Trial · NCT00617058
Improving Metabolic Parameters of Antipsychotic Child Treatment With Ziprasidone, Aripiprazole, and Clozapine
NCT00617058, Phase 2, Terminated, University of North Carolina, Chapel Hill; results first posted 2012-12-31
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Improving Metabolic Parameters of Antipsychotic Child Treatment With Ziprasidone, Aripiprazole, and Clozapine. Trials, record NCT00617058. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00617058
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Improving Metabolic Parameters of Antipsychotic Child Treatment With Ziprasidone, Aripiprazole, and Clozapine
- NCT number
- NCT00617058
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 1 participants, actual
- Lead sponsor
- University of North Carolina, Chapel Hill
- Conditions
- Weight Gain
- Interventions
- metformin, healthy lifestyle intervention
- First posted
- 2008-02-15
- Last updated
- 2012-12-31
- Results first posted
- 2012-12-31
- Limitations and caveats
In terms of study limitations, this research study was only able to enroll a single study participant before the trial was terminated prematurely due to study start-up for a larger, multisite effort examining similar outcome measures.
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change in BMI | 24 weeks | |
| Primary | Absolute Change in Weight | 24 weeks | |
| Primary | Percent Change in Fat Mass | 24 weeks | |
| Primary | Percent Change in Weight | 24 weeks | |
| Secondary | Percent Change in Insulin Levels | 24 weeks | |
| Secondary | Percent Change in Total Cholesterol | 24 weeks | |
| Secondary | Percent Change in Triglycerides | 24 weeks | |
| Secondary | Incidence of Metabolic Syndrome | 24 weeks | |
| Secondary | Percent Change in Glucose Levels | 24 weeks | |
| Secondary | Percent Change in HDL | 24 weeks |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change in BMI | 24 weeks | This research study only enrolled a single study participant before the entire research study was terminated due to the start of a larger, multi-site trial evaluating similar outcome measures. | percent change | NUMBER |
| PRIMARY | Absolute Change in Weight | 24 weeks | lbs. | NUMBER | |
| PRIMARY | Percent Change in Fat Mass | 24 weeks | percent change | NUMBER | |
| SECONDARY | Percent Change in Insulin Levels | 24 weeks | percent change | NUMBER | |
| SECONDARY | Percent Change in Total Cholesterol | 24 weeks | percent change | NUMBER | |
| SECONDARY | Percent Change in Triglycerides | 24 weeks | percent change | NUMBER | |
| SECONDARY | Incidence of Metabolic Syndrome | 24 weeks | participants | NUMBER | |
| PRIMARY | Percent Change in Weight | 24 weeks | percent change | NUMBER | |
| SECONDARY | Percent Change in Glucose Levels | 24 weeks | percent change | NUMBER | |
| SECONDARY | Percent Change in HDL | 24 weeks | percent change | NUMBER |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group11
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change in BMI | Co-Treatment With Metformin | -2.65 | percent change | ||
| Absolute Change in Weight | Co-Treatment With Metformin | -10.6 | lbs. | ||
| Percent Change in Fat Mass | Co-Treatment With Metformin | 3.80 | percent change | ||
| Percent Change in Insulin Levels | Co-Treatment With Metformin | -23.08 | percent change | ||
| Percent Change in Total Cholesterol | Co-Treatment With Metformin | 2.84 | percent change | ||
| Percent Change in Triglycerides | Co-Treatment With Metformin | 46.60 | percent change | ||
| Incidence of Metabolic Syndrome | Co-Treatment With Metformin | 0 | participants | ||
| Percent Change in Weight | Co-Treatment With Metformin | -4.00 | percent change | ||
| Percent Change in Glucose Levels | Co-Treatment With Metformin | -3.41 | percent change | ||
| Percent Change in HDL | Co-Treatment With Metformin | 7.04 | percent change |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Co-Treatment With Metformin | 1 | |
| Overall Study | STARTED | Healthy Lifestyle Instruction Group | 0 | |
| Overall Study | STARTED | Elective Monitoring Control Group | 0 | |
| Overall Study | COMPLETED | Co-Treatment With Metformin | 1 | |
| Overall Study | COMPLETED | Healthy Lifestyle Instruction Group | 0 | |
| Overall Study | COMPLETED | Elective Monitoring Control Group | 0 | |
| Overall Study | NOT COMPLETED | Co-Treatment With Metformin | 0 | |
| Overall Study | NOT COMPLETED | Healthy Lifestyle Instruction Group | 0 | |
| Overall Study | NOT COMPLETED | Elective Monitoring Control Group | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Co-Treatment With Metformin | ||
| Total, all-cause mortality | Healthy Lifestyle Instruction Group | ||
| Total, all-cause mortality | Elective Monitoring Control Group | ||
| Total, other adverse events | Co-Treatment With Metformin | 0 | 1 |
| Total, other adverse events | Healthy Lifestyle Instruction Group | 0 | 0 |
| Total, other adverse events | Elective Monitoring Control Group | 0 | 0 |
| Total, serious adverse events | Co-Treatment With Metformin | 0 | 1 |
| Total, serious adverse events | Healthy Lifestyle Instruction Group | 0 | 0 |
| Total, serious adverse events | Elective Monitoring Control Group | 0 | 0 |
Source ClinicalTrials.gov
Papers0
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 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/NCT00617058
GET https://conductscience.org/api/trials/v1/NCT00617058/registered