NCT00395031

Brief Summary

The aim of the protocol is to study the effects of 320 mg/day of ziprasidone (Geodon) on glucose and lipid metabolism of patients with both Diabetes Type II (DM) and schizophrenia or schizoaffective disorder, after switching their antipsychotic medication/s from typical and/or atypical to ziprasidone monotherapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
57

participants targeted

Target at P25-P50 for phase_2 schizophrenia

Timeline
Completed

Started Sep 2003

Longer than P75 for phase_2 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

September 1, 2003

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

November 1, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 2, 2006

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

July 29, 2011

Status Verified

July 1, 2011

Enrollment Period

6.3 years

First QC Date

November 1, 2006

Last Update Submit

July 28, 2011

Conditions

SchizophreniaSchizoaffective Disorder

Keywords

schizophreniaSchizoaffective Disordermetabolic markersziprasidonediabetes

Outcome Measures

Primary Outcomes (1)

  • Reduced Glucose, Cholesterol and Lipid Levels

    11 weeks

Secondary Outcomes (2)

  • Reduction in dose requirement for antiglycemic agents

    11 week

  • Improvement in quality of life & Positive and Negative Symptoms

    11 weeks

Study Arms (1)

Ziprasidone

OTHER

Open label

Drug: Ziprasidone

Interventions

ZiprasidoneDRUG

Ziprasidone dose of between 40 mg po bid to 160 mg po bid for 8 weeks

Also known as: Geodon
Ziprasidone

Eligibility Criteria

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

You may qualify if:

  • Aged 18 to 65 years
  • DSM IV diagnosis of schizophrenia (all subtypes) or schizoaffective disorder
  • Diabetes Mellitus type II treated with oral antidiabetic drugs or insulin
  • Stable dose of antipsychotic regimen for previous one month.
  • Stable dose of antidepressant regimen for previous one month.
  • Stable dose of adjunctive mood stabilizer and/or anticholinergic regimen for previous 1 month
  • Signed informed consent
  • Absence of significant cardiovascular pathology as demonstrated by EKG (QTc \< 450 millisec)
  • Absence of severe medical conditions (except for DM) requiring frequent changes in medication.

You may not qualify if:

  • DSM IV diagnosis other than Schizophrenia or Schizoaffective disorder
  • Unstable epilepsy
  • Acute, unstable or significant medical condition
  • Suicidal or physically violent behavioral episodes in the previous month
  • Current DSM IV diagnosis of substance or alcohol abuse with positive urine toxicology in the past two weeks.
  • Liver enzyme test values ≥ three times upper normal limit for AST, ALT, GGT, and Alkaline Phosphatase; ≥ two times upper limit for LDH.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Manhattan Psychiatric Center

New York, New York, 10035, United States

Location

Related Publications (3)

  • Levy WO, Robichaux-Keene NR, Nunez C. No significant QTc interval changes with high-dose ziprasidone: a case series. J Psychiatr Pract. 2004 Jul;10(4):227-32. doi: 10.1097/00131746-200407000-00003.

    PMID: 15552544BACKGROUND

  • Deutschman DA, Deutschman DH. High-dose ziprasidone in treatment-resistant schizophrenia and affective spectrum disorders: a case series. J Clin Psychopharmacol. 2007 Oct;27(5):513-4. doi: 10.1097/JCP.0b013e31814cface. No abstract available.

    PMID: 17873687BACKGROUND

  • Kaushik S, Maccabee N, Kaushik S, Lindenmayer JP. Activation induced by high-dose ziprasidone: a case report. J Clin Psychiatry. 2009 Sep;70(9):1326-7. doi: 10.4088/JCP.08l04400. No abstract available.

    PMID: 19818257DERIVED

Related Links

MeSH Terms

Conditions

SchizophreniaPsychotic DisordersDiabetes Mellitus

Interventions

ziprasidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Saurabh Kaushik, M.D.

    Manhattan Psychiatric Center, New York University, Nathan Kline Institute

    STUDY CHAIR

  • Jean-Pierre Lindenmayer, M.D.

    Manhattan Psychiatric Center, New York University, Nathan Kline Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 2006

First Posted

November 2, 2006

Study Start

September 1, 2003

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

July 29, 2011

Record last verified: 2011-07

Locations

US(1)