SchizophreniaPhase 4CAMPNCT00423878

Comparison of Antipsychotics for Metabolic Problems in Schizophrenia or Schizoaffective Disorder

A Phase 4 study testing Risperidone, Olanzapine and Quetiapine in people with Schizophrenia and Schizoaffective Disorder, run by National Institute of Mental Health (NIMH) at 28 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The study will compare the effectiveness of antipsychotic medications for patients with schizophrenia or schizoaffective disorder for whom a medication change may be indicated because of an increased risk of cardiovascular disease. 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?: Risperidone, Olanzapine and Quetiapine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 215 participants
Where: 28 sitesUnited States
Study dates: Jan 2007to Mar 2010
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Diagnosed with schizophrenia or schizoaffective disorder
Currently treated with olanzapine, quetiapine or risperidone
BMI greater than or equal to 27
Non-HDL cholesterol greater than or equal to 130 mg/dL (if non-HDL cholesterol is between 130 - 139 mg/dL, then LDL cholesterol must be greater than 100 mg/dL).

Who cannot join

Diabetes (FBS greater than or equal to 126) or treatment with oral hypoglycemic drug or insulin
Non-HDL cholesterol greater than 300 mg/dL
Serum triglycerides greater than 500 mg/dL
Patients in the first episode of schizophrenia or schizoaffective disorder
Known hypersensitivity to aripiprazole
On weight loss medications

Trial locations and contacts

28 sites in 1 country.

City, postcode or hospital

28 sites in 1 country

United States28 sites

New Mexico VA Healthcare System
Albuquerque, New Mexico, 87108
Emory University
Atlanta, Georgia, 30329
Medical College of Georgia
Augusta, Georgia, 30912
Mental Health Advocates
Boca Raton, Florida, 33431
Freedom Trail Clinic
Boston, Massachusetts, 02114
John Umstead Hospital/Duke University
Butner, North Carolina, 27509
The University of North Carolina
Chapel Hill, North Carolina, 27599-7160
Carolinas HealthCare System
Charlotte, North Carolina, 28211
University of Cincinnati
Cincinnati, Ohio, 45267
SHANTI Clinical Trials
Colton, California, 92324
University of Texas Southwestern Medical Center
Dallas, Texas, 75235
Wayne State University
Detroit, Michigan, 48201
John C Corrigan Community Mental Health Center
Fall River, Massachusetts, 02720
Clinical Insights
Glen Burnie, Maryland, 21061
Baylor College of Medicine
Houston, Texas, 77030
University of Iowa
Iowa City, Iowa, 52242
University of Miami School of Medicine
Miami, Florida, 33316
University of Minnesota
Minneapolis, Minnesota, 55454
Yale University
New Haven, Connecticut, 06519
Research Foundation for Mental Hygiene
New York, New York, 10032
Stanford University
Palo Alto, California, 94305
Philadelphia VA Medical Center-116A
Philadelphia, Pennsylvania, 19104
University of Rochester
Rochester, New York, 14623
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
Lousiana State University Health Sciences Center
Shreveport, Louisiana, 71130
Washington University School of Medicine
St Louis, Missouri, 63110
Clinical Research Institute
Wichita, Kansas, 67207
University of Massachusetts
Worcester, Massachusetts, 01605

Other trials in United States

About this study

Official title: Clinical Management of Metabolic Problems in Patients With Schizophrenia

Read the detailed description

Metabolic abnormalities associated with cardiovascular morbidity and premature mortality are more common in patients with schizophrenia than in matched controls. Although there is some evidence that patients with schizophrenia have intrinsic abnormalities in lipid and carbohydrate metabolism, some antipsychotics (i.e., clozapine, olanzapine, quetiapine, and risperidone) are associated with increased rates of metabolic abnormalities that predispose patients to cardiovascular disease.

This is an investigator-initiated clinical trial that will be conducted at 30 research sites that are a part of the NIMH Schizophrenia Trials Network.

The aims of the study are to (1) determine the relative effects of switching to aripiprazole, versus continued treatment with olanzapine, quetiapine, or risperidone, on metabolic parameters associated with cardiovascular disease, and (2) to determine the effects of switching to aripiprazole versus continued treatment with olanzapine, quetiapine, or risperidone on the clinical stability of schizophrenic illness.

