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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00001777 |
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Date of registration:
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03/11/1999 |
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Primary sponsor: |
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Public title:
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Sertraline for the Treatment of Patients With Frontal Lobe Dementia (FLD)
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Scientific title:
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A Controlled, Randomized, Double-Blind Trial of Sertraline in Patients With Frontal Lobe Dementia (FLD) |
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Date of first enrolment:
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December 1997 |
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Target sample size:
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30 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00001777 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety Study, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Key inclusion & exclusion criteria
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Characterized as having behavioral manifestations using a standardized neuropsychiatric
scale and interview.
FLD patients' frontal cognitive sysfunctions characterized using a short neurobehavioral
test battery.
Patients must be able to be tested and cooperative with the procedures required in this
protocol.
No contraindications to the use of Sertraline.
No medical conditions that can reasonably be expected to subject the patient to
unwarranted risk (e.g., cancer) or require frequent changes in medication.
Well-controlled medical conditions such as hypertension and diabetes will not be excluded.
Patients must not be pregnant or nursing and must be using effective contraception, if
still at child-bearing age.
No history of prior severe traumatic brain injury or other severe neurologic or
psychiatric condition, such as psychosis, stroke, multiple sclerosis, or spinal cord
injury.
Not using any psychotropic medication which cannot be stopped 4 weeks before the study.
Age minimum:
N/A
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Dementia
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Intervention(s)
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Drug: Sertraline
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Secondary ID(s)
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98-N-0046
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980046
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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