NCT00528359

Brief Summary

The purpose of this study is to determine whether atypical antipsychotic drugs (commonly prescribed for treating schizophrenia) induce changes in anthropometry and metabolism, including alteration in insulin sensitivity and/or insulin secretion by the pancreas, when given to lean, non-diabetic, individuals who are antipsychotic drug(s)-naïve, and free of metabolic syndrome at enrollment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2005

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 11, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 12, 2007

Completed
Last Updated

March 11, 2008

Status Verified

March 1, 2008

First QC Date

September 11, 2007

Last Update Submit

March 10, 2008

Conditions

Schizophrenia

Keywords

antipsychotic drugsschizophreniaβ-cell functioninsulin resistance

Study Arms (1)

A

36 lean schizophrenic subjects free of metabolic syndrome(M:F 24:12; Caucasian n=23; North-African n=12; South-Asian n=1)aged 35±9 years

Drug: quetiapine or olanzapine or risperidone or aripiprazole

Interventions

quetiapine or olanzapine or risperidone or aripiprazoleDRUG
A

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • age 18-55 years
  • body mass index \<25.0 kg/m²
  • waist circumference \<102 (men) and \<88 cm (women)
  • absence of a metabolic syndrome according to NCEP ATPIII criteria
  • normoglycaemic (fasting plasma glucose levels \<100 mg/dl)

You may not qualify if:

  • previous use of antipsychotic drugs
  • concomitant therapy with drugs known to possess an inherent potential to increase weight and/or to alter glucose metabolism (including antihistaminic drugs, glucocorticoids, β-blockers, antiepileptic drugs and mirtazapine)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanatia Hospital

Brussels, 1030, Belgium

Location

MeSH Terms

Conditions

SchizophreniaInsulin Resistance

Interventions

Quetiapine FumarateOlanzapineRisperidoneAripiprazole

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

DibenzothiazepinesThiazepinesThiepinsSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsBenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingPiperazinesQuinolonesQuinolines

Study Officials

  • Philippe M ORIOT, MD

    Université Catholique de Louvain

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 11, 2007

First Posted

September 12, 2007

Study Start

October 1, 2005

Study Completion

February 1, 2007

Last Updated

March 11, 2008

Record last verified: 2008-03

Locations

BE(1)