Evaluation of sertraline effects on the time of engraftmen and serum levels of such inflammatory and anti-inflammatory factors as IL-6, CRP and IL-10 in depressed HSCT patients
The main aim of this study is to evaluate the effect of sertraline on the time of engraftment as well as the anti-inflammatory effect of sertraline in depressed or anxious patients undergoing Hematopoietic stem cell transplantation ( HSCTs) . To this aim, forty adult patients with depression or anxiety based on the initial diagnosis by psychiatric and also the results of the filled in questionnaire of Hospital Anxiety & Depression Scale (HADS) are randomized to receive sertraline (100 mg orally once daily) (n =20) or placebo (n = 20) for 3 month duration. Blood sampling are performed at baseline (before starting sertraline) and 4 and 8 weeks after sertraline and placebo treatment. Inflammatory and anti-inflammatory cytokines such as IL-6 (Interleukin 6) and IL-10 (Interleukin 10) and also hs-CRP (high sensitivity C-reactive protein) are measured for all patients. Also after beginning the treatment in weeks 2, 4, 8 and 12 anti-depression response to treatment again will be evaluated using HADS questionnaire. Furthermore, to evaluate the effect of sertraline on the time of engraftment, white blood cell (WBC) and platelet will be recorded daily after transplantation until engraftment. Adverse outcomes and complications induced by medications and transplantation such as nausea , vomiting , mucositis ,VOD (veno-occlusive disease) , seizure and aGVHD (acute graft-versus-host disease) after transplantation will be evaluated too. Demographic & clinical data including the underlying disease that has led to transplantation , current medications, the most recent laboratory values and co-morbidities are obtained from the patient’s medical records.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201310083210N4
Registration date:2013-12-11, 1392/09/20
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-12-11, 1392/09/20
Registrant information
Name
Maria Tavakoli Ardakani
Name of organization / entity
Faculty of pharmacy, Shaid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8887 3704
Email address
mariatavakoli@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Sciences
Tehran
Iran
Iran, Islamic Republic Of
Expected recruitment start date
2013-09-23, 1392/07/01
Expected recruitment end date
2014-05-22, 1393/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of sertraline effects on the time of engraftmen and serum levels of such inflammatory and anti-inflammatory factors as IL-6, CRP and IL-10 in depressed HSCT patients
Public title
Evaluation of sertraline in depressed or anxious HSCT patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age between 18 to 60 years for allo-HSCT and auto-HSCT; presence of depression or based on Hospital Anxiety & Depression Scale (HADS) ; Stable & normal renal and liver function and ; Ability for oral taking of medication . Exclusion criteria: Patients with baseline kidney dysfunction (GFR less than 60 mL/min) ;Patients with abnormal LFT (bilirubin & aminotransferases level of more than 2 normal) ; Patient with sepsis or uncontrolled infection at baseline ; Patients unable to take orally ; Non-cooporable patients with mental dysfunctionality ; pregnant or lactating women ; HIV+ patients ; Patients who who have taken antidepressant medication later than a month ago ;Intolerance of Sertraline adverse effects.
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Behesti University Of Medical Sciences
Street address
Valiasr street
City
Tehran
Postal code
0098
Approval date
2013-10-29, 1392/08/07
Ethics committee reference number
253
Health conditions studied
1
Description of health condition studied
Depression and anxiety
ICD-10 code
F32,F41.1
ICD-10 code description
Depressive episode,Generalized anxiety disorder
Primary outcomes
1
Description
Depression
Timepoint
Baseline 2 ,4, 8 and 12 weeks after
Method of measurement
Hospital Anxiety and Depression Scale (HADS) questionnaire
2
Description
Anxiety
Timepoint
Baseline 2 ,4, 8 and 12 weeks after
Method of measurement
Hospital Anxiety and Depression Scale (HADS) questionnaire
3
Description
IL-10 Inflammatort biomarker
Timepoint
Baseline, 2 and 4weeks after
Method of measurement
serum level pg/ml
4
Description
IL-6 inflammatory biomarker
Timepoint
Baseline, 4 and 8 weeks after
Method of measurement
Serum level pg / mL
5
Description
Hs-CRP inflammatory biomarker
Timepoint
Baseline, 4 and 8 weeks after
Method of measurement
Serum level mg / dl
Secondary outcomes
1
Description
engraftment time
Timepoint
Daily until absolute neutrophil count (ANC) more than 500 and platelet more than 20000 for 3 consecutive days
Method of measurement
Cell blood count(CBC)
Intervention groups
1
Description
Control group: Placebo 50 to 100 mg orally per day for 90 days
Category
Placebo
2
Description
Intervention group: sertraline 50 to 100mg orally per day for 90 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Bone Marrow Transplantation center of Tehran Taleghani Hospital
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
School of pharmacy,Research of deputy ,Shahid Beheshti University Of Medical Sciences
Full name of responsible person
Shams
Street address
Valiasr
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
School of pharmacy,Research of deputy ,Shahid Beheshti University Of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Maryam Mehrpooya
Position
PharmD, Resident of Clinical Pharmacy
Other areas of specialty/work
Street address
Department of Clinical Pharmacy (Pharmacotherapy), Pharmacy Faculty, Shahid Beheshti University of Medical Sciences
City
Tehran
Postal code
Phone
+98 918 316 3926
Fax
Email
m_mehrpooya2003@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Maria Tavakoli - Ardakani
Position
PharmD, BCPS, Associate Professor
Other areas of specialty/work
Street address
Department of Clinical Pharmacy (Pharmacotherapy), Pharmacy Faculty, Shahid Beheshti University of Medical Sciences
City
Tehran
Postal code
Phone
+98 21 8820 0085
Fax
Email
Mariatavakoli@sbmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Maryam Mehrpooya
Position
PharmD, Resident of Clinical Pharmacy
Other areas of specialty/work
Street address
Department of Clinical Pharmacy (Pharmacotherapy), Pharmacy Faculty, Shahid Beheshti University of Medical Sciences
City
Tehran
Postal code
Phone
00
Fax
Email
m_mehrpooya2003@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)