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CompletedNCT00423878CAMPUpdated Nov 2, 2016Results posted

Comparison of Antipsychotics for Metabolic Problems in Schizophrenia or Schizoaffective Disorder

A Phase 4 interventional study of Risperidone and Olanzapine in Schizophrenia and Schizoaffective Disorder, sponsored by National Institute of Mental Health (NIMH). Completed at 28 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-11-02.

Sponsored by National Institute of Mental Health (NIMH) · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
215
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Schizophrenia
  • Schizoaffective Disorder
03

In context

Schizophrenia

3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.

This study's enrollment of 215 is above the median of 70 across 2,872 interventional studies indexed under Schizophrenia.

Browse Schizophrenia studies →

Lead sponsor

National Institute of Mental Health (NIMH) is the lead sponsor of 359 studies on the registry; 46 are open to participants now.

Of its 25 completed or terminated interventional studies of FDA-regulated products, 24 (96%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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).

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
215 participants (actual)

Study arms

  • Experimental
    1

    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

    Drug: Aripiprazole

  • Active comparator
    2

    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.

    Drug: Risperidone · Drug: Olanzapine · Drug: Quetiapine

Interventions

  • DrugRisperidone

    Continued treatment with the medication risperidone for schizophrenia for up to 6 months in study

    Also known as: Risperdal

  • DrugOlanzapine

    Continued treatment with the medication olanzapine for schizophrenia for up to 6 months in study

    Also known as: Zyprexa

  • DrugQuetiapine

    Continued treatment with the medication quetiapine for schizophrenia for up to 6 months in study

    Also known as: Seroquel

  • DrugAripiprazole

    Switching medication to aripiprazole for schizophrenia for up to 6 months in study

    Also known as: Abilify

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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)

    Time frame: Measured at Month 6

07

Results

Posted Dec 19, 2012
Limitations and caveats
Open-label treatment is a limitation of this study, particularly for outcomes not measured in the laboratory but instead subject to clinical judgment.

Participant flow

Participant flow — Overall Study
MilestoneSwitch GroupStay Group
Started109106
Completed8998
Not completed208

Outcome measures

PrimaryChange 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.

Time frame:
24 weeks
Reported as:
Least squares mean · mg/dL non-HDL cholesterol
Change in Non-HDL Cholesterol Level for Patients Assigned to Stay and Patients Assigned to Switch Over 24 Weeks
mg/dL non-HDL cholesterolSwitch GroupStay Group
Change in Non-HDL Cholesterol Level for Patients Assigned to Stay and Patients Assigned to Switch Over 24 Weeks-20.2 ± 2.87-10.8 ± 2.57
SecondaryEfficacy 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
Reported as:
Number · participants
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)
participantsSwitch GroupStay Group
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)2218

Adverse events

Non-serious events are listed at a 2% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Switch Group—18/107 (16.8%)77/107 (72%)
Stay Group—9/106 (8.5%)77/106 (72.6%)
Most frequent serious events
Showing 10 of 12
Most frequent serious events
EventSwitch GroupStay Group
Exacerbation of schizophreniaPsychiatric disorders9/1073/106
SuicidalityPsychiatric disorders0/1072/106
PneumoniaRespiratory, thoracic and mediastinal disorders1/1071/106
SyncopeCardiac disorders0/1071/106
Accidental overdoseGeneral disorders1/1071/106
Slurred speech/sedationGeneral disorders1/1070/106
AgitationPsychiatric disorders1/1070/106
AgranulocytosisBlood and lymphatic system disorders1/1070/106
GastroenteritisGastrointestinal disorders1/1070/106
Neuropathic painNervous system disorders1/1070/106
Most frequent other events
Showing 10 of 20
Most frequent other events
EventSwitch GroupStay Group
InsomniaPsychiatric disorders44/10729/106
Dry mouthGastrointestinal disorders24/10736/106
SleepinessPsychiatric disorders27/10735/106
Akathisia/activationNervous system disorders29/10726/106
Problems with sex driveEndocrine disorders24/10726/106
Increased appetiteGeneral disorders18/10726/106
AkinesiaNervous system disorders14/10725/106
Weight gainGeneral disorders20/10721/106
HypersomniaGeneral disorders16/10721/106
ConstipationGastrointestinal disorders20/10720/106

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Switch GroupStay GroupTotal
<=18 years000
Between 18 and 65 years109106215
>=65 years000
Age, Continuous
Age, Continuous(years)Switch GroupStay GroupTotal
Mean40 ± 11.742 ± 10.541 ± 11.1
Sex: Female, Male
Sex: Female, Male(Participants)Switch GroupStay GroupTotal
Female413778
Male6869137
Region of Enrollment
Region of Enrollment(participants)Switch GroupStay GroupTotal
United States109106215
non-HDL cholesterol
non-HDL cholesterol(mg/dL)Switch GroupStay GroupTotal
Mean169 ± 31.9176 ± 33.5173 ± 32.8
08

Study locations

28 sites
  • SHANTI Clinical Trials
    Colton, California 92324, United States
  • Stanford University
    Palo Alto, California 94305, United States
  • Yale University
    New Haven, Connecticut 06519, United States
  • Mental Health Advocates
    Boca Raton, Florida 33431, United States
  • University of Miami School of Medicine
    Miami, Florida 33316, United States
  • Emory University
    Atlanta, Georgia 30329, United States
  • Medical College of Georgia
    Augusta, Georgia 30912, United States
  • University of Iowa
    Iowa City, Iowa 52242, United States
  • Clinical Research Institute
    Wichita, Kansas 67207, United States
  • Lousiana State University Health Sciences Center
    Shreveport, Louisiana 71130, United States
  • Clinical Insights
    Glen Burnie, Maryland 21061, United States
  • Freedom Trail Clinic
    Boston, Massachusetts 02114, United States
  • John C Corrigan Community Mental Health Center
    Fall River, Massachusetts 02720, United States
  • University of Massachusetts
    Worcester, Massachusetts 01605, United States
  • Wayne State University
    Detroit, Michigan 48201, United States
  • University of Minnesota
    Minneapolis, Minnesota 55454, United States
  • Washington University School of Medicine
    St. Louis, Missouri 63110, United States
  • New Mexico VA Healthcare System
    Albuquerque, New Mexico 87108, United States
  • Research Foundation for Mental Hygiene
    New York, New York 10032, United States
  • University of Rochester
    Rochester, New York 14623, United States
  • John Umstead Hospital/Duke University
    Butner, North Carolina 27509, United States
  • The University of North Carolina
    Chapel Hill, North Carolina 27599-7160, United States
  • Carolinas HealthCare System
    Charlotte, North Carolina 28211, United States
  • University of Cincinnati
    Cincinnati, Ohio 45267, United States
  • Philadelphia VA Medical Center-116A
    Philadelphia, Pennsylvania 19104, United States
  • University of Texas Southwestern Medical Center
    Dallas, Texas 75235, United States
  • Baylor College of Medicine
    Houston, Texas 77030, United States
  • University of Texas Health Science Center at San Antonio
    San Antonio, Texas 78229, United States
09

References and documents

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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 2, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00423878
Lead sponsor
National Institute of Mental Health (NIMH)
Responsible party
Sponsor
First posted
Jan 18, 2007
Start date
Jan 2007
Primary completion
Oct 2009
Completion
Mar 2010
Results posted
Dec 19, 2012
Last update
Nov 2, 2016

Study contacts

T. Scott Stroup, MD, MPH
principal investigator · Columbia University
Joseph P. McEvoy, MD
study director · Duke University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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