EUCTR2014-003076-22-DE进行中（未招募）1 期
Multimodal Prevention of First Psychotic Episode – a 2x2-Factorial Randomized Trial investigating the efficacy of Acetylcysteine (ACC) and Integrated Preventive Psychological Intervention (IPPI) in Subjects Clinically at High Risk for Psychosis - ESPRIT B1
Central Institute of Mental Health Mannheim (ZI)0 个研究点目标入组 130 人开始时间: 2015年11月27日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 130
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
- •Age 18 – 40 years
- •Subjects with the ability to follow study instructions and likely to attend and complete all required visits
- •Written informed consent of the subject
- •Subjects are able to speak, write and understand the German lan-guage sufficiently well (at the investigators discretion) to complete all required study procedures
- •Subjects show impaired social functioning skills as measured by the Global Assessment of Functioning-Scale (Social) (GFS = 7)
- •Clinical High Risk Criteria
- •Ultra-high risk criteria (Attenuated Positive Symptoms and/or Brief Limited Intermittend Psychotic Symptoms and/or a com-bination of familial risk or schizotypal disorder with a significant loss of functioning; assessed by the Structured Interview for Prodromal Syndromes, SIPS 5.0)
- •The Basic Symptom Criterion 'Cognitive Disturbances, COGDIS' (2/9 cognitive-perceptive basic symptoms; assessed by the Schizophrenia Proneness Instrument – Adult Version, SPI-A)
- •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 130
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Known history of hypersensitivity to the investigational drug or to drugs with a similar chemical structure
- •2. Simultaneously participation in another clinical trial involving admin-istration of an investigational medicinal product within 30 days prior to clinical trial beginning. The simultaneous participation in a non-interventional clinical trial is permitted in case the subject is neverthe-less able and willing to attend and complete all required visits and in case there are no other contraindications.
- •3. Subjects with a physical or psychiatric condition which at the investigator’s discretion may put the subject at other clinically significant risks than those that are defined as outcome of this study (development of a first psychotic episode, functional deterioration), may confound the trial results, or may interfere with the subject’s per protocol participation in this clinical trial.
- •4. Suicidality in terms of subjects, scoring higher than 0 on the CDSS item 8 'Suicidality'.
- •5. Known substance abuse or dependency within the last month accord-ing to DSM-IV-TR. Patients at least have to be in Early Partial Remis-sion in order to participate (Patients have met one or more Substance Abuse or Dependency Diagnosis criteria for at least 1 month but less than 12 months. However, the patient has not met all criteria for a dependence or abuse diagnosis)
- •6. Patients with hepatic or renal failure
- •7. Patients with known problems of galactose intolerance, clinically significant lactase deficiency or glucose-galactose malabsorption or histamine-intolerance
- •8. Subjects with known asthma bronchiale
- •9. Subjects with a history of gastrointestinal ulcer
- •10. Intake of antitussives (cough-relieving agents)
- •11. Intake of nitroglycerin
- •Exclusion criteria regarding special restrictions for females:
- •12. Current pregnancy or pregnancy planned within 9 months after start of medication or nursing women
- •13. Females of childbearing potential, who are not using and not willing to use medically reliable methods of contraception for the entire study duration (such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices) unless they are surgically sterilized / hysterectomized or there are any other criteria considered sufficiently reliable by the investigator in individual cases
- •Indication specific exclusion criteria:
- •14. Having had a psychotic episode for > 1 week (according to SIPS 5.0);
- •15. Having symptoms relevant for inclusion potentially arising from a known general medical disorder
- •16. Life time antipsychotic medication for more than 30 days (cumulative number of days) at or above minimum dosage of the '1st episode psychosis' range of DGPPN S3 Guidelines (Exception: maximum dosage for aripiprazole 5 mg/d) (Deutsche Gesellschaft für Psychiatrie, Psychotherapie und Nervenheilkunde, 2006).
- •17. Any intake of antipsychotic medication (i.e., independent of duration of intake) within the past 3 months before psychopathological baseline assessments (including self-ratings and screening assessments) at or above minimum dosage of the '1st episode psychosis' range of DGPPN S3 Guidelines (Exception: maximum dosage for aripiprazole 5 mg/d) (Deutsche Gesellschaft für Psychiatrie, Psychotherapie und Nervenheilkunde, 2006).
- •18. Any intake of mood stabilizers (lithium, valproate, carbamazepine, ox-cabazepine, lamotrigine) > 30 days (cumulative number of days) dur-ing the past three months or any intake during the month before psy
研究者
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