Aripiprazole for Schizophrenia Outpatients Completing BMS Clinical Trials

NCT00239356 | Completed Phase 3 Results

• 1 other identifier: CN138-112
• Study Type: interventional
• Target: 119
• Locations: 11 countries
• Sites: 20

Brief Summary

The purpose of this study is to provide aripiprazole to schizophrenic outpatients and Community Treated Patients who are currently receiving aripiprazole therapy on another BMS sponsored clinical trial.

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

• Mean Clinical Global Impression Severity Score (CGI-S) From Baseline Through End of Study- - Safety Population.

  Baseline is Day 1 of the study, prior to first dose. CGI-S is a questionnaire completed by the clinician which evaluates the severity of mental illness of a participant at a specific point in time. It consists of 7 categories with the lower categories indicating less illness and the higher numbered categories indicating greater severity of illness: 0=not assessed; 1=normal, not at all ill; 2=borderline mentally ill; 3= mildly ill; 4=moderately ill; 5= markedly ill; 6=severely ill; 7=among the most extremely ill.

  Baseline to Week 348

Secondary Outcomes (6)

• Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs), and Discontinuation Due to an AE - Safety Population

  Baseline to Week 348

• Mean Exposure to Aripiprazole at Days 541 to 630, Days 721 to 810 and Days 1081 to 1170 - Safety Population

  Day 1 to Day 1170

• Number of Participants With Potentially Clinically Relevant Chemistry Laboratory Abnormalities During Treatment - Safety Population

  Baseline to end of study (Week 348)

• Number of Participants With Potentially Clinically Relevant Hematology Laboratory Abnormalities During Treatment - Safety Population

  Baseline to end of study (Week 348)

• Number of Participants With Potentially Clinically Relevant Vital Sign Abnormality During Treatment - Safety Population

  Baseline to end of study (Week 348)

Study Arms (1)

AI

EXPERIMENTAL

Drug: Aripiprazole

Interventions

Aripiprazole DRUG

Tablets, Oral, 10 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country

Also known as: Abilify, BMS-337039

AI

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Currently receiving aripiprazole at time of screening
• Men and women ages 18 to 70

You may not qualify if:

• All patients previously discontinued from an aripiprazole study for any reason
• Active alcohol or substance abuse
• Patients who represent a significant risk of committing suicide
• Patients with clinically significant abnormal laboratory test results, vital signs or ECG findings

Sponsors & Collaborators

• Otsuka Pharmaceutical Development & Commercialization, Inc.: lead
• Otsuka America Pharmaceutical: collaborator

Study Sites (20)

Local Institution

Ottawa, Ontario, Canada

Location

Local Institution

Sherbrooke, Quebec, Canada

Location

Local Institution

Rijeka, Croatia

Location

Local Institution

Zagreb, Croatia

Location

Local Institution

Hradec Králové, Czechia

Location

Local Institution

Prague, Czechia

Location

Local Institution

Nantes Orvault, France

Location

Local Institution

Rennes, France

Location

Local Institution

Uzès, France

Location

Local Institution

Budapest, Hungary

Location

Local Institution

Győr, Hungary

Location

Local Institution

Vught, Netherlands

Location

Local Institution

Krakow, Poland

Location

Local Institution

Poznan, Poland

Location

Local Institution

Bucharest, Romania

Location

Local Institution

Saint Petersburg, Russia

Location

Local Institution

Westdene, Free State, South Africa

Location

Local Institution

Johannesburg, Gauteng, South Africa

Location

Local Institution

Cape Town, Western Cape, South Africa

Location

Local Institution

Antrim, Antrim, United Kingdom

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Aripiprazole

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2005
• First Posted: October 17, 2005
• Study Start: March 1, 2003
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: December 19, 2014
• Results First Posted: January 10, 2014

Record last verified: 2014-12

Locations

RU (1); PL (2); GB (1); CA (2); CZ (2); CR (2); NL (1); RO (1); HU (2); ZA (3); FR (3)