EUCTR2005-005052-40-FI进行中（未招募）不适用
A Multi-Centre, Double-Blind, Randomised, Parallel Group, Placebo-Controlled and Active Controlled Phase III Study of the Efficacy and Safety of Quetiapine Fumarate Sustained Release (Seroquel SRTM) as Mono-Therapy in the Treatment of Adult Patients with Major Depressive Disorder (AMBER STUDY) - Amber Study
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
- 450
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. Provision of written informed consent before initiation of any study related procedures.
- •2. Men and women aged 18 to 65 years, inclusive.
- •3. Documented clinical diagnosis meeting criteria from the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) for any of the following; 296.2x Major Depressive Disorder, Single Episode, or 296.3x Major Depressive Disorder, Recurrent, as confirmed by the MINI.
- •4. HAM-D (17-item) total score of =22 and HAM-D Item 1 (depressed mood) score =2 both at enrolment and randomisation (Visit 2).
- •5. Female patients of childbearing potential must have a negative serum pregnancy test at enrolment and be willing to use a reliable method of birth control (i.e., barrier method, oral contraceptive, implant, dermal contraception, long-term injectable contraceptive, intrauterine device, or tubal ligation) during the study.
- •6. Be able to understand and comply with the requirements of the study, as judged by the investigator.
- •7. Outpatient status at enrolment.
- •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. Patients with a DSM-IV Axis I disorder other than MDD within 6 months of enrolment.
- •2. Patients with a diagnosis of DSM-IV Axis II disorder which has a major impact on the patient’s current psychiatric status.
- •3. Patients whose current episode of depression exceeds 12 months or is less than 4 weeks from enrolment.
- •4. History of in-adequate response to an adequate treatment (6 weeks) with 2 or more classes of antidepressants during current depressive episode
- •5. Substance or alcohol abuse or dependence within 6 months prior to enrolment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined in DSM-IV criteria. Patients with a positive UTS for a drug(s) legally available by prescription, must provide evidence of prescription for the drug(s).
- •6. Use of drugs that induce or inhibit the hepatic metabolizing cytochrome P450 3A4 enzymes within 2 weeks prior to randomisation.
- •7. Pregnancy or lactation.
- •8. Evidence of clinically relevant disease, e.g. renal or hepatic impairment, significant coronary artery disease, cerebrovascular disease, viral hepatitis B or C, acquired immunodeficiency syndrome (AIDS).
- •9. A clinical finding that is unstable (e.g. hypertension, poorly controlled diabetes, unstable angina) or that, in the opinion of the investigator, would be negatively affected by the study medication or that would affect the study medication.
- •10. Conditions that could affect absorption and metabolism of study medication (e.g. malabsorption syndrome, liver disease).
- •11. A current diagnosis of cancer (except basal or squamous cell skin carcinoma), unless in remission for at least 5 years.
- •12. Current or past diagnosis of stroke or Transient Ischemic Attacks (TIA).
- •13. History of seizure disorder, except febrile convulsions.
- •14. Receipt of electroconvulsive therapy (ECT) within 90 days prior to randomisation.
- •15. Use of antipsychotic, mood stabiliser, or antidepressant drugs within 7 days before randomisation, or use of fluoxetine within 28 days before randomisation, or use of MAOIs, anxiolytic or hypnotics within 14 days before randomisation (with the exception of those allowed with restriction per protocol), or use of a depot antipsychotic injection within 2 dosing interval before randomisation.
- •16. Patients who in the investigators opinion will require psychotherapy (other then supportive psychotherapy) during the study period, unless psychotherapy has been ongoing for a minimum of 3 months prior to randomisation.
- •17. Patients who, in the investigator’s judgment pose a current serious suicidal or homicidal risk, have a HAM-D Item 3 score of 3 or greater, or have made a suicide attempt within the past 6 months.
- •18. A patient with Diabetes Mellitus (DM).
- •19. Clinically significant deviation from the reference range in clinical laboratory test results as judged by the investigator.
- •20. An absolute neutrophil count (ANC) of less than or equal to 1.5 x 109 per liter.
- •21. A thyroid-stimulating hormone (TSH) concentration more than 10% above the upper limit of the normal range of the laboratory used for sample analysis at enrolment, whether or not the patient is being treated for hypothyroidism.
- •22. Liver Function Tests AST or ALT three times the upper normal limit.
- •23. ECG results considered being clinically significant as determined by the investigator based on assessment by a centrally located experienced cardiologist interpreting the ECG.
- •24. Use of quetiapine in doses =25 mg/day for insomnia w
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