None listed
Conditions
Brief summary
The study is a randomised controlled treatment (RCT) trial over 8 weeks in individuals with Major Depressive Disorder, with a 6 month post-RCT trial period, where study participants have the option to continue Vortioxetine. The purpose of the study is to investigate the effectiveness of using a simple blood test, prior to treatment of depression, to guide the use of anti-inflammatory medication as an addition to antidepressant medication. The study aims to find out whether adding the anti-inflammatory medication Celecoxib (also known as Celebrex) to the antidepressant medication Vortioxetine (also known as Brintellix) can improve symptoms of depression. There is evidence that raised levels of inflammatory markers in the blood are associated with depression. The study measures the inflammatory marker C-reactive protein (CRP) prior to commencing treatment, with study participants assigned to a study "arm" based on CRP levels. Within each study "arm", participants receive treatment for 6 weeks, with either Vortioxetine plus Celecoxib, or Vortioxetine plus placebo. Levels of circulating inflammatory markers, tests of cognitive function, and depression symptoms are measured at baseline (before treatment) and again at the end of this 6 week treatment period.
Interventions
This study is a randomised controlled treatment (RCT) trial over 8 weeks, with a 6 month post-RCT trial period, where study participants have the option to continue Vortioxetine in the post-RCT trial period. The study aims to investigate whether the use of a blood test of inflammation levels, prior to antidepressant treatment, can improve treatment of depression by guiding the decision to add anti-inflammatory medication to antidepressant treatment. Specifically, the study aims to find out whether adding the anti-inflammatory medication Celecoxib to the antidepressant medication Vortioxetine can improve symptoms of depression. At the start of the study, participants would undergo a blood test to measure levels of the inflammatory marker C-reactive protein (CRP). For CRP, a cut-off level of 3mg/L will be used to determine whether participants are assigned to the "Depression with inflammation" arm, or to the "Depression without inflammation" arm. Within each study arm, participants would then be randomly assigned to 6 weeks of treatment with Vortioxetine plus Celecoxib, or Vortioxetine plus placebo. All study medications are oral tablets. The dose of Vortioxetine is initially 5 mg daily in those receiving Celecoxib, with an option to increase to Vortioxetine 10mg daily 2 weeks into the study (after review by the Psychiatrist, and if it is thought this dose may benefit the study participant). The planned dose of Celecoxib is 400mg daily. Study participants will be asked at each visit if any doses of study medication have been missed.
Sponsors
Study design
Eligibility
Inclusion criteria
1. The study participant is willing and able to provide informed consent. 2. Age 18 – 75 years of age. 3. Diagnosis of a Major Depressive Episode (MDE) as part of Major Depressive Disorder (MDD), using DSM-5 criteria. 4. Montgomery Asberg Depression Rating Scale (MADRS) score greater than or equal to 26 at screening visit and baseline. 5. Duration of the current MDE is at least 3 months. 6. Use of a previous treatment in at least one prior episode of depression
Exclusion criteria
1. Presence of a co-morbid psychiatric disorder other than MDD that is a focus of clinical concern as confirmed by the Mini International Neuropsychiatric Interview (MINI). 2. A known relevant inflammatory or immune-related disorder such as rheumatoid arthritis, colitis, clinically significant asthma, multiple sclerosis, SLE, acute infections or fever. 3. A known neurodegenerative disease 4. Any medication for a general medical disorder that may affect cognitive function 5. Electroconvulsive therapy (ECT) within the last 6 months. 6. The study participant has reported having received investigational agents as part of a separate study within 30 days of the screening visit. 7. Contraindications to the study drugs