Future strategies for vocational rehabilitation schizophrenia - Vocational rehabilitatio

Phase 1

• Conditions: The social implications and long-term consequences of mental disorders regarding sick days at work, unemployment rates and early retirement are considerable. This trial is being conducted to understand whether and how atypical antipsychotic treatment effects long-term job rehabilitation in daily life and 2) and whether, how and which social psychiatric strategies (job consulting, vocational services, work rehabilitation, individual cognitive training) support or amplify these beneficial effects.; MedDRA version: 8.1Level: LLTClassification code 10039626Term: Schizophrenia

• Registration Number: EUCTR2006-004891-10-DE
• Lead Sponsor: Charité - Universitätsmedizin Berlin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-11-22
• Last Update Posted: 30 August 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Primary objective for this study is to show, that the ability for successful working behavior, as measured by the Working Behaviour Inventory (WBI), is enhanced by the delivery of ‘job-consulting’;Primary end point(s): To assess, if<br>the atypical antipsychotic ziprasidone represents a better basis for <br>•neurocognitive training<br>•employability<br>•quality of life, <br>compared to the atypical antipsychotic risperidone.<br>;Secondary Objective: Secondary objetive is to show non-inferiority between atypical antipsychotics Zeldox® and Risperdal® in terms of Quality of life (QoL), cognitve function and psychopathological symptoms, measured by Subjective well being-Scales (SWN), neuropsychological tests and psychopathological symptom scales (PANSS).