
Phone
+98 41 3380 4486
Email
librazi@tbzmed.ac.ir
2
Recruitment center
Name of recruitment center
SHeykh Al-Rais clinic
Full name of responsible person
DR Zahra Moosavi
Street address
Sheikh Al-Rais Building , Azadi Street, not far from Golgasht
City
Tabriz
Province
East Azarbaijan
Postal code
5167846184
Phone
+98 41 3336 6215
Email
librazi@tbzmed.ac.ir
Web page address
http://enobat.tbzmed.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Sanaz Hamedyazdan
Street address
Faculty of Pharmacy, 6th floor, Department of Clinical Pharmacy, Daneshgah street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166414766
Phone
+98 41 3337 2250
Email
rezaeeha@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Dr Haleh Rezaee
Position
Assistant Professor of Clinical Pharmacy
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, 6th floor, Department of Clinical Pharmacy, University Street,Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166414766
Phone
+98 41 3337 2250
Email
Rezaeeha@tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Haleh Rezaee
Position
Assistant Professor of Clinical Pharmacy
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, 6th floor, Department of Clinical Pharmacy, University Street,Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166414766
Phone
+98 41 3337 2250
Email
Rezaeeha@tbzmed.ac.ir
Web page address
http://www.tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Haleh Rezaee
Position
Assistant Professor of Clinical Pharmacy
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, 6th floor, Department of Clinical Pharmacy, University Street,Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166414766
Phone
+98 41 3337 2250
Email
Rezaeeha@tbzmed.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