NCT00329810

Brief Summary

To evaluate the effectiveness of Aripiprazole after 12 weeks of therapy for Schizophrenic patients.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for phase_4 schizophrenia

Timeline
Completed

Started Mar 2005

Shorter than P25 for phase_4 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

March 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 25, 2006

Completed
Last Updated

November 8, 2013

Status Verified

February 1, 2012

Enrollment Period

1 year

First QC Date

September 12, 2005

Last Update Submit

November 7, 2013

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

  • Clinical Global Impression scale at endpoint

Secondary Outcomes (1)

  • Change in Clinical Global Impression scale and cognition scales at endpoint

Study Arms (1)

Switch

EXPERIMENTAL
Drug: Aripiprazole

Interventions

AripiprazoleDRUG

Tablets, oral, 15 mg, once daily, 12 weeks.

Also known as: Abilify
Switch

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of Schizophrenia
  • score of 2-6 in the CGI-S scale at basline
  • ambulatory or hospitalized subjects having symptoms which requires antipsychotic treatment

You may not qualify if:

  • women of child bearing potential
  • women pregnant or breast feeding
  • patients with a score of 0,-1 or 7
  • substance use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Bervoets C, Morrens M, Vansteelandt K, Kok F, de Patoul A, Halkin V, Pitsi D, Constant E, Peuskens J, Sabbe B. Effect of aripiprazole on verbal memory and fluency in schizophrenic patients : results from the ESCAPE study. CNS Drugs. 2012 Nov;26(11):975-82. doi: 10.1007/s40263-012-0003-4.

    PMID: 23018547DERIVED

MeSH Terms

Conditions

Schizophrenia

Interventions

Aripiprazole

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 12, 2005

First Posted

May 25, 2006

Study Start

March 1, 2005

Primary Completion

March 1, 2006

Study Completion

March 1, 2006

Last Updated

November 8, 2013

Record last verified: 2012-02