NCT00290121

Brief Summary

The purpose of this study is to understand, with the use of functional magnetic resonance imaging, the neural correlates involved in appetite control and the mechanism of weight gain in patients with schizophrenia treated with atypical antipsychotics. We hypothesize that a difference in cerebral activations between weight gaining and non-weight gaining patients will be detected after four months of treatment with olanzapine.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for phase_4 schizophrenia

Timeline
Completed

Started Sep 2006

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

First Submitted

Initial submission to the registry

February 8, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 10, 2006

Completed
7 months until next milestone

Study Start

First participant enrolled

September 1, 2006

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

March 14, 2013

Status Verified

October 1, 2005

Enrollment Period

1.8 years

First QC Date

February 8, 2006

Last Update Submit

March 13, 2013

Conditions

Schizophrenia

Keywords

SchizophreniaAtypical antipsychoticsWeight gainAppetitefMRI

Outcome Measures

Primary Outcomes (2)

  • fMRI (functional magnetic resonance imaging with appetizing films)

    16 weeks after beginning of Olanzapine treatment

  • Weight

    16 weeks after beginning of Olanzapine treatment

Secondary Outcomes (20)

  • Fasting glucose

    16 weeks after beginning of Olanzapine treatment

  • Insulin

    16 weeks after beginning of Olanzapine treatment

  • Leptin

    16 weeks after beginning of Olanzapine treatment

  • Ghrelin

    16 weeks after beginning of Olanzapine treatment

  • Endogenous cannabinoids

    16 weeks after beginning of Olanzapine treatment

  • +15 more secondary outcomes

Study Arms (1)

Olanzapine

ACTIVE COMPARATOR
Drug: Olanzapine

Interventions

OlanzapineDRUG
Olanzapine

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with schizophrenia (DMS-IV)
  • to 60 years old
  • Right handed
  • Begin a treatment with olanzapine and had not received it for at leat 6 months
  • Other medication accepted (except antipsychotic)

You may not qualify if:

  • concomitant axis-I or axis-II disorders
  • unstable medical condition
  • Concomitant antipsychotic medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre de recherche Fernand-Seguin

Montreal, Quebec, H1N 3V2, Canada

Location

Related Publications (3)

  • Orban P, Desseilles M, Mendrek A, Bourque J, Bellec P, Stip E. Altered brain connectivity in patients with schizophrenia is consistent across cognitive contexts. J Psychiatry Neurosci. 2017 Jan;42(1):17-26. doi: 10.1503/jpn.150247.

    PMID: 27091719DERIVED

  • Stip E, Lungu OV. Salience network and olanzapine in schizophrenia: implications for treatment in anorexia nervosa. Can J Psychiatry. 2015 Mar;60(3 Suppl 2):S35-9.

    PMID: 25886678DERIVED

  • Stip E, Lungu OV, Anselmo K, Letourneau G, Mendrek A, Stip B, Lipp O, Lalonde P, Bentaleb LA. Neural changes associated with appetite information processing in schizophrenic patients after 16 weeks of olanzapine treatment. Transl Psychiatry. 2012 Jun 19;2(6):e128. doi: 10.1038/tp.2012.53.

    PMID: 22714121DERIVED

MeSH Terms

Conditions

SchizophreniaWeight Gain

Interventions

Olanzapine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersBody Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Emmanuel Stip, MD, M.Sc.

    Centre de recherche Fernand-Seguin, Université de Montréal

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 8, 2006

First Posted

February 10, 2006

Study Start

September 1, 2006

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

March 14, 2013

Record last verified: 2005-10

Locations

CA(1)