Effect of Ziprasidone on Glucose & Plasma Lipids in Diabetes (II) and Schizophrenia or Schizoaffective Disorder
NCT ID: NCT00395031
Last Updated: 2011-07-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
57 participants
INTERVENTIONAL
2003-09-30
2010-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Ziprasidone
Open label
Ziprasidone
Ziprasidone dose of between 40 mg po bid to 160 mg po bid for 8 weeks
Interventions
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Ziprasidone
Ziprasidone dose of between 40 mg po bid to 160 mg po bid for 8 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. DSM IV diagnosis of schizophrenia (all subtypes) or schizoaffective disorder
3. Diabetes Mellitus type II treated with oral antidiabetic drugs or insulin
4. Stable dose of antipsychotic regimen for previous one month.
5. Stable dose of antidepressant regimen for previous one month.
6. Stable dose of adjunctive mood stabilizer and/or anticholinergic regimen for previous 1 month
7. Signed informed consent
8. Absence of significant cardiovascular pathology as demonstrated by EKG (QTc \< 450 millisec)
9. Absence of severe medical conditions (except for DM) requiring frequent changes in medication.
Exclusion Criteria
2. Unstable epilepsy
3. Acute, unstable or significant medical condition
4. Suicidal or physically violent behavioral episodes in the previous month
5. Current DSM IV diagnosis of substance or alcohol abuse with positive urine toxicology in the past two weeks.
6. Liver enzyme test values ≥ three times upper normal limit for AST, ALT, GGT, and Alkaline Phosphatase; ≥ two times upper limit for LDH.
18 Years
65 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Manhattan Psychiatric Center
OTHER
Responsible Party
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RFMH
Principal Investigators
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Saurabh Kaushik, M.D.
Role: STUDY_CHAIR
Manhattan Psychiatric Center, New York University, Nathan Kline Institute
Jean-Pierre Lindenmayer, M.D.
Role: PRINCIPAL_INVESTIGATOR
Manhattan Psychiatric Center, New York University, Nathan Kline Institute
Locations
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Manhattan Psychiatric Center
New York, New York, United States
Countries
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References
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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.
Related Links
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Site dedicated exclusively to ziprasidone sponsored by PharmaPromo a division of Anakena Internet Services.
Ziprasidone information on medlineplus, a service of NIH
Other Identifiers
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Pfizer Reference # 2001-0448
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
03I/C24
Identifier Type: -
Identifier Source: org_study_id