Effect of Ziprasidone on Glucose & Plasma Lipids in Diabetes (II) and Schizophrenia or Schizoaffective Disorder
NCT00395031
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Adult Trials: 18+ Years
1. Aged 18 to 65 years
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.
1. DSM IV diagnosis other than Schizophrenia or Schizoaffective disorder
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.
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| Descriptive Information | |||||||
|---|---|---|---|---|---|---|---|
| Brief Title ICMJE | Effect of Ziprasidone on Glucose & Plasma Lipids in Diabetes (II) and Schizophrenia or Schizoaffective Disorder | ||||||
| Official Title ICMJE | The Effects of Ziprasidone 320 mg on Glucose and Plasma Lipids in Patients With Diabetes Type II and Schizophrenia or Schizoaffective Disorder | ||||||
| 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. | ||||||
| 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 ICMJE | Interventional | ||||||
| Study Phase ICMJE | Phase 2 Phase 3 | ||||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | ||||||
| Condition ICMJE |
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| Intervention ICMJE | Drug: Ziprasidone
Ziprasidone dose of between 40 mg po bid to 160 mg po bid for 8 weeks Other Name: Geodon | ||||||
| Study Arms ICMJE | Ziprasidone
Open label Intervention: Drug: Ziprasidone | ||||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
| Recruitment Information | |||||||
| Recruitment Status ICMJE | Completed | ||||||
| Actual Enrollment ICMJE | 57 | ||||||
| Original Enrollment ICMJE | 55 | ||||||
| Actual Study Completion Date ICMJE | January 2010 | ||||||
| Actual Primary Completion Date | January 2010 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | ||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
| Listed Location Countries ICMJE | United States | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number ICMJE | NCT00395031 | ||||||
| Other Study ID Numbers ICMJE | 03I/C24 Pfizer Reference # 2001-0448 ( Other Grant/Funding Number: Pfizer Inc ) | ||||||
| Has Data Monitoring Committee | Yes | ||||||
| U.S. FDA-regulated Product | Not Provided | ||||||
| IPD Sharing Statement ICMJE | Not Provided | ||||||
| Responsible Party | Jean-Pierre Lindenmayer, Director of Psychopharmacology Research, Manhattan Psychiatric Center, NY, RFMH | ||||||
| Study Sponsor ICMJE | Manhattan Psychiatric Center | ||||||
| Collaborators ICMJE | Pfizer | ||||||
| Investigators ICMJE |
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| PRS Account | Manhattan Psychiatric Center | ||||||
| Verification Date | July 2011 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | |||||||