The main objective of the project: Assessment of the effect of Aripiprazole on smoking rate in the schizophrenic patients.
Study design: a randomized, controlled, before-after, tripple blind clinical trial
Study population: 40 patients with schizophrenia will be selected among the patients admitted to the psychiatric clinics of Tabriz by simple (available) method sampling and considering inclusion and exclusion criteria. Then the patients are divided into two groups by respective pairing method.
Inclusion criteria : diagnosis of schizophrenia according to DSM IV TR criteria using semi-structured interviews, having necessary criteria for the diagnosis of nicotine dependence criteria according to DSM IV TR
Exclusion Criteria: a history of allergy or any side effect due to Aripiprazole or other antipsychotics, dependency to other substances (based on the patient's history and morphine and methamphetamine test results at the time of intervention), use of other drugs used for nicotine withdrawal, active phase of psychosis.
First, Using FTQ questionnaire, smoking rates are determined in each patient, then the intervention group will receive a daily dose of 10 mg Aripiprazole for 6 weeks and the control group will receive placebo. During the intervention, the patients are not required to stop smoking. After 6 weeks the smoking rates are measured by FTQ questionair in all patients again. Finally the data are analyzed using the statistical software SPSS 19.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013010512018N1
Registration date:2013-04-06, 1392/01/17
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-04-06, 1392/01/17
Registrant information
Name
Hossein Javdani
Name of organization / entity
Tabriz university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1441 2002
Email address
javdanih@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Clinical Psychiatry Research Center - Tabriz university of medical sciences - Tabriz - Iran
Expected recruitment start date
2013-04-21, 1392/02/01
Expected recruitment end date
2013-10-23, 1392/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Comparision Between Effect of Aripiprazole and Placebo on the Rate of Nicotine Dependence in Schizophrenic patients
Public title
The Effect of Aripiprazole on Smoking Rate in Schizophrenic Patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: diagnosis of schizophrenia according to DSM IV TR criteria using semi-structured interviews,being in partial or complete remission phase, having necessary criteria for the diagnosis of nicotine dependence criteria according to DSM IV TR, aged 18 – 60 years, male sex.
exclusion Criteria: a history of allergy or any side effect due to Aripiprazole or other antipsychotics, dependency to other substances (based on the patient's history and morphine and methamphetamine test results at the time of intervention), comorbidity of the other major psychiatric disorders (such as unipolar and bipolar mood disorders), use of other drugs used for nicotine withdrawal, active phase of psychosis.
Age
From 18 years old to 60 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz university of medical sciences
Street address
Golgasht street
City
Tabriz
Postal code
Approval date
2013-01-21, 1391/11/02
Ethics committee reference number
91197
Health conditions studied
1
Description of health condition studied
schizophrenia
ICD-10 code
F20
ICD-10 code description
The schizophrenic disorders are characterized in general by fundamental and characteristic distortions of thinking and perception, and affects that are inappropriate or blunted. Clear consciousness and intellectual capacity are usually maintained although
Primary outcomes
1
Description
the rate of nicotine dependence
Timepoint
befor intervention and 6 weeks after intervention
Method of measurement
Nicotine Dependence Questionnaire (FAGERSTROM)
Secondary outcomes
1
Description
extrapyramidal side effects
Timepoint
befor intervention and 6 weeks after intervention
Method of measurement
abnormal involuntary movement scale
Intervention groups
1
Description
intervention group: tablet Aripiprazole, 10 mg, once daily, for 6 weeks
Category
Treatment - Drugs
2
Description
control group: placebo, one tablet daily, for 6 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Psychiatric Clinic of Razi Hospital.
Full name of responsible person
Hossein Javdani
Street address
Ealgoli avenue
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Clinical Psychiatry Research Center
Full name of responsible person
Ali Fakhari
Street address
Razi hospital, Ealgoli avenue
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Clinical Psychiatry Research Center
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
Tabriz university of medical sciences
Full name of responsible person
Asghar Arfaie
Position
Associate Professor of psychiatry
Other areas of specialty/work
Street address
Razi hospital, Ealgoli avenue
City
Tabriz
Postal code
Phone
+98 41 1380 3353
Fax
Email
arfaia@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz university of medical sciences
Full name of responsible person
Asghar Arfaie
Position
Associate Professor
Other areas of specialty/work
Street address
Razi hospital, Ealgoli avenue
City
Tabriz
Postal code
Phone
+98 41 1380 3353
Fax
Email
arfaia@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz university of medical sciences
Full name of responsible person
Hossein Javdani
Position
Assistant of psychiatry
Other areas of specialty/work
Street address
Razi hospital, Ealgoli avenue
City
Tabriz
Postal code
Phone
+98 41 1380 3353
Fax
Email
javdanih@tbzmed.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)