Efficacy of Bifeprunox in Patients With Schizophrenia

Phase 3

Terminated

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

• Registration Number: NCT00704509
• 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 (11915A).

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-06-24
• Study First Submitted QC: 2008-06-24
• Study First Posted: 2008-06-25
• 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: 346

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 (45)

IN006; 🇮🇳 Chennai, India

IN008; 🇮🇳 Ahmedabad, India

IN011; 🇮🇳 Ahmedabad, India

IN009; 🇮🇳 Aurangabad, India

IN007; 🇮🇳 Kanpur, India

IN002; 🇮🇳 Lucknow, India

IN010; 🇮🇳 Varanasi, India

IN005; 🇮🇳 Visakhapatnam, India

IN001; 🇮🇳 Mangalore, India

KR004; 🇰🇷 Busan, Korea, Republic of

ID001; 🇮🇩 Jakarta, Indonesia

ID003; 🇮🇩 Kabupaten Bandung, Indonesia

KR006; 🇰🇷 Seoul, Korea, Republic of

KR007; 🇰🇷 South Korea, Korea, Republic of

MY001; 🇲🇾 Kuala Lumpur, Malaysia

MY004; 🇲🇾 Kuala Lumpur, Malaysia

MY003; 🇲🇾 Perak, Malaysia

PH004; 🇵🇭 Cebu City, Philippines

PH001; 🇵🇭 Mandaluyong City, Philippines

MY005; 🇲🇾 Johor Bahru, Malaysia

PH002; 🇵🇭 Manila, Philippines

UA009; 🇺🇦 Donetsk, Ukraine

PH003; 🇵🇭 Pasig City, Philippines

PH005; 🇵🇭 Quezon City, Philippines

PL007; 🇵🇱 Kutno, Poland

PL003; 🇵🇱 Lublin, Poland

UA011; 🇺🇦 Odessa, Ukraine

PL006; 🇵🇱 Swicie n/Wisla, Poland

PL008; 🇵🇱 Skorzewo, Poland

PL001; 🇵🇱 Torun, Poland

UA008; 🇺🇦 Dnipropetrovsk, Ukraine

UA003; 🇺🇦 Kyiv, Ukraine

UA006; 🇺🇦 Kharkiv, Ukraine

UA004; 🇺🇦 Lviv, Ukraine

UA007; 🇺🇦 Stepanovka, Kherson, Ukraine

UA010; 🇺🇦 Vinnitsa, Ukraine

UA005; 🇺🇦 Poltava, Ukraine

KR008; 🇰🇷 Gyeongnam, Korea, Republic of

IN003; 🇮🇳 Bangalore, India

ID002; 🇮🇩 Bangli, Indonesia

PL002; 🇵🇱 Leszno, Poland

PL004; 🇵🇱 Lodz, Poland

KR005; 🇰🇷 Pusan, Korea, Republic of

PL005; 🇵🇱 Choroszcz, Poland

KR001; 🇰🇷 Seoul, Korea, Republic of