Trial · NCT00337662
Efficacy Study of Early Onset of Antipsychotic Drug Action in Schizophrenia
NCT00337662, Phase 4, Completed, Eli Lilly and Company; results first posted 2009-08-04
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ConductScience Library. Efficacy Study of Early Onset of Antipsychotic Drug Action in Schizophrenia. Trials, record NCT00337662. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00337662
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy Study of Early Onset of Antipsychotic Drug Action in Schizophrenia
- NCT number
- NCT00337662
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 628 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder
- Interventions
- olanzapine, risperidone, risperidone
- First posted
- 2006-06-16
- Last updated
- 2010-02-17
- Results first posted
- 2009-08-04
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Changes From Study Period II Baseline (Week 0) to Weeks 3, 4, 6, 8, and 12 in Positive and Negative Syndrome Scale (PANSS) Total Score in Early Onset Response and Not Early Onset Response-Risperidone Patients | Weeks 0, 3, 4, 6, 8, 12 | Assesses positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. Scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Sum of 30 items is PANSS total score and ranges from 30 to 210. Change = time point - single-blind baseline (Week 0). |
| Secondary | Changes From Study Period III Baseline (Week 2) to Weeks 3, 4, 6, 8, and 12 in Positive and Negative Syndrome Scale Total Score in Not Early Onset Response-Risperidone and Not Early Onset Response-Olanzapine Patients | Weeks 2, 3, 4, 6, 8, 12 | Assesses positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. Scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Sum of 30 items is PANSS total score and ranges from 30 to 210. Change = time point - double-blind baseline (Week 2). |
| Secondary | The Number of Participants in the Early Onset (EO) and Not Early Onset-Risperidone (NEO-RIS) Groups Who Show a 20% or Greater Reduction in Positive and Negative Syndrome Scale (PANSS) Total Score | Week 0 to Week 12 | The number of participants who experienced a 20% or greater reduction in their PANSS Total score during the 12 weeks they were on risperidone. |
| Secondary | The Number of Participants in the Not Early Onset-Risperidone (NEO-RIS) and Not Early Onset-Olanzapine (NEO-OLZ) Groups Who Show a 20% or Greater Reduction in Positive and Negative Syndrome Scale (PANSS) Total Score | Week 0 to Week 12 | The number of not early onset participants who experienced a 20% or greater reduction in PANSS Total Score at any time during the 12 weeks of combined Study Period II and Study Period III. |
| Secondary | Number of Participants in the Early Onset and Not Early Onset-Risperidone Groups Who Show a 50% or Greater Reduction in Positive and Negative Syndrome Scale (PANSS) Total Score From Baseline or Meet 'a Priori' Specified Criteria for Remission | Week 0 to Week 12 | 'a priori' specified criteria for remission defined as a score of 3 (mild), 2 (minimal), or 1 (absent) on all of the following 8 PANSS items: delusions, conceptual disorganization, hallucinatory behavior, unusual thought content, mannerisms and posturing, blunted effect, passive/apathetic withdrawal, lack of spontaneity and flow of conversation. |
| Secondary | Number of Participants in the Not Early Onset-Risperidone and Not Early Onset-Olanzapine Groups Who Show a 50% or Greater Reduction in Positive and Negative Syndrome Scale Total Score From Baseline or Meet 'a Priori' Specified Criteria for Remission | Week 2 to Week 12 | 'a priori' specified criteria for remission defined as a score of 3 (mild), 2 (minimal), or 1 (absent) on all of the following 8 PANSS items: delusions, conceptual disorganization, hallucinatory behavior, unusual thought content, mannerisms and posturing, blunted effect, passive/apathetic withdrawal, lack of spontaneity and flow of conversation. |
| Secondary | Number of Participants With Psychiatric Hospitalizations in the Early Onset and Not Early Onset-Risperidone Groups | Week 2 to Week 12 | Psychiatric Hospitalizations were measured by the Modified Schizophrenia Care and Assessment Program Health Questionnaire (SCAP-HQ) from which it could be determined the number of patients with a psychiatric episode that required an overnight stay in a hospital. |
| Secondary | Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Body Mass Index | Week 2 to Week 12 | Body mass index is an estimate of body fat based on body weight divided by height squared. Change = Endpoint minus baseline. |
| Secondary | Number of Participants With Treatment-Emergent Abnormal Fasting Laboratory Analytes Reported in >=2% of All Participants | Week 2 to Week 12 | Number of participants who experienced abnormal fasting laboratory values at any time during Study Period III. Laboratory reference ranges are dependent on the patient's gender, origin, and age. |
