NCT00080327

Brief Summary

A study to evaluate three doses of aripiprazole versus placebo in patients with an acute episode of schizophrenia

Trial Health

87
On Track

Trial Health Score

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

Enrollment
370

participants targeted

Target at P75+ for phase_4 schizophrenia

Timeline
Completed

Started Nov 2003

Shorter than P25 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

November 1, 2003

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 26, 2004

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 30, 2004

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2004

Completed
Last Updated

November 11, 2013

Status Verified

August 1, 2008

Enrollment Period

10 months

First QC Date

March 26, 2004

Last Update Submit

November 7, 2013

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

  • Change at endpoint in schizophrenia rating scale

Secondary Outcomes (1)

  • Clinical Global Improvement scale at endpoint and time to response

Study Arms (4)

1

ACTIVE COMPARATOR
Drug: Aripiprazole

2

ACTIVE COMPARATOR
Drug: Aripiprazole

3

ACTIVE COMPARATOR
Drug: Aripiprazole

4

PLACEBO COMPARATOR
Drug: Placebo

Interventions

AripiprazoleDRUG

Tablets, Oral, 2mg, Once daily, 6 weeks.

Also known as: Abilify
1
PlaceboDRUG

Tablets, Oral, 0mg, Once daily, 6 weeks.

4

Eligibility Criteria

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

You may qualify if:

  • Men and women, ages 18 and older, with a worsening of schizophrenia symptoms over the past three months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bristol-Meyers Squibb Call Center

Wallingford, Connecticut, United States

Location

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 Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 26, 2004

First Posted

March 30, 2004

Study Start

November 1, 2003

Primary Completion

September 1, 2004

Study Completion

September 1, 2004

Last Updated

November 11, 2013

Record last verified: 2008-08

Locations

US(1)