This study design is a multi-site, single-blind (rater) randomized controlled trial of 300 patients with schizophrenia or schizoaffective disorder comparing treatment with the following medications: olanzapine, quetiapine, risperidone, and aripiprazole. The study will enroll patients with schizophrenia or schizoaffective disorder for whom a medication change may be indicated because of an increased risk of cardiovascular disease in spite of adequate control of symptoms on their current antipsychotic medication. Patients who are taking olanzapine, quetiapine, or risperidone and who have a body-mass index (BMI) greater than or equal to 27 and non-HDL cholesterol greater than or equal to 130 mg/dl will be eligible (if non-HDL is between 130-139mg/dL, LDL cholesterol must be greater than 100mg/dL). All treatments will be open label. Raters will be blinded to treatment assignment. Patients will be followed for up to 6 months.

Conditions: Schizophrenia, Schizoaffective Disorder
Being tested: Risperidone, Olanzapine, Quetiapine, Aripiprazole
Medical subject headings: Schizophrenia, Psychotic Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RisperidoneDrug
Also called Risperdal
Continued treatment with the medication risperidone for schizophrenia for up to 6 months in study
OlanzapineDrug
Also called Zyprexa
Continued treatment with the medication olanzapine for schizophrenia for up to 6 months in study
QuetiapineDrug
Also called Seroquel
Continued treatment with the medication quetiapine for schizophrenia for up to 6 months in study
AripiprazoleDrug
Also called Abilify
Switching medication to aripiprazole for schizophrenia for up to 6 months in study

Study groups in NCT00423878
Study group	Role	What they receive
1	Experimental	Participants will switch to aripiprazole with a cross-titration from the current antipsychotic over 3-4 weeks. Allowed final dosage range for aripiprazole was 5-30 mg/day Receives: Drug: Aripiprazole
2	Active comparator	Participants will continue with their current antipsychotic treatment, either olanzapine 5-20 mg/day, quetiapine 200-1200 mg/day, or risperidone 1-16 mg/day. Receives: Drug: Risperidone; Drug: Olanzapine; Drug: Quetiapine

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Non-HDL Cholesterol Level for Patients Assigned to Stay and Patients Assigned to Switch Over 24 Weeks
Change in non-HDL cholesterol measured at baseline and every 4 weeks for 24 weeks. The efficacy analysis corresponded to a comparison of change in non-HDL cholesterol from baseline to 24 weeks between treatment groups (stay versus switch). Repeated measurements mixed effects linear models were fit for the primary analysis.
Measured: 24 weeks

Secondary outcomes (1)

Efficacy Failure, Defined as Psychiatric Hospitalization, a 25 Percent Increase From Baseline on the Positive and Negative Syndrome Scale or Substantial Clinical Deterioration on the Clinical Global Impressions-Change (CGI-C)
Measured: Measured at Month 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2007Mar 2010

First posted18 Jan 2007 (estimated)
Study startJan 2007
Primary completionOct 2009
Study completionMar 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for SchizophreniaStudies of the same condition, open and under way.
More trials run by National Institute of Mental Health (NIMH)The sponsor's other registered studies.
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: Single blind
Who is masked: Outcomes assessor
Enrolment: 215 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00423878
Sponsor's protocol ID: STROUP06STN0
Other IDs: DSIR AT-AP
Acronym: CAMP
Status last verified: Nov 2010
First submitted: 16 Jan 2007
Last updated: 2 Nov 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Stroup TS, McEvoy JP, Ring KD, Hamer RH, LaVange LM, Swartz MS, Rosenheck RA, Perkins DO, Nussbaum AM, Lieberman JA; Schizophrenia Trials Network. A randomized trial examining the effectiveness of switching from olanzapine, quetiapine, or risperidone to aripiprazole to reduce metabolic risk: comparison of antipsychotics for metabolic problems (CAMP). Am J Psychiatry. 2011 Sep;168(9):947-56. doi: 10.1176/appi.ajp.2011.10111609. Epub 2011 Jul 18.
PubMed 21768610

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Schizophrenia trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Management of Metabolic Problems in Patients With Schizophrenia
ClinicalTrials.gov ID: NCT00423878
Acronym / sponsor ID: CAMP / STROUP06STN0
Conditions: Schizophrenia, Schizoaffective Disorder
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 215 participants (actual)
Lead sponsor: National Institute of Mental Health (NIMH)US National Institutes of Health
Study start: Jan 2007
Primary completion: Oct 2009 (actual)
Study completion: Mar 2010 (actual)
First posted: 18 Jan 2007 (estimated)
Results: Posted 19 Dec 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

