EUCTR2018-002947-27-DE进行中（未招募）1 期
Simvastatin add-on to Escitalopram in patients with comorbid obesity and major depression: A multicenter, randomized, double-blind, placebo-controlled trial
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 160
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Written informed consent is present
- •- The patient has the capacity to give consent (He/she is able to understand the nature and anticipated effects/side effects of the proposed medical intervention)
- •- The patient has a major depressive episode according to DSM 5 (Diagnostic and Statistical Manual of Mental Disorders 5th Edition)
- •- The patient has a score of = 18 in the Montgomery-Asberg Depression Rating Scale (MADRS)
- •- The patient has a body mass index = 30
- •- The patient’s age is between 18 and 65 years (= 18 und = 65)
- •- The patient has not given childbirth within the 6 months prior to study entry and is not breastfeeding
- •- In case of non-psychotropic medication: The patient received stable pharmacological medication for at least 14 days prior to study entry (any changes in medication dose or frequency of therapy must be answered with no)
- •- The patient did not take antidepressants during the last 7 days prior to study entry (discontinuation of effective medication to enable study participation is prohibited)
- •- The patient did not receive prior treatment with Escitalopram in index episode
- •- The patient had less than three (<3) trials with antidepressants in index episode
- •- The patient does not have a history of non-response to Escitalopram
- •- The patient did not receive treatment with ketamine, electroconvulsive therapy (ECT) or other stimulatory treatments in index episode
- •- The patient does not meet any of the following criteria:
- •- schizophrenia
- •- schizoaffective disorder
- •- bipolar disorder
- •- The patient is not diagnosed with dementia and does not have moderate or severe impairment of general cognitive function according to clinical impression
- •- The patient does not have clinically relevant elevated liver enzymes [GOT or GPT > 3 x upper limit normal (ULN)] and does not have elevated Carbohydrate Deficient Transferrin (CDT) = 2.4 %
- •- The patient does not meet the criteria for alcohol use disorder (DSM-5: 303.90; ICD-10: F10.20) or substance use disorder (DSM-5: 304; ICD-10: F11.20 – F19.20) in M.I.N.I. for DSM-5 and a urine/serum drug screening is negative (except for benzodiazepines and opiates)
- •- The patient does not have a history of suicide attempt
- •- The patient does not have diagnosed epilepsy or increased bleeding diathesis or a history of angle closure glaucoma or other glaucomas
- •- The patient did not have bariatric surgery prior to study entry
- •- The patient does not have a known allergy or contraindication against Escitalopram or Simvastatin
- •- The patient does not meet any of the following criteria:
- •- hereditary muscle disease
- •- known history of rhabdomyolysis
- •- elevated creatine kinase (CK) outside of the sex-specific reference intervals
- •- History of muscular symptoms under treatment with statins or fibrates
- •- The patient does not have elevated TSH level outside of the age- and sex-specific reference intervals.
- •- The patient does not have insulin-dependent diabetes mellitus
- •- The patient does not have uncontrolled hepatic disorder, renal or cardiovascular disease
- •- The patient does not have untreated hypothyroidism
- •- The patient does not have a history of myocardial infarction or stroke
- •- The patient does not have symptomatic peripheral arterial disease
- •- The patient does not have monogenic familial hypercholesterolemia
- •- The patient does not have clinically significant laboratory abnormalities
- •- The patient did not participate in other interventional trials during the
排除标准
- •- The patient has current use of statins (for visits 2-6 applies: except for IMP Simvastatin)
- •- The patient has current use of antidepressants (for visits 2-6 applies: except for standard medication Escitalopram)
- •- The patient has acute suicidal tendencies (MADRS Item 10 > 4)
- •- The patient uses potent CYP3A4-inhibitors (e.g. clarithromycin, erythromycin, HIV protease inhibitors – see Risks, adverse drug reactions, drug interactions, restrictions, contraindications, procedures in case of emergency”)
- •- The patient uses potent CYP3A4 inductors (carbamazepine, efavirenz, nevirapin, etravirine).
- •- The patient uses Fibrates, Amiodaron, Amlodipin, Verapamil, Fluconazol, Diltiazem, Fusidic acid, Niacin, Daptomycin or Lomitapid or BCRP-Inhibtors (e.g. Elbasvir or Grazoprevir)
- •- The patient uses Gemfibrozil, Ciclosporin or Danazol
- •- The patient has known hypersensitivity to other ingredients of Simvastatin and Escitalopram [butylated hydroxyanisole, microcrystalline celluose, citric acid, starch, lactose, magnesium stearate, hypromellose, talc, titanium dioxide, iron oxies, colloidal silicon dioxide, croscarmellose sodium, polyethylene glycol]
- •- The patient uses medication that is associated with QTc-prolongation [antiarrhythmica class IA and III, antipsychotics (e.g. haloperidol), phenothiazines, tricyclic antidepressants, antibiotics (e.g. moxifloxacin), and certain antihistaminergic drugs (e.g. astemizol, mizolastin)]
- •- The patient has clinically significant abnormalities in 12-lead ECG (e.g. QTc-prolongation = 500 ms or increase = 60 ms from baseline visit)
- •- The patient is pregnant
- •- The patient with childbearing potential is not willing to use an acceptable form of contraception (defined as Pearl index < 1)
- •- The patient has current use of psychotropic medication (e.g. antipsychotics, anticonvulsants, lithium or St. John's Wort) except for benzodiazepines, non-benzodiazepines and opiates
- •- The patient uses nonselective, irreversible monoamine oxidase (MAO) inhibitor (e.g. Tranylcypromine) or selective, reversible inhibitor of monoamine oxidase A (e.g. Moclobemide) or the nonselective, reversible monoamine oxidase inhibitor Linezolid
- •- The patient is unwilling to consent to saving, processing and propagation of pseudonymized medical data for study reasons
- •- The patient is legally detained in an official institution
- •- The patient has active SARS-CoV-2 infection
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