EUCTR2011-004294-87-DK进行中（未招募）1 期
Treatment of multi-organ bodily distress syndrome.A double-blinded placebo controlled trial of the effect of Imipramine (STreSS-3) - Stress-3
Per Klausen Fink0 个研究点目标入组 138 人开始时间: 2011年10月25日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 138
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
- •1. Functional disorder defined as Bodily Distress Syndrome multi organ type with symptoms from at least three out of four symptom categories
- •2. Moderate or severe impact on daily life
- •3. Symptoms lasting for at least 2 years
- •4. Age 20-50 years
- •5. Born in Denmark or by Danish parents. The patients must understand, speak, write and read Danish.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 140
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Exclusion criteria
- •1. Presence of other physical or mental illness if it is not possible to separate the symptoms of this illness from the symptoms of BDS
- •2. Current major or moderate depressive disorder, continuous treatment because of this, other severe psychiatric disorder that demands treatment, or suicidal thoughts
- •3. A lifetime diagnosis of psychosis, mania or depression with psychotic symptoms (ICD-10: F20-29, F30-31, F32.3, F33.3)
- •4. Abuse of alcohol, narcotics, or drugs
- •5. Pregnancy, breastfeeding or current pregnancy wish. Fertile women must use effective anticonception, (hormonal contraception, contraceptive injection, implant or patch, intrauterine system and device, vaginal ring).
- •6. Treatment with all pain modulating drugs, e.g. all analgesics, antidepressants, antiepileptica and other types of medication with pain relieving properties must be discontinued at least two weeks before the treatment phase.
- •7. Imipramine treatment in sufficient dosage within the last year, i.e. 25 mg daily continuously for at least 8 weeks.
- •8. Allergy to study medication or excipients in study medication.
- •9. Myocardial infarction, congestive heart failure, signs of conduction defects or abnormalities on ECG (first degree AV-block, bundle branch block or prolonged QT-interval), narrow-angle glaucoma, porphyria, inherited galactose intolerance, epilepsy, hepatic insufficiency, and severe renal impairment
- •10. Simultaneous use of:
- •- antipsychotics
- •- oral anticoagulantia
- •- diuretics
- •- sympatomimetica and CNS-stimulating drugs (amphetamine-like drugs)
- •- all serotonergic drugs, e.g. SSRI, SNRI and TCA, the dietary supplement pericum (hypericum perforatum), monoamine oxidase (MAO) inhibitors, triptans, tramadol, petidin and tryptofan
- •- the drugs cimetidin (H2-antagonist), quinidin (antiarrythmica), cclonidin (antihypertensive), fluconazol (antimycotica), clindamycin, clarithromycin, erythromycin (antibiotic), droperidol (anaesthetic), levodopa (antiparkinson), mefloquin (antimalaria), phenytoin, barbiturates, carbamazepin (antiepilepitica), hydroxizin (antihistamine), buspiron (anxiolytica)
- •- Bupropion (tobacco dependence), celecoxib (NSAID), cinacalcet (antiparatyroidea drug), duloxetine (SNRI), flufenazin (antipsychotic), fluoxetine (SSRI), gefitinib (antineoplastic), moclobemid (MAO), paroxetin, sertralin (SSRI), terbinafin (antimycotica), yohimbine (erectil dysfunction) and fluvoxamin (SSRI), ciprofloxacin and enoxacin (microbiotic), because plasma concentration of imipramine can increase with simultaneous use of these potent CYP2D6- and CYP1A2- inhibitors.
研究者
相似试验
招募中
Unknown
A study of treatment of multi-organ dysfunction with MSC-CMMulti-Organ DysfunctionD001342JPRN-jRCT1051230180Sugawara Kou5
招募中
不适用
Bodily distress disorder in primary careICD 11 Chapter 6 C20 Bodily distress disorderDRKS00033653VR-Klinik für Psychosomatische Medizin und Psychotherapie100
招募中
Unknown
Osteopathic treatment of patients with bodily distress syndrome of the cardiovascular systemF45.3Somatoform autonomic dysfunctionDRKS00031533Akademie für Osteopathie e. V.150
招募中
不适用
Multimodal physiotherapy as an add-on treatment to botulinum toxin type A therapy in patients with cervical dystonia: a pilot trial”G24DystoniaDRKS00006562niversitätsklinikum Jena, Institut f. Physiotherapie20
招募中
不适用
Multimodal physiotherapy as an add-on treatment to botulinum neurotoxin type A therapy in patients with cervical dystonia: a multicenter, single-blind, randomized, controlled studyG24.3Spasmodic torticollisDRKS00020411eurologie Universitätsklinikum Jena224