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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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PACTR |
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Last refreshed on:
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29 April 2013 |
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Main ID: |
PACTR201008000246399 |
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Date of registration:
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30/07/2010 |
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Primary sponsor: |
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Public title:
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Pentoxifylline as an add on to SSRIs
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Scientific title:
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The Role of pentoxifylline as an Anti Tumor Necrosis Factor-? In Improving the Outcome of Depressed Elderly Treated With Selective Serotonin Reuptake Inhibitors: a pilot randomized, double-blinded, placebo controlled trial |
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Date of first enrolment:
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2010-07-08 |
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Target sample size:
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40 |
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Recruitment status: |
Open to recruitment: actively recruiting participa |
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URL:
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HTTP://www.pactr.org/ATMWeb/appmanager/atm/atmregistry?da=true&tno=PACTR201008000246399 |
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Study type:
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interventional |
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Study design:
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Parallel: different groups receive different interventions at same time during study,
Randomised,
Block randomisation each block of 4 ,
Numbered containers,
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Countries of recruitment
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South Africa
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Contacts
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Name:
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Ahmed M.
Abdel-tawab |
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Address:
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Department of Pharmacology, Faculty of Medicine, Ain Shams University
Abbassia 11566
Cairo
Egypt |
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Telephone:
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0020-12-3937457 |
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Email:
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amtawab@yahoo.com |
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Affiliation:
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Director, Clinical Pharmacology Unit, Faculty of Medicine, Ain Shams University |
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Name:
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Ahmed M.
Abdel-tawab |
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Address:
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Department of Pharmacology, Faculty of Medicine, Ain Shams University
Abbassia 11566
Cairo
Egypt |
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Telephone:
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0020-12-3937457 |
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Email:
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amtawab@yahoo.com |
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Affiliation:
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Director, Clinical Pharmacology Unit, Faculty of Medicine, Ain Shams University |
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Key inclusion & exclusion criteria
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Inclusion criteria: Age above 60 yrs
Depression according to DSM-IV criteria
At least moderate severity of depression as assessed by HDS and GDS
Exclusion criteria: Liver cell dysfunction by clinical evaluation and ? 3 fold ALT.
Compromised renal function (creatinine clearance less than 50 mL/minute, as estimated by the MDRD calculator).
Reported history of arrhythmias
Use of corticosteroids or high dose of any NSAID in the last 3 months.
Age minimum:
60 Year
Age maximum:
85 Year
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Depression (major depressive episode)
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Primary Outcome(s)
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? Serum TNF-? level measured by ELISA technique.
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? Severity of depression as assessed by Hamilton Depression Rating Scale [HDRS-17] and Geriatric Depression Scale [GDS-30]
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Secondary Outcome(s)
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? The need for augmentation beside SSRI (e.g. another group of antidepressant, ECT)
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The time to response
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Secondary ID(s)
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FAMSU 666/2010
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Source(s) of Monetary Support
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Faculty of Medicine, Ain Shams University
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