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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: www.pactr.org

Trial no.: PACTR201008000246399 Date registered: 2010/07/30
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
Purpose of the trial Treatment
Anticipated trial start date 2010-07-01
Actual trial start date 2010-07-08
Anticipated date of last follow up 2010-12-31
Actual date of last follow up
Anticipated target sample size (number of participants) 40   
Actual target sample size (number of participants)   
Recruitment status Open to recruitment: actively recruiting participants
Secondary Ids Issuing authority/Trial register Links to Secondary ID
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

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 Min age Max 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 Years 85 Years 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 2010/07/13 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
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
Hany Ibrahim Hassanin Ibrahim Geriatric Medicine Department - 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
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

CONTACT PEOPLE
Role Name Email Phone Fax
Principal Investigator Prof Ahmed M. Abdel-tawab amtawab@yahoo.com 0020-12-3937457
Street address City Postal code Country Position / Affiliation
Department of Pharmacology, Faculty of Medicine, Ain Shams University Cairo Abbassia 11566 Egypt Director, Clinical Pharmacology Unit, Faculty of Medicine, Ain Shams University
Role Name Email Phone Fax
Public Enquiries Prof Ahmed M. Abdel-tawab amtawab@yahoo.com 0020-12-3937457
Street address City Postal code Country Position / Affiliation
Department of Pharmacology, Faculty of Medicine, Ain Shams University Cairo Abbassia 11566 Egypt Director, Clinical Pharmacology Unit, Faculty of Medicine, Ain Shams University
Role Name Email Phone Fax
Scientific Enquiries Prof Ahmed M. Abdel-tawab amtawab@yahoo.com 0020-12-3937457
Street address City Postal code Country Position / Affiliation
Department of Pharmacology, Faculty of Medicine, Ain Shams University Cairo Abbassia 11566 Egypt Director, Clinical Pharmacology Unit, Faculty of Medicine, Ain Shams University