| Secondary | Mean Change From Baseline to 10 Week Endpoint in Extrapyramidal Symptoms as Measured by the Modified Simpson-Angus Scale | Week 2 to Week 12 | Measures neuroleptic-induced parkinsonism. Total score consists of the sum of 10 items: 7 items (items 1, 3, 4, 7, 8, 9, 10) rated on a 4-point severity scale where 0=normal and 4=extreme, and 3 items (items 2, 5, 6) rated on a 2-point severity scale where 0=normal and 2=definitely abnormal/present. The total score ranges from 0 to 34. |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Changes From Study Period II Baseline (Week 0) to Weeks 3, 4, 6, 8, and 12 in Positive and Negative Syndrome Scale (PANSS) Total Score in Early Onset Response and Not Early Onset Response-Risperidone Patients | Weeks 0, 3, 4, 6, 8, 12 | Intention to treat for patients with both baseline and any postbaseline assessment | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Changes From Study Period III Baseline (Week 2) to Weeks 3, 4, 6, 8, and 12 in Positive and Negative Syndrome Scale Total Score in Not Early Onset Response-Risperidone and Not Early Onset Response-Olanzapine Patients | Weeks 2, 3, 4, 6, 8, 12 | Intention to treat patients with both baseline and postbaseline assessment | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | The Number of Participants in the Early Onset (EO) and Not Early Onset-Risperidone (NEO-RIS) Groups Who Show a 20% or Greater Reduction in Positive and Negative Syndrome Scale (PANSS) Total Score | Week 0 to Week 12 | Total number of patients having nonmissing values at both baseline (last of visit 1 - visit 2) and post baseline (last of visit 5 - visit 9) visits. | participants | NUMBER |
| SECONDARY | The Number of Participants in the Not Early Onset-Risperidone (NEO-RIS) and Not Early Onset-Olanzapine (NEO-OLZ) Groups Who Show a 20% or Greater Reduction in Positive and Negative Syndrome Scale (PANSS) Total Score | Week 0 to Week 12 | Total number of patients having nonmissing values at both baseline (last of visit 1 - visit 2) and post baseline (last of visit 5 - visit 9) visits. | participants | NUMBER |
| SECONDARY | Number of Participants in the Early Onset and Not Early Onset-Risperidone Groups Who Show a 50% or Greater Reduction in Positive and Negative Syndrome Scale (PANSS) Total Score From Baseline or Meet 'a Priori' Specified Criteria for Remission | Week 0 to Week 12 | Total number of patients having nonmissing values at both baseline (last of visit 1 - visit 2) and post baseline (last of visit 5 - visit 9) visits. | participants | NUMBER |
| SECONDARY | Number of Participants in the Not Early Onset-Risperidone and Not Early Onset-Olanzapine Groups Who Show a 50% or Greater Reduction in Positive and Negative Syndrome Scale Total Score From Baseline or Meet 'a Priori' Specified Criteria for Remission | Week 2 to Week 12 | Total number of patients having nonmissing values at both baseline (last of visit 3 - visit 4) and post baseline (last of visit 5 - visit 9) visits. | participants | NUMBER |
| SECONDARY | Number of Participants With Psychiatric Hospitalizations in the Early Onset and Not Early Onset-Risperidone Groups | Week 2 to Week 12 | Total number of patients having nonmissing values at both baseline (last of visit 3 - visit 4) and post baseline (last of visit 5 - visit 9) visits. | participants | NUMBER |
| SECONDARY | Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Body Mass Index | Week 2 to Week 12 | Total number of patients having nonmissing values at both baseline (last of visit 3 - visit 4) and post baseline (last of visit 5 - visit 9) visits. | kilogram per square meter | MEAN |
| SECONDARY | Number of Participants With Treatment-Emergent Abnormal Fasting Laboratory Analytes Reported in >=2% of All Participants | Week 2 to Week 12 | Total number of patients with the lab test at baseline and post-baseline. | participants | NUMBER |
| SECONDARY | Mean Change From Baseline to 10 Week Endpoint in Extrapyramidal Symptoms as Measured by the Modified Simpson-Angus Scale | Week 2 to Week 12 | Total number of patients having nonmissing values at both baseline (last of visit 3 - visit 4) and post baseline (last of visit 5 - visit 9) visits. | units on a scale | MEAN |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 outcomesResults by group109
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
Changes From Study Period II Baseline (Week 0) to Weeks 3, 4, 6, 8, and 12 in Positive and Negative Syndrome Scale (PANSS) Total Score in Early Onset Response and Not Early Onset Response-Risperidone Patients | NEO-RIS | Change from Week 0 to Week 3 | -11.90 | Standard Error 1.15 | units on a scale |
