Quetiapine versus placebo in the treatment of obsession symptoms in bipolar patients wih lithium +benzodiazepin medication,A double blind randomized controlled clinical trial
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General information
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According to assessment of previous paper we change time of prescribe medication to 8 weeks.
According to assessment of previous paper we change time of prescribe medication to 8 weeks.
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با توجه به بررسی مجدد مطالعات انجام شده تغییری در زمان تجویز دارو به ۸ هفته انجام گرفت.
با توجه به بررسی مجدد مطالعات انجام شده تغییری در زمان تجویز دارو به ۸ هفته انجام گرفت.
Primary outcomes
#1
Before intervention and 4,8 and 12 weeks after intervention
Before intervention and 4,8 and 8 weeks after intervention
Before intervention and 4,8 and 128 weeks after intervention
قبل از مداخله و 6،4 و 12 هفته بعد از انجام مداخله
قبل از مداخله و 6،4 و 8 هفته بعد از انجام مداخله
قبل از مداخله و 6،4 و 128 هفته بعد از انجام مداخله
Recruitment centers
#1
Name of recruitment center - English: Hafez hospital
Name of recruitment center - Persian: بیمارستان حافظ
Full name of responsible person - English: Dr bahareh ghahramanpouri
Full name of responsible person - Persian: دکتر بهاره قهرمان پوری
Street address - English: Chamran Blvd, Hagez hospital
Street address - Persian: بولوار چمران،بیمارستان حافظ
City - English: Shiraz
City - Persian: شیراز
Province: Fars
Country: Iran (Islamic Republic of)
Postal code: 7194634786
Phone: +98 71 3647 9531
Fax:
Email: Bahareh.ghaheamanpouri@gmail.com
Web page address:
Name of recruitment center - English: Hafez Hospital
Name of recruitment center - Persian: بیمارستان حافظ
Full name of responsible person - English: Dr Bahareh Ghahramanpouri
Full name of responsible person - Persian: دکتر بهاره قهرمان پوری
Street address - English: Chamran Blvd, Hafez Hospital
Street address - Persian: بولوار چمران،بیمارستان حافظ
City - English: Shiraz
City - Persian: شیراز
Province: Fars
Country: Iran (Islamic Republic of)
Postal code: 7194634786
Phone: +98 71 3647 9531
Fax:
Email: Bahareh.ghaheamanpouri@gmail.com
Web page address:
Name of recruitment center - English: Hafez hospitalHospital Name of recruitment center - Persian: بیمارستان حافظ Full name of responsible person - English: Dr bahareh ghahramanpouriBahareh Ghahramanpouri Full name of responsible person - Persian: دکتر بهاره قهرمان پوری Street address - English: Chamran Blvd, Hagez hospitalHafez Hospital Street address - Persian: بولوار چمران،بیمارستان حافظ City - English: Shiraz City - Persian: شیراز Province: Fars Country: Iran (Islamic Republic of) Postal code: 7194634786 Phone: +98 71 3647 9531 Fax: Email: Bahareh.ghaheamanpouri@gmail.com Web page address:
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr mohammad javad ashraf
Full name of responsible person - Persian: دکتر محمد جواد اشرف
Street address - English: Zand street, medical science university
Street address - Persian: خیابان زند،دانشکده علوم پزشکی شیراز
City - English: Shiraz
City - Persian: شیراز
Province: Fars
Country: Iran (Islamic Republic of)
Postal code: 7194685115
Phone: +98 71 3230 5645
Fax:
Email: Ashrafm@sums.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr Mohammad Javad Ashraf
Full name of responsible person - Persian: دکتر محمد جواد اشرف
Street address - English: Zand Street, Medical Science University
Street address - Persian: خیابان زند،دانشکده علوم پزشکی شیراز
City - English: Shiraz
City - Persian: شیراز
Province: Fars
Country: Iran (Islamic Republic of)
Postal code: 7194685115
Phone: +98 71 3230 5645
Fax:
Email: Ashrafm@sums.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Dr mohammad javad ashrafMohammad Javad Ashraf Full name of responsible person - Persian: دکتر محمد جواد اشرف Street address - English: Zand streetStreet, medical science universityMedical Science University Street address - Persian: خیابان زند،دانشکده علوم پزشکی شیراز City - English: Shiraz City - Persian: شیراز Province: Fars Country: Iran (Islamic Republic of) Postal code: 7194685115 Phone: +98 71 3230 5645 Fax: Email: Ashrafm@sums.ac.ir Web page address:
Protocol summary
Study aim
comparison of Quetiapine versus placebo in the treatment of obssesion symptoms in bipolar patients wih lithium +benzodiazepin medication
Design
Randomised, double blinded controlled, parallel group clinical trial
Settings and conduct
40 patients with bipolar disorder and obsessional symptom were divided randomly in basis of block permutation into two groups of intervention and control.20 patients in intervention group give quetiapin with lithium and benzodiazepin. 20 other patient in control group give pelacebo instead of quetiapin.
