CompletedPhase 4

Ziprasidone for Clozapine- or Olanzapine-Associated Diabetes Mellitus

United States24 participantsStarted 2005-01

Plain-language 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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change From Baseline in Fasting Glucose

Timeframe: baseline, week 6

Change From Baseline on Fasting Insulin

Timeframe: baseline, week 6

Trial details

NCT IDNCT00351000

SponsorNorth Suffolk Mental Health Association

Sponsor typeOTHER

Study typeINTERVENTIONAL

Results submitted2012-12-20

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