Schizophrenia ICD-10 code F20 or schizophreniform disorder ICD-10 code F23.1 MedDRA version: 16.1 Level: PT Classification code 10039626 Term: Schizophrenia System Organ Class: 10037175 - Psychiatric disorders MedDRA version: 16.1 Level: PT Classification code 10039647 Term: Schizophreniform disorder System Organ Class: 10037175 - Psychiatric disorders
Conditions
Interventions
Trade Name: zyprexa
Product Name: encapsulated olanzapine
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: OLANZAPINE
CAS Number: 132539-06-1
Concentration unit: mg milligram(s)
Concentration t
Sponsors
University Medical Center Utrecht
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Diagnosis of schizophrenia, schizophreniform or schizoaffective disorder as defined by DSM-IV on the basis of the Mini International Neuropsychiatric Interview Plus (M.I.N.I. Plus; Sheehan et al. 1998). •Age 18-40 years •Written 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 500 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: •A time interval between the onset of positive symptoms (hallucinations and/or delusions) and study entry exceeding two years. •Prior use of antipsychotic medication longer than an episode of two weeks in the previous year and/or 6 weeks lifetime. •Intolerance to one of the drugs in this study. •Patients who are coercively treated at a psychiatric ward (based on a judicial ruling) •Patients who are represented by a legal ward or under legal custody •The presence of one or more of the contraindications against any of the study drugs as mentioned in the IB texts •Pregnancy or lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To test guideline recommendation that non-responders to an antipsychotic drug benefit from a switch to an antipsychotic with a different receptor binding profile. ;Secondary Objective: To test applicability of amisulpride as the first step in a treatment algorithm. ;Primary end point(s): The primary outcome is the number of participants in remission at the end of phase I (4 weeks open treatment with amisulpride), phase II (double-blind treatment with amisulpride or olanzapine, comparison between arms). Symptomatic remission will be defined according to the criteria of Andreasen et al. (2005): 8 specific symptoms (PANSS items P1, P2, P3, N1, N4, N6, G5 and G9) of schizophrenia as measured by the Positive and Negative Syndrome Scale (Kay et al. 1987) are at the most only mildly present (maximum rating of “3”) so that they do not interfere with daily life functioning. | — |
Countries
Austria, Belgium, Bulgaria, Czech Republic, Denmark, Germany, Italy, Netherlands, Romania, Spain, United Kingdom
Outcome results
None listed