Non-interventional Study of Ziprasidone in the Treatment of Bipolar and Schizoaffective Disorders.

This study has been completed.
Information provided by (Responsible Party):
Pfizer Identifier:
First received: March 29, 2007
Last updated: June 30, 2015
Last verified: June 2015
Assessment of ziprasidone safety and efficacy in the treatment of bipolar and schizoaffective disorders.

Condition Intervention
Affective Psychosis, Bipolar
Manic-Depressive Psychosis
Drug: ziprasidone

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Treatment Of Manic Or Mixed Episodes Of Up To Moderate Severity In Patients With Bipolar Disorder And Schizoaffective Disorder

Resource links provided by NLM:

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Clinical global impression [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Recording of extrapyramidal symptoms [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Changes in manic symptoms over course of treatment [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Severity of disease [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Adverse Events [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Enrollment: 379
Study Start Date: April 2007
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1 cohort of patients treated with ziprasidone Drug: ziprasidone
Ziprasidone 40 mg twice daily taken with food. Daily dosage may subsequently be adjusted on the basis of individual clinical status up to a maximum of 80 mg twice daily. If indicated, the maximum recommended dose may be reached as early as day 3 of treatment.
Other Name: Geodon, Zeldox

Detailed Description:
Method: Consecutive patient sampling. Patients were included in the study in consecutive manner if they fulfilled the inclusion criteria and any of the exclusion criteria were not present.

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The patients were identified in in- and outpatients settings (university departments, hospital wards, outpatients clinics, daily psychiatric hospitals)

Inclusion Criteria:

  • Manic and mixed episodes of up to moderate severity in patients with Type I and II bipolar disorder and schizoaffective disorder; either first diagnosed or repeated episodes

Exclusion Criteria:

  • Hypersensitivity to ziprasidone
  • prolonged QTc interval
  • coadministration with substances that are prolonging the QTc interval
  • recent acute MI, cardiac failure, patients with arrhythmias treated with class IA or III medicaments
  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 identifier: NCT00454883

Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer Identifier: NCT00454883     History of Changes
Other Study ID Numbers: A1281159 
Study First Received: March 29, 2007
Last Updated: June 30, 2015
Health Authority: Slovakia: State Institute for Drug Control

Keywords provided by Pfizer:
Safety of ziprasidone, efficacy of ziprasidone, manic episodes in bipolar disorder, mixed episodes in bipolar disorder, schizoaffective disorder.

Additional relevant MeSH terms:
Affective Disorders, Psychotic
Bipolar Disorder
Mental Disorders
Psychotic Disorders
Bipolar and Related Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Antipsychotic Agents
Central Nervous System Depressants
Dopamine Agents
Dopamine Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Antagonists
Tranquilizing Agents processed this record on May 22, 2016