2022-501428-45-00招募中3 期
The DEXA-PSYCH Study: Dexamethasone Repurposing for Moderate to Severe Depression - A Double-Blind, Randomized, Parallel-Group, Placebo-Controlled Trial
Region Hovedstadens Psykiatriske1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2022年10月12日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Change from baseline (day 0) on the Montgomery-Asberg Depression Rating Scale (MADRS-10) at day 7.
研究概览
简要总结
The objective of the DEXA-PSYCH trial is to test the efficacy and safety of dexamethasone, a well-tolerated glucocorticoid, as add-on to treatment as usual (TAU) in treatment of moderate to severe depression.
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
-
Auxiliary
Participants receiving -
干预措施: - (Drug)
结局指标
主要结局
Change from baseline (day 0) on the Montgomery-Asberg Depression Rating Scale (MADRS-10) at day 7.
Change from baseline (day 0) on the Montgomery-Asberg Depression Rating Scale (MADRS-10) at day 7.
次要结局
- Number of participants with remission (MADRS10 score less than or equal to 11) on day 7
- Change in quality of life as measured by change from baseline (day 0) on the EQ-5D-5L on day 7.
- Safety outcomes (ARs (including SARs) occurring on or before day 10, all-cause discontinuation, vital signs, suicidal ideation (C-SSRS, day 7), laboratory tests, ECG, toxicity (GTI, day 7), side-effects of antidepressant (UKU-SSRI, day 7), positive psychotic symptoms (SAPS, day 7), manic symptoms (YMRS, day 7), admission (somatic and psychiatric, day 28), suicide attempts and completed suicides (day 28), all-cause mortality (day 28)
- Change from baseline (day 0) on the MADRS10 at day 4, 14 and 28.
- Change from baseline (day 0) on the Hamilton Depression Rating Scale (HAM-D6 and HAM-D17) on day 7 and 28 and at 6-months follow-up.
- Relative risk of being unemployed or on full time sick leave at day 7, day 28 and at 6-months follow-up (as assessed through patient interviews) as well as beyond (as assessed through national Danish registers).
- Change in quality of life as measured by change from baseline (day 0) on the EQ-5D-5L on day 28 and at 6-months follow up.
- Change in suicidal ideation as measured by change from baseline (day 0) on the Columbia-Suicide Severity Rating Scale (C-SSRS) on day 28 and at 6-months follow up.
- Number of participants with remission (MADRS10 score less than or equal to 11) at 6-month follow up.
- Relative risk of admissions due to psychiatric illness before 6-months follow-up (as assessed through patient interview and electronic health records) as well as beyond (as assessed through national Danish registers).
- Relative risk of suicide attempts before 6-months follow-up (as assessed through patient interview and electronic health records) as well as beyond (as assessed through national Danish registers).
- All-cause mortality at 6-months follow-up (as assessed through electronic health records) as well as beyond (as assessed through national Danish registers).
- Change in anxiety symptoms as measured by change from baseline (day 0) on the Hamilton Anxiety Rating Scale (HAM-A) on day 7, 28 and at 6 months follow-up.
- Change in functioning as measured by change from baseline (day 0) on the Global Assessment of Functioning (GAF) scale on day 7, 28 and at 6 months follow-up.
- Change from baseline (day 0) on MDI on day 7 and 28 and at 6-months follow-up.
- Baseline levels of CRP and leucocytes in responders and non-responders as well as other biochemical markers assayed in biological samples.
- General level of physical and social activity as measured in the Monsenso app day 1- 28
- Change in fatigue as measured by change from baseline (day 0) on the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scale on day 7, 28 and at 6 months follow up.
- Number of participants with response (MADRS10 score <50 % of the score at day 0) on day 7
- Change from baseline (day 0) on the MADRS10 at 6-months follow up.
- Change from baseline (day 0) on the MADRS6 at day 4, 7, 14 and 28 and at 6-months follow up.
- Self-rated MADRS scores on day 1-28 based on data collection in the Monsenso app.
研究者
Michael Eriksen Benros
Scientific
Region Hovedstadens Psykiatriske
研究点 (1)
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