EUCTR2007-001335-54-CZ进行中（未招募）不适用
SAFETY AND EFFICACY OF CIMICOXIB, A SELECTIVE COX-2 INHIBITOR, IN COMBINATION WITH SERTRALINE COMPARED TO SERTRALINE COMBINED WITH PLACEBO IN TREATMENT OF MAJOR DEPRESSION - SECIM
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 150
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. Major depression diagnosed by psychiatrist
- •2. DSM IV TR: 296.2x single depressive episode or 296.3x recurrent depressive episode
- •3. HamD-17 score = 22
- •4. Informed consent
- •5. Age between 18 and 60 years
- •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
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Psychotic depression or bipolar disorder, obsessive compulsive disorder, anxiety disorder, personality disorder, drug or alcohol abuse, schizoaffective disorders, schizophrenia
- •2. All DSM IV TR Axis-I disorders except depression
- •3. All DSM IV TR Axis-II disorders without exception
- •4. Unsuccessful treatment with more than 2 antidepressant medications (at therapeutically adequate doses and duration)
- •5. Concomitant use of psychotropic drugs, including mood stabilizers
- •6. Immediate risk for suicidal behaviour (3 on HamD-17 rating scale or 5 on MAD Rating Scale)
- •7. Women who are pregnant, breast feeding or planning to become pregnant during the course of study
- •8. Women who are not post-menopausal (no natural menopause established in retrospect after 12 consecutive months of amenorrhoea without hormone replacement therapy during the last 5 months), surgically sterilized or using a highly effective method of contraception (an implanted or injected hormonal contraceptive, some intrauterine contraceptive devices (IUDs) containing hormones, sexual abstinence, or have a vasectomised partner). Females using combined oral contraceptives should use a different or additional highly effective method of contraception as listed above.
- •9. Any history of cardiovascular disease (e.g. angina, heart attack, stroke, congestive heart failure), uncontrolled high blood pressure, documented peripheral arterial insufficiency and symptomatic, clinically significant claudication, or a history of peripheral arterial embolism
- •10. Patients at risk of QT/QTc interval prolongation (QTC> 450 ms, family history of long QT syndrome or use of medication prolonging QT/QTc interval)
- •11. History of coronary heart disease (CHD) or any other heart disease
- •12. Serum NTproBNP = 125 pg/ml indicating (sub-)clinical heart failure
- •13. History of upper or lower gastrointestinal (GI) ulceration, perforation and/or obstruction
- •14. History of upper or lower GI bleeding within the previous year
- •15. History of inflammatory bowel disease
- •16. Undergoing cancer chemotherapy
- •17. Known HIV infection or clinically manifest Acquired Immune Deficiency Syndrome (AIDS), liver function tests (AST, ALT) > 2x ULN, diabetes, asthma, COPD, Parkinson’s or Alzheimer’s disease, or any other serious condition likely to interfere with the conduct of the trial
- •18. Clinically relevant hepatic or renal impairment, or other clinically significant physical findings or clinically significant laboratory results at screening or baseline, as determined by the investigator
- •19. History of allergy to sertraline, cimicoxib or closely related compounds or excipients
- •20. History of hypersensitivity or intolerance to pain medications
- •21. Currently taking a monoamine oxidase inhibitor (MAOI) or within 14 days of discontinuing treatment with an MAOI
- •22. Currently taking pimozide
- •23. Currently taking fluoxetin
- •24. Use of pain medication, such as a COX-2 inhibitor, NSAID (non-steroidal anti-inflammatory drug, including aspirin) or acetaminophen (paracetamol) within 72 hours prior to study entry (24 hours for short-acting drugs such as aspirin or acetaminophen)
- •25. Currently taking sucralfate or misoprostol
- •26. Participation in a study of an investigational drug or device concomitantly or within 30 days prior to this study
- •27. Patients thought to be unreliable or incapable of complying with the requirements of the protocol
- •28. Positive drug test (except for benzodiazipine)
- •29. Patient is relative of, or staff directly report
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