Trial · NCT01248195
Optimization of Treatment and Management of Schizophrenia in Europe
NCT01248195, Phase 4, Completed, Rene Kahn
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Optimization of Treatment and Management of Schizophrenia in Europe. Trials, record NCT01248195. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01248195
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Optimization of Treatment and Management of Schizophrenia in Europe
- NCT number
- NCT01248195
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 479 participants, actual
- Lead sponsor
- Rene Kahn
- Conditions
- Schizophrenia, Schizophreniform Disorder, Schizoaffective Disorder
- Interventions
- Amisulpride open label, 6-week amisulpride double blind treatment, 6-week olanzapine double blind treatment, 12-week clozapine open-label treatment, Psychosocial intervention
- First posted
- 2010-11-25
- Last updated
- 2018-05-15
- Other registries' IDs
- eudract:2010-020185-19
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | PANSS | Jan 2016 | Study consists of multiple components, each with their own objectives. For this (medication) component: number of patients in remission, based on PANSS scores (criteria of Andreasen et al.; 2005) after 4 weeks open label amisulpride, after 6 weeks double blind amisulpride or olanzapine and after 12 weeks of open label clozapine. |
| Primary | Sellwood rating scale | Jan 2016 | Psychosocial intervention component, objective A: drug adherence rates as a function of (standardized self report and) Sellwood rating scales after 12 and 52 weeks. |
| Primary | Biological profile | jan 2016 | Biological predictors component, objective A: drug response (remission vs non-remission) as a function of biological profile, after 4 weeks, 10 weeks and 22 weeks (after each medication phase). |
| Primary | MRS measures | jan 2016 | Biological predictors component, objective B: using MRS scans, differences between responders and non-responders in regional glutamate levels a) at baseline and b) between baseline and after one month of treatment with amisulpiride. |
| Primary | SOFAS global functioning | jan 2016 | Psychosocial intervention component, objective B: drug adherence rates as a function of standardized global functioning (SOFAS score after 1 year) following psychosocial intervention vs treatment as usual. |
| Primary | MRI assessments | jan 2016 | MRI component objective: the percentage of first episode patients that show radiological abnormalities suggestive of neurological disorders which may explain the occurrence of psychotic symptoms - measurement at baseline only. |
| Secondary | All cause treatment discontinuation | jan 2016 | The different components of the study have their own secondary objectives: Medication component has multiple secondary objectives, most important one is all-cause treatment discontinuation after 4 weeks, 10 weeks and 22 weeks. Number and reason for premature discontinuations (treatment discontinuation) of the amisulpride and the olanzapine group will be compared (after 10 weeks). |
| Secondary | All cause discontinuation | jan 2016 | Psychosocial intervention component has multiple secondary objectives, most important one is all-cause treatment discontinuation between treatment groups after 12 and 52 weeks. |
| Secondary | Biological markers | jan 2016 | Biological predictors component has multiple secondary objectives, most important one is the ability of biological markers to predict response to antipsychotic and treatment tolerability in schizophrenia, after 4, 10 and 22 weeks. |
| Secondary | MRI assessments | jan 2016 | The ability of MRI to predict response to antipsychotic treatment in schizophrenia, after 4, 10 and 22 weeks. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01248195
GET https://conductscience.org/api/trials/v1/NCT01248195/registered