Trial · NCT00053703
Treatment of Early Onset Schizophrenia Spectrum Disorders (TEOSS)
NCT00053703, Phase 4, Completed, University of North Carolina, Chapel Hill; results first posted 2014-03-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Treatment of Early Onset Schizophrenia Spectrum Disorders (TEOSS). Trials, record NCT00053703. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00053703
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Treatment of Early Onset Schizophrenia Spectrum Disorders (TEOSS)
- NCT number
- NCT00053703
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 116 participants, actual
- Lead sponsor
- University of North Carolina, Chapel Hill
- Conditions
- Schizophrenia
- Interventions
- Risperidone, Olanzapine (enrollment closed in this treatment), Molindone
- First posted
- 2003-02-05
- Last updated
- 2014-03-26
- Results first posted
- 2014-03-26
- Limitations and caveats
The most significant weakness of this study was the sample size, which was sufficient only to detect large differences across the three treatments and limited our ability to identify predictors of response or adverse effects.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at 8 Weeks | 8 weeks | Assessed with the Positive and Negative Syndrome Scale in which a clinician rates various psychotic symptoms on the basis of observation of the participant, interview with the participant, and review of all other available information including informant reports. The scale consists of 30 items which are rated categorically between 1 - no symptoms to 7 - extreme symptoms. The minimal score is 0 and the maximal score is 210, with higher scores reflecting more symptoms. Typically scores \> that 60 are considered clinically significant. |
| Primary | Change From Baseline in PANSS Positive Symptom Subscale Score at 8 Weeks. | 8 weeks | The PANSS (described above) includes 7 items that reflect positive psychotic symptoms such as hallucinations and delusions. As are all items within the PANSS, items are categorically rated by the clinician between 0 - no symptoms to 7 extreme symptoms. The minimal score is 0 reflecting no positive symptoms to 49 reflecting that all items were extreme. Higher scores reflect more severe symptoms. Scores above 18 are usually clinically significant. |
| Primary | Change From Baseline in PANSS Negative Symptom Subscale at Week 8 | 8 weeks | The PANSS (described above) includes 7 items that reflect negative psychotic symptoms such as amotivation and social withdrawal. As are all items within the PANSS, items are categorically rated by the clinician between 0 - no symptoms to 7 extreme symptoms. The minimal score is 0 reflecting no positive symptoms to 49 reflecting that all items were extreme. Higher scores reflect more severe symptoms. Scores above 18 are usually clinically significant. |
| Secondary | Change From Baseline in Weight at Week 8 | 8 weeks | change in weight from baseline to week 8 in kg |
| Secondary | Change From Baseline in Barnes Akathisia Scale at Week 8 | 8 weeks | Barnes Akathisia Scale is a clinician rated scale which considers information based on observation of the participant as well as participant report. The scale includes 3 items rated between 0- none to 3 severe and 1 summary item rated between 0 none to 5 severe. All items are summed to obtain the total score. The minimal total score is 0 and the maximal score is 14 with higher scores reflecting more severe akathisia. A score of 4 or more is clinically significant. |
| Secondary | Change From Baseline in Body Mass Index Change, kg/m2, at Week 8 | 8 weeks | Change from baseline in Body Mass Index Change, kg/m2, at week 8, last observation was carried forward for individuals who withdrew from treatment early. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at 8 Weeks | 8 weeks | All randomized patients who took at least one dose of drug and had at least one post-baseline assessment. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Weight at Week 8 | 8 weeks | All randomized patients who took at least one dose of drug and had at least one post-baseline assessment. | Kg | MEAN |
| SECONDARY | Change From Baseline in Barnes Akathisia Scale at Week 8 | 8 weeks | All randomized patients who took at least one dose of drug and had at least one post-baseline assessment. | units on a scale | MEAN |