This is an investigator-initiated clinical trial that will be conducted at 30 research sites that are a part of the NIMH Schizophrenia Trials Network.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
1	Experimental	Drug: AripiprazoleParticipants will switch to aripiprazole with a cross-titration from the current antipsychotic over 3-4 weeks. Allowed final dosage range for aripiprazole was 5-30 mg/day
2	Active comparator	Drug: Risperidone, Drug: Olanzapine, Drug: QuetiapineParticipants will continue with their current antipsychotic treatment, either olanzapine 5-20 mg/day, quetiapine 200-1200 mg/day, or risperidone 1-16 mg/day.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Diagnosed with schizophrenia or schizoaffective disorder
Currently treated with olanzapine, quetiapine or risperidone
BMI greater than or equal to 27
Non-HDL cholesterol greater than or equal to 130 mg/dL (if non-HDL cholesterol is between 130 - 139 mg/dL, then LDL cholesterol must be greater than 100 mg/dL).

Key exclusion criteria (6 listed)

Diabetes (FBS greater than or equal to 126) or treatment with oral hypoglycemic drug or insulin
Non-HDL cholesterol greater than 300 mg/dL
Serum triglycerides greater than 500 mg/dL
Patients in the first episode of schizophrenia or schizoaffective disorder
Known hypersensitivity to aripiprazole

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
RisperidoneAlso: RisperdalContinued treatment with the medication risperidone for schizophrenia for up to 6 months in study	Drug	2
OlanzapineAlso: ZyprexaContinued treatment with the medication olanzapine for schizophrenia for up to 6 months in study	Drug	2
QuetiapineAlso: SeroquelContinued treatment with the medication quetiapine for schizophrenia for up to 6 months in study	Drug	2
AripiprazoleAlso: AbilifySwitching medication to aripiprazole for schizophrenia for up to 6 months in study	Drug	1

Primary outcome

Change in Non-HDL Cholesterol Level for Patients Assigned to Stay and Patients Assigned to Switch Over 24 Weeks
Time frame: 24 weeks
Change in non-HDL cholesterol measured at baseline and every 4 weeks for 24 weeks. The efficacy analysis corresponded to a comparison of change in non-HDL cholesterol from baseline to 24 weeks between treatment groups (stay versus switch). Repeated measurements mixed effects linear models were fit for the primary analysis.

1 secondary outcome

Efficacy Failure, Defined as Psychiatric Hospitalization, a 25 Percent Increase From Baseline on the Positive and Negative Syndrome Scale or Substantial Clinical Deterioration on the Clinical Global Impressions-Change (CGI-C)
Time frame: Measured at Month 6

Results and safety

Results posted to the registry on 19 Dec 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Switch Group	109	89
Stay Group	106	98

Primary outcome: Change in Non-HDL Cholesterol Level for Patients Assigned to Stay and Patients Assigned to Switch Over 24 Weeks

Time frame: 24 weeks. Least squares mean (Standard Error). Unit: mg/dL non-HDL cholesterol

Measure	Switch Group n = 89	Stay Group n = 98
Value	-20.2 (2.87)	-10.8 (2.57)

Population analysed: The primary efficacy analysis was conducted on the efficacy evaluable population, defined as all patients randomly assigned to a study group who received at least one dose of study medication and completed at least one post-baseline efficacy assessment.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Switch Group	18 of 107 (16.8%)	77 of 107 (72%)	Not reported
Stay Group	9 of 106 (8.5%)	77 of 106 (72.6%)	Not reported

Limitations and caveats (from the sponsor): Open-label treatment is a limitation of this study, particularly for outcomes not measured in the laboratory but instead subject to clinical judgment.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 21768610Stroup TS, McEvoy JP, Ring KD, Hamer RH, LaVange LM, Swartz MS, Rosenheck RA, Perkins DO, Nussbaum AM, Lieberman JA; Schizophrenia Trials Network. A randomized trial examining the effectiveness of switching from olanzapine, quetiapine, or risperidone to aripiprazole to reduce metabolic risk: comparison of antipsychotics for metabolic problems (CAMP). Am J Psychiatry. 2011 Sep;168(9):947-56. doi: 10.1176/appi.ajp.2011.10111609. Epub 2011 Jul 18.

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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.

T. Scott Stroup, MD, MPH principal investigator

Columbia University

Joseph P. McEvoy, MD study director

Duke University

28 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 4 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 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites 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?

Yes. Results are posted in the registry (first posted 19 Dec 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Non-HDL Cholesterol Level for Patients Assigned to Stay and Patients Assigned to Switch Over 24 Weeks (time frame: 24 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 NCT00423878, which also lists 1 linked publication.

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 2 Nov 2016; AzTrials last refreshed its copy on 7 Nov 2026.