Ziprasidone for Clozapine- or Olanzapine-Associated Diabetes Mellitus

NCT00351000 | Completed Phase 4 Results

• 1 other identifier: 1-2005
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a six-week, open label trial of the novel antipsychotic agent, ziprasidone, added to a stable dose of clozapine or olanzapine in 40 diabetes mellitus patients, patients with an impaired fasting glucose or insulin resistance with schizophrenia or schizoaffective disorder. The first two weeks will be a fixed-dose of ziprasidone 40 mg twice a day. During weeks 2-6, the ziprasidone dose may be increased up to 80 mg twice a day.

Conditions

Schizophrenia

Keywords

Schizophrenia; Ziprasidone; Diabetes; Insulin Resistance

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in Fasting Glucose

  Subjects on clozapine with adjunctive ziprasidone were compared to subjects on olanzapine with adjunctive ziprasidone on change in fasting glucose levels from baseline to study endpoint (week 6 - baseline)

  baseline, week 6

• Change From Baseline on Fasting Insulin

  Subjects on clozapine with adjunctive ziprasidone were compared to subjects on olanzapine with adjunctive ziprasidone on change in fasting insulin levels from baseline to study endpoint (week 6 - baseline)

  baseline, week 6

Interventions

Ziprasidone DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of Schizophrenia, any subtype or schizoaffective disorder
• Ages 18-65 years
• Capable of providing informed consent
• Antipsychotic Agents -associated diabetes mellitus, impaired fasting glucose or insulin resistance
• Stable dose of clozapine or olanzapine for at least 1 month
• Optimal dose of clozapine or olanzapine, or a maximal dose if limited by significant side effects

You may not qualify if:

• Serious medical or neurological illness (unstable cardiac disease including recent myocardial infarction or heart failure, seizure disorder, malignancy, liver or renal impairment, etc.)
• Current substance abuse
• Pregnancy, nursing, or unwilling to use appropriate birth control measures during participation if female and fertile
• History of serious blood dyscrasia requiring discontinuation of clozapine
• Serious suicidal or homicidal risk within the past six months
• History of diabetes mellitus prior to treatment with clozapine or olanzapine
• H/o prolongation of QTc interval (\>450) on EKG or clinically significant EKG abnormalities.
• Treatment with medications that significantly prolong QTc interval such as dofetilde, sotalol, quinidine, class Ia and III antiarrhythmics, mesoridazine, thioridazine, chlorpromazine, droperidol, pimozide, sparfloxacin, gatifloxacin, moxifloxacine, halofantrine, mefloquine, pentamidine, arsenic trioxide, levomethadyul acetate, dolasetron myselate, probucol, or tacrolimus.

Sponsors & Collaborators

• North Suffolk Mental Health Association: lead
• Pfizer: collaborator

Study Sites (1)

Freedom Trail Clinic

Boston, Massachusetts, 02114, United States

Location

Related Publications (30)

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MeSH Terms

Conditions

Schizophrenia; Diabetes Mellitus; Insulin Resistance

Interventions

ziprasidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Limitations and Caveats

The sample size in this study may not have been adequate to demonstrate the effectiveness of ziprasidone as an adjuvant therapy. The receptor-binding profile of ziprasidone may not significantly counteract the mechanisms of metabolic disturbances.

Results Point of Contact

• Title: Dr. David Henderson
• Organization: Massachusetts General Hospital Schizophrenia Research Program

dchenderson@partners.org

(617) 912-7800

Study Officials

• David C Henderson, MD

  North Suffolk Mental Health Association

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychiatry

Study Record Dates

• First Submitted: July 11, 2006
• First Posted: July 12, 2006
• Study Start: January 1, 2005
• Study Completion: March 1, 2007
• Last Updated: January 13, 2017
• Results First Posted: January 28, 2013

Record last verified: 2016-11

Locations

US (1)