Effect of Ziprasidone on Glucose & Plasma Lipids in Diabetes (II) and Schizophrenia or Schizoaffective Disorder
The Effects of Ziprasidone 320 mg on Glucose and Plasma Lipids in Patients With Diabetes Type II and Schizophrenia or Schizoaffective Disorder
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Inpatients with DSM IV diagnosis of schizophrenia or schizoaffective disorder and DM II will be enrolled after giving informed consent. Participants may stay on their original ward at MPC, if their clinical care would be better served on their home ward because of patient programs and/or continuity of care reasons. Patients recruited from other participating sites will be transferred to MPC research ward.
There will be a screening phase (two weeks) on the prior antipsychotic regimen, a cross-titration phase (three week) and a ziprasidone phase (eight weeks; four time points).
All medications, except for the antipsychotic agents, will be kept stable throughout the protocol. These medications may include anticholinergics, mood stabilizers and antidepressants. After the screening phase lasting two weeks, patients will enter the cross-titration phase lasting three week. The cross titration schedule will be changed in accordance with Deutschman & Deutschman's 2005 recommendations. The current antipsychotic will be gradually decreased to zero and ziprasidone will be started at 40 mg bid po and raised up to 160 mg po bid during the cross-titration phase, according to clinical response and tolerance. After the cross-titration phase has concluded, the ziprasidone dose will range from 80 mg bid p.o. to 160 mg bid p.o. daily according to clinical response during the eight week treatment phase.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10035
- Manhattan Psychiatric Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Ziprasidone
Open label
|
Ziprasidone dose of between 40 mg po bid to 160 mg po bid for 8 weeks
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Reduced Glucose, Cholesterol and Lipid Levels
Time Frame: 11 weeks
|
11 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Reduction in dose requirement for antiglycemic agents
Time Frame: 11 week
|
11 week
|
|
Improvement in quality of life & Positive and Negative Symptoms
Time Frame: 11 weeks
|
11 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Saurabh Kaushik, M.D., Manhattan Psychiatric Center, New York University, Nathan Kline Institute
- Principal Investigator: Jean-Pierre Lindenmayer, M.D., Manhattan Psychiatric Center, New York University, Nathan Kline Institute
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Schizophrenia Spectrum and Other Psychotic Disorders
- Schizophrenia
- Disease
- Psychotic Disorders
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Serotonin Agents
- Dopamine Agents
- Serotonin Antagonists
- Dopamine Antagonists
- Ziprasidone
Other Study ID Numbers
- 03I/C24
- Pfizer Reference # 2001-0448 (Other Grant/Funding Number: Pfizer Inc)
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