Psychiatrische Klinik und Poliklinik fuer Psychiatrie und Psychotherapie der Technischen Universitaet Muenchen am Klinikum rechts der Isar
Munich, Bavaria, 81675, Germany
NCT Number: NCT02307396
The main objective of the trial is to evaluate, how long an antipsychotic relapse-prevention should be continued and to which time a patient with schizophrenia is protected enough, so that a withdrawal or reduction of the medication seems appropriate. Relapse is defined as primary outcome.
Looking for future studies?
Notify Me18 year–65 year
All sexes
Interventional
Phase 4
Munich, Bavaria, 81675, Germany
The main objective of the trial is to evaluate for the first time, how long an antipsychotic relapse-prevention should be continued and to which time a patient is protected enough, so that a guided withdrawal or reduction of the medication seems appropriate. Relapse is defined as primary outcome. We include patients with schizophrenia or schizoaffective disorder in remission for at least 3 years under a stable antipsychotic medication.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Every 2 weeks up to 26 weeks
The criterion is measured at every visit (every two weeks) two weeks with two criteria, both have to be fullfilled:
"Delusions" (P1), "Conceptual disorganisation" (P2), "Halluzinations" (P3), "Mannerisms and posturing" (G5) and "Unusual thought content" (G9) (PANSS; Kay et al., 1987)
Time frame: Every 2 weeks up to 26 weeks
Time frame: Baseline, then every 4 weeks up to 26 weeks
PANSS-Scale
Time frame: Baseline,then every 4 weeks up to 26 weeks
Time frame: Baseline, then every 4 weeks up to 26 weeks
CGI-I Scale
Time frame: Baseline, and after 12 and 26 weeks
SW-N-Scale
Time frame: Baseline, and after 12 and 26 weeks
Time frame: Baseline, and after 12 and 26 weeks
PSP-Scale
Time frame: Baseline, and after 12 and 26 weeks
MARS-Scale
Time frame: Every 2 weeks up to 26 weeks
Time frame: Baseline, and after 12 and 26 weeks
AIMS-Scale
Time frame: Baseline, and after 12 and 26 weeks
Technical University of Munich
Other
Evaluation of the Necessity of Long-term Pharmacological Treatment With Antipsychotics for the Prevention of Relapse in Long-term Stabilized Schizophrenic Patients: a Randomized, Single-blind, Longitudinal Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT00526877
Mental Disorders, Psychotic Disorders
Taipei, Taiwan
View Trial DetailsNCT03919760
Affective Disorders, Psychotic, Behavior
Greater Sudbury, Ontario, Canada
View Trial DetailsNCT04298450
Affective Disorders, Psychotic, Bipolar Disorder
Toronto, Ontario, Canada
View Trial DetailsNCT05664594
Mental Disorders, Psychosis
Minneapolis, Minnesota, United States
View Trial Details