NCT00446992

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_1 schizophrenia

Timeline
Completed

Started Apr 2006

Longer than P75 for phase_1 schizophrenia

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

April 1, 2006

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

March 12, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 13, 2007

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
4.7 years until next milestone

Results Posted

Study results publicly available

November 6, 2014

Completed
Last Updated

November 19, 2014

Status Verified

November 1, 2014

Enrollment Period

3.9 years

First QC Date

March 12, 2007

Results QC Date

October 22, 2014

Last Update Submit

November 6, 2014

Conditions

Schizophrenia

Keywords

SchizophreniaSchizoaffectivepsychosisolanzapine

Outcome Measures

Primary Outcomes (9)

  • Body Mass Index

    Baseline and 4 week intervals

  • Fasting Glucose

    Baseline and 4 week intervals

  • Fasting Insulin

    Baseline and 4 week intervals

  • Hemoglobin A1c

    Baseline and 4 week intervals

  • IL-6

    Baseline and 4 week intervals

  • Triglycerides

    Baseline and 4 week intervals

  • Cholesterol Total

    Baseline and 4 week intervals

  • HDL

    Baseline and 4 week intervals

  • LDL

    Baseline and 4 week intervals

Study Arms (1)

Open Trial Group

EXPERIMENTAL

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

Drug: Olanzapine

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.

Also known as: Zyprexa, Zydis, Relprevv
Open Trial Group

Eligibility Criteria

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

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

Barcelona, 08036, Spain

Location

Related Publications (1)

  • 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.

    PMID: 21346617BACKGROUND

MeSH Terms

Conditions

SchizophreniaPsychotic Disorders

Interventions

Olanzapine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Limitations and Caveats

The most important limitations in our study were sample size and duration. With a larger sample, some of these measures may have a significant change within this time frame.

Results Point of Contact

Title
Dr. Brian Kirkpatrick
Organization
University of Nevada School of Medicine
bkirkpatrick@medicine.nevada.edu
775-682-8459

Study Officials

  • Brian Kirkpatrick, M.D.

    Vice Chair of Psychiatry MCG

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 12, 2007

First Posted

March 13, 2007

Study Start

April 1, 2006

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

November 19, 2014

Results First Posted

November 6, 2014

Record last verified: 2014-11

Locations

ES(1)