NCT00712686

Brief Summary

The purpose of this study is to compare the efficacy and tolerability of aripiprazole to olanzapine over 26 weeks for the treatment of schizophrenia

Trial Health

100
On Track

Trial Health Score

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

Enrollment
690

participants targeted

Target at P75+ for phase_3 schizophrenia

Timeline
Completed

Started Jun 2000

Longer than P75 for phase_3 schizophrenia

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

June 1, 2000

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2003

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

July 8, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 10, 2008

Completed
Last Updated

November 8, 2013

Status Verified

June 1, 2010

Enrollment Period

3.5 years

First QC Date

July 8, 2008

Last Update Submit

November 7, 2013

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (2)

  • The mean change in the PANSS Total Score

    from baseline to Week 6

  • The percentage of patients showing significant weight gain (a≥ 7% increase)

    from baseline to Week 26

Secondary Outcomes (9)

  • Change from baseline on the CGI-S Score

    at the end of study

  • Change from baseline on PANSS Total Score

    at the end of study

  • Change from baseline on PANSS-Positive Scale Total Score

    at the end of study

  • Change from baseline on PANSS-Negative Scale Total Score

    at the end of study

  • Mean change from baseline in PANSS-derived Brief Psychiatric Rating Scale (BPRS) Core Score

    at the end of study

  • +4 more secondary outcomes

Study Arms (2)

A1

ACTIVE COMPARATOR
Drug: Aripiprazole

B1

ACTIVE COMPARATOR
Drug: Olanzapine

Interventions

AripiprazoleDRUG

Tablets, Oral, 15-30 mg, once daily, 140 weeks

Also known as: Abilify
A1
OlanzapineDRUG

Capsule, Oral, 10-20 mg, once daily, 140 weeks

B1

Eligibility Criteria

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

You may qualify if:

  • Patients with DSM-IV diagnosis of schizophrenia patients in acute relapse
  • Treated as outpatients for at least one continuous 3-month period during the past 12 months
  • PANSS total score ≥60
  • Previously responsive to neuroleptics (other than clozapine)
  • Able to give informed consent and comprehend and satisfactorily comply with the protocol requirements

You may not qualify if:

  • An Axis I (DSM-IV) diagnosis of schizoaffective disorder
  • A clinical picture and/or history that was consistent with: (a) Delirium, dementia, amnestic or other cognitive disorders; (b) Bipolar disorder; (c)personality disorder
  • Nonresponsive to prior olanzapine therapy
  • Likely to require prohibited concomitant therapy
  • DSM-IV criteria for any significant substance abuse within the past three months, including addiction to cocaine or alcohol
  • Known to be allergic or hypersensitive to study drugs
  • Represented a significant risk of committing suicide based on history or mental status exam
  • Unstable thyroid pathology and treatment within the past six months
  • A history or evidence of a medical condition that would expose the patient to an undue risk
  • Clinically significant abnormal laboratory test results (including urine drug screen), vital sign, or ECG findings

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Fleischhacker WW, McQuade RD, Marcus RN, Archibald D, Swanink R, Carson WH. A double-blind, randomized comparative study of aripiprazole and olanzapine in patients with schizophrenia. Biol Psychiatry. 2009 Mar 15;65(6):510-7. doi: 10.1016/j.biopsych.2008.07.033. Epub 2008 Nov 4.

    PMID: 18986646BACKGROUND

MeSH Terms

Conditions

Schizophrenia

Interventions

AripiprazoleOlanzapine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingBenzodiazepinesBenzazepines

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 8, 2008

First Posted

July 10, 2008

Study Start

June 1, 2000

Primary Completion

December 1, 2003

Study Completion

December 1, 2003

Last Updated

November 8, 2013

Record last verified: 2010-06