Switch Study of Existing Atypical Antipsychotics to Bifeprunox

This study has been completed.
Sponsor:
Collaborators:
H. Lundbeck A/S
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00347425
First received: June 30, 2006
Last updated: May 20, 2008
Last verified: May 2008
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Adverse events [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
  • Adverse events [ Time Frame: 26 weeks ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Loretta Stallings, Solvay Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00347425     History of Changes
Other Study ID Numbers: S154.3.020, 2006-004972-11
Study First Received: June 30, 2006
Last Updated: May 20, 2008
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Czech Republic: State Institute for Drug Control
Estonia: The State Agency of Medicine
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Hungary: National Institute of Pharmacy
Latvia: State Agency of Medicines
Lithuania: State Medicine Control Agency - Ministry of Health

Keywords provided by Solvay Pharmaceuticals:
Switch Study
Schizophrenia
Atypical Antipsychotics

Additional relevant MeSH terms:
Psychotic Disorders
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Antipsychotic Agents
Risperidone
Quetiapine
Olanzapine
Aripiprazole
Ziprasidone
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Dopamine Antagonists
Dopamine Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on July 28, 2014