Trial · NCT00982020
Study in Adolescents With Schizophrenia or Bipolar Disorder
NCT00982020, Phase 4, Completed, Eli Lilly and Company; results first posted 2014-12-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study in Adolescents With Schizophrenia or Bipolar Disorder. Trials, record NCT00982020. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00982020
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study in Adolescents With Schizophrenia or Bipolar Disorder
- NCT number
- NCT00982020
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 203 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Bipolar I Disorder, Schizophrenia
- Interventions
- Olanzapine, Standard behavioral weight intervention, Intense behavioral weight intervention
- First posted
- 2009-09-22
- Last updated
- 2014-12-17
- Results first posted
- 2014-12-17
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Change From Baseline to 52 Weeks in Body Mass Index (BMI) for All Participants | Baseline, 52 weeks | |
| Secondary | Mean Change From Baseline to Endpoint in Body Mass Index (BMI) for Participants With Duration of Treatment of at Least 6 Months | Baseline, 52 weeks | |
| Secondary | Time to Event for 7%, 15%, and 25% Weight Gain for All Participants | Baseline up to 52 weeks | Kaplan-Meier methodology used to estimate time to event. Participants who never reached the target weight gain contributed to the set of patients at risk up to the point at which they discontinued from the study and were then censored (i.e., removed from the risk set). |
| Secondary | Mean Change From Baseline to 52 Weeks in Adolescent Structured Young Mania Rating Scale (YMRS) for Participants With Bipolar I Disorder | Baseline, 52 weeks | The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 (symptom not present) to 60 (symptom extremely severe). |
| Secondary | Mean Clinical Global Impression of Improvement (CGI-I) at 52 Weeks for All Participants | 52 weeks | The Clinical Global Impression of Improvement (CGI-I) is used by the clinician to record the improvement of illness at the time of assessment. The score ranges from 1 (very much improved) to 7 (very much worse). |
| Secondary | Mean Change From Baseline to 52 Weeks in Waist Circumference for All Participants | Baseline, 52 weeks | |
| Secondary | Mean Change From Baseline to 52 Weeks in Clinical Global Impression - Severity (CGI-S) for All Participants | Baseline, 52 weeks | The CGI-S is used by the clinician to record the severity of illness at the time of assessment. The score ranges from 1 = normal, not at all ill to 7 = among the most extremely ill. |
| Secondary | Mean Change From Baseline to 52 Weeks in Anchored Version of the Brief Psychiatric Rating Scale for Children (BPRS-C) for Participants With Schizophrenia | Baseline, 52 weeks | The BPRS-C characterizes psychopathology. A total of 21 items are rated on a scale from 0 (not present) to 6 (extremely severe) with a total score ranging from 0 to 126. A decrease in score indicates a reduction in psychopathology. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Change From Baseline to 52 Weeks in Body Mass Index (BMI) for All Participants | Baseline, 52 weeks | All randomized participants who received at least one dose of study drug. Mixed model repeated measures (MMRM) methodology used. | kilograms per meter squared (kg/m^2) | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline to Endpoint in Body Mass Index (BMI) for Participants With Duration of Treatment of at Least 6 Months | Baseline, 52 weeks | All randomized participants who received at least one dose of study drug and who had at least 6 months of data. Last observation carried forward (LOCF) methodology. | kg/m^2 | LEAST_SQUARES_MEAN |
| SECONDARY | Time to Event for 7%, 15%, and 25% Weight Gain for All Participants | Baseline up to 52 weeks | 65 participants (32%; 34% in Standard Group \[SG\], 30% in Intense Group \[IG\]) did not meet 7% weight gain criterion \[WGC\] by the time they discontinued.~122 participants (60%; 58% in SG, 62% in IG) did not meet 15% WGC by the time they discontinued.~161 participants (79%; 76% in SG, 82% in IG) did not meet 25% WGC by the time they discontinued. | days | MEDIAN |
| SECONDARY | Mean Change From Baseline to 52 Weeks in Adolescent Structured Young Mania Rating Scale (YMRS) for Participants With Bipolar I Disorder | Baseline, 52 weeks | All randomized participants with bipolar I disorder, who received at least one dose of study drug. Mixed model repeated measures (MMRM) methodology. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Clinical Global Impression of Improvement (CGI-I) at 52 Weeks for All Participants | 52 weeks | All randomized participants who received at least one dose of study drug. Mixed model repeated measures (MMRM) methodology. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline to 52 Weeks in Waist Circumference for All Participants | Baseline, 52 weeks | All randomized participants who received at least one dose of study drug. | centimeters (cm) | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline to 52 Weeks in Clinical Global Impression - Severity (CGI-S) for All Participants | Baseline, 52 weeks | All randomized participants who received at least one dose of study drug. Mixed model repeated measures (MMRM) methodology. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline to 52 Weeks in Anchored Version of the Brief Psychiatric Rating Scale for Children (BPRS-C) for Participants With Schizophrenia | Baseline, 52 weeks | All randomized participants with schizophrenia who received at least one dose of study drug. Mixed model repeated measures (MMRM) methodology. | units on a scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Change From Baseline to 52 Weeks in Body Mass Index (BMI) for All Participants | Olanzapine/Standard Behavioral Weight Intervention | 3.64 | Standard Error .39 | kilograms per meter squared (kg/m^2) | |
