Effect of addition of anti-inflammatory medication to anti-depressant medication in the treatment of depressio
- Conditions
- DepressionMental Health - Depression
- Registration Number
- ACTRN12617000527369
- Lead Sponsor
- Professor Bernhard Baune
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Stopped early
- Sex
- All
- Target Recruitment
- 122
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in MADRS, with a primary endpoint of proportion of study participants with a score reduction by 50% from baseline to 6 weeks (end of treatment).[Baseline (before treatment) and 6 weeks (end of treatment)]
- Secondary Outcome Measures
Name Time Method