Trial of Mirtazapine for Depression in IBD
- Conditions
- Major Depressive DisorderInflammatory Bowel Diseases
- Registration Number
- NCT06309472
- Lead Sponsor
- King's College London
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 76
Inclusion Criteria:<br><br> 1. Established diagnosis of Crohn's disease (CD) or ulcerative colitis (UC) according<br> to clinical notes<br><br> 2. Fulfil Diagnostic and Statistical Manual of Mental Disorders (5th Edition) (DSM-5)<br> criteria for current single or recurrent episodes of major depressive disorder of at<br> least moderate severity but without psychotic features, as defined by the Mini<br> Neuropsychiatric Interview<br><br> 3. Aged 18 years or over<br><br> 4. Use of contraception if female and of childbearing age. Female participants of<br> childbearing age will require a negative serum/urine pregnancy test before starting<br> the study and will also need to agree to use an acceptable form of contraception<br> throughout the intervention period, e.g. oral contraceptive pill, long-acting<br> reversible contraceptive<br><br> 5. Able to provide written informed consent to enter the trial<br><br>Exclusion Criteria:<br><br> 1. Diagnosis of drug or alcohol dependence syndrome according to the General<br> Practitioner (GP) summary care record or yes in answer to the question have you<br> ever been diagnosed with drug or alcohol dependence?<br><br> 2. Diagnosis of any personality disorder according to the GP summary care record or yes<br> in answer to the question have you ever been diagnosed with a personality<br> disorder?<br><br> 3. Diagnosis of any dementia according to the GP summary care record or yes in answer<br> to the question have you ever been diagnosed with any form of dementia?<br><br> 4. Diagnosis of psychosis or schizophrenia according to the GP summary care record or<br> yes in answer to the question have you ever been diagnosed with psychosis or<br> schizophrenia?<br><br> 5. Diagnosis of bipolar disorder according to the GP summary care record or yes in<br> answer to the question have you ever been diagnosed with bipolar disorder?<br><br> 6. Current active suicidal ideation on clinical assessment according to clinical<br> judgment by a study consultant psychiatrist<br><br> 7. Current treatment with mirtazapine, mianserin, trazodone or a monoamine oxidase<br> inhibitor<br><br> 8. Contraindications to the administration of mirtazapine, as per the current summary<br> of product characteristics<br><br> 9. Known allergy to mirtazapine or mianserin according to patient report or clinical<br> notes<br><br> 10. Non-registration with a GP or failure to consent to sharing of the GP summary care<br> record and any psychiatric assessments held<br><br> 11. Currently enrolled in another drug trial or psychological therapy trial<br><br> 12. Currently hospitalised for the treatment of IBD<br><br> 13. Currently being prescribed a course of budesonide or reducing course of prednisolone<br> for IBD<br><br> 14. Planned change in IBD treatment within the next 12 weeks according to clinical notes<br> or answer yes to the question: are you expecting any change in your IBD treatment<br> to take place in the next 12 weeks?
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Recruitment feasibility;Trial adherence;Treatment adherence;Study procedures acceptability and compliance;Overall acceptability
- Secondary Outcome Measures
Name Time Method