schizophrenia or schizoaffective disorder in remission for at least 3 years under a stable antipsychotic medication. MedDRA version: 17.0 Level: PT Classification code 10039626 Term: Schizophrenia System Organ Class: 10037175 - Psychiatric disorders MedDRA version: 17.0 Level: PT Classification code 10039621 Term: Schizoaffective disorder System Organ Class: 10037175 - Psychiatric disorders
Conditions
Interventions
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: OLANZAPINE
CAS Number: 132539-06-1
Pharmaceutical Form: Tablet
INN or Proposed INN: AMISULPRIDE
CAS Number: 71675-85-9
Pharmaceutical Form: Ta
Sponsors
Technische Universität München, vertreten durch das Klinikum rechts der Isar
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female patients, 18 to 65 years of age. 2. Diagnosis of schizophrenia or schizoaffective disorder. 3. The participants have to be in remission for at least 3 years (i.e. no psychiatric hospitalisation) under a stable antipsychotic medication. 4. Able to give informed consent. 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 25 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Actively suicidal. 2. Serious medical illnesses. 3. Known non-complience concerning the medication. 4. Medication with clozapin. 5. Patients with substance dependence other than nicotine or caffeine within 6 months prior to baseline. 6. Pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of the Trial is to evaluate for the first time employing high-Quality methodology, how long an antipsychotic relapse-prevention should be continued and to which time a patient is protected enough, so that a withdrawal of the medication seems appropriate. Relapse is defined as primary outcome.;Secondary Objective: Secondary objectives of the trial are psychiatric rehospitalisation, changes in psychiatric rating scales, quality of life, ability to work, personal and social functioning, adherence, drop-outs, movement disorders, and the occurrence of specific adverse effects.;Primary end point(s): Relapse is defined as primary outcome. ;Timepoint(s) of evaluation of this end point: every two weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary outcomes are psychiatric rehospitalisation, changes in psychiatric rating scales, quality of life, ability to work, personal and social functioning, adherence, drop-outs, movement disorders, and the occurrence of specific adverse effects.;Timepoint(s) of evaluation of this end point: most of the secondary endpoints will be evaluated every two weeks. | — |
Countries
Germany
Contacts
Public ContactKlinik fuer Psychiatrie
Technische Universität München, Klinikum rechts der Isar
Outcome results
None listed