| PRIMARY | Change From Baseline in PANSS Positive Symptom Subscale Score at 8 Weeks. | 8 weeks | All randomized patients who took at least one dose of drug and had at least one post-baseline assessment. | units on a scale | MEAN |
| PRIMARY | Change From Baseline in PANSS Negative Symptom Subscale at Week 8 | 8 weeks | units on a scale | MEAN | |
| SECONDARY | Change From Baseline in Body Mass Index Change, kg/m2, at Week 8 | 8 weeks | All randomized patients who took at least one dose of drug and had at least one post-baseline assessment. | kg/m2 | MEAN |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at 8 Weeks | Olanzapine | -26.6 | Standard Deviation 17.8 | units on a scale | |
| Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at 8 Weeks | Risperidone | -23.7 | Standard Deviation 25.5 | units on a scale | |
| Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at 8 Weeks | Molindone | -27.0 | Standard Deviation 17.7 | units on a scale | |
| Change From Baseline in Weight at Week 8 | Olanzapine | 6.12 | Standard Deviation 3.60 | Kg | |
| Change From Baseline in Weight at Week 8 | Risperidone | 3.64 | Standard Deviation 3.95 | Kg | |
| Change From Baseline in Weight at Week 8 | Molindone | 0.34 | Standard Deviation 2.86 | Kg | |
| Change From Baseline in Barnes Akathisia Scale at Week 8 | Olanzapine | 0.19 | Standard Deviation 2.12 | units on a scale | |
| Change From Baseline in Barnes Akathisia Scale at Week 8 | Risperidone | 0.41 | Standard Deviation 2.37 | units on a scale | |
| Change From Baseline in Barnes Akathisia Scale at Week 8 | Molindone | 1.23 | Standard Deviation 3.34 | units on a scale | |
| Change From Baseline in PANSS Positive Symptom Subscale Score at 8 Weeks. | Olanzapine | -8.9 | Standard Deviation 6.0 | units on a scale |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Olanzapine | 35 | |
| Overall Study | STARTED | Risperidone | 41 | |
| Overall Study | STARTED | Molindone | 40 | |
| Overall Study | COMPLETED | Olanzapine | 17 | |
| Overall Study | COMPLETED | Risperidone | 28 | |
| Overall Study | COMPLETED | Molindone | 25 | |
| Overall Study | NOT COMPLETED | Olanzapine | 18 | |
| Overall Study | NOT COMPLETED | Risperidone | 13 | |
| Overall Study | NOT COMPLETED | Molindone | 15 |
Source ClinicalTrials.gov
Adverse events45
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 | Agitation | Psychiatric disorders | Olanzapine | 6 | 35 | 6 |
| other | Agitation | Psychiatric disorders | Risperidone | 5 | 41 | 5 |
| other | Agitation | Psychiatric disorders | Molindone | 7 | 40 | 7 |
| other | Akathisia | Nervous system disorders | Olanzapine | 5 | 35 | 5 |
| other | Akathisia | Nervous system disorders | Risperidone | 4 | 41 | 4 |
| other | Akathisia | Nervous system disorders | Molindone | 17 | 40 | 17 |
| other | Anxiety | Psychiatric disorders | Olanzapine | 3 | 35 | 3 |
| other | Anxiety | Psychiatric disorders | Risperidone | 3 | 41 | 3 |
| other | Anxiety | Psychiatric disorders | Molindone | 9 | 40 | 9 |
| other | Blurred Vision | Eye disorders | Olanzapine | 0 | 35 | 0 |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Olanzapine | ||
| Total, all-cause mortality | Risperidone | ||
| Total, all-cause mortality | Molindone | ||
| Total, other adverse events | Olanzapine | 26 | 35 |
| Total, other adverse events | Risperidone | 35 | 41 |
| Total, other adverse events | Molindone | 36 | 40 |
| Total, serious adverse events | Olanzapine | 2 | 35 |
| Total, serious adverse events | Risperidone | 4 | 41 |
| Total, serious adverse events | Molindone | 2 | 40 |
Source ClinicalTrials.gov
Papers8
The papers the trial lists on ClinicalTrials.gov.
Grants3
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| U01MH061355 | TREATMENT OF EARLY ONSET SCHIZOPHRENIA SPECTRUM (TEOSS) | FINDLING, ROBERT L | CASE WESTERN RESERVE UNIVERSITY | NATIONAL INSTITUTE OF MENTAL HEALTH | 2001 to 2005 | NIH RePORTER |
| U01MH061464 | TREATMENT OF EARLY ONSET SCHIZOPHRENIA SPECTRUM (TEOSS) | MCCLELLAN, JON M | SEATTLE CHILDREN'S HOSPITAL | NATIONAL INSTITUTE OF MENTAL HEALTH | 2001 to 2005 | NIH RePORTER |
| U01MH062726 | TREATMENT OF EARLY ONSET SCHIZOPRENIA SPECTRUM (TEOSS) | FRAZIER, JEAN A | CAMBRIDGE HEALTH ALLIANCE | NATIONAL INSTITUTE OF MENTAL HEALTH | 2001 to 2005 | NIH RePORTER |
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/NCT00053703
GET https://conductscience.org/api/trials/v1/NCT00053703/events?page=2