Combined Sertraline and Ketoprofen Administration in Major Depressive Disorder (Srt+ktpMDD)
Primary Purpose
Major Depressive Disorder
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Combined Sertraline & Ketoprofen
Interleukins in MDD after treatment
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder focused on measuring Major depressive disorder, sertraline, ketoprofen
Eligibility Criteria
Inclusion Criteria:
- The patients were diagnosed by psychiatrists in accordance ICD10 as having major depressive disorder.
- The patients had no existing systemic disease that may affect the parameters to be diagnosed.
- Patients with negative serum C-reactive protein (CRP<6 mg/L).
Exclusion Criteria:
- Patients with any systemic disease particularly diabetes, liver disease, and renal disease
- Patients with positive CRP
- Patients who taking any other drugs
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Sertralin & Ketoprofen in MDD
Interleukins in MDD after treatment
Arm Description
To compare the median of Beck Depression Inventory-II (BDI-II) score of MDD patients after treatment with sertralin (50mg) daily+placebo and after treatment with combination of (sertralin & ketoprofen) for two months.
Some Interleukines level were estimated before and after treatment with sertralin 50 mg in combination with either placebo or ketoprofen 100mg daily.
Outcomes
Primary Outcome Measures
Reduction in the Beck Depression Inventory-II Score
BDI-II is a 21-item self-report scale measuring current depressive symptoms. The standardized cutoffs used differ from the original:
0-13: minimal depression
14-19: mild depression
20-28: moderate depression
29-63: severe depression. Reduction in the Beck Depression Inventory-II Score by Combined Sertraline and Ketoprofen Administration in Major Depressive Disorder
Secondary Outcome Measures
Decrease in Serum of IL-1β, IL-6, and IL-18 Levels
Decrease in Serum of IL-1β, IL-6, and IL-18 Levels by Combined Sertraline and Ketoprofen Administration in Major Depressive Disorder.
All these cytokines were measured using ng/ml unit.
Body mass index (BMI)
Body mass index (BMI) is a measure for obesity and low weight measure. It is chosen because the MDD patients have a change in appetite and monitoring the weight is importany indication of normal appetite and cure. BMI Categories:
Underweight = <18.5 Normal weight = 18.5-24.9 Overweight = 25-29.9 Obesity = BMI of 30 or greater
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03514810
Brief Title
Combined Sertraline and Ketoprofen Administration in Major Depressive Disorder
Acronym
Srt+ktpMDD
Official Title
Combined Sertraline and Ketoprofen Administration in Major Depressive Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
January 10, 2017 (Actual)
Primary Completion Date
September 10, 2017 (Actual)
Study Completion Date
December 31, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kufa University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Among the major depressive disorder (MDD) patients in the follow-up group, 16 were administered with 50 mg of oral sertralin once daily with placebo, whereas 28 were treated with 100 mg of ketoprofen once daily as adjuvant treatment for MDD. Controls do not take any medicine.
Detailed Description
The research is a prospective, 2-month, double-blind study of parallel groups of patients with MDD with or without ketoprofen administration in addition to sertralin.
Patients: A total of 140 patients with MDD (78 male and 62 female; aged 18-65 years) participated in the study. Two samples were obtained at the beginning and 2 months after treatment from 34 patients that were followed up for two months after treatment. The samples were collected from "The Psychiatry Unit" at Al-Hakeem General Hospital in Najaf Governorate-Iraq from November 2016 to August 2017. Patient samples were also obtained from a private psychiatric clinic that was run by an assistant professor in psychiatric medicine. The patients were diagnosed by psychiatrists in accordance with a semi-structured psychiatric interview schedule for MDD diagnosis based on the 10th revision of the International Statistical Classification of Diseases and Related Health Problems. The full medical histories of the patients were evaluated such that any existing systemic disease that may affect the parameters to be diagnosed, particularly diabetes, liver disease, and renal disease, were excluded. Patients with histories of these diseases were excluded from the study. Serum C-reactive protein (CRP) was negative in all of the samples (CRP<6 mg/L). This test was conducted to exclude the presence of any overt infection or inflammation that may elevate acute-phase-reactant proteins, especially CRP. The protocol was approved by the IRB of the University of Kufa. The patients or their close first-degree relatives provided informed consent in accordance with the procedures outlined by the current IRB.
