We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Switch Study of Existing Atypical Antipsychotics to Bifeprunox

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00347425
First Posted: July 4, 2006
Last Update Posted: May 21, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
H. Lundbeck A/S
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
Solvay Pharmaceuticals
  Purpose
The study will evaluate the safety and tolerability of switching subjects with schizophrenia or schizoaffective disorder from their existing antipsychotic medication to Bifeprunox.

Condition Intervention Phase
Schizophrenia and Schizoaffective Disorder Drug: Aripiprazole Drug: Olanzapine Drug: Risperidone Drug: Quetiapine Drug: Ziprasidone Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Open-Label, Parallel-Group, Randomized, Flexible Dose Study To Evaluate the Safety and Tolerability of Switching From Existing Atypical Antipsychotics to Bifeprunox in Subjects With Schizophrenia or Schizoaffective Disorder

Resource links provided by NLM:


Further study details as provided by Solvay Pharmaceuticals:

Primary Outcome Measures:
  • Successful switch defined as those who complete the 4 weeks core study with no worsening of 2 successive post baseline assessments on the CGIS, exacerbation of EPS, or cardiovascular risk factors (body weight and fasting triglycerides) from baseline. [ Time Frame: 4 weeks ]

Secondary Outcome Measures:
  • Adverse events [ Time Frame: 4 weeks ]
  • Adverse events [ Time Frame: 26 weeks ]

Enrollment: 286
Study Start Date: December 2006
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A Drug: Aripiprazole
Abrupt discontinuation of prior anti-psychotic med after a successful eight-day up titration of bifeprunox
Drug: Olanzapine
Abrupt discontinuation of prior anti-psychotic med after a successful eight-day up titration of bifeprunox
Drug: Risperidone
Abrupt discontinuation of prior anti-psychotic med after a successful eight-day up titration of bifeprunox
Drug: Quetiapine
Abrupt discontinuation of prior anti-psychotic med after a successful eight-day up titration of bifeprunox
Drug: Ziprasidone
Abrupt discontinuation of prior anti-psychotic med after a successful eight-day up titration of bifeprunox
B Drug: Aripiprazole
Cross-tapering during which prior anti-psychotic med will be tapered off at the same time while bifeprunox is being titrated up within 8 days
Drug: Olanzapine
Cross-tapering during which prior anti-psychotic med will be tapered off at the same time while bifeprunox is being titrated up within 8 days
Drug: Risperidone
Cross-tapering during which prior anti-psychotic med will be tapered off at the same time while bifeprunox is being titrated up within 8 days
Drug: Quetiapine
Cross-tapering during which prior anti-psychotic med will be tapered off at the same time while bifeprunox is being titrated up within 8 days
Drug: Ziprasidone
Cross-tapering during which prior anti-psychotic med will be tapered off at the same time while bifeprunox is being titrated up within 8 days

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males or females, 18-65 years, meeting DSM-IV TR diagnosis of Schizophrenia or Schizoaffective Disorder for whom a switch is indicated

Exclusion Criteria:

  • Acutely psychotic or with a current Axis I primary psychiatric diagnosis other than schizophrenia or schizoaffective disorder based on DSM-IV TR criteria
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00347425


  Show 122 Study Locations
Sponsors and Collaborators
Solvay Pharmaceuticals
H. Lundbeck A/S
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals
  More Information

Responsible Party: Loretta Stallings, Solvay Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00347425     History of Changes
Other Study ID Numbers: S154.3.020
2006-004972-11
First Submitted: June 30, 2006
First Posted: July 4, 2006
Last Update Posted: May 21, 2008
Last Verified: May 2008

Keywords provided by Solvay Pharmaceuticals:
Switch Study
Schizophrenia
Atypical Antipsychotics

Additional relevant MeSH terms:
Schizophrenia
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Risperidone
Ziprasidone
Antipsychotic Agents
Aripiprazole
Olanzapine
Quetiapine Fumarate
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators