Trial · NCT00345033
Effectiveness of Aripiprazole for Improving Side Effects of Clozapine in the Treatment of People With Schizophrenia
NCT00345033, Phase 4, Completed, Massachusetts General Hospital; results first posted 2012-09-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effectiveness of Aripiprazole for Improving Side Effects of Clozapine in the Treatment of People With Schizophrenia. Trials, record NCT00345033. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00345033
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effectiveness of Aripiprazole for Improving Side Effects of Clozapine in the Treatment of People With Schizophrenia
- NCT number
- NCT00345033
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 38 participants, actual
- Lead sponsor
- Massachusetts General Hospital
- Conditions
- Schizophrenia, Insulin Resistance
- Interventions
- Aripiprazole, Placebo
- First posted
- 2006-06-27
- Last updated
- 2014-06-23
- Results first posted
- 2012-09-13
- Limitations and caveats
The limitations of this study include the relatively small sample size, short intervention period (8 weeks) and the lack of generalizability of our findings to patients with schizophrenia treated by antipsychotic agents other than clozapine.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Total Cholesterol | Measured at Baseline and Week 8 | A comparison of aripiprazole group and placebo group in change in total cholesterol measured at Baseline and Week 8. |
| Primary | Change in Weight | Measured at Baseline and Week 8 | A comparison between aripiprazole group and placebo group in change in weight measured at Baseline and Week 8. |
| Primary | Change in Body Mass Index (BMI) | Measured at Baseline and Week 8 | A comparison between aripiprazole group and placebo group of change in Body Mass Index (BMI) measured at Baseline and Week 8. |
| Primary | Change in Glucose Metabolism | Measured at Baseline and Week 8 | A comparison between the aripiprazole group and placebo group in change in glucose metabolism measured at Baseline and Week 8. |
| Primary | Change in Triglycerides | Measured at Baseline and Week 8 | |
| Primary | Change in Insulin Resistance | Measured at Baseline and Week 8 | A comparison between aripiprazole group and placebo group of change in insulin resistance measured at Baseline and Week 8. |
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 in Total Cholesterol | Measured at Baseline and Week 8 | The number of participants for analysis (intent to treat) were those that completed the study (N = 30). | mg/dL | MEAN |
| PRIMARY | Change in Weight | Measured at Baseline and Week 8 | The number of participants for analysis (intent to treat) were those that completed the study (N=30). | kg | MEAN |
| PRIMARY | Change in Body Mass Index (BMI) | Measured at Baseline and Week 8 | The number of participants for analysis (intent to treat) were those that completed the study (N=30). | kg/m^2 | MEAN |
| PRIMARY | Change in Glucose Metabolism | Measured at Baseline and Week 8 | The number of participants for analysis (intent to treat) were those that completed the study (N=30). | min^-1 | MEAN |
| PRIMARY | Change in Triglycerides | Measured at Baseline and Week 8 | The number of participants for analysis (intent to treat) were those that completed the study (N=30) | mg/dL | MEAN |
| PRIMARY | Change in Insulin Resistance | Measured at Baseline and Week 8 | The number of participants for analysis (intent to treat) were those that completed the study (N=30) | HOMA score | MEAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Total Cholesterol | Aripiprazole | -15.3 | Standard Deviation 33.3 | mg/dL | |
| Change in Total Cholesterol | Placebo | 5.6 | Standard Deviation 34.0 | mg/dL | |
| Change in Weight | Aripiprazole | -1.5 | Standard Deviation 2.3 | kg | |
| Change in Weight | Placebo | 0.3 | Standard Deviation 2.3 | kg | |
| Change in Body Mass Index (BMI) | Aripiprazole | -0.52 | Standard Deviation 0.79 | kg/m^2 | |
| Change in Body Mass Index (BMI) | Placebo | 0.03 | Standard Deviation 0.85 | kg/m^2 | |
| Change in Glucose Metabolism | Aripiprazole | 0.003 | Standard Deviation 0.006 | min^-1 | |
| Change in Glucose Metabolism | Placebo | -0.005 | Standard Deviation 0.007 | min^-1 | |
| Change in Triglycerides | Aripiprazole | -5.9 | Standard Deviation 75.1 | mg/dL | |
| Change in Triglycerides | Placebo | -7.3 | Standard Deviation 100.3 | mg/dL |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Aripiprazole | 20 | |
| Overall Study | STARTED | Placebo | 18 | |
| Overall Study | COMPLETED | Aripiprazole | 16 | |
| Overall Study | COMPLETED | Placebo | 14 | |
| Overall Study | NOT COMPLETED | Aripiprazole | 4 | |
| Overall Study | NOT COMPLETED | Placebo | 4 |
Source ClinicalTrials.gov
Adverse events14
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 | dizziness during IVGTT procedure | General disorders | Aripiprazole | 0 | 16 | 0 |
| other | dizziness during IVGTT procedure | General disorders | Placebo | 1 | 14 | 1 |
| other | eye irritation/swelling | Eye disorders | Aripiprazole | 1 | 16 | 1 |
| other | eye irritation/swelling | Eye disorders | Placebo | 0 | 14 | 0 |
| other | psychiatric decompensation | Psychiatric disorders | Aripiprazole | 1 | 16 | 1 |
| other | psychiatric decompensation | Psychiatric disorders | Placebo | 0 | 14 | 0 |
| other | asthma | Respiratory, thoracic and mediastinal disorders | Aripiprazole | 0 | 16 | 0 |
| other | asthma | Respiratory, thoracic and mediastinal disorders | Placebo | 1 | 14 | 1 |
| other | stomach pain | Gastrointestinal disorders | Aripiprazole | 0 | 16 | 0 |
| other | stomach pain | Gastrointestinal disorders | Placebo | 1 | 14 | 1 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Aripiprazole | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Aripiprazole | 4 | 16 |
| Total, other adverse events | Placebo | 3 | 14 |
| Total, serious adverse events | Aripiprazole | 0 | 16 |
| Total, serious adverse events | Placebo | 0 | 14 |
Source ClinicalTrials.gov
Papers7
The papers the trial lists on ClinicalTrials.gov.
Grants1
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 |
|---|---|---|---|---|---|
| R01MH072635 | Aripiprazole for Clozapine Associated Medical Morbidity | HENDERSON, DAVID C | MASSACHUSETTS GENERAL HOSPITAL | NATIONAL INSTITUTE OF MENTAL HEALTH | 2005 to 2007 |
Source NIH RePORTER
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Aripiprazole vs Placebo: 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/NCT00345033
GET https://conductscience.org/api/trials/v1/NCT00345033/registered