| September 7, 2005 |
| January 28, 2008 |
| November 2001 |
| relapse rate [ Time Frame: 1 year ] [ Designated as safety issue: No ] |
| Same as current |
| Complete list of historical versions of study NCT00159120 on ClinicalTrials.gov Archive Site |
- psychopathology [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- social and cognitive functioning [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- side-effects [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- drop-out [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- quality of life [ Time Frame: 1 year ] [ Designated as safety issue: No ]
|
- 1 year course regarding psychopathology
- social and cognitive functioning
- side-effects
- drop-out
- quality of life
|
| |
| Maintenance Treatment vs. Stepwise Drug Discontinuation in First-Episode Schizophrenia |
| Maintenance Treatment vs. Stepwise Drug Discontinuation After One Year of Maintenance Treatment in First-Episode Schizophrenia |
After one year neuroleptic maintenance treatment in patients with first episode schizophrenia, neuroleptic treatment will be continued vs. stepwise discontinued (randomized design) over a period of 1 year. Under both conditions prodrome based early intervention take place. |
After one year neuroleptic maintenance treatment in patients with first episode schizophrenia, neuroleptic treatment will be continued vs. stepwise discontinued (randomized design) over a period of 1 year. Under both conditions pharmacologic early intervention strategies in case of early sign of relapse will be applied. |
| Phase IV |
| Interventional |
| Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
|
|
| Other: maintained antipsychotic treatment vs. stepwise drug discontinuation |
- Active Comparator: further maintenance antipsychotic treatment and prodrome-based early intervention
- Experimental: stepwise drug discontinuation (after 1 year maintenance antipsychotic treatment) and prodrome-based early intervention
|
| Gaebel W, Moller HJ, Buchkremer G, Ohmann C, Riesbeck M, Wolwer W, Von Wilmsdorff M, Bottlender R, Klingberg S. Pharmacological long-term treatment strategies in first episode schizophrenia--study design and preliminary results of an ongoing RCT within the German Research Network on Schizophrenia. Eur Arch Psychiatry Clin Neurosci. 2004 Apr;254(2):129-40. |
| |
| Completed |
| 71 |
| June 2006 |
| June 2006 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Patients after 1 year of maintenance treatment after their first-episode in schizophrenia (according ICD-10 F20)
- Age between 18 and 55
- Informed consent
- One year neuroleptic maintenance treatment
- Reaching stable course
Exclusion Criteria:
- Residence outside of the catchment area
- Legal reasons
- Insufficient knowledge of the german language
- Substance abuse or addiction
- Pregnancy
- Serious physical illness
- Organic brain disease
- Contraindication to neuroleptic treatment
|
| Both |
| 18 Years to 55 Years |
| No |
|
| Germany |
|
| |
| NCT00159120 |
|
|
| Heinrich-Heine University, Duesseldorf |
- German Federal Ministry of Education and Research
- German Research Network On Schizophrenia
- Janssen-Cilag Ltd.
- University Hospital, Bonn
- Humboldt-Universität zu Berlin
- Ludwig-Maximilians - University of Munich
- University of Göttingen
- University of Cologne
- Mainz University
- University Hospital Tuebingen
- Univeristat Duisburg-Essen
- University of Mannheim
- University of Jena
- Martin-Luther-Universität Halle-Wittenberg
- RWTH Aachen University
- University of Wuerzburg
|
| Study Chair: |
Wolfgang Gaebel, Professor |
Department of Psychiatry and Psychotherapy at the Heinrich-Heine-University of Düsseldorf, Rhineland State Clinics Düsseldorf, Bergische Landstraße 2,
40629 Düsseldorf, Germany |
|
|
| Heinrich-Heine University, Duesseldorf |
| January 2008 |
