search
Back to results

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
Kufa University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Major depressive disorder, sertraline, ketoprofen

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    April 13, 2018
    Last Updated
    May 1, 2018
    Sponsor
    Kufa University
    search

    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

    We'll reach out to this number within 24 hrs