NCT00454883

Brief Summary

Assessment of ziprasidone safety and efficacy in the treatment of bipolar and schizoaffective disorders.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
379

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2007

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 29, 2007

Completed
3 days until next milestone

Study Start

First participant enrolled

April 1, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 2, 2007

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

February 21, 2021

Status Verified

February 1, 2021

Enrollment Period

8 months

First QC Date

March 29, 2007

Last Update Submit

February 18, 2021

Conditions

Affective Psychosis, BipolarManiaManic-Depressive Psychosis

Keywords

Safety of ziprasidone, efficacy of ziprasidone, manic episodes in bipolar disorder, mixed episodes in bipolar disorder, schizoaffective disorder.

Outcome Measures

Primary Outcomes (3)

  • Clinical global impression

    3 months

  • Recording of extrapyramidal symptoms

    3 months

  • Changes in manic symptoms over course of treatment

    3 months

Secondary Outcomes (2)

  • Severity of disease

    3 months

  • Adverse Events

    3 months

Study Arms (1)

1 cohort of patients treated with ziprasidone

Drug: ziprasidone

Interventions

ziprasidoneDRUG

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.

Also known as: Geodon, Zeldox
1 cohort of patients treated with ziprasidone

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The patients were identified in in- and outpatients settings (university departments, hospital wards, outpatients clinics, daily psychiatric hospitals)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Bipolar DisorderManiaPsychotic Disorders

Interventions

ziprasidone

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsSchizophrenia Spectrum and Other Psychotic Disorders

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2007

First Posted

April 2, 2007

Study Start

April 1, 2007

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

February 21, 2021

Record last verified: 2021-02