Combined Sertraline and Ketoprofen Administration in Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 1

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.

        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.
    

Intervention name(s): Combined Sertraline & Ketoprofen; Interleukins in MDD after treatment
Intervention type(s): Combination Product; Other
Intervention description(s): The first group of patients has administered sertralin (50mg)+placebo. The second group has administered sertralin (50mg)+ketoprofen (100mg) (Sertraline & Ketoprofen) daily.; 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 intervention name(s): Zoloft & Ketoprofen; Effect Ketoprofen & Sertraline on MDD
Intervention MeSH terms: Ketoprofen; Sertraline
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Major depressive disorder; sertraline; ketoprofen