The DEXA-PSYCH Study: Dexamethasone Repurposing for Moderate to Severe Depression - A Double-Blind, Randomized, Parallel-Group, Placebo-Controlled Trial
- Conditions
- DepressionTherapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
- Registration Number
- CTIS2022-501428-45-00
- Lead Sponsor
- Region Hovedstadens Psykiatriske
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 300
Diagnosis of non-psychotic, moderate to severe depressive disorder (single episode or recurrent) by a medical doctor according to ICD-10 criteria (ICD-10 codes: F32.1, F32.2, F33.1, F33.2) as operationalized in the Schedule for Clinical Assessment in Neuropsychiatry (SCAN), Section 6-8, A score of 22 or above on the MADRS10 scale at day 0, Age between 18 and 64 years (both included) at the date of enrollment, Habile (i.e. able to give informed consent), Speaks Danish fluently, Are currently receiving pharmacological treatment for depression
Have a known hypersensitivity to glucocorticoid treatment (including any drug in the glucocorticoid class) either explicitly stated in the patient journal or known to the patient from prior glucocorticoid treatment, Are currently undergoing treatment with potassium-depleting diuretics, Are currently undergoing immunosuppressive treatments or treatments affecting the CYP3A4 system (i.e. erythromycin, itraconazole, ritonavir, lopinavir, phenobarbital, phenytoin, rifampicin), Have undergone treatment with monoamine oxidase (MAO) inhibitors in the last 14 days, Are pregnant (i.e. fertile woman below 60 with a positive urine or plasma human gonadotropin test), currently breast-feeding or not adherent to a sufficient anticontraceptive plan, Are undergoing or have undergone systemic (oral or intravenous) treatment with any drug in the glucocorticoid class within the last 14 days, Have previously been diagnosed with a psychotic disorder (including depression with psychotic symptoms), personality disorder, eating disorder or bipolar disorder, Have experienced or are experiencing manic and/or hypomanic episodes as uncovered according to section 10 of the SCAN assessment, Are currently using psychoactive substances and fulfill ICD-10 criteria for harmful use (F1X.1) or dependence syndrome (F1X.2.), Have a known 1st degree family history of bipolar disorder (i.e. among parents, siblings and children), Are diagnosed with disorders that are listed as contra-indications for glucocorticoid treatment in Danish guidelines including immunodeficiencies, systemic fungal infections, active tuberculosis, hematological malignancies, epilepsy, myasthenia gravis, ocular herpes simplex, pheochromocytoma, systemic sclerosis or acute coronary syndrome (within the last 6 months), Have prolonged QTc-interval on ECG (>480 ms), Have clinically significant reduction in liver function (ALT >2.5 x upper limit of normal range, ULN: men >70 U/l, women >45 U/l), Have diagnosed diabetes mellitus or suspected diabetes mellitus (as measured by HbA1c of >45 mmol/mol), Have suicidal plans, Have undergone electroconvulsive treatment (ECT) or transcranial magnetic stimulation (TMS) within the last 2 weeks, Have been vaccinated within 14 days before intervention initiation or is planning on being vaccinated during the intervention or within 14 days after the vaccination
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method