NCT00225498

Brief Summary

Ziprasidone is a newer drug intended for the treatment of the symptoms of schizophrenia. This new drug may have an added benefit of being able to help with some of the difficulties in problem solving and memory that many patients with schizophrenia experience. The present study wants to look at ziprasidone and two other drugs frequently used to treat the symptoms of schizophrenia (risperidone and olanzapine) to see if problem solving and memory get better with ziprasidone treatment. Moreover, we will look at symptoms and how they change with treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at below P25 for not_applicable schizophrenia

Timeline
Completed

Started Jun 2002

Longer than P75 for not_applicable schizophrenia

Geographic Reach
1 country

1 active site

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

June 1, 2002

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

September 21, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 23, 2005

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
6.9 years until next milestone

Results Posted

Study results publicly available

September 10, 2015

Completed
Last Updated

September 10, 2015

Status Verified

September 1, 2015

Enrollment Period

6.3 years

First QC Date

September 21, 2005

Results QC Date

December 12, 2012

Last Update Submit

September 2, 2015

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

  • Working Memory

    California Verbal Learning Test (CVLT) trials 1 through 5 is a well established neuropsychological test of working memory. The maximum score is 80 which reflects a better outcome and the minimum score is 0 which reflects a worse outcome. The only meaningful analyses with adequate statistical power that could be reported were of the 10 schizophrenia patients who met nonresponse criteria to ziprasidone. The overall enrollment of 35 subjects was insufficient to perform the originally planned analyses in a statistically valid manner.

    3 months

Study Arms (2)

1

EXPERIMENTAL

ziprasidone

Drug: ziprasidone vs risperidone or olanzapine

2

ACTIVE COMPARATOR

risperidone or olanzapine

Drug: ziprasidone vs risperidone or olanzapine

Interventions

ziprasidone vs risperidone or olanzapineDRUG

ziprasidone target dose is 160 mg/day risperidone target dose is 4 mg/day olanzapine target dose is 20 mg/day

Also known as: Geodon vs Risperdal or Zyprexa
12

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Diagnosis of schizophrenia, schizoaffective disorder or schizophreniform disorder
  • Ages 18 - 50
  • Ability to provide written informed consent
  • Brief Psychiatric Rating Scale (BPRS) total score \> 40 and Clinical Global Impressions (CGI) \> 4 (moderately ill) and/or intolerant to current antipsychotic drug treatment

You may not qualify if:

  • History of prior treatment with ziprasidone
  • History of medical condition that contraindicates ziprasidone treatment
  • Treatment with depot antipsychotic medication in past 3 months
  • Current diagnosis of alcohol or psychoactive substance dependence
  • Impaired ability to provide written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Zucker Hillside Hospital

Glen Oaks, New York, 11004, United States

Location

Related Publications (1)

  • Malhotra AK, Burdick KE, Razi K, Bates JA, Sanders M, Kane JM. Ziprasidone-induced cognitive enhancement in schizophrenia: specificity or pseudospecificity? Schizophr Res. 2006 Oct;87(1-3):181-4. doi: 10.1016/j.schres.2006.05.015. Epub 2006 Jul 3.

    PMID: 16820282BACKGROUND

MeSH Terms

Conditions

Schizophrenia

Interventions

Olanzapine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Limitations and Caveats

This is a small sample.

Results Point of Contact

Title
Anil K. Malhotra, MD
Organization
Feinstein Institute for Medical Research, Zucker Hillside Hospital
malhotra@lij.edu
718-470-8012

Study Officials

  • Anil K Malhotra, M.D.

    Psychiatry Research The Zucker Hillside Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Psychiatry Research

Study Record Dates

First Submitted

September 21, 2005

First Posted

September 23, 2005

Study Start

June 1, 2002

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

September 10, 2015

Results First Posted

September 10, 2015

Record last verified: 2015-09

Locations

US(1)