Progressively Decreasing Titration Schedules of Bifepruno... | NCT00139919

Studies
Progressively Decreasing Titration Schedules of Bifeprunox in Subjects With Schizophrenia or Bipolar Disorder

NCT00139919

Sponsor

Solvay Pharmaceuticals

Status

Completed

Last Update Posted

Jan 16, 2015Estimated

Enrollment

Not provided

Phase

Phase 2

Conditions

Schizophrenia
Schizoaffective Disorder
Bipolar Disorder

Interventions

Bifeprunox

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Jan 2006

Primary Completion Date

Oct 2007Actual

Completion Date

Oct 2007Actual

First Submitted Date

Aug 30, 2005

First Submission Date that Met QC Criteria

Aug 30, 2005

First Posted Date

Aug 31, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 15, 2015

Last Update Posted Date

Jan 16, 2015Estimated

Name	Class
H. Lundbeck A/S	INDUSTRY
Wyeth is now a wholly owned subsidiary of Pfizer	INDUSTRY

Description Module

Brief Summary

This study is to assess the tolerability of bifeprunox with the progressive elimination of titration steps to achieve the shortest tolerated titration dosing to a dose of 40 mg/day in either schizophrenia or bipolar disorder subjects. Study duration is 2 months with an optional open-label 26-week extension study.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Bifeprunox	Drug

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects with the current Diagnosis of Schizophrenia, Bipolar Type I Disorder according to DSM-IV TR criteria
Age 18 to 55
Body weight 100-250 lbs
Be sufficiently stable to allow discontinuation of antipsychotic medication

Exclusion Criteria:

Acutely psychotic subjects
Subjects that are acutely manic
Subjects with a psych diagnosis other than Bipolar Type I Disorder

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Global Clinical Director Solvay	Solvay Pharmaceuticals	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Site 1		Orange	California		United States

Condition Browse Module

MeSH Terms

ID	Term
D012559	Schizophrenia
D011618	Psychotic Disorders
D001714	Bipolar Disorder

Ancestor Terms

ID	Term
D019967	Schizophrenia Spectrum and Other Psychotic Disorders
D001523	Mental Disorders
D000068105	Bipolar and Related Disorders
D019964	Mood Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C509981	bifeprunox

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided