Determining Metabolic Effects of Valproate and Antipsychotic Therapy
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| ClinicalTrials.gov Identifier: NCT00167934 |
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Recruitment Status :
Completed
First Posted : September 14, 2005
Results First Posted : February 10, 2020
Last Update Posted : February 10, 2020
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Schizophrenia | Drug: Valproate Drug: Placebo | Not Applicable |
This project aims to study the whole-body metabolic processes responsible for hyperglycemia, dyslipidemia and increased adiposity in schizophrenia patients treated with antipsychotic medications in combination with valproate. The project hypothesizes that combined treatment with valproate and antipsychotic medications will decrease insulin sensitivity at the level of skeletal muscle, liver and adipose tissue, in comparison to antipsychotic monotherapy. The decrease in insulin sensitivity is hypothesized to be associated with defects in glucose and lipid metabolism and increased adiposity
Treatment effects of antipsychotic/valproate combination therapy on different components of insulin secretion and action, and treatment effects on abdominal versus peripheral adiposity, are unknown despite the availability of gold-standard methods and the prognostic significance of these issues. Relevant data are needed to target basic research, to identify the potential for acute and long-term complications, and to plan therapeutic interventions. The following specific aims will be addressed in non-diabetic schizophrenia patients treated with atypical antipsychotics who will be randomized to open label treatment with either valproate or no adjuvant. Evaluations are performed at baseline and 3 months of treatment.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 164 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Participant) |
| Primary Purpose: | Treatment |
| Official Title: | Metabolic Effects of Valproate and Antipsychotic Therapy |
| Study Start Date : | December 2004 |
| Actual Primary Completion Date : | December 2008 |
| Actual Study Completion Date : | December 2008 |
| Arm | Intervention/treatment |
|---|---|
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Placebo Comparator: Placebo
50% of participants will receive placebo
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Drug: Placebo
Placebo given at same frequency as Valproate |
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Experimental: Experimental
50% of participants will receive Depakote ER
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Drug: Valproate
Depakote ER 500 mg to 3000 mg taken every night
Other Name: Depakote ER |
- Change From Baseline in Total Body Fat Composition Using Dual Energy X-ray Absorptiometry at 12 Weeks [ Time Frame: Measured at baseline and Week 12 ]Change in body composition (total body fat) was assessed using dual energy x-ray absorptiometry
- Effects of Medication on Insulin Secretion at Skeletal Muscle (Glucose Disposal) [ Time Frame: Measured at baseline and Week 12 ]
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| Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00167934
| United States, Missouri | |
| Washington University School of Medicine | |
| Saint Louis, Missouri, United States, 63110 | |
| Principal Investigator: | Dan W. Haupt, MD | Washington University School of Medicine |
Publications:
| Responsible Party: | Washington University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00167934 |
| Other Study ID Numbers: |
K23MH067795 ( U.S. NIH Grant/Contract ) K23MH067795 ( U.S. NIH Grant/Contract ) DAHBR AK-TNET1 |
| First Posted: | September 14, 2005 Key Record Dates |
| Results First Posted: | February 10, 2020 |
| Last Update Posted: | February 10, 2020 |
| Last Verified: | January 2020 |
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Diabetes Metabolic |
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Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Mental Disorders Valproic Acid Anticonvulsants Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
GABA Agents Neurotransmitter Agents Physiological Effects of Drugs Antimanic Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs |