Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201008000246399 Date of Approval: 30/07/2010
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Pentoxifylline as an add on to SSRIs
Official scientific title 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
Brief summary describing the background and objectives of the trial It is speculated that depression is associated with increased levels of inflammatory cytokines, mainly, IL-6 and TNF-¿. Pentoxifylline, reportedly decreases synthesis of TNF-¿. The aim is to study the effect of pentoxifylline as an add-on to SSRIs, so as to enhance the clinical outcome of depressed elderly patients. The clinical outcome will be assessed using HDS and GDS. The serum levels of TNF-¿ will be measured before and after treatments.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Depression ,Mental and Behavioural Disorders
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/07/2010
Actual trial start date 08/07/2010
Anticipated date of last follow up 31/12/2010
Actual Last follow-up date
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
FAMSU 666/2010 Research Ethics Committee, Faculty of Medicine, Ain Shams Univserity, Cairo, Egypt FWA000064444
FAMSU 666/2010 Research Ethics Committee, Faculty of Medicine, Ain Shams Univserity, Cairo, Egypt FWA000064444
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Block randomisation each block of 4 Numbered containers Masking/blinding used
Parallel: different groups receive different interventions at same time during study Randomised Block randomisation each block of 4 Numbered containers Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group SSRI + Placebo Two tablets of placebo per day. SSRI according to standard 3 months Patients will receive palcebo instead of pentoxifylline besides the standard SSRI treatment 20 Placebo
Experimental Group SSRI + pentoxifylline pentoxifylline: 400 mg/ twice daily 3 months Patients will receive pentoxifylline (400 mg b.i.d) as an add on to standard SSRI treatment. This will continue for the whole trial period (3 months) 20 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Age above 60 yrs Depression according to DSM-IV criteria At least moderate severity of depression as assessed by HDS and GDS 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. 60 Year(s) 85 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 13/07/2010 REC, Faculty of Medicine, Ain Shams University. FWA 00006444
Ethics Committee Address
Street address City Postal code Country
Faculty of Medicine, Ain Shams University, Abbassia, CAiro, Egypt Cairo 11566 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome ¿ Serum TNF-¿ level measured by ELISA technique. Before starting intervention After 3 months of intervention
Primary Outcome ¿ Severity of depression as assessed by Hamilton Depression Rating Scale [HDRS-17] and Geriatric Depression Scale [GDS-30] Before intervention After 6 weeks of intervention After 3 months of intervention
Secondary Outcome ¿ The need for augmentation beside SSRI (e.g. another group of antidepressant, ECT) After 6 weeks of intervention
Secondary Outcome The time to response After 6 and 12 weeks of intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ain Shams University Hospitals Abbassia Cairo 11566 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Faculty of Medicine, Ain Shams University Faculty of Medicine, Ain Shams University Cairo Abbassia 11566 Egypt
Faculty of Medicine, Ain Shams University Faculty of Medicine, Ain Shams University Cairo Abbassia 11566 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Medicine, Ain Shams University Faculty of Medicine, Ain Shams University Cairo Abbassia 11566 Egypt University
Primary Sponsor Faculty of Medicine, Ain Shams University Faculty of Medicine, Ain Shams University Cairo Abbassia 11566 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Ahmed M. Abdel-tawab Department of Pharmacology, Faculty of Medicine, Ain Shams University Cairo Abbassia 11566 Egypt
Ahmed M. Abdel-tawab Department of Pharmacology, Faculty of Medicine, Ain Shams University Cairo Abbassia 11566 Egypt
Mohammed Hassan El-banoby Geriatric Medicine- Faculty of Medicine, Ain Shams University Cairo Abbassia 11566 Egypt
Mohammed Hassan El-banoby Geriatric Medicine- Faculty of Medicine, Ain Shams University Cairo Abbassia 11566 Egypt
Abeer Mahmoud Eissa Department of Psychiatry, Faculty of Medicine, Ain Shams University Cairo Abbassia 11566 Egypt
Abeer Mahmoud Eissa Department of Psychiatry, Faculty of Medicine, Ain Shams University Cairo Abbassia 11566 Egypt
Hany Ibrahim Hassanin Ibrahim Geriatric Medicine Department - Faculty of Medicine, Ain Shams University Cairo Abbassia 11566 Egypt
Hany Ibrahim Hassanin Ibrahim Geriatric Medicine Department - Faculty of Medicine, Ain Shams University Cairo Abbassia 11566 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed M. Abdel-tawab amtawab@yahoo.com 0020-12-3937457 Department of Pharmacology, Faculty of Medicine, Ain Shams University
City Postal code Country Position/Affiliation
Cairo Abbassia 11566 Egypt Director, Clinical Pharmacology Unit, Faculty of Medicine, Ain Shams University
Role Name Email Phone Street address
Public Enquiries Ahmed M. Abdel-tawab amtawab@yahoo.com 0020-12-3937457 Department of Pharmacology, Faculty of Medicine, Ain Shams University
City Postal code Country Position/Affiliation
Cairo Abbassia 11566 Egypt Director, Clinical Pharmacology Unit, Faculty of Medicine, Ain Shams University
Role Name Email Phone Street address
Scientific Enquiries Ahmed M. Abdel-tawab amtawab@yahoo.com 0020-12-3937457 Department of Pharmacology, Faculty of Medicine, Ain Shams University
City Postal code Country Position/Affiliation
Cairo Abbassia 11566 Egypt Director, Clinical Pharmacology Unit, Faculty of Medicine, Ain Shams University
REPORTING
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