EUCTR2006-006427-39-DE进行中（未招募）不适用
The Effect of the Atypical Antipsychotic Quetiapine in the Treatment of Postpartum Depressive Disorders with or without Psychotic Symptoms
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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
- Female
入选标准
- •1.Provision of written informed consent to take part in the study prior to enrolment.
- •2.Women aged ³ 18 to < 40 years
- •3.Female patients with severe postpartum (maximum: 12 months postpartum) depressive disorders with a minimum HAM-D cut-off score of 20 points receiving at the start of the study inpatient hospital care at the Mother-Baby-Unit of the Westphalia Centre of Herten.
- •4.Patients who have weaned/are about to wean and do no longer breast-feed their child
- •5.In- or outpatients during the course of the study
- •6.Patients must have a negative serum pregnancy test at enrolment and be willing to use a reliable method of birth control.
- •7.Be able to understand and comply with the requirements of the study, as judged by the investigator
- •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.Women with pre-existing psychotic disorder.
- •2.Patients with alcohol or substance abuse or dependence.
- •3.Patients with risk of transmitting human immune-deficiency virus (HIV) or hepatitis B, via blood or other body fluids (as judged by the investigator).
- •4.Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others.
- •5.Patients with a history of non-compliance (as judged by the investigator).
- •6.Evidence of clinical relevant disease
- •7.Clinically significant deviation from the reference range in clinical laboratory test results at enrolment ( as judged by the investigator).
- •8.ECG considered to show clinically significant abnormality at enrolment (as determined by the cardiologist and judged by the investigator).
- •9.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 subject is being treated for hypothyroidism.
- •10.Use of Antipsychotic, mood stabilizer, antidepressant, anxiolytic, hypnotic or other psychoactive drugs within 48 hours before involvement and throughout the study (except medications specified in the protocol).
- •11.Use of drugs that induce or inhibit the hepatic metabolising cyp3A4 enzymes within 2 weeks prior to enrolment
- •12.Patients who are pregnant or lactating
- •13.Known intolerance or lack of response to quetiapine
- •14.Neutropenia with an absolute neutrophile count (ANC) of £1.5 x 109 per litter.
- •15.Patients with unstable diabetes mellitus (DM)/HbA1c
- •16.Participation in another drug trial within 4 weeks prior enrolment into this study
- •17.Previous enrolment in the present study
- •18.Involvement in the planning and conduct of the study (applies to both AstraZeneca staff or staff at the investigational site)
研究者
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