Comparative Effect of Citalopram vs. Escitalopram in the Management of Depressive Symptoms among Patients with Schizophrenia
Design
A randomized clinical trial without control group, with parallel groups, blindness, 60 patients randomly divided into two groups of 30 subjects with block sizes of 4 and 6.
Settings and conduct
The population of this study was aged 18< years old who referred to Yahyanezhad Hospital in Babol.Patients are randomly divided into two Intervention groups.En Intervention group: Treatment with citalopram (Ramofarmine Co) started at 10 mg and gradually increased to 40 mg daily.Intervention group2: Treatment with Sitalopram (Abidi Co) at a dose of 5 mg and gradually increased to a dose of 20 mg daily.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Diagnosis of schizophrenia based on DSM-IV TR structured clinical interview by a psychiatrist (faculty member and psychiatry resident) Diagnosis of depression based on DSM-IV TR structured clinical interview by a psychiatrist (faculty member and psychiatry resident
Exclusion Criteria: Drug abuse, Epilepsy, Ischemia Heart Disease, Heart Failure, Mental retardation, Parkinson
Intervention groups
Intervention group1: Treatment with citalopram (Ramofarmine Co) started at 10 mg and gradually increased to 40 mg daily.
Intervention group2: Treatment with Sitalopram (Abidi Co) at a dose of 5 mg and gradually increased to a dose of 20 mg daily.
Main outcome variables
patient´s depressive condition
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190525043700N1
Registration date:2019-10-11, 1398/07/19
Registration timing:retrospective
Last update:2019-10-11, 1398/07/19
Update count:0
Registration date
2019-10-11, 1398/07/19
Registrant information
Name
Romina Hamzehpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3229 1951
Email address
r.hamzehpour@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-20, 1397/12/01
Expected recruitment end date
2019-09-21, 1398/06/30
Actual recruitment start date
2019-02-20, 1397/12/01
Actual recruitment end date
2019-09-21, 1398/06/30
Trial completion date
2019-09-21, 1398/06/30
Scientific title
Comparative Effect of Citalopram and Escitalopram in the Management of Depressive Symptoms among Patients with Schizophrenia
Public title
Comparative Effect of Citalopram and Escitalopram in the Patients with Schizophrenia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of schizophrenia based on DSM-IV TR structured clinical interview by a psychiatrist (faculty member and psychiatry resident)
Diagnosis of depression based on DSM-IV TR structured clinical interview by a psychiatrist (faculty member and psychiatry resident)
The patients randomly divided into two groups of 20 subjects with four and six blocks and an allocation ratio of 1: 1.The participants allocation sequence in two groups performed with a Randomizer software. Opaque sealed sequentially numbered envelops used for allocation concealment.
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to blind the researcher and thepatients from the study, afetr randomization, opaque sealed sequentially numbered envelops used for allocation concealment.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Ethics Committee of Babol University of Medical Sciences
Street address
Daneshgah Square, Ganjafrooz Avenue
City
Babol
Province
Mazandaran
Postal code
4717647745
Approval date
2019-02-19, 1397/11/30
Ethics committee reference number
IR.MUBABOL.HRI.REC.1397.293
Health conditions studied
1
Description of health condition studied
Depression
ICD-10 code
F32.0
ICD-10 code description
Major depressive disorder, single episode, mild
2
Description of health condition studied
Schizophrenia
ICD-10 code
F20
ICD-10 code description
Schizophrenia
Primary outcomes
1
Description
patient´s depressive condition
Timepoint
Before intervention (first visit) ,the end of the fourth week (second visit),the end of the eighth week (third visit)
Method of measurement
(Calgary Depression Scale for Schizophrenia (CDSS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Treatment with citalopram (Ramofarmine Co) started at 10 mg and gradually increased to 40 mg daily.
Category
Treatment - Drugs
2
Description
Intervention group2: Treatment with Sitalopram (Abidi Co) at a dose of 5 mg and gradually increased to a dose of 20 mg daily.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Yahyanezhed Haspital
Full name of responsible person
Romina Hamzehpour
Street address
Shahid Mostafa Khomeini St., Modarres St
City
Babol
Province
Mazandaran
Postal code
4713566547
Phone
+98 11 3222 5035
Email
r.hamzehpour@mubabol.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Reza Ghadimi
Street address
Babol University Of Medical Sciences, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Province
Mazandaran
Postal code
4713566547
Phone
+98 11 3219 7667
Email
rezaghadimi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol University of Medical Sciences
Full name of responsible person
Romina Hamzehpour
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Babol University Of Medical Sciences, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Province
Mazandaran
Postal code
4713566547
Phone
+98 11 3233 8301
Email
r.hamzehpour@mubabol.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Romina Hamzehpour
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Babol University Of Medical Sciences, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Province
Mazandaran
Postal code
4713566547
Phone
+98 11 3233 8301
Email
r.hamzehpour@mubabol.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Romina Hamzehpour
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Babol University Of Medical Sciences, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Province
Mazandaran
Postal code
4713566547
Phone
+98 11 3233 3308
Email
r.hamzehpour@mubabol.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
No more information
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