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Effect on Cognitive Function of a Treatment With Aripiprazole

A Prospective, Multicenter, Open-Label Study to Evaluate the Effectiveness and the Effect on Cognitive Function of a Treatment With Aripiprazole in a Board Range of Schizophrenic Patients

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00329810
Enrollment
500
Registered
2006-05-25
Start date
2005-03-31
Completion date
2006-03-31
Last updated
2013-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Brief summary

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

Interventions

DRUGAripiprazole

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

Sponsors

Otsuka Pharmaceutical Development & Commercialization, Inc.
Lead SponsorINDUSTRY
Otsuka America Pharmaceutical
CollaboratorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Clinical Global Impression scale at endpoint

Secondary

MeasureTime frame
Change in Clinical Global Impression scale and cognition scales at endpoint

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026