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

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by:
Manhattan Psychiatric Center
ClinicalTrials.gov Identifier:
NCT00395031
First received: November 1, 2006
Last updated: July 28, 2011
Last verified: July 2011
  Purpose

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.


Condition Intervention Phase
Schizophrenia
Schizoaffective Disorder
Drug: Ziprasidone
Phase 2
Phase 3

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Manhattan Psychiatric Center:

Primary Outcome Measures:
  • Reduced Glucose, Cholesterol and Lipid Levels [ Time Frame: 11 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 57
Study Start Date: September 2003
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Ziprasidone
Open label
Drug: Ziprasidone
Ziprasidone dose of between 40 mg po bid to 160 mg po bid for 8 weeks
Other Name: Geodon

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00395031

Locations
United States, New York
Manhattan Psychiatric Center
New York, New York, United States, 10035
Sponsors and Collaborators
Manhattan Psychiatric Center
Pfizer
Investigators
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
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jean-Pierre Lindenmayer, Director of Psychopharmacology Research, Manhattan Psychiatric Center, NY, RFMH
ClinicalTrials.gov Identifier: NCT00395031     History of Changes
Other Study ID Numbers: 03I/C24, Pfizer Reference # 2001-0448
Study First Received: November 1, 2006
Last Updated: July 28, 2011
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Manhattan Psychiatric Center:
schizophrenia
Schizoaffective Disorder
metabolic markers
ziprasidone
diabetes

Additional relevant MeSH terms:
Psychotic Disorders
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Ziprasidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on August 28, 2014