SchizophreniaPhase 2/3NCT00395031
Effect of Ziprasidone on Glucose & Plasma Lipids in Diabetes (II) and Schizophrenia or Schizoaffective Disorder
A Phase 2/3 study testing Ziprasidone in people with Schizophrenia and Schizoaffective Disorder, run by Manhattan Psychiatric Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder
- What is being tested?
- Ziprasidone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2003to Jan 2010
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 to 65 years
- DSM IV diagnosis of schizophrenia (all subtypes) or schizoaffective disorder
- Diabetes Mellitus type II treated with oral antidiabetic drugs or insulin
- Stable dose of antipsychotic regimen for previous one month.
- Stable dose of antidepressant regimen for previous one month.
- Stable dose of adjunctive mood stabilizer and/or anticholinergic regimen for previous 1 month
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- Signed informed consent
- Absence of significant cardiovascular pathology as demonstrated by EKG (QTc < 450 millisec)
- Absence of severe medical conditions (except for DM) requiring frequent changes in medication.
Who cannot join
- DSM IV diagnosis other than Schizophrenia or Schizoaffective disorder
- Unstable epilepsy
- Acute, unstable or significant medical condition
- Suicidal or physically violent behavioral episodes in the previous month
- Current DSM IV diagnosis of substance or alcohol abuse with positive urine toxicology in the past two weeks.
- Liver enzyme test values ≥ three times upper normal limit for AST, ALT, GGT, and Alkaline Phosphatase; ≥ two times upper limit for LDH.
Trial locations and contacts
1 site in 1 country.
United States1 site
Manhattan Psychiatric Center
New York, New York, 10035
About this study
Official title: The Effects of Ziprasidone 320 mg on Glucose and Plasma Lipids in Patients With Diabetes Type 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.
Read the 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.
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Being tested
- Ziprasidone
- Keywords
- schizophrenia, Schizoaffective Disorder, metabolic markers, ziprasidone, diabetes
- Medical subject headings
- Schizophrenia, Psychotic Disorders, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZiprasidoneDrug
Also called Geodon
Ziprasidone dose of between 40 mg po bid to 160 mg po bid for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Ziprasidone | Other | Open label Receives: Drug: Ziprasidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduced Glucose, Cholesterol and Lipid Levels
Measured: 11 weeks
Secondary outcomes (2)
Reduction in dose requirement for antiglycemic agents
Measured: 11 week
Improvement in quality of life & Positive and Negative Symptoms
Measured: 11 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2006 (estimated)
- Study startSep 2003
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manhattan Psychiatric Center
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Investigators
- Saurabh Kaushik, M.D., Study chair, Manhattan Psychiatric Center, New York University, Nathan Kline InstituteJean-Pierre Lindenmayer, M.D., Principal investigator, Manhattan Psychiatric Center, New York University, Nathan Kline Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00395031
- Sponsor's protocol ID
- 03I/C24
- Other IDs
- Pfizer Reference # 2001-0448
- Status last verified
- Jul 2011
- First submitted
- 1 Nov 2006
- Last updated
- 29 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Levy WO, Robichaux-Keene NR, Nunez C. No significant QTc interval changes with high-dose ziprasidone: a case series. J Psychiatr Pract. 2004 Jul;10(4):227-32. doi: 10.1097/00131746-200407000-00003.
PubMed 15552544Deutschman DA, Deutschman DH. High-dose ziprasidone in treatment-resistant schizophrenia and affective spectrum disorders: a case series. J Clin Psychopharmacol. 2007 Oct;27(5):513-4. doi: 10.1097/JCP.0b013e31814cface. No abstract available.
PubMed 17873687Kaushik S, Maccabee N, Kaushik S, Lindenmayer JP. Activation induced by high-dose ziprasidone: a case report. J Clin Psychiatry. 2009 Sep;70(9):1326-7. doi: 10.4088/JCP.08l04400. No abstract available.
PubMed 19818257
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Ziprasidone 320 mg on Glucose and Plasma Lipids in Patients With Diabetes Type II and Schizophrenia or Schizoaffective Disorder
- ClinicalTrials.gov ID
- NCT00395031
- Acronym / sponsor ID
- 03I/C24
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Keywords
- schizophrenia, Schizoaffective Disorder, metabolic markers, ziprasidone, diabetes
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Manhattan Psychiatric CenterUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Sep 2003
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 2 Nov 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ziprasidone | Other | Drug: ZiprasidoneOpen label |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Aged 18 to 65 years
- DSM IV diagnosis of schizophrenia (all subtypes) or schizoaffective disorder
- Diabetes Mellitus type II treated with oral antidiabetic drugs or insulin
- Stable dose of antipsychotic regimen for previous one month.
- Stable dose of antidepressant regimen for previous one month.
Key exclusion criteria (6 listed)
- DSM IV diagnosis other than Schizophrenia or Schizoaffective disorder
- Unstable epilepsy
- Acute, unstable or significant medical condition
- Suicidal or physically violent behavioral episodes in the previous month
- Current DSM IV diagnosis of substance or alcohol abuse with positive urine toxicology in the past two weeks.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZiprasidoneAlso: GeodonZiprasidone dose of between 40 mg po bid to 160 mg po bid for 8 weeks | Drug | Ziprasidone |
Primary outcome
Reduced Glucose, Cholesterol and Lipid Levels
Time frame: 11 weeks
2 secondary outcomes
Reduction in dose requirement for antiglycemic agents
Time frame: 11 week
Improvement in quality of life & Positive and Negative Symptoms
Time frame: 11 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2011.
- Background: PubMed 15552544Levy WO, Robichaux-Keene NR, Nunez C. No significant QTc interval changes with high-dose ziprasidone: a case series. J Psychiatr Pract. 2004 Jul;10(4):227-32. doi: 10.1097/00131746-200407000-00003.
- Background: PubMed 17873687Deutschman DA, Deutschman DH. High-dose ziprasidone in treatment-resistant schizophrenia and affective spectrum disorders: a case series. J Clin Psychopharmacol. 2007 Oct;27(5):513-4. doi: 10.1097/JCP.0b013e31814cface. No abstract available.
- Derived from this study: PubMed 19818257Kaushik S, Maccabee N, Kaushik S, Lindenmayer JP. Activation induced by high-dose ziprasidone: a case report. J Clin Psychiatry. 2009 Sep;70(9):1326-7. doi: 10.4088/JCP.08l04400. No abstract available.
- Site dedicated exclusively to ziprasidone sponsored by PharmaPromo a division of Anakena Internet Services.Link provided by the sponsor.
- Ziprasidone information on medlineplus, a service of NIHLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Saurabh Kaushik, M.D. study chair
Manhattan Psychiatric Center, New York University, Nathan Kline Institute
Jean-Pierre Lindenmayer, M.D. principal investigator
Manhattan Psychiatric Center, New York University, Nathan Kline Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Ziprasidone in people with Schizophrenia and Schizoaffective Disorder, run by Manhattan Psychiatric Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduced Glucose, Cholesterol and Lipid Levels (time frame: 11 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00395031, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2011.