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ISRCTN
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ISRCTN05964399
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ClinicalTrials.gov identifier
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Public title
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Treatment of hot flashes with low-dose risperidone
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Scientific title
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Treatment of hot flashes with low-dose risperidone: An uncontrolled pilot study
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Acronym
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N/A
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Serial number at source
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KTCT-P2a
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Study hypothesis
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By chance, risperidone was reported to have an effect on remission of hot flashes. We postulate that risperidone could sereve as a potential drug to treat hot flashes.
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Lay summary
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Ethics approval
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The Research Ethics Committee of Kuang-Tein General Hospital approved on the 20th of March 2005 (ref: KTCTP2a)
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Study design
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Pilot prospective non-randomised uncontrolled trial
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Countries of recruitment
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Taiwan
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Disease/condition/study domain
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Hot flashes
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Participants - inclusion criteria
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Menopausal (perimenopausal or postmenopausal) women with at least a moderate severity (i.e., ≥ 2 on a 0–4 scale) of hot flashes
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Participants - exclusion criteria
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1. Menopausal women who take antipsychotic drug or/and antidepressants
2. Menopausal women who have breast cancer
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Anticipated start date
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01/06/2005
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Anticipated end date
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31/05/2006
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use contact details below to request a patient information sheet
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Target number of participants
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6
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Interventions
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Patients complete hot flash diaries regarding the frequency and severity of hot flashes everyday in a one-week baseline period, in the 3-month risperidone treatment period, and during the first two weeks after total risperidone withdrawal.
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Primary outcome measure(s)
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The efficacy of risperidone for hot flashes is assessed by the average number of hot flashes per day, and the average daily hot-flash score (frequency × severity)
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Secondary outcome measure(s)
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None
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Sources of funding
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Kuang-Tien General Hospital (Taiwan) - investigator led study
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Trial website
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Publications
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Contact name
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Dr
Hung-Ming
Wu
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Address
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135 Nanxiao St.
Changhua City
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City/town
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Changhua
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Zip/Postcode
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500
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Country
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Taiwan
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Sponsor
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Kuang-Tien General Hospital (Taiwan)
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Address
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135 Nanxiao St.
Changhua City
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City/town
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Changhua
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Zip/Postcode
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500
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Country
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Taiwan
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Date applied
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23/06/2010
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Last edited
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08/07/2010
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Date ISRCTN assigned
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08/07/2010
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