Protocol summary
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Study aim
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comparison of Quetiapine versus placebo in the treatment of obssesion symptoms in bipolar patients wih lithium +benzodiazepin medication
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Design
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Randomised, double blinded controlled, parallel group clinical trial
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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
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Main outcome variables
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Evaluate severiry of obsession after treatment with quetiapin in bipolar patient
General information
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Reason for update
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According to assessment of previous paper we change time of prescribe medication to 8 weeks.
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Acronym
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IRCT registration information
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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
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Registration date
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2019-04-14, 1398/01/25
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-05-22, 1398/03/01
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Expected recruitment end date
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2020-03-19, 1398/12/29
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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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Public title
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Analysis of treatment with quetiapin in bipolar patients with obsessional symptom
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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No age limit
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Outcome assessor
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Sample size
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Target sample size:
40
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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They were divided randomly in basis of block permutation into two groups of intervention and control.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2019-04-07, 1398/01/18
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Ethics committee reference number
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IR.SUMS.MED.REC.1398.008
Health conditions studied
1
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Description of health condition studied
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Bipolar disorders
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ICD-10 code
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F06.34
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ICD-10 code description
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Mood disorder due to known physiological condition with mixed features
2
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Description of health condition studied
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Obsessive compulsive disorder
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ICD-10 code
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F42
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ICD-10 code description
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Obsessive-compulsive disorder
Primary outcomes
1
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Description
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Evaluate severity of obsession in bipolar patients
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Timepoint
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Before intervention and 4,8 and 8 weeks after intervention
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Method of measurement
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Yale brown scale
Intervention groups
1
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Description
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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
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Category
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Treatment - Drugs
2
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Description
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Control group: 20 patient give pelacebo with lithium and benzodiazepin
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Shiraz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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Yale brown scal, young mania questionnaire and hamilton questionnaire of patients-
Analysis of data in spss
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When the data will become available and for how long
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starting 6 months after publication
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To whom data/document is available
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this only available for people working in academic institutions
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Under which criteria data/document could be used
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We can give data to academic institutions by email and they can use our data with mention refrence
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From where data/document is obtainable
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By email:bahareh.ghahramanpouri@gmail.com
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What processes are involved for a request to access data/document
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About 1 month after recive message we send data
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Comments
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