Trial · NCT01029769
Efficacy of an Early Antipsychotic Switch in Case of Poor Initial Response to the Treatment of Schizophrenia
NCT01029769, Not applicable, Completed, Technical University of Munich; results first posted 2024-10-21
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy of an Early Antipsychotic Switch in Case of Poor Initial Response to the Treatment of Schizophrenia. Trials, record NCT01029769. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01029769
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy of an Early Antipsychotic Switch in Case of Poor Initial Response to the Treatment of Schizophrenia
- NCT number
- NCT01029769
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 350 participants, actual
- Lead sponsor
- Technical University of Munich
- Conditions
- Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder
- Interventions
- Olanzapine or amisulpride
- First posted
- 2009-12-10
- Last updated
- 2024-10-21
- Results first posted
- 2024-10-21
- Limitations and caveats
- Patients with poor response to antipsychotic treatment in the past (treatment resistant patients) were not excluded by definition from study participation.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients in Symptomatic Remission at Week 8 Comparing the "Switched" With the "Non Switched" Early Non-responders | 8 weeks | 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 |
| Secondary | PANSS Total Score Change | 8 weeks | The Positive and Negative Syndrome Scale (Kay SR, Fiszbein A, Opler LA: The positive and negative syndrome scale (PANSS) for schizophrenia. Schizophrenia Bull 1987; 13:261-276) is a 30- item inventory assessing the absence or severity of schizophrenia symptoms across three subscales: positive symptoms (items P1-P7, including hallucinatory behavior, delusions, and conceptual disorganization), negative symptoms (items N1-N7, including blunted affect, social and emotional withdrawal, and lack of spontaneity), and general psychopathology symptoms (items G1-G16, including mannerisms and posturing, unusual thought content, and lack of insight). Each item is scored on a scale ranging from 1 (absent) to 7 (extreme), with item ratings incorporating the presence, effects of symptoms on an individuum's thinking, feeling or behaving as well as their severity. The min. sum rating is 30, the max. sum rating is 210. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Patients in Symptomatic Remission at Week 8 Comparing the Switched With the Non Switched Early Non-responders | 8 weeks | 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!) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | PANSS Total Score Change | 8 weeks | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Patients in Symptomatic Remission at Week 8 Comparing the Switched With the Non Switched Early Non-responders | Early Non-responders Switched | 41 | Participants | ||
| Number of Patients in Symptomatic Remission at Week 8 Comparing the Switched With the Non Switched Early Non-responders | Early Non-responders Non-switched | 25 | Participants | ||
| PANSS Total Score Change | Early Non-responders Switched | -22.8 | Standard Deviation 19.9 | units on a scale | |
| PANSS Total Score Change | Ealy Non-responders Non-switched | -17.3 | Standard Deviation 15.1 | units on a scale |
Source ClinicalTrials.gov
Participant flow30
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Period 1: Initial 2-week Treatment | STARTED | Initial Olanzapin | 163 | |
| Period 1: Initial 2-week Treatment | STARTED | Initial Amisulpride | 164 | |
| Period 1: Initial 2-week Treatment | STARTED | Early Responders | 0 | |
| Period 1: Initial 2-week Treatment | STARTED | Early Non-responders Switched | 0 | |
| Period 1: Initial 2-week Treatment | STARTED | Ealy Non-responders Non-switched | 0 | |
| Period 1: Initial 2-week Treatment | COMPLETED | Initial Olanzapin | 140 | |
| Period 1: Initial 2-week Treatment | COMPLETED | Initial Amisulpride | 145 | |
| Period 1: Initial 2-week Treatment | COMPLETED | Early Responders | 0 | |
| Period 1: Initial 2-week Treatment | COMPLETED | Early Non-responders Switched | 0 | |
| Period 1: Initial 2-week Treatment | COMPLETED | Ealy Non-responders Non-switched | 0 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 participant flowAdverse events55
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | akathisia | Musculoskeletal and connective tissue disorders | Period 1: Initital 2-week Treatment - Amisulpride Treated Patients | 10 | 163 | 10 |
| other | akathisia | Musculoskeletal and connective tissue disorders | Period 1: Initital 2-week Treatment - Olanzapine Treated Patients | 2 | 164 | 2 |
| other | akathisia | Musculoskeletal and connective tissue disorders | Period 2: Extended 6-week Treatment - Early Responders | 7 | 140 | 7 |
| other | akathisia | Musculoskeletal and connective tissue disorders | Period 2: Extended 6-week Treatment - Early Non-responders Switched | 3 | 70 | 3 |
| other | akathisia | Musculoskeletal and connective tissue disorders | Period 2: Extended 6-week Treatment - Early Non-responders Not Switched | 1 | 72 | 1 |
| other | tremor | Musculoskeletal and connective tissue disorders | Period 1: Initital 2-week Treatment - Amisulpride Treated Patients | 10 | 163 | 10 |
| other | tremor | Musculoskeletal and connective tissue disorders | Period 1: Initital 2-week Treatment - Olanzapine Treated Patients | 7 | 164 | 7 |
| other | tremor | Musculoskeletal and connective tissue disorders | Period 2: Extended 6-week Treatment - Early Responders | 8 | 140 | 8 |
| other | tremor | Musculoskeletal and connective tissue disorders | Period 2: Extended 6-week Treatment - Early Non-responders Switched | 4 | 70 | 4 |
| other | tremor | Musculoskeletal and connective tissue disorders | Period 2: Extended 6-week Treatment - Early Non-responders Not Switched | 2 | 72 | 2 |
1 to 10 of 55Source ClinicalTrials.gov
See all 55 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Period 1: Initital 2-week Treatment - Amisulpride Treated Patients | 0 | 163 |
| Total, all-cause mortality | Period 1: Initital 2-week Treatment - Olanzapine Treated Patients | 1 | 164 |
| Total, all-cause mortality | Period 2: Extended 6-week Treatment - Early Responders | 1 | 140 |
| Total, all-cause mortality | Period 2: Extended 6-week Treatment - Early Non-responders Switched | 0 | 70 |
| Total, all-cause mortality | Period 2: Extended 6-week Treatment - Early Non-responders Not Switched | 0 | 72 |
| Total, other adverse events | Period 1: Initital 2-week Treatment - Amisulpride Treated Patients | 36 | 163 |
| Total, other adverse events | Period 1: Initital 2-week Treatment - Olanzapine Treated Patients | 33 | 164 |
| Total, other adverse events | Period 2: Extended 6-week Treatment - Early Responders | 32 | 140 |
| Total, other adverse events | Period 2: Extended 6-week Treatment - Early Non-responders Switched | 21 | 70 |
| Total, other adverse events | Period 2: Extended 6-week Treatment - Early Non-responders Not Switched | 7 | 72 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| 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 |
Source Trial comparisons
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/NCT01029769
GET https://conductscience.org/api/trials/v1/NCT01029769/flow?page=2