Effect of Ziprasidone on Glucose & Plasma Lipids in Diabetes (II) and Schizophrenia or Schizoaffective Disorder
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00395031|
Recruitment Status : Completed
First Posted : November 2, 2006
Last Update Posted : July 29, 2011
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia Schizoaffective Disorder||Drug: Ziprasidone||Phase 2 Phase 3|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||57 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effects of Ziprasidone 320 mg on Glucose and Plasma Lipids in Patients With Diabetes Type II and Schizophrenia or Schizoaffective Disorder|
|Study Start Date :||September 2003|
|Actual Primary Completion Date :||January 2010|
|Actual Study Completion Date :||January 2010|
Ziprasidone dose of between 40 mg po bid to 160 mg po bid for 8 weeks
Other Name: Geodon
- Reduced Glucose, Cholesterol and Lipid Levels [ Time Frame: 11 weeks ]
- Reduction in dose requirement for antiglycemic agents [ Time Frame: 11 week ]
- Improvement in quality of life & Positive and Negative Symptoms [ Time Frame: 11 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|