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| ID | Type | Description | Link |
|---|---|---|---|
| HAC File#: 05-12-141 |
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The purpose of this study was to describe metabolic changes in the first 16 weeks of anti-psychotic treatment in previously drug-naïve patients with psychosis.
We hypothesize that in drug-naive patients, greater insulin resistance prior to treatment predicts a disproportionately greater increase in insulin resistance with olanzapine treatment.
Antipsychotic medications are associated with an increased risk of diabetes. We focused on a description of early metabolic adverse effects and clinical and biochemical features that might predict these adverse effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open Trial Group | Experimental | The patients were newly diagnosed with psychosis and were recruited at their first clinical contact for psychosis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Olanzapine | Drug | 16-week open trial of olanzapine. The patients were started on a dose of 15 mg/d by mouth, which could be adjusted to as low as 10 mg/d or as high as 40 mg/d, based on clinical response. The trial began while they were hospitalized and continued after discharge. |
| Measure | Description | Time Frame |
|---|---|---|
| Body Mass Index | Baseline and 4 week intervals | |
| Fasting Glucose | Baseline and 4 week intervals | |
| Fasting Insulin | Baseline and 4 week intervals | |
| Hemoglobin A1c | Baseline and 4 week intervals | |
| IL-6 | Baseline and 4 week intervals | |
| Triglycerides | Baseline and 4 week intervals | |
| Cholesterol Total | Baseline and 4 week intervals | |
| HDL | Baseline and 4 week intervals | |
| LDL | Baseline and 4 week intervals |
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| Name | Affiliation | Role |
|---|---|---|
| Brian Kirkpatrick, M.D. | Vice Chair of Psychiatry MCG | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unitat Hospitalitzacio - Servei de Psiquiatria G096, Hospital Clinic C/Villarroel, 170 | Barcelona | 08036 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21346617 | Background | Fernandez-Egea E, Miller B, Garcia-Rizo C, Bernardo M, Kirkpatrick B. Metabolic effects of olanzapine in patients with newly diagnosed psychosis. J Clin Psychopharmacol. 2011 Apr;31(2):154-9. doi: 10.1097/JCP.0b013e31820fcea3. |
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Hospital Clinic of Barcelona
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| ID | Title | Description |
|---|---|---|
| FG000 | Antipsychotic-Naive Patients | The patients were newly diagnosed with psychosis and were recruited at their first clinical contact for psychosis. Olanzapine: 16-week open trial of olanzapine. The patients were started on a dose of 15 mg/d by mouth, which could be adjusted to as low as 10 mg/d or as high as 40 mg/d, based on clinical response. The trial began while they were hospitalized and continued after discharge. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Open Trial Group | The patients were newly diagnosed with psychosis and were recruited at their first clinical contact for psychosis. Olanzapine: 16-week open trial of olanzapine. The patients were started on a dose of 15 mg/d by mouth, which could be adjusted to as low as 10 mg/d or as high as 40 mg/d, based on clinical response. The trial began while they were hospitalized and continued after discharge. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Body Mass Index | Posted | Mean | Standard Deviation | kg/m^2 | Baseline and 4 week intervals |
|
|
16 weeks
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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 | Open Follow Up Group | The patients were newly diagnosed with psychosis and this is their first exposure to an antipsychotic. Olanzapine: 16-week open trial of olanzapine. The patients were started on a dose of 15 mg/d by mouth, which could be adjusted to as low as 10 mg/d or as high as 40 mg/d, based on clinical response. The trial began while they were hospitalized and continued after discharge. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Increased BMI | Metabolism and nutrition disorders | Systematic Assessment | Withdrawn because of Exclusion Criteria |
The most important limitations in our study were sample size and duration. With a larger sample, some of these measures may have a significant change within this time frame.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Brian Kirkpatrick | University of Nevada School of Medicine | 775-682-8459 | bkirkpatrick@medicine.nevada.edu |
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| 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 |
|---|---|
| D000077152 | Olanzapine |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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|
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Region of Enrollment | Number | participants |
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| Socioeconomic Status (SES) | Hollingshead Redlich Scale. Scale: five social classes 1 though 5 (5 being the poorest). | Mean | Standard Deviation | units on a scale |
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| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
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| Number of Cigarettes Per Day | Mean | Standard Deviation | cigarettes per day |
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| Duration of Untreated Psychosis | Mean | Standard Deviation | Months |
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| Fasting Glucose | Mean | Standard Deviation | mg/dL |
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| Oral Glucose Tolerance Test (OGGT) | 2-hour, 75-g OGGT, which began between 8 and 9 am after an overnight fast | Mean | Standard Deviation | mg/dL |
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| Fasting Insulin | Mean | Standard Deviation | mg/dL |
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| Hemoglobin A1c | Mean | Standard Deviation | Percentage |
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| Interleukin 6 (IL-6) | Mean | Standard Deviation | pg/mL |
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| Positive and Negative Syndromes Scale (PANSS) | Scale ranges from a minimum of 30 (not impaired) to a maximum of 210 (greatest impairment) for the total score. Positive, Negative and General scales range from 7 (not impaired) to 49 (greatest impairment), 7 (not impaired) to 49 (greatest impairment), and 16 (not impaired) to 112 (greatest impairment), respectively. | Mean | Standard Deviation | units on a scale |
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| C-Reactive Protein | Mean | Standard Deviation | mg/dL |
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| Adiponectin | Mean | Standard Deviation | mg/dL |
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| Leptin | Mean | Standard Deviation | mg/dL |
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| Cortisol | Mean | Standard Deviation | mg/dL |
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| Total Cholesterol | Mean | Standard Deviation | mg/dL |
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| Triglycerides | Mean | Standard Deviation | mg/dL |
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| LDL | Mean | Standard Deviation | mg/dL |
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| HDL | Mean | Standard Deviation | mg/dL |
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| Parental History of Type II Diabetes Mellitus | Number | participants |
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| Primary | Fasting Glucose | Posted | Mean | Standard Deviation | mg/dL | Baseline and 4 week intervals |
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| Primary | Fasting Insulin | Posted | Mean | Standard Deviation | mg/dL | Baseline and 4 week intervals |
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| Primary | Hemoglobin A1c | Posted | Mean | Standard Deviation | percentage | Baseline and 4 week intervals |
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| Primary | IL-6 | Posted | Mean | Standard Deviation | pg/mL | Baseline and 4 week intervals |
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| Primary | Triglycerides | Posted | Mean | Standard Deviation | mg/dL | Baseline and 4 week intervals |
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| Primary | Cholesterol Total | Posted | Mean | Standard Deviation | mg/dL | Baseline and 4 week intervals |
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| Primary | HDL | Posted | Mean | Standard Deviation | mg/dL | Baseline and 4 week intervals |
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| Primary | LDL | Posted | Mean | Standard Deviation | mg/dL | Baseline and 4 week intervals |
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| 0 |
| 30 |
| 11 |
| 30 |
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| Elevated LDL | Vascular disorders | Systematic Assessment | Withdrawn because of Exclusion Criteria |
|
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| D006571 | Heterocyclic Compounds |
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