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Clinical trial Comparison of the effect of Aripiprazole and placebo on the rate of smoking in male patients with type I bipolar disorder

Protocol summary

Summary
Among the patients referred to the clinics and psychiatric clinics of Tabriz 40, men with type bipolar I disorder were selected according to the method of access and according to the criteria for Inclusion and Exclusion, and by blocking method in one of the two intervention or Control groups. After reviewing the case and conducting a structured interview, a definitive diagnosis of bipolar I disorder was made by the psychiatrist and then the necessary explanations were presented morally and, if agreed, were selected as a statistical sample. At first, Fagerstrom Test for Nicotine Dependence was used to determine the rate of smoking in each patient. Then, in the intervention group, Aripiprazole was administered at a dose of 10 mg per day for 6 weeks and placebo control group. During the intervention, patients were not asked to stop their cigarette smoking. After 6 weeks, the rate of smoking in all patients was measured by Fagerstrom Test for Nicotine Dependence. In order to measure the side effects of the drug, a checklist was prepared based on the complications recorded by reviewing the scientific literature and completed on the first and fourth weeks based on interviews with the sample. People who were under the side effects of Aripiprazole were discontinued and excluded, and another was replaced.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016121228173N3
Registration date: 2017-08-01, 1396/05/10
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-08-01, 1396/05/10
Registrant information
Name
Salman Safikhanlou
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3380 4486
Email address
safikhanlous@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tabriz University of Medical Sciences
Expected recruitment start date
2017-01-20, 1395/11/01
Expected recruitment end date
2017-04-21, 1396/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial Comparison of the effect of Aripiprazole and placebo on the rate of smoking in male patients with type I bipolar disorder
Public title
Effect of Aripiprazole on Smoking Rate in Male Bipolar Mood Disorder I
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: The definitive diagnosis of bipolar I disorder according to DSM-IV-TR criteria; being in the partial or complete recovery phase based on Yang Mania Rating Scale; having the necessary criteria for diagnosis of nicotine dependence according to DSM-IV-TR criteria; age 18-60 Years old; male gender and consent to attend the study through the signing of informed consent. ٍExclusion Criteria: history of any allergic reaction to drug disorder with respect to Aripiprazole or other anti psychotics; dependence on other substances (based on the patient's history and the outcome of the test of morphine and methamphetamine at the start of the intervention); the use of other drugs used to quit nicotine; Use of medications other than bipolar disorder; history of physical illness (liver failure, renal failure); history of mental retardation; occurrence of any side effects due to Aripiprazole; history of cognitive impairment (dementia).
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)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomization by blocking method

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
International Relations Office, No 2 Central Building, Tabriz University of Medical Sciences, University Street.
City
Tabriz
Postal code
Approval date
2016-12-11, 1395/09/21
Ethics committee reference number
IR.TBZMED.REC.1395.922

Health conditions studied

1

Description of health condition studied
Bipolar Mood Disorder, current episode manic without psychotic feauters
ICD-10 code
f31.1
ICD-10 code description
The patient is currently manic, without psychotic symptoms (as in F30.1), and has had at least one other affective episode (hypomanic, manic, depressive, or mixed) in the past.

Primary outcomes

1

Description
Smoking rate (nicotine)
Timepoint
before intervention,Six weeks after the intervention
Method of measurement
Fagerstrom Test for Nicotine Dependence (FTQ)

Secondary outcomes

1

Description
Side effects of Aripiperazole
Timepoint
First and Fourth Week of Intervention
Method of measurement
Glasgow Antipsychotic Side‐effect Scale (GASS)

Intervention groups

1

Description
Intervention group: Aripiprazole is administered at a dose of 10 mg per day for 6 weeks
Category
Treatment - Drugs

2

Description
Control group: Placebo in terms of shape, size and weight similar to the َAripiprazole drug for 6 weeks
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Razi Hospital
Full name of responsible person
DR Mohammad Taher Taieb Zadegan
Street address
Razi Hospital, Shahid Bakeri Blvd (El Goli), Tabriz.
City
Tabriz

2

Recruitment center
Name of recruitment center
Clinic
Full name of responsible person
DR Asghar Arfaie
Street address
Fifth Floor, Parsa Faculty Building, Between Hajj Jabar Nayib and Taleghani, New Pasteur Street, Southern Artesh Street, Tabriz.
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Tabriz University of Medical Sciences
Full name of responsible person
DR Alireza Shafiee
Street address
Razi Hospital, Shahid Bakeri Blvd (Elgoli), Tabriz.
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tabriz University of Medical Sciences
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
Razi Hospital
Full name of responsible person
DR Mohammad Taher Taieb Zadegan
Position
resident
Other areas of specialty/work
Street address
Razi Hospital, Shahid Bakeri Blvd (Elgoli), Tabriz.
City
Tabriz
Postal code
Phone
+98 41 3380 4486
Fax
Email
drtayebzadeganmt@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Research Center of Psychiatry and Behavioral Sciences
Full name of responsible person
DR Sepideh Herizchi
Position
Assistant Professor
Other areas of specialty/work
Street address
Razi Hospital, Shahid Bakeri Blvd (Elgoli), Tabriz.
City
Tabriz
Postal code
Phone
+98 41 3380 4486
Fax
Email
herizchis@tbzmed.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Razi Hospital
Full name of responsible person
Salman Safikhanlou
Position
MA of Clinical Psychology
Other areas of specialty/work
Street address
Razi Hospital, Shahid Bakeri Blvd (Elgoli), Tabriz.
City
Tabriz
Postal code
Phone
00
Fax
Email
safikhanlous@tbzmed.ac.ir; salman_safikhanlou@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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