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Diabetes in Neuropsychiatric Disorders

NCT ID: NCT00446992

Last Updated: 2014-11-19

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2010-03-31

Brief Summary

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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

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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.

Conditions

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Schizophrenia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Open Trial Group

The patients were newly diagnosed with psychosis and were recruited at their first clinical contact for psychosis.

Group Type EXPERIMENTAL

Olanzapine

Intervention Type DRUG

16-week open trial of olanzapine. The patients were started on a dose of 15 mg/d by mouth, which could be adjusted to as low as 10 mg/d or as high as 40 mg/d, based on clinical response. The trial began while they were hospitalized and continued after discharge.

Interventions

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Olanzapine

16-week open trial of olanzapine. The patients were started on a dose of 15 mg/d by mouth, which could be adjusted to as low as 10 mg/d or as high as 40 mg/d, based on clinical response. The trial began while they were hospitalized and continued after discharge.

Intervention Type DRUG

Other Intervention Names

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Zyprexa, Zydis, Relprevv

Eligibility Criteria

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Inclusion Criteria

* Age 18-64
* Maximum cumulative (lifetime) antipsychotic exposure of one week, and no antipsychotic use in the previous 30 days before enrolling in the study
* No history of diabetes or other serious medical or neurological condition associated with glucose intolerance or insulin resistance (eg, Cushing disease),
* Not taking a medication associated with insulin resistance (eg, hydrochlorothiazide, furosemide, ethacrynic acid, metolazone, chlorthalidone), beta blockers, glucocorticoids, phenytoin, nicotinic acid, cyclosporine, pentamidine, or narcotics)
* No history of cocaine use in the previous 30 days, and
* No laboratory evidence of diabetes at baseline (fasting glucose \<126 mg/dL or 2-hour glucose \<200 mg/dL on a glucose tolerance test)
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role lead

Responsible Party

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Brian Kirkpatrick

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Brian Kirkpatrick, M.D.

Role: PRINCIPAL_INVESTIGATOR

Vice Chair of Psychiatry MCG

Locations

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

Barcelona, , Spain

Site Status

Countries

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Spain

References

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Fernandez-Egea E, Miller B, Garcia-Rizo C, Bernardo M, Kirkpatrick B. Metabolic effects of olanzapine in patients with newly diagnosed psychosis. J Clin Psychopharmacol. 2011 Apr;31(2):154-9. doi: 10.1097/JCP.0b013e31820fcea3.

Reference Type BACKGROUND
PMID: 21346617 (View on PubMed)

Other Identifiers

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HAC File#: 05-12-141

Identifier Type: -

Identifier Source: secondary_id

DK69265

Identifier Type: -

Identifier Source: org_study_id