NCT00458211

Brief Summary

Because ziprasidone has not been extensively studied and is not widely accepted in the severely mentally ill in State hospitals this study aims to demonstrate its effectiveness and relative lack of side effects. 75 patients with schizophrenia or schizoaffective disorder who need a change of medication because of ineffectiveness or side effects will be changed to ziprasidone and followed with detailed assessments for eight weeks. The hypothesis is that they will improve and have fewer side effects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_4 schizophrenia

Timeline
Completed

Started May 2005

Typical duration for phase_4 schizophrenia

Geographic Reach
1 country

2 active sites

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

Study Start

First participant enrolled

May 1, 2005

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

April 6, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 10, 2007

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
5.1 years until next milestone

Results Posted

Study results publicly available

May 6, 2013

Completed
Last Updated

May 1, 2020

Status Verified

April 1, 2020

Enrollment Period

2.9 years

First QC Date

April 6, 2007

Results QC Date

April 25, 2012

Last Update Submit

April 22, 2020

Conditions

SchizophreniaSchizoaffective Disorder

Keywords

SchizophreniaZiprasidone

Outcome Measures

Primary Outcomes (1)

  • Positive and Negative Syndrome Scale (PANSS) Measuring Symptoms of Schizophrenia

    Minimum score 32 (best) maximum 210 (worst)

    Baseline to 8 weeks

Secondary Outcomes (15)

  • Clinical Global Impression (CGI) Scores the Evaluator's Overall Impression of Severity (CGI-S) or Change (CGI-I) in Illness.

    8 weeks

  • Weight

    8 weeks

  • Fasting Glucose

    8 weeks

  • Cholesterol

    8 weeks

  • Abnormal Involuntary Movement Scale (AIMS) Measures Tardive Dyskinesia

    8 weeks

  • +10 more secondary outcomes

Study Arms (1)

Experimental

EXPERIMENTAL

Open label change to ziprasidone

Drug: ziprasidone

Interventions

ziprasidoneDRUG

Ziprasidone by mouth 40mg twice a day (bid) for one day, then 80mg bid; may be increased to 120mg bid after three weeks

Experimental

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Schizophrenia or schizoaffective
  • Capacity to give consent
  • Stable, on the same medication for a month but only partial response or with unacceptable side effects 18-65 years of age

You may not qualify if:

  • Repeated non-compliance
  • Current depot medication
  • Active medical conditions
  • QTc \>500msec
  • Previous non-response
  • Previous treatment with ziprasidone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Buffalo Psychiatric Center

Buffalo, New York, 14213, United States

Location

Bronx Psychiatric Center

The Bronx, New York, 10461, United States

Location

MeSH Terms

Conditions

SchizophreniaPsychotic Disorders

Interventions

ziprasidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Results Point of Contact

Title
Nigel Bark MD
Organization
Bronx Psychiatric Center
Nigel.Bark@omh.ny.gov
718 862 5429

Study Officials

  • Nigel Bark, MD

    Bronx Psychiatric Center

    PRINCIPAL INVESTIGATOR

  • Jeffrey Grace, MD

    Buffalo Psychiatric Center

    PRINCIPAL INVESTIGATOR

  • Steven Schwarzkopf, MD

    Rochester Psychiatric Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Scizophrenia Research

Study Record Dates

First Submitted

April 6, 2007

First Posted

April 10, 2007

Study Start

May 1, 2005

Primary Completion

April 1, 2008

Study Completion

April 1, 2008

Last Updated

May 1, 2020

Results First Posted

May 6, 2013

Record last verified: 2020-04

Locations

US(2)