NCT00287820

Brief Summary

The primary objective of the study is to assess whether chronic treatment with olanzapine over a five-month period produces a significant increase in abnormalities in glucose levels. The main secondary objective is to evaluate whether the increase in glucose levels and rate of glucose abnormalities differs between Olanzapine and Risperidone during this treatment period. Additional secondary objectives of the study are to investigate similar questions with respect to glycohemoglobin, triglycerides and other measures of glucose and lipid metabolism. We hypothesize that Olanzapine will not be inferior to Risperidone in extent of increase in the primary outcome measure of serum glucose, and secondary measures of glycohemoglobin, insulin and lipids.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for phase_4 schizophrenia

Timeline
Completed

Started Feb 2004

Typical duration for phase_4 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

February 1, 2004

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

February 6, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 7, 2006

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

July 25, 2011

Status Verified

December 1, 2007

First QC Date

February 6, 2006

Last Update Submit

July 22, 2011

Conditions

SchizophreniaDiabetesMetabolic SyndromeHyperglycemia

Keywords

schizophreniadiabetesmetabolic syndromehyperglycemiaglucoseinsulinlipidsIL-6prolactin

Outcome Measures

Primary Outcomes (6)

  • Serum glucose

    during 5 months of treatment compared to baseline

  • Hb1AC

    during 5 months of treatment compared to baseline

  • triglycerides

    during 5 months of treatment compared to baseline

  • cholesterol

    during 5 months of treatment compared to baseline

  • insulin

    during 5 months of treatment compared to baseline

  • c-peptide

    during 5 months of treatment compared to baseline

Secondary Outcomes (9)

  • ghrelin

    during 5 months of treatment compared to baseline

  • CRP

    during 5 months of treatment compared to baseline

  • Thyroid hormones

    during 5 months of treatment compared to baseline

  • prolactin

    during 5 months of treatment compared to baseline

  • Il-6

    during 5 months treatment compared to baseline

  • +4 more secondary outcomes

Study Arms (2)

1

ACTIVE COMPARATOR

olanzapine

Drug: Olanzapine

2

ACTIVE COMPARATOR

risperidone

Drug: risperidone

Interventions

olanzapineDRUG

olanzapine 5-40 mg/day

Also known as: ayprexa
1
risperidoneDRUG

risperidone 1-12 mg/day

Also known as: riperidal
2

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis
  • Schizophrenia or schizoaffective psychosis
  • years of age

You may not qualify if:

  • Currently being treated with oral antidiabetics or insulin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Manhattan Psychaitric Center

New York, New York, 10035, United States

Location

Related Publications (3)

  • Smith RC, Rachakonda S, Dwivedi S, Davis JM. Olanzapine and risperidone effects on appetite and ghrelin in chronic schizophrenic patients. Psychiatry Res. 2012 Oct 30;199(3):159-63. doi: 10.1016/j.psychres.2012.03.011. Epub 2012 Apr 3.

    PMID: 22475524DERIVED

  • Smith RC, Lindenmayer JP, Hu Q, Kelly E, Viviano TF, Cornwell J, Vaidhyanathaswamy S, Marcovina S, Davis JM. Effects of olanzapine and risperidone on lipid metabolism in chronic schizophrenic patients with long-term antipsychotic treatment: a randomized five month study. Schizophr Res. 2010 Jul;120(1-3):204-9. doi: 10.1016/j.schres.2010.04.001. Epub 2010 May 10.

    PMID: 20457512DERIVED

  • Smith RC, Lindenmayer JP, Davis JM, Kelly E, Viviano TF, Cornwell J, Hu Q, Khan A, Vaidhyanathaswamy S. Effects of olanzapine and risperidone on glucose metabolism and insulin sensitivity in chronic schizophrenic patients with long-term antipsychotic treatment: a randomized 5-month study. J Clin Psychiatry. 2009 Nov;70(11):1501-13. doi: 10.4088/JCP.08m04446yel. Epub 2009 Oct 6.

    PMID: 19814947DERIVED

MeSH Terms

Conditions

SchizophreniaDiabetes MellitusMetabolic SyndromeHyperglycemiaInsulin Resistance

Interventions

OlanzapineRisperidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinism

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Robert C Smith, MD PhD

    NYU Medical School, Dept of Psychiatry and Manhattan Psychiatric Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 6, 2006

First Posted

February 7, 2006

Study Start

February 1, 2004

Study Completion

September 1, 2007

Last Updated

July 25, 2011

Record last verified: 2007-12

Locations

US(1)