CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 30 enrolled
Drug / intervention
Olanzapinedrug
Likely dose
Olanzapine 15 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00446992
NCT00446992Phase 2Completed
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Metabolic Effects of Olanzapine in Patients With Newly Diagnosed Psychosis

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·interventional·Posted Mar 13, 2007·Updated Nov 19, 2014

In Brief

A Phase 2 clinical trial evaluating Olanzapine for Schizophrenia. Completed, enrolled 30 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia
CountriesSpain
Collaborators--

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 13, 2007
Enrollment StartApr 1, 2006
Primary CompletionMar 1, 2010
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 19.3 years ago

Interventions

Olanzapinedrug

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.