EUCTR2012-005435-87-ES进行中（未招募）不适用
EFFECT OF ADJUVANT TREATMENT WITH N - ACETYLCYSTEINE DURING 48 WEEKS ON THE LOSS OF GREY SUBSTANCE AND OXIDATIVE METABOLISM IN PATIENTS WITH EARLY ONSET PSYCHOTIC EPISODES: BLIND, PLACEBO-CONTROLLED, RANDOMIZED CLINICAL TRIA
Fundación para la Investigación Biomédica Hospital Gregorio Marañón0 个研究点开始时间: 2012年12月20日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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 Age between 12 and 18 years;
- •2 Presence of at least one psychotic symptom of onset before 18 years of age, with a diagnosis of psychotic disorder criteria DSM-IV (F20 or F30), evaluated through the K-SADS (Kiddie Schedule for Affective Disorders and Schizophrenia);
- •3 Previous exposure to antipsychotics ? 30 days;
- •4 Informed consent of the patient and of the guardian or legal representative.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 70
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 30
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1 Co-morbidity with other disorders of axis I, included abuse or dependence on toxic (use is accepted);
- •2. Presence of organic diseases of the central nervous system (CNS) or a history of head trauma with loss of consciousness;
- •3. Mental retardation;
- •4. Pervasive development disorders;
- •5. Clinically relevant renal, hepatic or haematological findings in the analysis of screening;
- •6. Active medical conditions (e.g. seizures not controlled);
- •7 Patients with ulcus gastroduodenal, asthmatic or with severe respiratory failure;
- •8 Persons who have previously submitted adverse effects to the NAC or any of the components of the preparation;
- •9 Pregnancy, breastfeeding or risk of pregnancy (contraceptive measures an intrauterine device, oral contraceptives and barrier methods are considered);
- •10 People who are in treatment with other agents antioxidants or precursors of GSH, except if treatment has been abandoned at least 3 weeks;
- •11 Patients who are participating or have participated in another clinical trial during the previous 30 days;
- •12 Patients unable to meet the requirements of the study.
研究者
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