SchizophreniaPhase 4NCT00245206
Side Effects of Newer Antipsychotics in Older Adults
A Phase 4 study testing Aripiprazole, Olanzapine and Risperidone in people with Schizophrenia and Alzheimer's Disease, run by Veterans Medical Research Foundation at 1 site in United States.
Trial summary
This study will compare four atypical antipsychotic medications in terms of the risk of specific side effects each of them presents in middle-aged and elderly individuals. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia, Alzheimer's Disease, Dementia
- What is being tested?
- Aripiprazole, Olanzapine and Risperidone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 406 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2005to Oct 2010
- 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- DSM-IV diagnosis of a disease or disorder that requires treatment with an atypical antipsychotic medication
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Diego
San Diego, California, 92037
About this study
Official title: Metabolic Effects of Newer Antipsychotics in Older Patients
This study will compare four atypical antipsychotic medications in terms of the risk of specific side effects each of them presents in middle-aged and elderly individuals.
Read the detailed description
Atypical antipsychotic medications introduced within the last decade have been used increasingly for the treatment of several types of psychotic disorders and severe behavioral disturbances in older individuals. This trend is primarily due to a decrease in side effects caused by the new medications, as compared to conventional neuroleptic medications. There is a lower risk for developing tardive dyskinesia and extrapyramidal symptoms, both of which are movement abnormalities, with new antipsychotic medications. However, there has been a growing concern that the newer medications can cause a different set of potentially serious adverse side effects. Specifically, they may cause long-term metabolic, cardiovascular, and cerebrovascular effects, which may result in weight gain, diabetes, or stroke. This study will compare four atypical antipsychotic medications in terms of the risk of metabolic, cardiovascular, and cerebrovascular side effects that each presents in middle-aged and elderly individuals.
Participants in this open-label study will be randomly assigned to receive one of three atypical antipsychotic medications: aripiprazole; olanzapine; or risperidone. Although assignment is random, a technique that may reflect the participant's own interests or the researcher's knowledge of relevant participant characteristics will be used to assign the participant to a medication. Dosing will be determined by each participant's psychiatrist. Participants will be followed for up to 5 years to assess the side effects of the study medications, with study visits at baseline, Week 6, and every 3 months thereafter.
- Conditions
- Schizophrenia, Alzheimer's Disease, Dementia
- Being tested
- Aripiprazole, Olanzapine, Risperidone
- Keywords
- Antipsychotic, Diabetes, Hyperlipidemia, Stroke
- Medical subject headings
- Schizophrenia, Alzheimer Disease, Dementia, Diabetes Mellitus, Hyperlipidemias, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AripiprazoleDrug
Participant will take aripiprazole. Dosing will be determined by each participant's psychiatrist.
OlanzapineDrug
Participant will take olanzapine. Dosing will be determined by each participant's psychiatrist.
RisperidoneDrug
Also called Risperidal
Participant will take risperidone. Dosing will be determined by each participant's psychiatrist.
| Study group | Role | What they receive |
|---|---|---|
| 1: Risperdal | Experimental | Participants randomized to this arm will be prescribed risperdal. They will continue to be followed by their psychiatrist. In addition, they will take part in ongoing biological, cognitive, and psycho-social assessments with study staff. Receives: Drug: Risperidone |
| 3: Aripiprazole | Experimental | Participants randomized to this arm will be prescribed aripiprazole. They will continue to be followed by their psychiatrist. In addition, they will take part in ongoing biological, cognitive, and psycho-social assessments with study staff. Receives: Drug: Aripiprazole |
| 4: Olanzapine | Experimental | Participants randomized to this arm will be prescribed olanzapine. They will continue to be followed by their psychiatrist. In addition, they will take part in ongoing biological, cognitive, and psycho-social assessments with study staff. Receives: Drug: Olanzapine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body Mass Index
Change in body mass index (BMI) between each study visit. weight and height will be combined to report BMI in kg/m^2. (This hypothesis is non-directional because of uncertainties with respect to significant between-drug differences on these measures.)
Measured: Measured at baseline, Week 6, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Change in Fasting Plasma Glucose (FPG)
Blood sample collected to measure Fasting Plasma Glucose (FPG) to determine if there are changes between study visits. (This hypothesis is non-directional because of uncertainties with respect to significant between-drug differences on these measures.)
Measured: Measured at baseline, Week 6, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Change in LDL cholesterol, HDL cholesterol, and triglycerides
Lipid Panel collected to measure LDL cholesterol, HDL cholesterol, and triglycerides and determine if there are changes between study visits. (This hypothesis is non-directional because of uncertainties with respect to significant between-drug differences on these measures.)
Measured: Measured at baseline, Week 6, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2005 (estimated)
- Study startAug 2005
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- 406 participants (actual)
Sponsor and investigators
- Lead sponsor
- Veterans Medical Research Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Dilip V. Jeste, Veterans Medical Research Foundation
- Investigators
- Dilip V. Jeste, MD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00245206
- Sponsor's protocol ID
- R01MH071536
- Other IDs
- DATR A5-ETSE, R01MH071536
- Status last verified
- Dec 2018
- First submitted
- 25 Oct 2005
- Last updated
- 17 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Jin H, Shih PA, Golshan S, Mudaliar S, Henry R, Glorioso DK, Arndt S, Kraemer HC, Jeste DV. Comparison of longer-term safety and effectiveness of 4 atypical antipsychotics in patients over age 40: a trial using equipoise-stratified randomization. J Clin Psychiatry. 2013 Jan;74(1):10-8. doi: 10.4088/JCP.12m08001. Epub 2012 Nov 27.
