Efficacy of Bifeprunox in Patients With Schizophrenia

Schizophrenia Clinical Trial

Official title:

A Multinational, Randomised, Double-blind, Fixed-dose, Bifeprunox Study Combining a 12-Week Placebo-controlled, Quetiapine-referenced Phase With a 12-month Quetiapine-controlled Phase in Patients With Schizophrenia

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00658645
• Other study ID #: 11915A
• Secondary ID: 2007-001097-90
• Status: Terminated
• Phase: Phase 3
• First received: April 9, 2008
• Last updated: September 24, 2010
• Start date: March 2008
• Est. completion date: November 2009

Study information

• Verified date: September 2010
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: National Organization of MedicinesRomania: National Medicines AgencyRussia: Pharmacological Committee, Ministry of HealthTaiwan: National Bureau of Controlled DrugsThailand: Food and Drug AdministrationUkraine: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The primary purpose of the study is to evaluate the efficacy of bifeprunox in the maintenance phase of schizophrenia compared to placebo.

Description:

Schizophrenia is a serious and disabling mental disorder that affects approximately 1% of the world's population. There are a number of antipsychotic drugs in use but none is ideal, in particular because their safety profile is complex and their effectiveness is limited. In particular, after having overcome acute exacerbations many patients continue to experience significant symptoms that prevent an adequate functioning. In the current study, patients suffering from schizophrenia and currently in a post-acute maintenance phase of the disease will be included. Non-treatment resistant patients will be included in the study, since they have partially responded to their current antipsychotic treatment but still have clinically significant symptoms and/or impairment of functioning in their daily life. The study is a 12-month study with an initial 12-week placebo-controlled, quetiapine-referenced phase. After this initial 12-week phase, the patients allocated to placebo will be switched to bifeprunox. In the final non-inferiority analysis of the 12-month data, the results from this study will be combined with the data from a similar study (11916A).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 227
• Est. completion date: November 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

Main inclusion criteria

• The subject has a primary diagnosis of schizophrenia

• The subject experiences clinically significant symptoms

• The subject's medication remained stable for 8 weeks prior to screening

• The subject is currently in the post-acute maintenance phase of his/her disease

Exclusion Criteria:

Main exclusion criteria

• The subject is at significant risk of suicide

• The subject is treatment resistant

• The subject has experienced an acute exacerbation within 8 weeks prior screening

• The subject is unlikely to comply with the protocol

• The subject has a current diagnosis or a history of substance abuse

Study Design

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

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• Bifeprunox
20 mg daily, encapsulated tablets, orally, 12 months
• Placebo
Encapsulated tablets, orally, 12 weeks
• Quetiapine
600 mg daily, encapsulated tablets, orally, 12 months

Locations

Country	Name	City	State
Bulgaria	BG002	Radnevo
Bulgaria	BG003	Radnevo
China	CN008	Beijing
China	CN009	Beijing
Greece	GR001	Maroussi
Greece	GR003	Tripoli
Romania	RO004	Brasov
Romania	RO001	Bucuresti
Romania	RO002	Bucuresti
Romania	RO003	Bucuresti
Romania	RO009	Bucuresti
Romania	RO008	Iasi
Romania	RO005	Pitesti
Romania	RO007	Sibiu
Romania	RO006	Targoviste
Russian Federation	RU003	Arkhangelsk
Russian Federation	RU017	Chita
Russian Federation	RU001	Moscow
Russian Federation	RU005	Moscow
Russian Federation	RU002	Saratov
Russian Federation	RU004	St. Petersburg
Russian Federation	RU009	St. Petersburg
Russian Federation	RU010	St. Petersburg
Russian Federation	RU011	St. Petersburg
Russian Federation	RU012	St. Petersburg
Russian Federation	RU013	St. Petersburg
Russian Federation	RU014	St. Petersburg
Russian Federation	RU015	Tomsk
Taiwan	TW001	Hualien Town
Taiwan	TW003	Taipei
Thailand	TH001	Bangkok
Thailand	TH002	Bangkok
Thailand	TH003	Chiang Mai
Thailand	TH004	Chiang Mai
Ukraine	UA002	Glevakha
Ukraine	UA001	Kyiv
Ukraine	UA013	Kyiv
Ukraine	UA012	Lugansk

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Countries where clinical trial is conducted

Bulgaria,  China,  Greece,  Romania,  Russian Federation,  Taiwan,  Thailand,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The difference in change from baseline to the 12-week time point between bifeprunox and placebo using the Positive and Negative Syndrome Scale (PANSS).		12 weeks	No
Secondary	The difference in PANSS score at the 12-month time point between bifeprunox and quetiapine. Also, responder rate, time to response/withdrawal, global clinical assessments (CGI), assessment of depressive symptoms (CDSS) and health economic assessments		12 months	No