Comparison of the effectiveness of aripiprazole with other second-generation antipsychotics in reducing smoking dependence in hospitalized manic patients.
Design
This study was a non-randomized blind clinical trial with parallel groups.After obtaining informed consent, the patients were visited by a psychiatrist and according to their opinion were assigned to one of the two groups for specialized treatment.According to the inclusion and exclusion criteria, 50 patients were included in the study and were evaluated in a 6-week period in two groups of intervention (treated with aripiprazole, n = 25) and control (treated with other second-generation antipsychotics, n = 25) by NDSS questionnaire.
Settings and conduct
Type1 bipolar patients referred to Amirkabir Hospital in the mania phase according to the opinion of a psychiatrist for treatment with aripiprazole (5 to 15 mg daily) or other second-generation antipsychotics (risperidone 2-3 mg , olanzapine 10-15 mg, quetiapine 100 mg daily) were assigned to one of the two groups.Due to the similarity of drugs, patients were not aware of their group.
Participants/Inclusion and exclusion criteria
Inclusion criteria :
Smoker; Age over 18 years; Bipolar I mental disorder hospitalized in the mania phase
Exclusion criteria:
Unwillingness to continue; Not allowing the use of information; Use of antipsychotic drugs in the past 30 days; Use of ECT in the last 6 months; Pregnancy or lactation; Alcohol dependence; Mental disorder other than bipolar disorder; High risk of suicide; Use of mood stabilizing drugs other than sodium valproate; Liver disorders; History of polycystic ovaries; Thrombocytopenia
Intervention groups
Smokers with bipolar disorder in mania phase and referred to Amirkabir Hospital in Arak
Main outcome variables
Criteria for "arousal", "priority", "tolerance", "continuity" and "stereotyped behavior" of the NDSS questionnaire
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201116049406N1
Registration date:2020-11-25, 1399/09/05
Registration timing:retrospective
Last update:2020-11-25, 1399/09/05
Update count:0
Registration date
2020-11-25, 1399/09/05
Registrant information
Name
Sahar Hajihashemi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3312 3936
Email address
sahar.hajihashemi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-24, 1397/12/05
Expected recruitment end date
2020-07-26, 1399/05/05
Actual recruitment start date
2020-02-24, 1398/12/05
Actual recruitment end date
2020-07-26, 1399/05/05
Trial completion date
2020-07-26, 1399/05/05
Scientific title
Comparing the effectiveness of Aripiprazole with other second-generation antipsychotics on smoking dependency in manic patients admitted
Public title
effectiveness of Aripiprazole on smoking dependency in manic patients admitted to Amir Kabir Hospital in Arak
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Conscious consent to participate in the study
Smokers over 18 years of age with bipolar I psychiatric disorder in phase mania (based on DSM-V)
Exclusion criteria:
All patients who do not want to continue the study and do not consent to participate in the study.
Patients who have been taking antipsychotic medications for the past 30 days.
Patients who have been treated with ECT for the past 6 months.
Pregnancy or lactation, Alcohol dependence, Mental disorder other than bipolar disorder, High risk of suicide, Use of non-loading dose stabilizing drugs other than sodium valproate, Liver disorders, History of polycystic ovary and thrombocytopenia
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Sample size
Target sample size:
50
Actual sample size reached:
50
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients participating in the study were unaware of their group.
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
Arak, Sardasht, Arak University of Medical Sciences, Faculty of Medicine
City
Arak
Province
Markazi
Postal code
٣٨١٩٦٩٣٣٤٥
Approval date
2019-02-24, 1397/12/05
Ethics committee reference number
IR.ARAKMU.REC1397.366
Health conditions studied
1
Description of health condition studied
Bipolar type 1 mood disorder
ICD-10 code
F31.1
ICD-10 code description
Bipolar disorder, current episode manic without psychotic features
Primary outcomes
1
Description
nicotine dependence
Timepoint
0-2-4-6
Method of measurement
NDSS questioner
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Smoking patients with bipolar disorder type 1 receiving aripiprazole
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir kabir Hospital
Full name of responsible person
Sahar Hajihashemi
Street address
Arak, Parstar Square, Amir Kabir Hospital
City
Arak
Province
Markazi
Postal code
٣٨١٩٦٩٣٣٤٥
Phone
+98 86 3313 4715
Fax
+98 86 3313 2510
Email
info@arakmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Alireza Kamali
Street address
Arak, Sardasht, Arak University of Medical Sciences
City
Arak
Province
Markazi
Postal code
٣٨١٩٦٩٣٣٤٥
Phone
+98 86 3417 3505
Email
info@arakmu.ac.ir
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
Sahar Hajihashemi
Position
intern
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
PO Box: 646 Arak, Sardasht, Arak University of Medical Sciences, Medicine faculty