Comparison · NCT01029769-f3c451ce
Early Non-responders Switched vs Early Non-responders Non-switched: Number of Patients in Symptomatic Remission at Week 8 Comparing the Switched With the Non Switched Early Non-responders
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Early Non-responders Switched vs Early Non-responders Non-switched: Number of Patients in Symptomatic Remission at Week 8 Comparing the Switched With the Non Switched Early Non-responders. Trial comparisons, record NCT01029769-f3c451ce. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01029769-f3c451ce
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.683 | 0.558 | 0.787 | wilson | |
| Risk in group 2 | 0.455 | 0.33 | 0.585 | wilson | |
| Risk difference, group 1 minus group 2 | 0.229 | 0.0478 | 0.391 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.5 | 1.07 | 2.11 | log | |
| Odds ratio, group 1 over group 2 | 2.59 | 1.21 | 5.54 | log | |
| Number needed to treat, for one more participant with the outcome on Early Non-responders Switched than on Early Non-responders Non-switched | 4.37 | 2.56 | 20.9 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Early Non-responders Switched | Olanzapine or amisulpride: Oral olanzapine 5mg to 20mg/d OR oral amisulpride 200mg to 800mg/d; both preferably once daily, both encapsulated for blinding | 41 | 60 | OG000 |
| Group 2 | Early Non-responders Non-switched | Olanzapine or amisulpride: Oral olanzapine 5mg to 20mg/d OR oral amisulpride 200mg to 800mg/d; both preferably once daily, both encapsulated for blinding | 25 | 55 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Patients in Symptomatic Remission at Week 8 Comparing the Switched With the Non Switched Early Non-responders
- Description
Remission is defined as a maximum rating of 3 points (equals a severity rating of mild) in each of all the following eight items of the PANSS (Kay et al.) rating scale: Delusions (P1), unusual thought content (G9), hallucinatory behavior (P3), conceptual disorganization (P2), mannerisms/posturing (G5), blunted affect (N1), social withdrawal (N4) and lack of spontaneity (N6); if one item is \>3 the remission status is no (non-remission); all times have a rating from 1 to 7, so the min. rating is 8, the max. rating is 56. Remission is a dichotomous item (yes/no) without a specific min. or max. rating
- Time frame
- 8 weeks
- Population
please note that all patients, regardless of the medication received, were combined in these groups for the primary endpoint analysis solely depending on whether they have met the criteria for early non-response at the end of phase I of the trial; so the statistical analysis does not follow the treatment arms in phase I of the trial (patients received alternatively olanzapine or amisulpride, but both types of treatment appear in one and the same analysis group!)
Source ClinicalTrials.gov
Trial
- Title
- Efficacy of an Early Antipsychotic Switch in Case of Poor Initial Response to the Treatment of Schizophrenia
- NCT number
- NCT01029769
- Phases
- NA
- Conditions
- Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder
- Interventions
- Olanzapine or amisulpride
- Lead sponsor
- Technical University of Munich
- Results first posted
- 2024-10-21
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01029769?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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