Effect of Ziprasidone on Glucose & Plasma Lipids in Diabetes (II) and Schizophrenia or Schizoaffective Disorder
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||The Effects of Ziprasidone 320 mg on Glucose and Plasma Lipids in Patients With Diabetes Type II and Schizophrenia or Schizoaffective Disorder|
- Reduced Glucose, Cholesterol and Lipid Levels [ Time Frame: 11 weeks ] [ Designated as safety issue: Yes ]
- Reduction in dose requirement for antiglycemic agents [ Time Frame: 11 week ] [ Designated as safety issue: Yes ]
- Improvement in quality of life & Positive and Negative Symptoms [ Time Frame: 11 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||September 2003|
|Study Completion Date:||January 2010|
|Primary Completion Date:||January 2010 (Final data collection date for primary outcome measure)|
Ziprasidone dose of between 40 mg po bid to 160 mg po bid for 8 weeks
Other Name: Geodon
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00395031
|United States, New York|
|Manhattan Psychiatric Center|
|New York, New York, United States, 10035|
|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|