Comparing the Efficacy of Aripiprazole with other Second-Generation Antipsychotics for smoke cessation
Design
This assessment is a clinical trial. 40 patients diagnosed with mania and with acute mania symptoms and confirmed by a psychiatrist and who have the inclusion criteria will be considered as sample. Patients will be classified into two groups by randomization; 20 patients in the Aripiprazole group and 20 patients in the second-generation anti psychotics other than Aripiprazole group. Accordingly, at the beginning of the diagnosis, and at 2, 4 and 6 weeks, the status of symptoms of nicotine dependency will be assessed using questionnaires.
Settings and conduct
This study will be conducted as a clinical trial in the psychiatric ward of the Amir Kabir Hospital in Arak. It will be a one-sided blind study in which patients will be blinded.
Participants/Inclusion and exclusion criteria
over 18 years old inpatient Manic sufferers except those who:
used anti-psychotic medicines during the recent past 30 days
recieved ECT during the recent past 6 months
are pregnant or breast-feeding
are alcohol dependent
suffer from psychiatric disorders other than bipolar disorder
are in high risk for suicide
are using mood stabilizers other than sodium valproate
suffer from liver disease
have a positive history of polycystic ovaries
suffer from Thrombocytopenia
Intervention groups
In the intervention group, treatment with Aripiprazole will initiate at baseline dose of 5 to 15 mg per day. After two weeks the dose may increase by 5 mg, as well as at weeks 4 and 6. This can be 5 mg per day to reach maximum 30 mg per day at the end of 6 weeks. Also in control group, second-generation anti-psychotics except Aripiprazole including Risperidone, Olanzapine and Quetiapine will be used.
Main outcome variables
nicotine dependency
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181026041468N1
Registration date:2019-07-04, 1398/04/13
Registration timing:prospective
Last update:2019-07-04, 1398/04/13
Update count:0
Registration date
2019-07-04, 1398/04/13
Registrant information
Name
Mehran Shayganfard
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3313 5075
Email address
mshayganfard@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-23, 1398/07/01
Expected recruitment end date
2020-09-22, 1399/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the Efficacy of Aripiprazole with other Second-Generation Antipsychotics in smoke cessation of inpatient Manic sufferers
Public title
Comparing the Efficacy of Aripiprazole with other Second-Generation Antipsychotics in smoke cessation of inpatient Manic sufferers
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Bipolar disorder type-I patients in manic phase
older than 18
Informed consent
Exclusion criteria:
Use of anti-psychotic medicines during the recent past 30 days
Use of ECT during the recent past 6 months
Pregnancy or breast-feeding
Alcohol dependence
Psychiatric disorders other than bipolar disorder
High risk of suicide
The use of mood stabilizers other than sodium valproate
liver disease
Positive history of polycystic ovaries
Thrombocytopenia
Age
From 18 years old
Gender
Both
Phase
4
Groups that have been masked
Participant
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
In order to randomization, we will use the block method. Accordingly, the cases will be divided into two groups. The allocation of patients in two groups would be based on demographic characteristics and matching. Therefore, after considering the patients' demographic data, they will be divided into two equal groups of participants. The study will start by performing desired intervention on each group.
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients in either groups are unaware of the used drugs, and drugs has similar package.
Placebo
Not 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
Alamolhoda
City
Arak
Province
Markazi
Postal code
3881173533
Approval date
2019-02-24, 1397/12/05
Ethics committee reference number
IR.ARAKMU.REC.1397.366
Health conditions studied
1
Description of health condition studied
Bipolar mood disorder
ICD-10 code
F34
ICD-10 code description
Persistent mood [affective] disorders
2
Description of health condition studied
Nicotine dependence
ICD-10 code
F17
ICD-10 code description
Nicotine dependence
Primary outcomes
1
Description
nicotine dependence
Timepoint
0, 1, 2, 4, 6 weeks
Method of measurement
Nicotine Dependence Syndrome Scale (NDSS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the intervention group, treatment with Aripiprazole will initiate at baseline dose of 5 to 15 mg per day. After two weeks the dose may increase by 5 mg, as well as at weeks 4 and 6. This can be 5 mg per day to reach maximum 30 mg per day at the end of 6 weeks.
Category
Treatment - Drugs
2
Description
Control group: in control group, second-generation anti-psychotics except Aripiprazole including Risperidone, Olanzapine and Quetiapine will be prescribed.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amirkabir Hospital, Arak, Iran
Full name of responsible person
Mehran Shayganfard
Street address
Alamolhoda
City
Arak
Province
Markazi
Postal code
3818718781
Phone
+98 86 3313 5075
Email
mshayganfard@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Alireza Kamaly
Street address
Alamolhoda
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3313 5075
Email
mshayganfard@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
Mehran Shayganfard
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Alamolhoda
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3313 5075
Email
mshayganfard@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mehran Shayganfard
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Alamolhoda
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3313 5075
Email
mshayganfard@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mehran Shayganfard
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Alamolhoda
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3313 5075
Email
mshayganfard@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
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