PubMed 23218100Jin H, Meyer J, Mudaliar S, Henry R, Khandrika S, Glorioso DK, Kraemer H, Jeste D. Use of clinical markers to identify metabolic syndrome in antipsychotic-treated patients. J Clin Psychiatry. 2010 Oct;71(10):1273-8. doi: 10.4088/JCP.09m05414yel.
PubMed 21062616
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Effects of Newer Antipsychotics in Older Patients
- ClinicalTrials.gov ID
- NCT00245206
- Acronym / sponsor ID
- R01MH071536
- Conditions
- Schizophrenia, Alzheimer's Disease, Dementia
- Keywords
- Antipsychotic, Diabetes, Hyperlipidemia, Stroke
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 406 participants (actual)
- Lead sponsor
- Veterans Medical Research FoundationUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Aug 2005
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 27 Oct 2005 (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.
This study will compare four atypical antipsychotic medications in terms of the risk of specific side effects each of them presents in middle-aged and elderly individuals.
Detailed description
Atypical antipsychotic medications introduced within the last decade have been used increasingly for the treatment of several types of psychotic disorders and severe behavioral disturbances in older individuals. This trend is primarily due to a decrease in side effects caused by the new medications, as compared to conventional neuroleptic medications. There is a lower risk for developing tardive dyskinesia and extrapyramidal symptoms, both of which are movement abnormalities, with new antipsychotic medications. However, there has been a growing concern that the newer medications can cause a different set of potentially serious adverse side effects. Specifically, they may cause long-term metabolic, cardiovascular, and cerebrovascular effects, which may result in weight gain, diabetes, or stroke. This study will compare four atypical antipsychotic medications in terms of the risk of metabolic, cardiovascular, and cerebrovascular side effects that each presents in middle-aged and elderly individuals.
Participants in this open-label study will be randomly assigned to receive one of three atypical antipsychotic medications: aripiprazole; olanzapine; or risperidone. Although assignment is random, a technique that may reflect the participant's own interests or the researcher's knowledge of relevant participant characteristics will be used to assign the participant to a medication. Dosing will be determined by each participant's psychiatrist. Participants will be followed for up to 5 years to assess the side effects of the study medications, with study visits at baseline, Week 6, and every 3 months thereafter.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1: Risperdal | Experimental | Drug: RisperidoneParticipants randomized to this arm will be prescribed risperdal. They will continue to be followed by their psychiatrist. In addition, they will take part in ongoing biological, cognitive, and psycho-social assessments with study staff. |
| 3: Aripiprazole | Experimental | Drug: AripiprazoleParticipants randomized to this arm will be prescribed aripiprazole. They will continue to be followed by their psychiatrist. In addition, they will take part in ongoing biological, cognitive, and psycho-social assessments with study staff. |
| 4: Olanzapine | Experimental | Drug: OlanzapineParticipants randomized to this arm will be prescribed olanzapine. They will continue to be followed by their psychiatrist. In addition, they will take part in ongoing biological, cognitive, and psycho-social assessments with study staff. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- DSM-IV diagnosis of a disease or disorder that requires treatment with an atypical antipsychotic medication
Key exclusion criteria (1 listed)
- N/A
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 |
|---|---|---|
| AripiprazoleParticipant will take aripiprazole. Dosing will be determined by each participant's psychiatrist. | Drug | 3: Aripiprazole |
| OlanzapineParticipant will take olanzapine. Dosing will be determined by each participant's psychiatrist. | Drug | 4: Olanzapine |
| RisperidoneAlso: RisperidalParticipant will take risperidone. Dosing will be determined by each participant's psychiatrist. | Drug | 1: Risperdal |
Primary outcome
Change in Body Mass Index
Time frame: Measured at baseline, Week 6, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Change in body mass index (BMI) between each study visit. weight and height will be combined to report BMI in kg/m^2. (This hypothesis is non-directional because of uncertainties with respect to significant between-drug differences on these measures.)
Change in Fasting Plasma Glucose (FPG)
Time frame: Measured at baseline, Week 6, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Blood sample collected to measure Fasting Plasma Glucose (FPG) to determine if there are changes between study visits. (This hypothesis is non-directional because of uncertainties with respect to significant between-drug differences on these measures.)
Change in LDL cholesterol, HDL cholesterol, and triglycerides
Time frame: Measured at baseline, Week 6, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Lipid Panel collected to measure LDL cholesterol, HDL cholesterol, and triglycerides and determine if there are changes between study visits. (This hypothesis is non-directional because of uncertainties with respect to significant between-drug differences on these measures.)
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 17 Dec 2018.
- Derived from this study: PubMed 23218100Jin H, Shih PA, Golshan S, Mudaliar S, Henry R, Glorioso DK, Arndt S, Kraemer HC, Jeste DV. Comparison of longer-term safety and effectiveness of 4 atypical antipsychotics in patients over age 40: a trial using equipoise-stratified randomization. J Clin Psychiatry. 2013 Jan;74(1):10-8. doi: 10.4088/JCP.12m08001. Epub 2012 Nov 27.
- Derived from this study: PubMed 21062616Jin H, Meyer J, Mudaliar S, Henry R, Khandrika S, Glorioso DK, Kraemer H, Jeste D. Use of clinical markers to identify metabolic syndrome in antipsychotic-treated patients. J Clin Psychiatry. 2010 Oct;71(10):1273-8. doi: 10.4088/JCP.09m05414yel.
- Individual participant dataSharing planned: No
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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.
Dilip V. Jeste, MD principal investigator
University of California, San Diego
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 Aripiprazole, Olanzapine and Risperidone in people with Schizophrenia and Alzheimer's Disease, run by Veterans Medical Research Foundation 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 1 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 17 Dec 2018. 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?
Change in Body Mass Index (time frame: Measured at baseline, Week 6, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96). The study lists 3 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 NCT00245206, which also lists 2 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 17 Dec 2018.