NCT00182442

Brief Summary

People affected by schizophrenia often experience poor concentration, lapses in memory and difficulty with completing tasks; and this set of problems are known as neuro-cognitive deficits. Traditional medications used in the treatment of schizophrenia have not been particularly useful in improving these problems, while the recently introduced medications are expected to be superior in this respect. The proposed research study is designed to assess the effect of two of the new medications (Zyprexa and Seroquel) in improving the neurocognitive deficits associated with schizophrenia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for phase_4 schizophrenia

Timeline
Completed

Started Oct 2003

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

October 1, 2003

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

September 14, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
Last Updated

October 11, 2006

Status Verified

March 1, 2005

First QC Date

September 14, 2005

Last Update Submit

October 10, 2006

Conditions

Schizophrenia

Keywords

Cognitive deficitsPsychosocial functioningQuality of Life

Outcome Measures

Primary Outcomes (1)

  • Primary outcome measures include changes in neurocognitive test scores, changes in measures of community functioning and quality of life.

Secondary Outcomes (1)

  • Secondary outcomes include changes in treatment adherence, subjective satisfaction with antipsychotic drug therapy, clinical symptoms and side effects.

Interventions

Olanzapine & QuetiapineDRUG

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of schizophrenia confirmed by administering SCID and,
  • Subjects consecutively referred for optimizing antipsychotic drug therapy, i.e. a change of medication from conventional medications or Risperidone is indicated due to lack of efficacy, side-effects or poor subjective tolerability.
  • Competent to provide an informed consent.

You may not qualify if:

  • Substance dependence, mental retardation, head injury or other primary neurological disorders.
  • Imminent risk due to suicidal or aggressive behavior (a score of five or more on the hostility item on the PANSS).
  • A pattern of social instability, which could hamper long-term follow-up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McMaster University

Hamilton, Ontario, Canada

Location

MeSH Terms

Conditions

SchizophreniaCognition Disorders

Interventions

OlanzapineQuetiapine Fumarate

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersNeurocognitive Disorders

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsDibenzothiazepinesThiazepinesThiepinsSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 3-Ring

Study Officials

  • Lakshmi P Voruganti, MD

    McMaster University

    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

September 14, 2005

First Posted

September 16, 2005

Study Start

October 1, 2003

Study Completion

March 1, 2006

Last Updated

October 11, 2006

Record last verified: 2005-03

Locations

CA(1)