DRKS00006878尚未招募4 期
Evaluation of the necessity of long-term pharmacological treatment withantipsychotics for the prevention of relapse in long-term stabilizedschizophrenic patients: a randomized, single-blind, longitudinal trial
Klinikum rechts der Isar der TU München0 个研究点目标入组 25 人开始时间: 2014年11月6日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 25
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 65 Years（—）
- 性别
- All
入选标准
- •Male or female patients, 18 to 65 years of age.
- •- Diagnosis of schizophrenia or schizoaffective disorder.
- •- The participants have to be in remission for at least 3 years (i.e. no psychiatric
- •hospitalisation) under a stable antipsychotic medication. Remission will be measured using the remission criteria by Andreasen et al. (2005)
- •Score =3 for the items concerning psychosis of the Positive and Negative Syndrom Scale (PANSS; Kay et al., 1987):
- •Delusions (P1), Conceptual disorganisation (P2), Halluzinations (P3), Mannerisms and posturing (G5) and Unusual thought content (G9) and a score =3 on the Clinical Global Impression Severity Scale (CGI-S; Guy, 1976b)
- •- Able to give informed consent.
排除标准
- •- Actively suicidal.
- •- Serious medical illnesses.
- •- Known non-complience concerning the medication.
- •- Medication with clozapin.
- •- Medication with antidepressants and mood stabilisors that were initiated during the last 6 weeks before study enrollment.
- •- Patients with substance dependence other than nicotine or caffeine within 6 months prior to baseline.
- •- Unability to give informed consent.
- •- Pregnancy.
研究者
相似试验
进行中（未招募）
1 期
Pharmacoepidemiology study to define the long-term safety profile of tenofovir disoproxil fumarate (Tenofovir DF, Viread®) and describe the management of Tenofovir DF-associated renal and bone toxicity in Chronic Hepatitis B (CHB)-infected adolescents aged 12 to <18 years in EuropeChronic Hepatitis BMedDRA version: 20.1Level: PTClassification code 10008910Term: Chronic hepatitis BSystem Organ Class: 10021881 - Infections and infestationsEUCTR2014-004939-39-FRGilead Sciences International Ltd.100
进行中（未招募）
1 期
Pharmacoepidemiology study to define the long-term safety profile of tenofovir disoproxil fumarate (Tenofovir DF, Viread®) and describe the management of Tenofovir DF-associated renal and bone toxicity in Chronic Hepatitis B (CHB)-infected adolescents aged 12 to <18 years in EuropeEUCTR2014-004939-39-BGGilead Sciences International Ltd.100
进行中（未招募）
1 期
Pharmacoepidemiology study to define the long-term safety profile of tenofovir disoproxil fumarate (Tenofovir DF, Viread®) and describe the management of Tenofovir DF-associated renal and bone toxicity in Chronic Hepatitis B (CHB)-infected adolescents aged 12 to <18 years in EuropeChronic Hepatitis BMedDRA version: 18.0Level: PTClassification code 10008910Term: Chronic hepatitis BSystem Organ Class: 10021881 - Infections and infestationsEUCTR2014-004939-39-ESGilead Sciences International Ltd.100
进行中（未招募）
1 期
Pharmacoepidemiology study to define the long-term safety profile of tenofovir disoproxil fumarate (Tenofovir DF, Viread®) and describe the management of Tenofovir DF-associated renal and bone toxicity in Chronic Hepatitis B (CHB)-infected adolescents aged 12 to <18 years in EuropeChronic Hepatitis BMedDRA version: 18.0Level: PTClassification code 10008910Term: Chronic hepatitis BSystem Organ Class: 10021881 - Infections and infestationsEUCTR2014-004939-39-GBGilead Sciences International Ltd.30
进行中（未招募）
1 期
Pharmacoepidemiology study to define the long-term safety profile of tenofovir disoproxil fumarate (Tenofovir DF, Viread¿) and describe the management of Tenofovir DF-associated renal and bone toxicity in Chronic Hepatitis B (CHB)-infected adolescents aged 12 to <18 years in EuropeChronic Hepatitis BMedDRA version: 20.1Level: PTClassification code 10008910Term: Chronic hepatitis BSystem Organ Class: 10021881 - Infections and infestationsEUCTR2014-004939-39-ITGILEAD SCIENCES INCORPORATED30