Effect on Cognitive Function of a Treatment With Aripipra... | NCT00329810

Studies
Effect on Cognitive Function of a Treatment With Aripiprazole

NCT00329810

Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Status

Completed

Last Update Posted

Nov 8, 2013Estimated

Enrollment

500Actual

Phase

Phase 4

Conditions

Schizophrenia

Interventions

Aripiprazole

Countries

Not provided

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

Feb 2012

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

Mar 2005

Primary Completion Date

Mar 2006Actual

Completion Date

Mar 2006Actual

First Submitted Date

Sep 12, 2005

First Submission Date that Met QC Criteria

May 24, 2006

First Posted Date

May 25, 2006Estimated

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 8, 2013Estimated

Name	Class
Otsuka America Pharmaceutical	INDUSTRY

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

500Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Switch	Experimental		Drug: Aripiprazole

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Aripiprazole	Drug	Tablets, oral, 15 mg, once daily, 12 weeks.	Switch

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clinical Global Impression scale at endpoint

Secondary Outcomes

Measure	Description	Time Frame
Change in Clinical Global Impression scale and cognition scales at endpoint

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bristol-Myers Squibb	Bristol-Myers Squibb	Principal Investigator

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23018547	Derived	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.

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

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