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临床试验/EUCTR2006-004891-10-DE
EUCTR2006-004891-10-DE进行中(未招募)1 期

Future strategies for vocational rehabilitation schizophrenia - Vocational rehabilitation

Charité - Universitätsmedizin Berlin0 个研究点目标入组 100 人开始时间: 2006年11月22日最近更新:
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
入组人数
100

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.Diagnosis of schizophrenia spectrum disorder based on DSM IV
  • 2.Stable phase of disorder as defined as steady state treatment with either
  • one classical or one atypical anttipsychotic medication, day-clinic-status or
  • ambulant patients status
  • 3.Full contractual capability
  • 4.Written informed consent
  • 5.Unemployment at time of program admission
  • 6.Between the ages of 18 and 58
  • 7.Willingness to work
  • 8.Native German speaker
  • 9.Only subjects who were not enrolled in other trials at least for six months
  • will be included in the trial
  • 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.Comorbid Axis II disorder
  • 2.Comorbid substance use/-disorder
  • 3.Comorbid alcohol abusus
  • 4.Epilepsy
  • 5.Organic brain disease
  • 6.Diagnosis of mental retardation, neurological disorders or insult to the
  • brain which might affect cognitive performance (IQ has to be > 70)
  • 7.Changes in housing or other psychosocial life aspects
  • 8.Legal representative
  • 9.Persons who are detained officially or legally to an official institute
  • 10.Pregnancy or lactation
  • 11.Women of childbearing age without highly effective contraception (PEARL-
  • Index < 1%)
  • 12.Other concomitant psychopharmacological treatment
  • 13.Long-acting antipsychotic medication two weeks prior to inclusion
  • 14.Contraindications for treatment with Zeldox® or Risperdal® (refer to
  • product infomation)
  • 15.Patients with QT-prolongation
  • 16.Patients with hypotension or patients receiving antihypertensive therapy
  • 17.Patients with known hypersensitivity to the used agents
  • 18.Currently active gastrointestinal, cardiovascular, metabolic, renal, hepatic,
  • respiratory, inflammatory, or infectious disease

研究者

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