Study of Three Doses of Aripiprazole in Patients With Acu... | NCT00080327

Studies
Study of Three Doses of Aripiprazole in Patients With Acute Schizophrenia

NCT00080327

Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Status

Completed

Last Update Posted

Nov 11, 2013Estimated

Enrollment

370

Phase

Phase 4

Conditions

Schizophrenia

Interventions

Aripiprazole
Aripiprazole
Aripiprazole
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2003

Primary Completion Date

Sep 2004Actual

Completion Date

Sep 2004Actual

First Submitted Date

Mar 26, 2004

First Submission Date that Met QC Criteria

Mar 29, 2004

First Posted Date

Mar 30, 2004Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 7, 2013

Last Update Posted Date

Nov 11, 2013Estimated

Name	Class
Otsuka America Pharmaceutical	INDUSTRY

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

370

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
1	Active Comparator	Drug: Aripiprazole
2	Active Comparator	Drug: Aripiprazole
3	Active Comparator	Drug: Aripiprazole
4	Placebo Comparator	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Aripiprazole	Drug	Tablets, Oral, 2mg, Once daily, 6 weeks.	1	Abilify

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change at endpoint in schizophrenia rating scale

Secondary Outcomes

Measure	Description	Time Frame
Clinical Global Improvement scale at endpoint and time to response

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bristol-Meyers Squibb Call Center		Wallingford	Connecticut		United States

Condition Browse Module

MeSH Terms

ID	Term
D012559	Schizophrenia

Ancestor Terms

ID	Term
D019967	Schizophrenia Spectrum and Other Psychotic Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068180	Aripiprazole

Ancestor Terms

ID	Term
D010879	Piperazines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D015363	Quinolones

Browse Leaves

Not provided

Browse Branches

Not provided