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| ID | Type | Description | Link |
|---|---|---|---|
| DSIR AT-AP | Other Identifier | National Institute of Mental Health |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Risperidone | Drug | Continued treatment with the medication risperidone for schizophrenia for up to 6 months in study |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 at Month 6 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| T. Scott Stroup, MD, MPH | Columbia University | Principal Investigator |
| Joseph P. McEvoy, MD | Duke University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SHANTI Clinical Trials | Colton | California | 92324 | United States | ||
| Stanford University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21768610 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Switch Group | 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. |
| FG001 | Stay Group |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Olanzapine | Drug | Continued treatment with the medication olanzapine for schizophrenia for up to 6 months in study |
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| Quetiapine | Drug | Continued treatment with the medication quetiapine for schizophrenia for up to 6 months in study |
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| Aripiprazole | Drug | Switching medication to aripiprazole for schizophrenia for up to 6 months in study |
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| 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 |
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.
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Switch Group | Participants will switch to aripiprazole. |
| BG001 | Stay Group | Participants will continue treatment with olanzapine, quetiapine, or risperidone. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| non-HDL cholesterol | Mean | Standard Deviation | mg/dL |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Least Squares Mean | Standard Error | mg/dL non-HDL cholesterol | 24 weeks |
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| Secondary | 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) | 2 participants who never took assigned study medication were excluded. | Posted | Number | participants | Measured at Month 6 |
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Two participants randomized to switch to aripiprazole withdrew from the study before taking the study medication.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Switch Group | Participants will switch to aripiprazole. | 18 | 107 | 77 | 107 | ||
| EG001 | Stay Group | Participants will continue treatment with olanzapine, quetiapine, or risperidone. | 9 | 106 | 77 | 106 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Exacerbation of schizophrenia | Psychiatric disorders | Non-systematic Assessment |
| ||
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Syncope | Cardiac disorders | Non-systematic Assessment |
| ||
| Slurred speech/sedation | General disorders | Non-systematic Assessment |
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| Suicidality | Psychiatric disorders | Non-systematic Assessment |
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| Agitation | Psychiatric disorders | Non-systematic Assessment |
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| Agranulocytosis | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Gastroenteritis | Gastrointestinal disorders | Non-systematic Assessment |
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| Accidental overdose | General disorders | Non-systematic Assessment |
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| Neuropathic pain | Nervous system disorders | Non-systematic Assessment |
| ||
| Victim of gunshot wound | General disorders | Non-systematic Assessment |
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| General disorders | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Insomnia | Psychiatric disorders | Systematic Assessment |
| ||
| Sleepiness | Psychiatric disorders | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | Systematic Assessment |
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| Akathisia/activation | Nervous system disorders | Systematic Assessment |
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| Problems with sex drive | Endocrine disorders | Systematic Assessment |
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| Increased appetite | General disorders | Systematic Assessment |
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| Weight gain | General disorders | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Akinesia | Nervous system disorders | Systematic Assessment |
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| Problems with sexual orgasm | Endocrine disorders | Systematic Assessment |
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| Problems with sexual arousal | Endocrine disorders | Systematic Assessment |
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| Hypersomnia | General disorders | Systematic Assessment |
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| Orthostatic faintness | General disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Incontinence/nocturia | Renal and urinary disorders | Systematic Assessment |
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| Skin rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Menstrual irregularities | Endocrine disorders | Systematic Assessment |
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| Sialorrhea | General disorders | Systematic Assessment |
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| Urinary hesistancy | Renal and urinary disorders | Systematic Assessment |
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| Gynecomastia/galactorrhea | Endocrine disorders | Systematic Assessment |
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Open-label treatment is a limitation of this study, particularly for outcomes not measured in the laboratory but instead subject to clinical judgment.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Scott Stroup | Columbia University | 212-543-5676 | stroups@nyspi.columbia.edu |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D018967 | Risperidone |
| D000077152 | Olanzapine |
| D000069348 | Quetiapine Fumarate |
| D000068180 | Aripiprazole |
| ID | Term |
|---|---|
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003987 | Dibenzothiazepines |
| D013841 | Thiazepines |
| D013846 | Thiepins |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D010879 | Piperazines |
| D015363 | Quinolones |
| D011804 | Quinolines |
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| >=65 years |
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| Male |
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