Among the patients in the follow-up group, 16 were administered with 50 mg of oral sertralin once daily with placebo, whereas 28 were treated with 100 mg of ketoprofen once daily as adjuvant treatment for MDD.
Controls: As part of the control group, 40 apparently healthy subjects (22 males and 18 females) were selected. Their sex and age were matched with those of the patients. These subjects were apparently free from psychiatric and somatic diseases.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
Major depressive disorder, sertraline, ketoprofen
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sertralin & Ketoprofen in MDD
Arm Type
Placebo Comparator
Arm Description
To compare the median of Beck Depression Inventory-II (BDI-II) score of MDD patients after treatment with sertralin (50mg) daily+placebo and after treatment with combination of (sertralin & ketoprofen) for two months.
Arm Title
Interleukins in MDD after treatment
Arm Type
Experimental
Arm Description
Some Interleukines level were estimated before and after treatment with sertralin 50 mg in combination with either placebo or ketoprofen 100mg daily.
Intervention Type
Combination Product
Intervention Name(s)
Combined Sertraline & Ketoprofen
Other Intervention Name(s)
Zoloft & Ketoprofen
Intervention Description
The first group of patients has administered sertralin (50mg)+placebo. The second group has administered sertralin (50mg)+ketoprofen (100mg) (Sertraline & Ketoprofen) daily.
Intervention Type
Other
Intervention Name(s)
Interleukins in MDD after treatment
Other Intervention Name(s)
Effect Ketoprofen & Sertraline on MDD
Intervention Description
Some interleukine levels were estimated in the first group of patients (administered sertralin,50mg+ketoprofen,100mg) and compared with their level in the second group (administered sertralin (50mg)+placebo).
Primary Outcome Measure Information:
Title
Reduction in the Beck Depression Inventory-II Score
Description
BDI-II is a 21-item self-report scale measuring current depressive symptoms. The standardized cutoffs used differ from the original:
0-13: minimal depression
14-19: mild depression
20-28: moderate depression
29-63: severe depression. Reduction in the Beck Depression Inventory-II Score by Combined Sertraline and Ketoprofen Administration in Major Depressive Disorder
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Decrease in Serum of IL-1β, IL-6, and IL-18 Levels
Description
Decrease in Serum of IL-1β, IL-6, and IL-18 Levels by Combined Sertraline and Ketoprofen Administration in Major Depressive Disorder.
All these cytokines were measured using ng/ml unit.
Time Frame
12 months
Title
Body mass index (BMI)
Description
Body mass index (BMI) is a measure for obesity and low weight measure. It is chosen because the MDD patients have a change in appetite and monitoring the weight is importany indication of normal appetite and cure. BMI Categories:
Underweight = <18.5 Normal weight = 18.5-24.9 Overweight = 25-29.9 Obesity = BMI of 30 or greater
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
The patients were diagnosed by psychiatrists in accordance ICD10 as having major depressive disorder.
The patients had no existing systemic disease that may affect the parameters to be diagnosed.
Patients with negative serum C-reactive protein (CRP<6 mg/L).
Exclusion Criteria:
Patients with any systemic disease particularly diabetes, liver disease, and renal disease
Patients with positive CRP
Patients who taking any other drugs
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arafat H Al-dujaili, PhD
Organizational Affiliation
Head of Department of Psychiatry
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Direct contact on my e-mail:headm2010@yahoo.com
Learn more about this trial
Combined Sertraline and Ketoprofen Administration in Major Depressive Disorder
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