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Effect on Cognitive Function of a Treatment With Aripiprazole

NCT ID: NCT00329810

Last Updated: 2013-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2006-03-31

Brief Summary

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

Detailed Description

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Conditions

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Schizophrenia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Switch

Group Type EXPERIMENTAL

Aripiprazole

Intervention Type DRUG

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

Interventions

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Aripiprazole

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

Intervention Type DRUG

Other Intervention Names

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Abilify

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Otsuka America Pharmaceutical

INDUSTRY

Sponsor Role collaborator

Otsuka Pharmaceutical Development & Commercialization, Inc.

INDUSTRY

Sponsor Role lead

Principal Investigators

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Bristol-Myers Squibb

Role: PRINCIPAL_INVESTIGATOR

Bristol-Myers Squibb

References

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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.

Reference Type DERIVED
PMID: 23018547 (View on PubMed)

Other Identifiers

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CN138-166

Identifier Type: -

Identifier Source: org_study_id