SchizophreniaPhase 4NCT00287820
Comparative Effects of Chronic Treatment With Olanzapine and Risperidone on Glucose and Lipid Metabolism
A Phase 4 study testing Olanzapine and risperidone in people with Schizophrenia and Diabetes, run by Nathan Kline Institute for Psychiatric Research at 1 site in United States.
Trial summary
The primary objective of the study is to assess whether chronic treatment with olanzapine over a five-month period produces a significant increase in abnormalities in glucose levels. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia, Diabetes, Metabolic Syndrome
- What is being tested?
- Olanzapine and risperidone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2004to Sep 2007
- Phase
- Phase 4
- 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
- Diagnosis
- Schizophrenia or schizoaffective psychosis
- 18-65 years of age
Who cannot join
- Currently being treated with oral antidiabetics or insulin
Trial locations and contacts
1 site in 1 country.
United States1 site
Manhattan Psychaitric Center
New York, New York, 10035
About this study
Official title: Independent Investigator Grant Study-Comparative Effects of Chronic Treatment With Olanzapine and Risperidone on Glucose and Lipid Metabolism
The primary objective of the study is to assess whether chronic treatment with olanzapine over a five-month period produces a significant increase in abnormalities in glucose levels. The main secondary objective is to evaluate whether the increase in glucose levels and rate of glucose abnormalities differs between Olanzapine and Risperidone during this treatment period. Additional secondary objectives of the study are to investigate similar questions with respect to glycohemoglobin, triglycerides and other measures of glucose and lipid metabolism.
We hypothesize that Olanzapine will not be inferior to Risperidone in extent of increase in the primary outcome measure of serum glucose, and secondary measures of glycohemoglobin, insulin and lipids.
Read the detailed description
In the on-going study in progress we use an extensive battery of assessments to investigate a)fasting levels of glucose and lipids at baseline and monthly during 5 months of treatment, b) glucose tolerance tests to investigate glucose and insulin abnormalities after a glucose load at baseline and during study treatment, and c)the effects of treatment with olanzapine and risperidone of post prandial glucose metabolism after a fatty meal (as detailed in the body of the proposal). Recent studies have shown that increased postprandial lipidemia is an important feature of many patients with type 2 diabetes and atherosclerosis. In addition to the biochemical measures, we will also assess clinical effects (PANSS and CGI ratings) and other side-effects (weight gain, appetite, somnolence, and EPS and TD). The specific plan calls for inpatients in a tertiary care hospital to be randomly assigned to olanzapine or risperidone, using a stratified random assignment procedure, and treated for five months with either olanzapine or risperidone. We estimate that we will have to enroll a sample of approximately 50-55 patients to obtain 46 acceptable complete cases(as specified in proposal below). On the basis of preliminary results from our prior and ongoing studies we predict no significant increase in glucose abnormalities from baseline during chronic treatment with olanzapine and no significant differences in development of glucose abnormalities in patients in patient treated with olanzapine and risperidone.
Additional measures being investigated include: comparison of olanzapine and risperidone in glucose and lipid responses to a fatty meal, ghrelin changes in response to a fatty mean, and CRP and IL-6, and thyroid and prolactin response to five months of treatment with the two drugs.
- Conditions
- Schizophrenia, Diabetes, Metabolic Syndrome, Hyperglycemia
- Being tested
- Olanzapine, risperidone
- Keywords
- schizophrenia, diabetes, metabolic syndrome, hyperglycemia, glucose, insulin, lipids, IL-6, prolactin
- Medical subject headings
- Schizophrenia, Diabetes Mellitus, Metabolic Syndrome, Hyperglycemia, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OlanzapineDrug
Also called ayprexa
olanzapine 5-40 mg/day
olanzapineDrug
Also called zyprexa
olanzapine 5-40 ,mg/day
risperidoneDrug
Also called riperidal
risperidone 1-12 mg/day
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | olanzapine Receives: Drug: Olanzapine |
| 2 | Active comparator | risperidone Receives: Drug: risperidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum glucose
Measured: during 5 months of treatment compared to baseline
Hb1AC
Measured: during 5 months of treatment compared to baseline
triglycerides
Measured: during 5 months of treatment compared to baseline
cholesterol
Measured: during 5 months of treatment compared to baseline
insulin
Measured: during 5 months of treatment compared to baseline
c-peptide
Measured: during 5 months of treatment compared to baseline
Secondary outcomes (9)
ghrelin
Measured: during 5 months of treatment compared to baseline
CRP
Measured: during 5 months of treatment compared to baseline
Thyroid hormones
Measured: during 5 months of treatment compared to baseline
prolactin
Measured: during 5 months of treatment compared to baseline
Il-6
Measured: during 5 months treatment compared to baseline
PANSS scores
Measured: during 5 months of treatment compared to baseline
CGI score
Measured: during 5 months of treatment compared to baseline
EPS scores
Measured: during 5 months of treatment compared to baseline
TD Scores
Measured: during 5 months of treatment compared to baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2006 (estimated)
- Study startFeb 2004
- Study completionSep 2007
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nathan Kline Institute for Psychiatric Research
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company
- Investigators
- Robert C Smith, MD PhD, Principal investigator, NYU Medical School, Dept of Psychiatry and Manhattan Psychiatric Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00287820
- Sponsor's protocol ID
- FiD-MC-x226(7524)
- Status last verified
- Dec 2007
- First submitted
- 6 Feb 2006
- Last updated
- 25 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Smith RC, Rachakonda S, Dwivedi S, Davis JM. Olanzapine and risperidone effects on appetite and ghrelin in chronic schizophrenic patients. Psychiatry Res. 2012 Oct 30;199(3):159-63. doi: 10.1016/j.psychres.2012.03.011. Epub 2012 Apr 3.
PubMed 22475524Smith RC, Lindenmayer JP, Hu Q, Kelly E, Viviano TF, Cornwell J, Vaidhyanathaswamy S, Marcovina S, Davis JM. Effects of olanzapine and risperidone on lipid metabolism in chronic schizophrenic patients with long-term antipsychotic treatment: a randomized five month study. Schizophr Res. 2010 Jul;120(1-3):204-9. doi: 10.1016/j.schres.2010.04.001. Epub 2010 May 10.
PubMed 20457512Smith RC, Lindenmayer JP, Davis JM, Kelly E, Viviano TF, Cornwell J, Hu Q, Khan A, Vaidhyanathaswamy S. Effects of olanzapine and risperidone on glucose metabolism and insulin sensitivity in chronic schizophrenic patients with long-term antipsychotic treatment: a randomized 5-month study. J Clin Psychiatry. 2009 Nov;70(11):1501-13. doi: 10.4088/JCP.08m04446yel. Epub 2009 Oct 6.
PubMed 19814947
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Independent Investigator Grant Study-Comparative Effects of Chronic Treatment With Olanzapine and Risperidone on Glucose and Lipid Metabolism
- ClinicalTrials.gov ID
- NCT00287820
- Acronym / sponsor ID
- FiD-MC-x226(7524)
- Conditions
- Schizophrenia, Diabetes, Metabolic Syndrome, Hyperglycemia
- Keywords
- schizophrenia, diabetes, metabolic syndrome, hyperglycemia, glucose, insulin, lipids, IL-6
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Nathan Kline Institute for Psychiatric ResearchUniversity, hospital or other
- Collaborators
- Eli Lilly and Company
- Study start
- Feb 2004
- Study completion
- Sep 2007 (actual)
- First posted
- 7 Feb 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 primary objective of the study is to assess whether chronic treatment with olanzapine over a five-month period produces a significant increase in abnormalities in glucose levels. The main secondary objective is to evaluate whether the increase in glucose levels and rate of glucose abnormalities differs between Olanzapine and Risperidone during this treatment period. Additional secondary objectives of the study are to investigate similar questions with respect to glycohemoglobin, triglycerides and other measures of glucose and lipid metabolism.
We hypothesize that Olanzapine will not be inferior to Risperidone in extent of increase in the primary outcome measure of serum glucose, and secondary measures of glycohemoglobin, insulin and lipids.
Detailed description
In the on-going study in progress we use an extensive battery of assessments to investigate a)fasting levels of glucose and lipids at baseline and monthly during 5 months of treatment, b) glucose tolerance tests to investigate glucose and insulin abnormalities after a glucose load at baseline and during study treatment, and c)the effects of treatment with olanzapine and risperidone of post prandial glucose metabolism after a fatty meal (as detailed in the body of the proposal). Recent studies have shown that increased postprandial lipidemia is an important feature of many patients with type 2 diabetes and atherosclerosis. In addition to the biochemical measures, we will also assess clinical effects (PANSS and CGI ratings) and other side-effects (weight gain, appetite, somnolence, and EPS and TD). The specific plan calls for inpatients in a tertiary care hospital to be randomly assigned to olanzapine or risperidone, using a stratified random assignment procedure, and treated for five months with either olanzapine or risperidone. We estimate that we will have to enroll a sample of approximately 50-55 patients to obtain 46 acceptable complete cases(as specified in proposal below). On the basis of preliminary results from our prior and ongoing studies we predict no significant increase in glucose abnormalities from baseline during chronic treatment with olanzapine and no significant differences in development of glucose abnormalities in patients in patient treated with olanzapine and risperidone.
Additional measures being investigated include: comparison of olanzapine and risperidone in glucose and lipid responses to a fatty meal, ghrelin changes in response to a fatty mean, and CRP and IL-6, and thyroid and prolactin response to five months of treatment with the two drugs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Olanzapineolanzapine |
| 2 | Active comparator | Drug: risperidonerisperidone |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis
- Schizophrenia or schizoaffective psychosis
- 18-65 years of age
Key exclusion criteria (1 listed)
- Currently being treated with oral antidiabetics or insulin
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 |
|---|---|---|
| OlanzapineAlso: ayprexaolanzapine 5-40 mg/day | Drug | 1 |
| olanzapineAlso: zyprexaolanzapine 5-40 ,mg/day | Drug | 1 |
| risperidoneAlso: riperidalrisperidone 1-12 mg/day | Drug | 2 |
Primary outcome
Serum glucose
Time frame: during 5 months of treatment compared to baseline
Hb1AC
Time frame: during 5 months of treatment compared to baseline
triglycerides
Time frame: during 5 months of treatment compared to baseline
cholesterol
Time frame: during 5 months of treatment compared to baseline
insulin
Time frame: during 5 months of treatment compared to baseline
c-peptide
Time frame: during 5 months of treatment compared to baseline
9 secondary outcomes
ghrelin
Time frame: during 5 months of treatment compared to baseline
CRP
Time frame: during 5 months of treatment compared to baseline
Thyroid hormones
Time frame: during 5 months of treatment compared to baseline
prolactin
Time frame: during 5 months of treatment compared to baseline
Il-6
Time frame: during 5 months treatment compared to baseline
PANSS scores
Time frame: during 5 months of treatment compared to baseline
CGI score
Time frame: during 5 months of treatment compared to baseline
EPS scores
Time frame: during 5 months of treatment compared to baseline
TD Scores
Time frame: during 5 months of treatment compared to baseline
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 25 Jul 2011.
- Derived from this study: PubMed 22475524Smith RC, Rachakonda S, Dwivedi S, Davis JM. Olanzapine and risperidone effects on appetite and ghrelin in chronic schizophrenic patients. Psychiatry Res. 2012 Oct 30;199(3):159-63. doi: 10.1016/j.psychres.2012.03.011. Epub 2012 Apr 3.
- Derived from this study: PubMed 20457512Smith RC, Lindenmayer JP, Hu Q, Kelly E, Viviano TF, Cornwell J, Vaidhyanathaswamy S, Marcovina S, Davis JM. Effects of olanzapine and risperidone on lipid metabolism in chronic schizophrenic patients with long-term antipsychotic treatment: a randomized five month study. Schizophr Res. 2010 Jul;120(1-3):204-9. doi: 10.1016/j.schres.2010.04.001. Epub 2010 May 10.
- Derived from this study: PubMed 19814947Smith RC, Lindenmayer JP, Davis JM, Kelly E, Viviano TF, Cornwell J, Hu Q, Khan A, Vaidhyanathaswamy S. Effects of olanzapine and risperidone on glucose metabolism and insulin sensitivity in chronic schizophrenic patients with long-term antipsychotic treatment: a randomized 5-month study. J Clin Psychiatry. 2009 Nov;70(11):1501-13. doi: 10.4088/JCP.08m04446yel. Epub 2009 Oct 6.
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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.
Robert C Smith, MD PhD principal investigator
NYU Medical School, Dept of Psychiatry and Manhattan Psychiatric Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Olanzapine and risperidone in people with Schizophrenia and Diabetes, run by Nathan Kline Institute for Psychiatric Research 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 3 inclusion and 1 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 25 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Serum glucose (time frame: during 5 months of treatment compared to baseline). The study lists 6 primary outcomes in all. 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 NCT00287820, 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 25 Jul 2011.