NCT00167934

Brief Summary

This study will determine the metabolic processes responsible for high levels of blood glucose, metabolism disorders, and weight gain in people with schizophrenia who have been treated with antipsychotic medications in combination with valproate.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
164

participants targeted

Target at P75+ for not_applicable schizophrenia

Timeline
Completed

Started Dec 2004

Typical duration for not_applicable schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2004

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
11.2 years until next milestone

Results Posted

Study results publicly available

February 10, 2020

Completed
Last Updated

February 10, 2020

Status Verified

January 1, 2020

Enrollment Period

4 years

First QC Date

September 9, 2005

Results QC Date

November 18, 2015

Last Update Submit

January 28, 2020

Conditions

Schizophrenia

Keywords

DiabetesMetabolic

Outcome Measures

Primary Outcomes (2)

  • Change From Baseline in Total Body Fat Composition Using Dual Energy X-ray Absorptiometry at 12 Weeks

    Change in body composition (total body fat) was assessed using dual energy x-ray absorptiometry

    Measured at baseline and Week 12

  • Effects of Medication on Insulin Secretion at Skeletal Muscle (Glucose Disposal)

    Measured at baseline and Week 12

Study Arms (2)

Placebo

PLACEBO COMPARATOR

50% of participants will receive placebo

Drug: Placebo

Experimental

EXPERIMENTAL

50% of participants will receive Depakote ER

Drug: Valproate

Interventions

ValproateDRUG

Depakote ER 500 mg to 3000 mg taken every night

Also known as: Depakote ER
Experimental
PlaceboDRUG

Placebo given at same frequency as Valproate

Placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Meets DSM-IV criteria for schizophrenia, any type, treated with the same antipsychotic for at least 6 months
  • No antipsychotic medication dose changes for 1 month, and no other medication changes for 1 month prior to study entry

You may not qualify if:

  • Meets DSM-IV criteria for substance abuse within 3 months of study entry
  • Involuntary legal status (as per Missouri law)
  • Any serious medical disorder that may confound the assessment of relevant biologic measures or diagnosis, including: significant organ system dysfunction, metabolic diseases, type 1 or 2 diabetes mellitus, pregnancy, endocrine disease, coagulopathy, anemia, or acute infection
  • Currently taking more than one antipsychotic medication
  • Currently taking prescription medications (except certain psychotropic medications as discussed below), including oral contraceptive pills, any glucose lowering agent, lipid lowering agent, exogenous testosterone, recombinant human growth hormone, or any other endocrine agent that might confound substrate metabolism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (1)

  • Haupt DW, Newcomer JW. Hyperglycemia and antipsychotic medications. J Clin Psychiatry. 2001;62 Suppl 27:15-26; discussion 40-1.

    PMID: 11806485BACKGROUND

Related Links

MeSH Terms

Conditions

SchizophreniaDiabetes Mellitus

Interventions

Valproic Acid

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Pentanoic AcidsValeratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsFatty Acids, VolatileFatty AcidsLipids

Results Point of Contact

Title
Michael Yingling
Organization
Washington University School of Medicine
yinglingm@wustl.edu
573-579-1412

Study Officials

  • Dan W. Haupt, MD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 14, 2005

Study Start

December 1, 2004

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

February 10, 2020

Results First Posted

February 10, 2020

Record last verified: 2020-01

Locations

US(1)