A Study of Adjunctive Treatment of Aripiprazole in Schizophrenic Patients

Schizophrenia Clinical Trial

Official title:

A Multicenter, Comparative, Randomized, Double-Blind, Placebo Controlled Study on the Effect on Weight of Adjunctive Treatment With Aripiprazole in Patients With Schizophrenia.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00300846
• Other study ID #: CN138-170
• Status: Completed
• Phase: Phase 4
• First received: March 8, 2006
• Last updated: November 7, 2013
• Start date: December 2005
• Est. completion date: July 2007

Study information

• Verified date: June 2008
• Source: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the effect on patient weight of adjunctive therapy of aripiprazole with clozapine versus clozapine monotherapy, in schizophrenic patients who are not optimally controlled on clozapine.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: July 2007
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patients with schizophrenia treated with clozapine (200-900 mg/day), who gained at least 2.5 kg while on clozapine.

Exclusion Criteria:

• Patients known to be allergic to aripiprazole

• Hospitalized patients

• Patients who have previously received study medication in an aripiprazole clinical study or who have participated in any clinical trial with an investigational agent within the past month.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• aripiprazole
Tablets, Oral, 5 mg, 10 mg, 15 mg, once daily, 16 weeks followed by 12 weeks of Open-Label extension phase (optional).
• Placebo
Tablets, Oral, 0 mg, once daily, 16 weeks followed by 12 weeks of Open-Label extension phase (optional)

Locations

Country	Name	City	State
Austria	Local Institution	Graz
Austria	Local Institution	Innsbruck
Austria	Local Institution	Wien
Czech Republic	Local Institution	Brno - Bohunice
Czech Republic	Local Institution	Hradec Kralove
Czech Republic	Local Institution	Litomerice
Czech Republic	Local Institution	Opava
Czech Republic	Local Institution	Praha
Finland	Local Institution	Helsingin Kaupunki
Finland	Local Institution	Tampere
Finland	Local Institution	Turku
France	Local Institution	Brumath Cedex
France	Local Institution	Bully Les Mines
France	Local Institution	Clermont-Ferrand Cedex
France	Local Institution	Limoges Cedex
France	Local Institution	Lyon Cedex 08
France	Local Institution	Nimes
France	Local Institution	Paris Cedex 14
France	Local Institution	Rennex Cedex 7
France	Local Institution	Sotteville Les Rouen
Germany	Local Institution	Augsburg
Germany	Local Institution	Berlin
Germany	Local Institution	Duisburg
Germany	Local Institution	Haar
Germany	Local Institution	Heidelberg
Germany	Local Institution	Mannheim
Hungary	Local Institution	Budapest
Hungary	Local Institution	Szolnok
Poland	Local Institution	Krakow
Poland	Local Institution	Leszno
Poland	Local Institution	Skorzewo
Poland	Local Institution	Torun
Poland	Local Institution	Warszawa
South Africa	Local Institution	Bellville	Western Cape
South Africa	Local Institution	Cape Town	Western Cape
South Africa	Local Institution	Durban	Kwa Zulu Natal
South Africa	Local Institution	Soweto	Gauteng
South Africa	Local Institution	Vereeniging	Gauteng
Sweden	Local Institution	Bromma
Sweden	Local Institution	Falkoping
Sweden	Local Institution	Linkoping
Sweden	Local Institution	Lulea
Sweden	Local Institution	Malmo
Sweden	Local Institution	Solna
Sweden	Local Institution	Uppsala
Sweden	Local Institution	Varberg
Sweden	Local Institution	Vastra Frolunda
Switzerland	Local Institution	Bern 60
Turkey	Local Institution	Antalya
Turkey	Local Institution	Istanbul
Turkey	Local Institution	Izmir
United Kingdom	Local Institution	Dundee	Tayside
United Kingdom	Local Institution	Exeter	Devon
United Kingdom	Local Institution	Hull	North Yorkshire
United Kingdom	Local Institution	London
United Kingdom	Local Institution	Teignmouth	Devon
United Kingdom	Local Institution	Welwyn Garden City	Hertfordshire

Sponsors (2)

Lead Sponsor	Collaborator
Otsuka Pharmaceutical Development & Commercialization, Inc.	Otsuka America Pharmaceutical

Countries where clinical trial is conducted

Austria,  Czech Republic,  Finland,  France,  Germany,  Hungary,  Poland,  South Africa,  Sweden,  Switzerland,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate effect on patient weight of adjunctive therapy of aripiprazole with clozapine versus clozapine mono-therapy in schizophrenic patients who are not optimally controlled on clozapine.
Primary	The mean change from baseline in patient weight at Week 16 (LOCF) will be compared between the 2 groups.
Secondary	Efficacy (PANSS, CGI)
Secondary	Effectiveness (IAQ, GAF)
Secondary	Patient Reported Outcomes
Secondary	Safety

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm