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Effect of Ziprasidone on Glucose & Plasma Lipids in Diabetes (II) and Schizophrenia or Schizoaffective Disorder

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ClinicalTrials.gov Identifier: NCT00395031
Recruitment Status : Completed
First Posted : November 2, 2006
Last Update Posted : July 29, 2011
Sponsor:
Collaborator:
Pfizer
Information provided by:
Manhattan Psychiatric Center

Tracking Information
First Submitted Date  ICMJE November 1, 2006
First Posted Date  ICMJE November 2, 2006
Last Update Posted Date July 29, 2011
Study Start Date  ICMJE September 2003
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 22, 2007)
Reduced Glucose, Cholesterol and Lipid Levels [ Time Frame: 11 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 1, 2006)
  • Glucose metabolism
  • Lipid Metabolism
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 22, 2007)
  • Reduction in dose requirement for antiglycemic agents [ Time Frame: 11 week ]
  • Improvement in quality of life & Positive and Negative Symptoms [ Time Frame: 11 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 1, 2006)
  • Improvment in positive and negative symptoms
  • Improvement in quality of life
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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
  • Schizophrenia
  • Schizoaffective Disorder
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 *

*   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
 (submitted: October 22, 2007)
57
Original Enrollment  ICMJE
 (submitted: November 1, 2006)
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:

  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.

Exclusion Criteria:

  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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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
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
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