| Mean Change From Baseline to 52 Weeks in Body Mass Index (BMI) for All Participants | Olanzapine/Intense Behavioral Weight Intervention | 2.83 | Standard Error .40 | kilograms per meter squared (kg/m^2) | |
| Mean Change From Baseline to Endpoint in Body Mass Index (BMI) for Participants With Duration of Treatment of at Least 6 Months | Olanzapine/Standard Behavioral Weight Intervention | 3.36 | Standard Error 0.41 | kg/m^2 | |
| Mean Change From Baseline to Endpoint in Body Mass Index (BMI) for Participants With Duration of Treatment of at Least 6 Months | Olanzapine/Intense Behavioral Weight Intervention | 2.99 | Standard Error 0.40 | kg/m^2 | |
| Time to Event for 7%, 15%, and 25% Weight Gain for All Participants | Olanzapine/Standard Behavioral Weight Intervention | Time to First 7% Weight Gain | 57 | 95% Confidence Interval 44.00 to 84.00 | days |
| Time to Event for 7%, 15%, and 25% Weight Gain for All Participants | Olanzapine/Intense Behavioral Weight Intervention | Time to First 7% Weight Gain | 57 | 95% Confidence Interval 44.00 to 84.00 | days |
| Time to Event for 7%, 15%, and 25% Weight Gain for All Participants | Olanzapine/Standard Behavioral Weight Intervention | Time to First 15% Weight Gain | 197 | 95% Confidence Interval 140.00 to 359.00 | days |
| Time to Event for 7%, 15%, and 25% Weight Gain for All Participants | Olanzapine/Intense Behavioral Weight Intervention | Time to First 15% Weight Gain | 198 | 95% Confidence Interval 141.00 to NA | days |
| Time to Event for 7%, 15%, and 25% Weight Gain for All Participants | Olanzapine/Standard Behavioral Weight Intervention | Time to First 25% Weight Gain | NA | 95% Confidence Interval NA to NA | days |
| Time to Event for 7%, 15%, and 25% Weight Gain for All Participants | Olanzapine/Intense Behavioral Weight Intervention | Time to First 25% Weight Gain | NA | 95% Confidence Interval NA to NA | days |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Olanzapine/Standard Behavioral Weight Intervention | 102 | |
| Overall Study | STARTED | Olanzapine/Intense Behavioral Weight Intervention | 101 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Olanzapine/Standard Behavioral Weight Intervention | 102 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Olanzapine/Intense Behavioral Weight Intervention | 101 | |
| Overall Study | COMPLETED | Olanzapine/Standard Behavioral Weight Intervention | 45 | |
| Overall Study | COMPLETED | Olanzapine/Intense Behavioral Weight Intervention | 37 | |
| Overall Study | NOT COMPLETED | Olanzapine/Standard Behavioral Weight Intervention | 57 | |
| Overall Study | NOT COMPLETED | Olanzapine/Intense Behavioral Weight Intervention | 64 |
Source ClinicalTrials.gov
Adverse events90
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 | Dry mouth | Gastrointestinal disorders | Olanzapine/Standard Behavioral Weight Intervention | 6 | 102 | 6 |
| other | Dry mouth | Gastrointestinal disorders | Olanzapine/Intense Behavioral Weight Intervention | 4 | 101 | 4 |
| other | Vomiting | Gastrointestinal disorders | Olanzapine/Standard Behavioral Weight Intervention | 7 | 102 | 8 |
| other | Vomiting | Gastrointestinal disorders | Olanzapine/Intense Behavioral Weight Intervention | 4 | 101 | 7 |
| other | Fatigue | General disorders | Olanzapine/Standard Behavioral Weight Intervention | 9 | 102 | 10 |
| other | Fatigue | General disorders | Olanzapine/Intense Behavioral Weight Intervention | 6 | 101 | 6 |
| other | Nasopharyngitis | Infections and infestations | Olanzapine/Standard Behavioral Weight Intervention | 14 | 102 | 16 |
| other | Nasopharyngitis | Infections and infestations | Olanzapine/Intense Behavioral Weight Intervention | 11 | 101 | 11 |
| other | Blood creatine phosphokinase increased | Investigations | Olanzapine/Standard Behavioral Weight Intervention | 7 | 102 | 9 |
| other | Blood creatine phosphokinase increased | Investigations | Olanzapine/Intense Behavioral Weight Intervention | 5 | 101 | 6 |
1 to 10 of 90Source ClinicalTrials.gov
See all 90 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Olanzapine/Standard Behavioral Weight Intervention | ||
| Total, all-cause mortality | Olanzapine/Intense Behavioral Weight Intervention | ||
| Total, other adverse events | Olanzapine/Standard Behavioral Weight Intervention | 81 | 102 |
| Total, other adverse events | Olanzapine/Intense Behavioral Weight Intervention | 81 | 101 |
| Total, serious adverse events | Olanzapine/Standard Behavioral Weight Intervention | 13 | 102 |
| Total, serious adverse events | Olanzapine/Intense Behavioral Weight Intervention | 20 | 101 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 27676420 | DERIVED |
Source PubMed
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 |
|---|
| Olanzapine/Standard Behavioral Weight Intervention vs Olanzapine/Intense Behavioral Weight Intervention: serious adverse events |
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/NCT00982020
GET https://conductscience.org/api/trials/v1/NCT00982020/events?page=2