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.
Conditions
Interventions
Trade Name: Zeldox Hartkapseln
Product Name: Ziprasidon
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Ziprasidon
Concentration unit: mg/g milligram(s)/gram
Concentration type: equal
Concentr
Sponsors
Charité - Universitätsmedizin Berlin
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 the atypical antipsychotic ziprasidone represents a better basis for • neurocognitive training • employability • quality of life, compared to the atypical antipsychotic risperidone. ;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). | — |
Countries
Germany
Outcome results
None listed