Efficacy of Bifeprunox in Patients With Schizophrenia

Phase 3

Terminated

• Conditions: Schizophrenia
• Interventions: Drug: Bifeprunox; Drug: Placebo; Drug: Quetiapine

• Registration Number: NCT00658645
• Lead Sponsor: H. Lundbeck A/S

Brief Summary

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

Detailed 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).

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-04-09
• Study First Submitted QC: 2008-04-09
• Study First Posted: 2008-04-15
• Primary Completion: 2009-08
• Study Completion: 2009-11
• Status Verified: 2010-09
• Last Update Submitted: 2010-09-24
• Last Update Posted: 2010-09-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 227

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bifeprunox	Bifeprunox	-
Placebo	Placebo	-
Quetiapine	Quetiapine	-

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (38)

RU017; 🇷🇺 Chita, Russian Federation

RU005; 🇷🇺 Moscow, Russian Federation

RO002; 🇷🇴 Bucuresti, Romania

RO005; 🇷🇴 Pitesti, Romania

TW001; 🇨🇳 Hualien Town, Taiwan

UA002; 🇺🇦 Glevakha, Ukraine

CN009; 🇨🇳 Beijing, China

TH003; 🇹🇭 Chiang Mai, Thailand

UA001; 🇺🇦 Kyiv, Ukraine

CN008; 🇨🇳 Beijing, China

GR001; 🇬🇷 Maroussi, Greece

RO003; 🇷🇴 Bucuresti, Romania

RO009; 🇷🇴 Bucuresti, Romania

RO007; 🇷🇴 Sibiu, Romania

BG002; 🇧🇬 Radnevo, Bulgaria

RO004; 🇷🇴 Brasov, Romania

RO006; 🇷🇴 Targoviste, Romania

RU009; 🇷🇺 St. Petersburg, Russian Federation

TH001; 🇹🇭 Bangkok, Thailand

BG003; 🇧🇬 Radnevo, Bulgaria

RU003; 🇷🇺 Arkhangelsk, Russian Federation

RU002; 🇷🇺 Saratov, Russian Federation

RU004; 🇷🇺 St. Petersburg, Russian Federation

RU014; 🇷🇺 St. Petersburg, Russian Federation

TH002; 🇹🇭 Bangkok, Thailand

TH004; 🇹🇭 Chiang Mai, Thailand

RU001; 🇷🇺 Moscow, Russian Federation

GR003; 🇬🇷 Tripoli, Greece

RO001; 🇷🇴 Bucuresti, Romania

RO008; 🇷🇴 Iasi, Romania

RU012; 🇷🇺 St. Petersburg, Russian Federation

RU011; 🇷🇺 St. Petersburg, Russian Federation

RU013; 🇷🇺 St. Petersburg, Russian Federation

RU010; 🇷🇺 St. Petersburg, Russian Federation

UA012; 🇺🇦 Lugansk, Ukraine

RU015; 🇷🇺 Tomsk, Russian Federation

UA013; 🇺🇦 Kyiv, Ukraine

TW003; 🇨🇳 Taipei, Taiwan