Changes From Study Period II Baseline (Week 0) to Weeks 3, 4, 6, 8, and 12 in Positive and Negative Syndrome Scale (PANSS) Total Score in Early Onset Response and Not Early Onset Response-Risperidone Patients | EO-RIS | Change from Week 0 to Week 3 | -30.80 | Standard Error 1.23 | units on a scale |
Changes From Study Period II Baseline (Week 0) to Weeks 3, 4, 6, 8, and 12 in Positive and Negative Syndrome Scale (PANSS) Total Score in Early Onset Response and Not Early Onset Response-Risperidone Patients | NEO-RIS | Change from Week 0 to Week 4 | -14.81 | Standard Error 1.16 | units on a scale |
Changes From Study Period II Baseline (Week 0) to Weeks 3, 4, 6, 8, and 12 in Positive and Negative Syndrome Scale (PANSS) Total Score in Early Onset Response and Not Early Onset Response-Risperidone Patients | EO-RIS | Change from Week 0 to Week 4 | -32.53 | Standard Error 1.24 | units on a scale |
Changes From Study Period II Baseline (Week 0) to Weeks 3, 4, 6, 8, and 12 in Positive and Negative Syndrome Scale (PANSS) Total Score in Early Onset Response and Not Early Onset Response-Risperidone Patients | NEO-RIS | Change from Week 0 to Week 6 | -16.23 | Standard Error 1.26 | units on a scale |
Changes From Study Period II Baseline (Week 0) to Weeks 3, 4, 6, 8, and 12 in Positive and Negative Syndrome Scale (PANSS) Total Score in Early Onset Response and Not Early Onset Response-Risperidone Patients | EO-RIS | Change from Week 0 to Week 6 | -32.90 | Standard Error 1.36 | units on a scale |
Changes From Study Period II Baseline (Week 0) to Weeks 3, 4, 6, 8, and 12 in Positive and Negative Syndrome Scale (PANSS) Total Score in Early Onset Response and Not Early Onset Response-Risperidone Patients | NEO-RIS | Change from Week 0 to Week 8 | -18.10 | Standard Error 1.31 | units on a scale |
Changes From Study Period II Baseline (Week 0) to Weeks 3, 4, 6, 8, and 12 in Positive and Negative Syndrome Scale (PANSS) Total Score in Early Onset Response and Not Early Onset Response-Risperidone Patients | EO-RIS | Change from Week 0 to Week 8 | -34.10 | Standard Error 1.43 | units on a scale |
Changes From Study Period II Baseline (Week 0) to Weeks 3, 4, 6, 8, and 12 in Positive and Negative Syndrome Scale (PANSS) Total Score in Early Onset Response and Not Early Onset Response-Risperidone Patients | NEO-RIS | Change from Week 0 to Week 12 | -18.62 | Standard Error 1.38 | units on a scale |
Changes From Study Period II Baseline (Week 0) to Weeks 3, 4, 6, 8, and 12 in Positive and Negative Syndrome Scale (PANSS) Total Score in Early Onset Response and Not Early Onset Response-Risperidone Patients | EO-RIS | Change from Week 0 to Week 12 | -35.09 | Standard Error 1.50 | units on a scale |
1 to 10 of 109Source ClinicalTrials.gov
See all 109 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Study Period II | STARTED | NEO-OLZ | 0 | |
| Study Period II | STARTED | NEO-RIS | 0 | |
| Study Period II | STARTED | EO-RIS | 0 | |
| Study Period II | STARTED | Risperiodone Open-Label Lead-In | 628 | |
| Study Period II | COMPLETED | NEO-OLZ | 0 | |
| Study Period II | COMPLETED | NEO-RIS | 0 | |
| Study Period II | COMPLETED | EO-RIS | 0 | |
| Study Period II | COMPLETED | Risperiodone Open-Label Lead-In | 522 | |
| Study Period II | NOT COMPLETED | NEO-OLZ | 0 | |
| Study Period II | NOT COMPLETED | NEO-RIS | 0 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events162
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 | Vision blurred | Eye disorders | NEO-OLZ | 1 | 186 | 1 |
| other | Vision blurred | Eye disorders | NEO-RIS | 2 | 192 | 2 |
| other | Vision blurred | Eye disorders | EO-RIS | 3 | 144 | 3 |
| other | Constipation | Gastrointestinal disorders | NEO-OLZ | 3 | 186 | 3 |
| other | Constipation | Gastrointestinal disorders | NEO-RIS | 4 | 192 | 5 |
| other | Constipation | Gastrointestinal disorders | EO-RIS | 2 | 144 | 2 |
| other | Diarrhoea | Gastrointestinal disorders | NEO-OLZ | 2 | 186 | 2 |
| other | Diarrhoea | Gastrointestinal disorders | NEO-RIS | 10 | 192 | 11 |
| other | Diarrhoea | Gastrointestinal disorders | EO-RIS | 4 | 144 | 4 |
| other | Dry mouth | Gastrointestinal disorders | NEO-OLZ | 4 | 186 | 4 |
1 to 10 of 162Source ClinicalTrials.gov
See all 162 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | NEO-OLZ | ||
| Total, all-cause mortality | NEO-RIS | ||
| Total, all-cause mortality | EO-RIS | ||
| Total, other adverse events | NEO-OLZ | 97 | |
| Total, other adverse events | NEO-RIS | 100 | |
| Total, other adverse events | EO-RIS | 83 | |
| Total, serious adverse events | NEO-OLZ | 19 | 186 |
| Total, serious adverse events | NEO-RIS | 12 | 192 |
| Total, serious adverse events | EO-RIS | 14 | 144 |
Source ClinicalTrials.gov
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/NCT00337662
GET https://conductscience.org/api/trials/v1/NCT00337662/results?page=2