Schizophrenia is by all means a human tragedy. Not only for the patient but for the family and the community is the same. The purpose of this study will compare the effects of Citalopram treatment with Olanzapine and Citalopram with Aripiprazole in patients with Schizophrenia. This study will be a randomized clinical trial and population consist of all schizophrenia patients will be admitted to the psychiatric clinic of Fatemi Hospital in Ardabil from December until March 2014. In this study, all members will be selected for population and Patients will be randomly allocated into two treatment groups, Olanzapine with Citalopram and Aripiprazole with Citalopram. Patients and medicine providers will not know the name of the drug and Medications will be administered for eight weeks in both groups. After eight weeks, patients will complete the PANSS scale and brief psychiatric evaluation and Side effects will be reviewed for all patients.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013090714577N1
Registration date:2014-12-06, 1393/09/15
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-12-06, 1393/09/15
Registrant information
Name
Abbas Naghizadeh- Baghi
Name of organization / entity
Ardabil University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 45 3323 0673
Email address
a.naghizadeh@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ardabil University of Medical Sciences
Expected recruitment start date
2013-03-20, 1391/12/30
Expected recruitment end date
2014-03-20, 1392/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of therapeutic effects of Citalopram and Olanzapine with Citalopram and Aripiprazole in Schizophrenia patients.
Public title
Effect of Olanzapine and Aripiprazole in schizophrenic patients
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria: Diagnosis of schizophrenia according to the criteria of DSM-IV-TR ; Referred to the psychiatric clinic Fatemi Hospital.
Exclusion criteria:Individual or patient reluctance to participate in the study; History of other psychiatric disorders, patients who are currently treated with other drugs; History of known medical condition under treatment .
Age
From 18 years old to 52 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ardabil University of Medical science
Street address
Daneshgah Street, Medical School, Ardabil University of Medical Sciences
City
Ardabil
Postal code
Approval date
2013-01-20, 1391/11/01
Ethics committee reference number
1025
Health conditions studied
1
Description of health condition studied
Schizophrenia
ICD-10 code
F20
ICD-10 code description
Schizophrenia
Primary outcomes
1
Description
Brief Psychiatric Rating Scale
Timepoint
Pre-intervention and eight weeks after intervention
Method of measurement
individual's self-report
2
Description
Blood Pressure
Timepoint
Pre-intervention and eight weeks after intervention
Method of measurement
mm/hg
3
Description
Weight
Timepoint
Pre-intervention and eight weeks after intervention
Method of measurement
Kg
4
Description
Positive and Negative Syndrome Scale
Timepoint
Pre-intervention and eight weeks after intervention
Method of measurement
Clinical Interview
5
Description
Insomnia
Timepoint
Pre-intervention and eight weeks after intervention
Method of measurement
Observation and Self-reported
6
Description
Anxiety
Timepoint
Pre-intervention and eight weeks after intervention
Method of measurement
Observation and Self-reported
7
Description
Drowsiness
Timepoint
Pre-intervention and eight weeks after intervention
Method of measurement
Observation and Self-reported
8
Description
Weakness
Timepoint
Pre-intervention and eight weeks after intervention
Method of measurement
Observation and Self-reported
9
Description
Headache
Timepoint
Pre-intervention and eight weeks after intervention
Method of measurement
Self-reported
10
Description
Restlessness
Timepoint
Pre-intervention and eight weeks after intervention
Method of measurement
Observation and Self-reported
11
Description
Xerostomia
Timepoint
Pre-intervention and eight weeks after intervention
Method of measurement
Observation and Self-reported
12
Description
Aggression
Timepoint
Pre-intervention and eight weeks after intervention
Method of measurement
Observation
13
Description
Nausea
Timepoint
Pre-intervention and eight weeks after intervention
Method of measurement
Observation and Self-reported
14
Description
Vomiting
Timepoint
Pre-intervention and eight weeks after intervention
Method of measurement
Observation and Self-reported
15
Description
Tremor
Timepoint
Pre-intervention and eight weeks after intervention
Method of measurement
Observation and Self-reported
16
Description
Extrapyramidal side effects
Timepoint
Pre-intervention and eight weeks after intervention
Method of measurement
Observation and Self-reported
17
Description
Delusions
Timepoint
Pre-intervention and eight weeks after intervention
Method of measurement
Interview
18
Description
Mental Turbulence
Timepoint
Pre-intervention and eight weeks after intervention
Method of measurement
Interview
19
Description
Hallucinations
Timepoint
Pre-intervention and eight weeks after intervention
Method of measurement
Interview
20
Description
Disorganized speech
Timepoint
Pre-intervention and eight weeks after intervention
Method of measurement
Interview
21
Description
Chaotic behavior
Timepoint
Pre-intervention and eight weeks after intervention
Method of measurement
Interview
22
Description
Incuriosity
Timepoint
Pre-intervention and eight weeks after intervention
Method of measurement
Interview
23
Description
Inability
Timepoint
Pre-intervention and eight weeks after intervention
Method of measurement
Interview
24
Description
Conservation
Timepoint
Pre-intervention and eight weeks after intervention
Method of measurement
Interview
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Citalopram(Sobhandarou) dose of 40mg/day plus Olanzapine (Sobhandarou) dose of 15mg per day for 8 weeks.
Category
Treatment - Drugs
2
Description
Control group: Citalopram(Sobhandarou) dose of 40mg/day plus Aripiprazole (Bakhtar-Bioshimi-Company) dose of 20mg per day for 8 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemi Hospital
Full name of responsible person
Javad Ghyami
Street address
Fatemi Hospital, Shariati Square, Ardabil
City
Ardabil
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research deputy of Ardabil University of Medical Science
Full name of responsible person
Dr Hadi Piri
Street address
Daneshgah Street, Ardabil University of Medical Sciences
City
Ardabil
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research deputy of Ardabil University of Medical Science
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Javad Ghyami
Position
Medical Student
Other areas of specialty/work
Street address
Daneshgah Street, Ardabil University of Medical Sciences, Medical School.
City
Ardabil
Postal code
5618953141
Phone
+98 41 1385 0951
Fax
Email
yalgiz.q@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Dr Fariba Sadeghi Movahed
Position
Psychiatrist
Other areas of specialty/work
Street address
Fatemi Hospital, Shariati Square, Ardabil
City
Ardabil
Postal code
5614733775
Phone
+98 45 1771 6187
Fax
Email
f.sadeghi.m@arums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ardabil university of Medical Sciences
Full name of responsible person
Dr Abbas Naghizadeh-Baghi
Position
PhD in Physical Education
Other areas of specialty/work
Street address
Medical School, Ardabil University of Medical Sciences, Daneshgah Street, Ardabil
City
Ardabil
Postal code
5618953141
Phone
+98 45 1223 0673
Fax
Email
a.naghizade@arums.ac.ir
Web page address
htpp//www.arums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)