The patients and supervisor physicion donnot know about kind of gorups.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
The patients with impression of bipolare disorder according to dsm v
The patients have score of more than 16 in yale brown score
The patients have score of equal or lesser than 17 in Young mania questionnaire
The patients have score of equal or lesser than 7 in Hamilton depression questionnaire
Exclusion criteria:
The patients in acute phase of depression or mania
The patients with cardiac, respiratory, renal or GI disorder
Pregnant patients
Intervention groups
The patients divided to two group s. The first group give quetiapin for 12 weeks with lithium and benzodiazepin and control group give pelacebo instead of quetiapin
Main outcome variables
Evaluate severiry of obsession after treatment with quetiapin in bipolar patient
General information
Reason for update
According to assessment of previous paper we change time of prescribe medication to 8 weeks.
Acronym
IRCT registration information
IRCT registration number:IRCT20190307042963N1
Registration date:2019-04-14, 1398/01/25
Registration timing:prospective
Last update:2019-12-08, 1398/09/17
Update count:1
Registration date
2019-04-14, 1398/01/25
Registrant information
Name
Bahareh Ghahramanpouri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3649 0551
Email address
bahareh.ghahramanpouri@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-22, 1398/03/01
Expected recruitment end date
2020-03-19, 1398/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Quetiapine versus placebo in the treatment of obsession symptoms in bipolar patients wih lithium +benzodiazepin medication,A double blind randomized controlled clinical trial
Public title
Analysis of treatment with quetiapin in bipolar patients with obsessional symptom
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The patients with impression of bipolare disorder according to dsm v
The patients have score of more than 16 in yale brown score
The patients have score of equal or lesser than 17 in Young mania questionnaire
The patients have score of equal or lesser than 7 in Hamilton depression questionnaire
Exclusion criteria:
The patients in acute phase of depression or mania
The patients with cardiac, respiratory, renal or GI disorder
Pregnant patients
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
They were divided randomly in basis of block permutation into two groups of intervention and control.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patients divided into two groups according to table of randome number.one group give quetiapin and another one give pelacebo. The patients and supervisor physician do not know about kinds of group.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of shiraz university medical sciencs
Street address
Zand street, medical science university
City
Shiraz
Province
Fars
Postal code
7194685115
Approval date
2019-04-07, 1398/01/18
Ethics committee reference number
IR.SUMS.MED.REC.1398.008
Health conditions studied
1
Description of health condition studied
Bipolar disorders
ICD-10 code
F06.34
ICD-10 code description
Mood disorder due to known physiological condition with mixed features
2
Description of health condition studied
Obsessive compulsive disorder
ICD-10 code
F42
ICD-10 code description
Obsessive-compulsive disorder
Primary outcomes
1
Description
Evaluate severity of obsession in bipolar patients
Timepoint
Before intervention and 4,8 and 8 weeks after intervention
Method of measurement
Yale brown scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 20 patient give quetiapin with lithium and benzodiazepin, start with 25 mg twice daily and increase 50 mg weekly until 200 mg daily
Category
Treatment - Drugs
2
Description
Control group: 20 patient give pelacebo with lithium and benzodiazepin
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Hafez Hospital
Full name of responsible person
Dr Bahareh Ghahramanpouri
Street address
Chamran Blvd, Hafez Hospital
City
Shiraz
Province
Fars
Postal code
7194634786
Phone
+98 71 3647 9531
Email
Bahareh.ghaheamanpouri@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Mohammad Javad Ashraf
Street address
Zand Street, Medical Science University
City
Shiraz
Province
Fars
Postal code
7194685115
Phone
+98 71 3230 5645
Email
Ashrafm@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Bahareh Ghahramanpouri
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Chamran Blvd, Hafez Hospital
City
Shiraz
Province
Fars
Postal code
7194634786
Phone
+98 71 3647 9531
Email
Bahareh.ghahramanpouri@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Bahareh Ghahramanpouri
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Chamran Blvd, Hafez hospital
City
Shiraz
Province
Fars
Postal code
7194634786
Phone
+98 71 3647 9531
Email
Bahareh.ghahramanpouri@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Bahareh Ghahramanpouri
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Chamran Blvd, Hafez Hospital
City
Shiraz
Province
Fars
Postal code
7194634786
Phone
+98 71 3647 9531
Email
Bahareh.ghahramanpouri@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Yale brown scal, young mania questionnaire and hamilton questionnaire of patients-
Analysis of data in spss
When the data will become available and for how long
starting 6 months after publication
To whom data/document is available
this only available for people working in academic institutions
Under which criteria data/document could be used
We can give data to academic institutions by email and they can use our data with mention refrence
From where data/document is obtainable
By email:bahareh.ghahramanpouri@gmail.com
What processes are involved for a request to access data/document