Combined Sertraline and Ketoprofen Administration in Major Depressive Disorder

NCT03514810 | Completed Phase 1 DMC

• 2 other identifiers: KufaUArafataldujaili
• Study Type: interventional
• Target: 28
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Major Depressive Disorder

Keywords

Major depressive disorder; sertraline; ketoprofen

Outcome Measures

Primary Outcomes (1)

• 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

  12 months

Secondary Outcomes (2)

• Decrease in Serum of IL-1β, IL-6, and IL-18 Levels

  12 months

• Body mass index (BMI)

  2 months

Study Arms (2)

Sertralin & Ketoprofen in MDD

PLACEBO COMPARATOR

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; Other: Interleukins in MDD after treatment

Interleukins in MDD after treatment

EXPERIMENTAL

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; Other: Interleukins in MDD after treatment

Interventions

Combined Sertraline & Ketoprofen COMBINATION_PRODUCT

The first group of patients has administered sertralin (50mg)+placebo. The second group has administered sertralin (50mg)+ketoprofen (100mg) (Sertraline \& Ketoprofen) daily.

Also known as: Zoloft & Ketoprofen

Interleukins in MDD after treatment; Sertralin & Ketoprofen in MDD

Interleukins in MDD after treatment OTHER

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).

Also known as: Effect Ketoprofen & Sertraline on MDD

Interleukins in MDD after treatment; Sertralin & Ketoprofen in MDD

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Patients with any systemic disease particularly diabetes, liver disease, and renal disease
• Patients with positive CRP
• Patients who taking any other drugs

Sponsors & Collaborators

• Kufa University: lead

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Ketoprofen; Sertraline; Interleukins

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; 1-Naphthylamine; Amines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Arafat H Al-dujaili, PhD

  Head of Department of Psychiatry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 13, 2018
• First Posted: May 2, 2018
• Study Start: January 10, 2017
• Primary Completion: September 10, 2017
• Study Completion: December 31, 2017
• Last Updated: May 3, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share