NCT01160991

Brief Summary

Patients suffering from schizophrenia have a high risk to become obese and develop diabetes. Risk of obesity is particularly high with some newer schizophrenia drugs, such as clozapine or olanzapine. These drugs are called atypical drugs and exert their action in part by occupying receptors for serotonin, particularly the 5HT2A receptor subtype. This receptor may also interfere with glucose metabolism and insulin action. The purpose of this study is to compare an atypical antipsychotic drugs, olanzapine, which acts by occupying the 5HT2A receptor, to another antipsychotic drug, amisulpride, which mainly acts through the dopamine pathway. Healthy volunteers are recruited and asked to take a single dose of each drug and of placebo on separate days. Then, a combined glucose clamp study will be performed in order to test the effects of these drugs on insulin sensitivity and insulin secretion.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable schizophrenia

Timeline
Completed

Started May 2004

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

May 1, 2004

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

July 9, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 13, 2010

Completed
Last Updated

August 3, 2010

Status Verified

August 1, 2010

Enrollment Period

2.4 years

First QC Date

July 9, 2010

Last Update Submit

August 2, 2010

Conditions

SchizophreniaDiabetesInsulin Resistance

Keywords

schizophreniaolanzapineatypical antipsychotic drugsamisulpridediabetesinsulin resistanceinsulin secretionglucoseeuglycemic hyperinsulinemic clamphyperglycemic clamp

Outcome Measures

Primary Outcomes (1)

  • insulin sensitivity

    m-value during euglycemic glucose clamp (glucose infusion rate divided by time and body weight)

    90 thru 120 min after application of study drug

Secondary Outcomes (1)

  • pancratic c-peptide secretion

    120 thru 180 minutes after administration of study drug

Study Arms (3)

Amisulpride

ACTIVE COMPARATOR

Single dose of amisulpride 200 mg p.o. given at 8:00 a.m.

Procedure: Glucose clamp techniqueDrug: Amisulpride

Olanzapine

EXPERIMENTAL

Single dose of olanzapine 10 mg p.o. given at 8:00 a.m.

Procedure: Glucose clamp techniqueDrug: Olanzapine

Placebo

PLACEBO COMPARATOR

Placebo capsules are given at 8:00 a.m. Procedures are performed as described above.

Procedure: Glucose clamp techniqueDrug: Placebo

Interventions

Glucose clamp techniquePROCEDURE

euglycemic hyperinsulinemic clamp with target blood glucose of 90 mg/dl (5 mmol/l), followed by hyperglycemic clamp, target blood glucose of 180 mg/dl (10 mmol/l) for measurement of insulin sensitivity and insulin secretion

AmisulprideOlanzapinePlacebo
AmisulprideDRUG

Single dose of amisulpride 200 mg p.o. given at 8:00 a.m.

Amisulpride
OlanzapineDRUG

Single dose of olanzapine 10 mg p.o. given at 8:00 a.m.

Olanzapine
PlaceboDRUG

Placebo capsules are given at 8:00 a.m.

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy male volunteers
  • written informed consent

You may not qualify if:

  • BMI \> 30 kg/m²
  • Diabetes mellitus
  • Hypertension
  • Treatment with drugs interfering with lipid or glucose metabolism (e.g. statins, oral antidiabetic drugs, glucocorticoids)
  • History of seizures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Central Institute of Mental Health

Mannheim, 68159, Germany

Location

MeSH Terms

Conditions

SchizophreniaDiabetes MellitusInsulin Resistance

Interventions

Glucose Clamp TechniqueAmisulprideOlanzapine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Blood Chemical AnalysisClinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisChemistry Techniques, AnalyticalInvestigative TechniquesBenzamidesAmidesOrganic ChemicalsBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsBenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Daniel Kopf, M.D.

    Central Institute of Mental Health, Mannheim

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 9, 2010

First Posted

July 13, 2010

Study Start

May 1, 2004

Primary Completion

October 1, 2006

Study Completion

October 1, 2006

Last Updated

August 3, 2010

Record last verified: 2010-08

Locations

DE(1)