Trial · NCT00167934
Determining Metabolic Effects of Valproate and Antipsychotic Therapy
NCT00167934, Not applicable, Completed, Washington University School of Medicine; results first posted 2020-02-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Determining Metabolic Effects of Valproate and Antipsychotic Therapy. Trials, record NCT00167934. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00167934
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Determining Metabolic Effects of Valproate and Antipsychotic Therapy
- NCT number
- NCT00167934
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 164 participants, actual
- Lead sponsor
- Washington University School of Medicine
- Conditions
- Schizophrenia
- Interventions
- Valproate, Placebo
- First posted
- 2005-09-14
- Last updated
- 2020-02-10
- Results first posted
- 2020-02-10
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Total Body Fat Composition Using Dual Energy X-ray Absorptiometry at 12 Weeks | Measured at baseline and Week 12 | Change in body composition (total body fat) was assessed using dual energy x-ray absorptiometry |
| Primary | Effects of Medication on Insulin Secretion at Skeletal Muscle (Glucose Disposal) | Measured at baseline and Week 12 |
Source ClinicalTrials.gov
Outcomes2
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 Total Body Fat Composition Using Dual Energy X-ray Absorptiometry at 12 Weeks | Measured at baseline and Week 12 | percent change | MEAN | |
| PRIMARY | Effects of Medication on Insulin Secretion at Skeletal Muscle (Glucose Disposal) | Measured at baseline and Week 12 | percent change | MEAN |
Source ClinicalTrials.gov
Results by group4
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 Total Body Fat Composition Using Dual Energy X-ray Absorptiometry at 12 Weeks | Placebo | -0.51 | Standard Deviation 2.13 | percent change | |
| Change From Baseline in Total Body Fat Composition Using Dual Energy X-ray Absorptiometry at 12 Weeks | Experimental | 2.03 | Standard Deviation 2.17 | percent change | |
| Effects of Medication on Insulin Secretion at Skeletal Muscle (Glucose Disposal) | Placebo | 0.27 | Standard Deviation 1.23 | percent change | |
| Effects of Medication on Insulin Secretion at Skeletal Muscle (Glucose Disposal) | Experimental | -0.35 | Standard Deviation 1.13 | percent change |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 82 | |
| Overall Study | STARTED | Experimental | 82 | |
| Overall Study | COMPLETED | Placebo | 82 | |
| Overall Study | COMPLETED | Experimental | 82 | |
| Overall Study | NOT COMPLETED | Placebo | 0 | |
| Overall Study | NOT COMPLETED | Experimental | 0 |
Source ClinicalTrials.gov
Adverse events10
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 | Drowsiness/Somnolence | General disorders | Placebo | 1 | 23 | |
| other | Drowsiness/Somnolence | General disorders | Experimental | 2 | 24 | |
| other | Tiredness/Fatigue | General disorders | Placebo | 0 | 23 | |
| other | Tiredness/Fatigue | General disorders | Experimental | 3 | 24 | |
| other | Anxiety | General disorders | Placebo | 1 | 23 | |
| other | Anxiety | General disorders | Experimental | 2 | 24 | |
| other | Restlessness | General disorders | Placebo | 2 | 23 | |
| other | Restlessness | General disorders | Experimental | 2 | 24 | |
| other | Tremor | General disorders | Placebo | 0 | 23 | |
| other | Tremor | General disorders | Experimental | 3 | 24 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Experimental | ||
| Total, other adverse events | Placebo | 4 | 23 |
| Total, other adverse events | Experimental | 12 | 24 |
| Total, serious adverse events | Placebo | 0 | 23 |
| Total, serious adverse events | Experimental | 0 | 24 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 11806485 | BACKGROUND |
Source PubMed
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 |
|---|---|---|---|---|---|
| K23MH067795 | Metabolic Effects of Valproate and Antipsychotic Therapy | HAUPT, DAN W | WASHINGTON UNIVERSITY | NATIONAL INSTITUTE OF MENTAL HEALTH | 2004 to 2008 |
Source NIH RePORTER
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Experimental 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/NCT00167934
GET https://conductscience.org/api/trials/v1/NCT00167934/registered