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Diabetes in Neuropsychiatric Disorders

Phase 1
Completed
Conditions
Schizophrenia
Interventions
Registration Number
NCT00446992
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Brief Summary

The purpose of this study was to describe metabolic changes in the first 16 weeks of anti-psychotic treatment in previously drug-naïve patients with psychosis.

We hypothesize that in drug-naive patients, greater insulin resistance prior to treatment predicts a disproportionately greater increase in insulin resistance with olanzapine treatment.

Detailed Description

Antipsychotic medications are associated with an increased risk of diabetes. We focused on a description of early metabolic adverse effects and clinical and biochemical features that might predict these adverse effects.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
30
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Open Trial GroupOlanzapineThe patients were newly diagnosed with psychosis and were recruited at their first clinical contact for psychosis.
Primary Outcome Measures
NameTimeMethod
Fasting InsulinBaseline and 4 week intervals
Hemoglobin A1cBaseline and 4 week intervals
HDLBaseline and 4 week intervals
LDLBaseline and 4 week intervals
Cholesterol TotalBaseline and 4 week intervals
Fasting GlucoseBaseline and 4 week intervals
TriglyceridesBaseline and 4 week intervals
Body Mass IndexBaseline and 4 week intervals
IL-6Baseline and 4 week intervals
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Unitat Hospitalitzacio - Servei de Psiquiatria G096, Hospital Clinic C/Villarroel, 170

🇪🇸

Barcelona, Spain

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