Clinical trial NCT03514810: Combined Sertraline and Ketoprofen Administration in Major Depressive Disorder
Official title: Combined Sertraline and Ketoprofen Administration in Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Major Depressive Disorder
Keywords: Major depressive disorder
sertraline
ketoprofen
Lead sponsor: Kufa University
Sponsor class: OTHER
First posted: 2018-05-02
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

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

Primary outcomes:
measure: Reduction in the Beck Depression Inventory-II Score
timeFrame: 12 months
Secondary outcomes:
measure: Decrease in Serum of IL-1β, IL-6, and IL-18 Levels
timeFrame: 12 months
measure: Body mass index (BMI)
timeFrame: 2 months
Other outcomes:
Locations:
Study officials:
affiliation: Head of Department of Psychiatry
name: Arafat H Al-dujaili, PhD
role: PRINCIPAL_INVESTIGATOR
References: