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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

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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

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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.

ListOutcomeTime frameDescription
PrimaryChange From Baseline in Total Body Fat Composition Using Dual Energy X-ray Absorptiometry at 12 WeeksMeasured at baseline and Week 12Change in body composition (total body fat) was assessed using dual energy x-ray absorptiometry
PrimaryEffects of Medication on Insulin Secretion at Skeletal Muscle (Glucose Disposal)Measured at baseline and Week 12

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYChange From Baseline in Total Body Fat Composition Using Dual Energy X-ray Absorptiometry at 12 WeeksMeasured at baseline and Week 12percent changeMEAN
PRIMARYEffects of Medication on Insulin Secretion at Skeletal Muscle (Glucose Disposal)Measured at baseline and Week 12percent changeMEAN

Results by group4

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Change From Baseline in Total Body Fat Composition Using Dual Energy X-ray Absorptiometry at 12 WeeksPlacebo-0.51Standard Deviation 2.13percent change
Change From Baseline in Total Body Fat Composition Using Dual Energy X-ray Absorptiometry at 12 WeeksExperimental2.03Standard Deviation 2.17percent change
Effects of Medication on Insulin Secretion at Skeletal Muscle (Glucose Disposal)Placebo0.27Standard Deviation 1.23percent change
Effects of Medication on Insulin Secretion at Skeletal Muscle (Glucose Disposal)Experimental-0.35Standard Deviation 1.13percent change

Participant flow6

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDPlacebo82
Overall StudySTARTEDExperimental82
Overall StudyCOMPLETEDPlacebo82
Overall StudyCOMPLETEDExperimental82
Overall StudyNOT COMPLETEDPlacebo0
Overall StudyNOT COMPLETEDExperimental0

Adverse events10

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

TypeEventOrgan systemGroupAffectedAt riskEvents
otherDrowsiness/SomnolenceGeneral disordersPlacebo123
otherDrowsiness/SomnolenceGeneral disordersExperimental224
otherTiredness/FatigueGeneral disordersPlacebo023
otherTiredness/FatigueGeneral disordersExperimental324
otherAnxietyGeneral disordersPlacebo123
otherAnxietyGeneral disordersExperimental224
otherRestlessnessGeneral disordersPlacebo223
otherRestlessnessGeneral disordersExperimental224
otherTremorGeneral disordersPlacebo023
otherTremorGeneral disordersExperimental324

Adverse event totals6

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityPlacebo
Total, all-cause mortalityExperimental
Total, other adverse eventsPlacebo423
Total, other adverse eventsExperimental1224
Total, serious adverse eventsPlacebo023
Total, serious adverse eventsExperimental024

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMIDListed as
11806485BACKGROUND

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.

ProjectTitlePrincipal investigatorsOrganizationFunderFiscal years
K23MH067795Metabolic Effects of Valproate and Antipsychotic TherapyHAUPT, DAN WWASHINGTON UNIVERSITYNATIONAL INSTITUTE OF MENTAL HEALTH2004 to 2008

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Experimental vs Placebo: serious adverse events

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.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

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