ClinicalTrials.gov
ClinicalTrials.gov Menu

Combined Sertraline and Ketoprofen Administration in Major Depressive Disorder (Srt+ktpMDD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03514810
Recruitment Status : Completed
First Posted : May 2, 2018
Last Update Posted : May 2, 2018
Sponsor:
Information provided by (Responsible Party):
Hussein Kadhem Al-Hakeim, Kufa University

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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Combination Product: Combined Sertraline & Ketoprofen Other: Interleukins in MDD after treatment Phase 1

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.

  1. 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.

  2. 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Combined Sertraline and Ketoprofen Administration in Major Depressive Disorder
Actual Study Start Date : January 10, 2017
Actual Primary Completion Date : September 10, 2017
Actual Study Completion Date : December 31, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Sertralin & Ketoprofen in MDD
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.
Combination Product: Combined Sertraline & Ketoprofen
The first group of patients has administered sertralin (50mg)+placebo. The second group has administered sertralin (50mg)+ketoprofen (100mg) (Sertraline & Ketoprofen) daily.
Other Name: Zoloft & Ketoprofen

Other: Interleukins in MDD after treatment
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).
Other Name: Effect Ketoprofen & Sertraline on MDD

Experimental: Interleukins in MDD after treatment
Some Interleukines level were estimated before and after treatment with sertralin 50 mg in combination with either placebo or ketoprofen 100mg daily.
Combination Product: Combined Sertraline & Ketoprofen
The first group of patients has administered sertralin (50mg)+placebo. The second group has administered sertralin (50mg)+ketoprofen (100mg) (Sertraline & Ketoprofen) daily.
Other Name: Zoloft & Ketoprofen

Other: Interleukins in MDD after treatment
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).
Other Name: Effect Ketoprofen & Sertraline on MDD




Primary Outcome Measures :
  1. Reduction in the Beck Depression Inventory-II Score [ Time Frame: 12 months ]

    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 :
  1. Decrease in Serum of IL-1β, IL-6, and IL-18 Levels [ Time Frame: 12 months ]

    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.


  2. Body mass index (BMI) [ Time Frame: 2 months ]

    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




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03514810


Sponsors and Collaborators
Kufa University
Investigators
Principal Investigator: Arafat H Al-dujaili, PhD Head of Department of Psychiatry

Responsible Party: Hussein Kadhem Al-Hakeim, Professor, Kufa University
ClinicalTrials.gov Identifier: NCT03514810     History of Changes
Other Study ID Numbers: KufaU
Arafataldujaili ( Other Identifier: College of Science )
First Posted: May 2, 2018    Key Record Dates
Last Update Posted: May 2, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Direct contact on my e-mail:headm2010@yahoo.com

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

Keywords provided by Hussein Kadhem Al-Hakeim, Kufa University:
Major depressive disorder
sertraline
ketoprofen

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Disease
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Sertraline
Ketoprofen
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors