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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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Primary Aim: To test the acute effects of olanzapine or ziprasidone administration, in comparison to placebo, on insulin sensitivity in antipsychotic-naïve healthy young men, measured as whole-body dextrose infusion rates (mg/kg/min), hepatic glucose production (glucose rate of appearance [Ra]), primarily muscle glucose utilization (glucose rate of disappearance [Rd]), and adipose tissue related free fatty acid production (glycerol rate of appearance [Ra]).
We hypothesize that olanzapine, but not ziprasidone, will result in acute decreases in insulin sensitivity.
Secondary Aim: To test the acute effects of olanzapine or ziprasidone on insulin signaling pathways in antipsychotic naïve healthy young men.
We hypothesize that olanzapine, but not ziprasidone, will result in acute alterations in insulin signaling.
See brief description
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| olanzapine | Active Comparator | olanzapine injection in healthy control |
|
| ziprasidone | Active Comparator | ziprasidone injection in healthy control |
|
| saline | Placebo Comparator | saline injection in healthy control |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Olanzapine | Drug | olanzapine/Zyprexa |
|
| Measure | Description | Time Frame |
|---|---|---|
| Whole Body Insulin Sensitivity | To evaluate, using a within-subject placebo-controlled comparison, the acute effects of olanzapine or ziprasidone administration on insulin sensitivity in antipsychotic-naïve healthy young men, measured as whole-body dextrose infusion rates (mg/kg/min). | approximately 3 hours |
| Hepatic Insulin Sensitivity | To evaluate, using a within-subject placebo-controlled comparison, the acute effects of olanzapine or ziprasidone administration on insulin sensitivity in antipsychotic-naïve healthy young men, measured as hepatic glucose production (glucose rate of appearance [Ra]). | approximately 3 hours |
| Peripheral Insulin Sensitivity | To evaluate, using a within-subject placebo-controlled comparison, the acute effects of olanzapine or ziprasidone administration on insulin sensitivity in antipsychotic-naïve healthy young men, measured as primarily muscle glucose utilization (glucose rate of disappearance [Rd]). | approximately 3 hours |
| Adipose Tissue Insulin Sensitivity | To evaluate, using a within-subject placebo-controlled comparison, the acute effects of olanzapine or ziprasidone administration on insulin sensitivity in antipsychotic-naïve healthy young men, measured as free fatty acid release (glycerol rate of appearance [Ra]). | approximately 3 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John W Newcomer, MD | Washington University School of Medicine and Florida Atlantic University | Principal Investigator |
| Ginger Nicol, MD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Olanzapine (Drug First) | Subjects from this group received an olanzapine injection at the first clamp followed by a saline injection at the second clamp. |
| FG001 | Ziprasidone (Drug First) | Subjects from this group received a ziprasidone injection at the first clamp followed by a saline injection at the second clamp. |
| FG002 | Olanzapine (Placebo First) | Subjects from this group received a saline injection at the first clamp followed by an olanzapine injection at the second clamp. |
| FG003 | Ziprasidone (Placebo First) | Subjects from this group received a saline injection at the first clamp followed by a ziprasidone injection at the second clamp. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | Olanzapine (Drug First) | Subjects from this group received an olanzapine injection at the first clamp followed by a saline injection at the second clamp. |
| BG001 | Ziprasidone (Drug First) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Intent-To-Treat (eg, completed at least one clamp) |
| 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 | Whole Body Insulin Sensitivity | To evaluate, using a within-subject placebo-controlled comparison, the acute effects of olanzapine or ziprasidone administration on insulin sensitivity in antipsychotic-naïve healthy young men, measured as whole-body dextrose infusion rates (mg/kg/min). | The analysis was per protocol and involved subjects who completed both a clamp that involved an injection of either olanzapine or ziprasidone, and a clamp that involved a placebo injection. Nine subjects did not complete a second clamp as they were lost to follow-up. This resulted in the analysis of 37 participants. | Posted | Mean | Standard Deviation | mg/kg/min | approximately 3 hours |
|
Not provided
Not provided
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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 | Olanzapine, to be Followed by Normal Saline | Subjects from this group received olanzapine (10 mg per IM injection) and will receive normal saline at the next visit. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Itching, rash, or hives-during past week | General disorders | Systematic Assessment | Any report of itching, rash, or hives anytime during the past 7 days. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Julie Schweiger/Michael Yingling | Washington University | 3143623153/5735791412 | schweigj@psychiatry.wustl.edu/yinglinm@psychiatry.wustl.edu |
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| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| D006949 | Hyperlipidemias |
| D057185 | Sedentary Behavior |
| D018761 | Multiple Endocrine Neoplasia Type 1 |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D050171 | Dyslipidemias |
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| ID | Term |
|---|---|
| D000077152 | Olanzapine |
| C092292 | ziprasidone |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Ziprasidone | Drug | ziprasidone/Geodon |
|
|
Subjects from this group received a ziprasidone injection at the first clamp followed by a saline injection at the second clamp.
| BG002 | Olanzapine (Placebo First) | Subjects from this group received a saline injection at the first clamp followed by an olanzapine injection at the second clamp. |
| BG003 | Ziprasidone (Placebo First) | Subjects from this group received a saline injection at the first clamp followed by a ziprasidone injection at the second clamp. |
| BG004 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Age, Continuous | Completer Sample (eg, completed both clamps) | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Intent-To-Treat (eg, completed at least one clamp) | Count of Participants | Participants |
|
| Sex/Gender, Customized | Completer Sample (eg, completed both clamps), which includes 37 subjects | Number | participants |
|
| Race/Ethnicity, Customized | Completer Sample (eg, completed both clamps), which includes 37 subjects | Number | participants |
|
| Race/Ethnicity, Customized | Intent-To-Treat (eg, completed at least one clamp) | Number | participants |
|
| Weight | Intent-To-Treat (eg, completed at least one clamp) | Mean | Standard Deviation | kilograms |
|
| Weight | Completer Sample (eg, completed both clamps) | Mean | Standard Deviation | kilograms |
|
| Body Mass Index (BMI) | Intent-To-Treat (eg, completed at least one clamp) | Mean | Standard Deviation | kg/m^2 |
|
| Body Mass Index (BMI) | Completer Sample (eg, completed both clamps) | Mean | Standard Deviation | kg/m^2 |
|
| Waist Circumference | Intent-To-Treat (eg, completed at least one clamp) | Mean | Standard Deviation | centimeters |
|
| Waist Circumference | Completer Sample (eg, completed both clamps) | Mean | Standard Deviation | centimeters |
|
| DEXA Total Fat | Intent-To-Treat (eg, completed at least one clamp) | Mean | Standard Deviation | kilograms |
|
| DEXA Total Fat | Completer Sample (eg, completed both clamps) | Mean | Standard Deviation | kilograms |
|
| Systolic Blood Pressure | Intent-To-Treat (eg, completed at least one clamp) | Mean | Standard Deviation | mmHg |
|
| Systolic Blood Pressure | Completer Sample (eg, completed both clamps) | Mean | Standard Deviation | mmHg |
|
| Diastolic Blood Pressure | Intent-To-Treat (eg, completed at least one clamp) | Mean | Standard Deviation | mmHg |
|
| Diastolic Blood Pressure | Completer Sample (eg, completed both clamps) | Mean | Standard Deviation | mmHg |
|
| Heart Rate | Intent-To-Treat (eg, completed at least one clamp) | Mean | Standard Deviation | beats per minute |
|
| Heart Rate | Completer Sample (eg, completed both clamps) | Mean | Standard Deviation | beats per minute |
|
| Fasting Cholesterol | Intent-To-Treat (eg, completed at least one clamp) | Mean | Standard Deviation | mg/dL |
|
| Fasting Cholesterol | Completer Sample (eg, completed both clamps) | Mean | Standard Deviation | mg/dL |
|
| Fasting HDL Cholesterol | Intent-To-Treat (eg, completed at least one clamp) | Mean | Standard Deviation | mg/dL |
|
| Fasting HDL Cholesterol | Completer Sample (eg, completed both clamps) | Mean | Standard Deviation | mg/dL |
|
| Fasting Triglycerides | Intent-To-Treat (eg, completed at least one clamp) | Mean | Standard Deviation | mg/dL |
|
| Fasting Triglycerides | Completer Sample (eg, completed both clamps) | Mean | Standard Deviation | mg/dL |
|
| Fasting LDL Cholesterol | Intent-To-Treat (eg, completed at least one clamp) | Mean | Standard Deviation | mg/dL |
|
| Fasting LDL Cholesterol | Completer Sample (eg, completed both clamps) | Mean | Standard Deviation | mg/dL |
|
| Fasting Insulin | Intent-To-Treat (eg, completed at least one clamp) | Mean | Standard Deviation | uIU/mL |
|
| Fasting Insulin | Completer Sample (eg, completed both clamps) | Mean | Standard Deviation | uIU/mL |
|
| OG001 | Olanzapine (Drug/Placebo)-Placebo | Subjects from this group received 0.9% normal saline (1 ml per IM injection) while having received olanzapine at the previous visit. |
| OG002 | Olanzapine (Placebo/Drug)-Placebo | Subjects from this group received 0.9% normal saline (1 ml per IM injection) and will receive olanzapine at the next visit. |
| OG003 | Olanzapine (Placebo/Drug)-Drug | Subjects from this group received olanzapine (10 mg per IM injection) while having received normal saline at previous visit. |
| OG004 | Ziprasidone (Placebo/Drug)-Placebo | Subjects from this group received 0.9% normal saline (1 ml per IM injection) and will receive ziprasidone at the next visit. |
| OG005 | Ziprasidone (Placebo/Drug)-Drug | Subjects from this group received ziprasidone (20 mg per IM injection) while having received normal saline at previous visit. |
| OG006 | Ziprasidone (Drug/Placebo)-Drug | Subjects from this group received ziprasidone (20 mg per IM injection) and will receive normal saline at the next visit. |
| OG007 | Ziprasidone (Drug/Placebo)-Placebo | Subjects from this group received 0.9% normal saline (1 ml per IM injection) while having received ziprasidone at the previous visit. |
|
|
|
| Primary | Hepatic Insulin Sensitivity | To evaluate, using a within-subject placebo-controlled comparison, the acute effects of olanzapine or ziprasidone administration on insulin sensitivity in antipsychotic-naïve healthy young men, measured as hepatic glucose production (glucose rate of appearance [Ra]). | The analysis was per protocol and involved subjects who completed both a clamp that involved an injection of either olanzapine or ziprasidone, and a clamp that involved a placebo injection. Nine subjects did not complete a second clamp as they were lost to follow-up. This resulted in the analysis of 37 participants. | Posted | Mean | Standard Deviation | % change from basal to insulin phase | approximately 3 hours |
|
|
|
| Primary | Peripheral Insulin Sensitivity | To evaluate, using a within-subject placebo-controlled comparison, the acute effects of olanzapine or ziprasidone administration on insulin sensitivity in antipsychotic-naïve healthy young men, measured as primarily muscle glucose utilization (glucose rate of disappearance [Rd]). | The analysis was per protocol and involved subjects who completed both a clamp that involved an injection of either olanzapine or ziprasidone, and a clamp that involved a placebo injection. Nine subjects did not complete a second clamp as they were lost to follow-up. This resulted in the analysis of 37 participants. | Posted | Mean | Standard Deviation | % change from basal to insulin phase | approximately 3 hours |
|
|
|
| Primary | Adipose Tissue Insulin Sensitivity | To evaluate, using a within-subject placebo-controlled comparison, the acute effects of olanzapine or ziprasidone administration on insulin sensitivity in antipsychotic-naïve healthy young men, measured as free fatty acid release (glycerol rate of appearance [Ra]). | The analysis was per protocol and involved subjects who completed both a clamp that involved an injection of either olanzapine or ziprasidone, and a clamp that involved a placebo injection. Nine subjects did not complete a second clamp as they were lost to follow-up. This resulted in the analysis of 37 participants. | Posted | Mean | Standard Deviation | % change from basal to insulin phase | approximately 3 hours |
|
|
|
|
| 0 |
| 14 |
| 12 |
| EG001 | Normal Saline, Following Olanzapine | Subjects from this group received 0.9% normal saline (1 ml per IM injection) while having received olanzapine at the previous visit. | 0 | 14 | 12 |
| EG002 | Normal Saline, to be Followed by Olanzapine | Subjects from this group received 0.9% normal saline (1 ml per IM injection) and will receive olanzapine at the next visit. | 0 | 5 | 63 |
| EG003 | Olanzapine, Following Normal Saline | Subjects from this group received olanzapine (10 mg per IM injection) while having received normal saline at previous visit. | 0 | 5 | 82 |
| EG004 | Normal Saline, to be Followed by Ziprasidone | Subjects from this group received 0.9% normal saline (1 ml per IM injection) and will receive ziprasidone at the next visit. | 0 | 6 | 72 |
| EG005 | Ziprasidone, Following Normal Saline | Subjects from this group received ziprasidone (20 mg per IM injection) while having received normal saline at previous visit. | 0 | 6 | 88 |
| EG006 | Ziprasidone, to be Followed by Normal Saline | Subjects from this group received ziprasidone (20 mg per IM injection) and will receive normal saline at the next visit. | 0 | 12 | 12 |
| EG007 | Normal Saline, Following Ziprasidone | Subjects from this group received 0.9% normal saline (1 ml per IM injection) while having received ziprasidone at the previous visit. | 0 | 12 | 10 |
|
| Chest pain-during past week | General disorders | Systematic Assessment | Any report of chest pain anytime during the past 7 days. |
|
| Heart palpitations-during past week | General disorders | Systematic Assessment | Any report of heart palpitations anytime during the past 7 days. |
|
| Dizziness-during past week | General disorders | Systematic Assessment | Any report of dizziness anytime during the past 7 days. |
|
| Dizziness-30 minutes post injection | General disorders | Systematic Assessment | Any report of dizziness 30 minutes following an injection of antipsychotic or saline. |
|
| Dizziness-1 hour post meal | Gastrointestinal disorders | Systematic Assessment | Any report of dizziness 1 hour following the meal (after the clamp procedure). |
|
| Dizziness-prior to discharge | General disorders | Systematic Assessment | Any report of dizziness prior to discharge from the hospital. |
|
| Angry or agitated-during past week | General disorders | Systematic Assessment | Any report of being angry or agitated anytime during the past 7 days. |
|
| Angry or agitated-prior to injection | General disorders | Systematic Assessment | Any report of being angry or agitated prior to injection of antipsychotic or saline. |
|
| Angry or agitated-end of clamp | General disorders | Systematic Assessment | Any report of being angry or agitated at the end of the clamp procedure. |
|
| Confused-30 minutes post injection | General disorders | Systematic Assessment | Any report of confusion 30 minutes following an injection of antipsychotic or saline. |
|
| Confused-end of clamp | General disorders | Systematic Assessment | Any report of confusion at the end of the clamp procedure. |
|
| Headache-during past week | General disorders | Systematic Assessment | Any report of headache anytime during the past 7 days. |
|
| Headache-prior to injection | General disorders | Systematic Assessment | Any report of headache prior to injection of antipsychotic or saline. |
|
| Headache-30 minutes post injection | General disorders | Systematic Assessment | Any report of headache 30 minutes following an injection of antipsychotic or saline. |
|
| Headache-end of clamp | General disorders | Systematic Assessment | Any report of headache at the end of the clamp procedure. |
|
| Sad, blue, or depressed-during past week | General disorders | Systematic Assessment | Any report of sadness, feeling blue, or feeling depressed anytime during the past 7 days . |
|
| Worried, anxious-during past week | General disorders | Systematic Assessment | Any report of being worried or anxious anytime during the past 7 days . |
|
| Worried, anxious-prior to injection | General disorders | Systematic Assessment | Any report of being worried or anxious prior to injection of antipsychotic or saline. |
|
| Worried, anxious-30 minutes post injection | General disorders | Systematic Assessment | Any report of being worried or anxious 30 minutes following an injection of antipsychotic or saline. |
|
| Worried, anxious-end of clamp | General disorders | Systematic Assessment | Any report of being worried or anxious at the end of the clamp procedure. |
|
| Tiredness, fatigue-during past week | General disorders | Systematic Assessment | Any report of being tired or fatigued anytime during the past 7 days . |
|
| Tiredness, fatigue-prior to injection | General disorders | Systematic Assessment | Any report of being tired or fatigued prior to injection of antipsychotic or saline. |
|
| Tiredness, fatigue-30 minutes post injection | General disorders | Systematic Assessment | Any report of being tired or fatigued 30 minutes following an injection of antipsychotic or saline. |
|
| Tiredness, fatigue-end of clamp | General disorders | Systematic Assessment | Any report of being tired or fatigued at the end of the clamp procedure. |
|
| Tiredness, fatigue-1 hour post meal | General disorders | Systematic Assessment | Any report of being tired or fatigued 1 hour following the meal (after the clamp procedure). |
|
| Tiredness, fatigue-prior to discharge | General disorders | Systematic Assessment | Any report of being tired or fatigued prior to discharge from the hospital. |
|
| Dry mouth, thirsty-during past week | General disorders | Systematic Assessment | Any report of dry mouth or thirstiness anytime during the past 7 days . |
|
| Dry mouth, thirsty-prior to injection | General disorders | Systematic Assessment | Any report of dry mouth or thirstiness prior to injection of antipsychotic or saline . |
|
| Dry mouth, thirsty-30 minutes post injection | General disorders | Systematic Assessment | Any report of dry mouth or thirstiness 30 minutes following an injection of antipsychotic or saline. |
|
| Dry mouth, thirsty-end of clamp | General disorders | Systematic Assessment | Any report of dry mouth or thirstiness at the end of the clamp procedure. |
|
| Dry mouth, thirsty-1 hour post meal | General disorders | Systematic Assessment | Any report of dry mouth or thirstiness 1 hour following the meal (after the clamp procedure). |
|
| Extra saliva-during past week | General disorders | Systematic Assessment | Any report of extra saliva anytime during the past 7 days. |
|
| Constipation, diarrhea-during past week | General disorders | Systematic Assessment | Any report of constipation or diarrhea anytime during the past 7 days. |
|
| Fever-during past week | General disorders | Systematic Assessment | Any report of fever anytime during the past 7 days. |
|
| Hypotension-end of clamp | General disorders | Systematic Assessment | Any report of hypotension at the end of the clamp procedure. |
|
| Hypotension-1 hour post meal | General disorders | Systematic Assessment | Any report of hypotension 1 hour following the meal (after the clamp procedure). |
|
| Drowsiness, somnolence-during past week | General disorders | Systematic Assessment | Any report of drowsiness or somnolence anytime during the past 7 days . |
|
| Drowsiness, somnolence-prior to injection | General disorders | Systematic Assessment | Any report of drowsiness or somnolence prior to injection of antipsychotic or saline. |
|
| Drowsiness, somnolence-30 minutes post injection | General disorders | Systematic Assessment | Any report of drowsiness or somnolence 30 minutes following an injection of antipsychotic or saline. |
|
| Drowsiness, somnolence-end of clamp | General disorders | Systematic Assessment | Any report of drowsiness or somnolence at the end of the clamp procedure. |
|
| Drowsiness, somnolence-1 hour post meal | General disorders | Systematic Assessment | Any report of drowsiness or somnolence 1 hour following the meal (after the clamp procedure). |
|
| Drowsiness, somnolence-prior to discharge | General disorders | Systematic Assessment | Any report of drowsiness or somnolence prior to discharge from the hospital. |
|
| Stiff muscles or jaw-during past week | General disorders | Systematic Assessment | Any report of stiff muscles or jaw anytime during the past 7 days. |
|
| Stiff muscles or jaw-30 minutes post injection | General disorders | Systematic Assessment | Any report of stiff muscles or jaw 30 minutes following an injection of antipsychotic or saline. |
|
| Stiff muscles or jaw-end of clamp | General disorders | Systematic Assessment | Any report of stiff muscles or jaw at the end of the clamp procedure. |
|
| Stiff muscles or jaw-1 hour post meal | General disorders | Systematic Assessment | Any report of stiff muscles or jaw 1 hour following the meal (after the clamp procedure). |
|
| Muscle tenderness-during past week | General disorders | Systematic Assessment | Any report of muscle tenderness anytime during the past 7 days. |
|
| Muscle tenderness-30 minutes post injection | General disorders | Systematic Assessment | Any report of muscle tenderness 30 minutes following an injection of antipsychotic or saline. |
|
| Muscle tenderness-1 hour post meal | General disorders | Systematic Assessment | Any report of muscle tenderness 1 hour following the meal (after the clamp procedure). |
|
| Big appetite-during past week | General disorders | Systematic Assessment | Any report of a big appetite anytime during the past 7 days. |
|
| Trouble sleeping-during past week | General disorders | Systematic Assessment | Any report of trouble sleeping anytime during the past 7 days. |
|
| Heartburn-during past week | General disorders | Systematic Assessment | Any report of heartburn anytime during the past 7 days. |
|
| Shakiness-during past week | General disorders | Systematic Assessment | Any report of shakiness anytime during the past 7 days. |
|
| Involuntary movements-during past week | General disorders | Systematic Assessment | Any report of involuntary movements anytime during the past 7 days. |
|
| Involuntary movements-30 minutes post injection | General disorders | Systematic Assessment | Any report of involuntary movements 30 minutes following an injection of antipsychotic or saline. |
|
| Involuntary movements-end of clamp | General disorders | Systematic Assessment | Any report of involuntary movements at the end of the clamp procedure. |
|
| Restlessness-during past week | General disorders | Systematic Assessment | Any report of restlessness anytime during the past 7 days. |
|
| Restlessness-prior to injection | General disorders | Systematic Assessment | Any report of restlessness prior to injection of antipsychotic or saline. |
|
| Restlessness-30 minutes post injection | General disorders | Systematic Assessment | Any report of restlessness 30 minutes following an injection of antipsychotic or saline. |
|
| Restlessness-end of clamp | General disorders | Systematic Assessment | Any report of restlessness at the end of the clamp procedure. |
|
| Restlessness-1 hour post meal | General disorders | Systematic Assessment | Any report of restlessness 1 hour following the meal (after the clamp procedure). |
|
| Restlessness-prior to discharge | General disorders | Systematic Assessment | Any report of restlessness prior to discharge from the hospital. |
|
| Runny nose-during past week | General disorders | Systematic Assessment | Any report of a runny nose anytime during the past 7 days. |
|
| Runny nose-prior to injection | General disorders | Systematic Assessment | Any report of a runny nose prior to injection of antipsychotic or saline. |
|
| Runny nose-30 minutes post injection | General disorders | Systematic Assessment | Any report of a runny nose 30 minutes following an injection of antipsychotic or saline. |
|
| Runny nose-end of clamp | General disorders | Systematic Assessment | Any report of a runny nose at the end of the clamp procedure. |
|
| Tremor-during past week | General disorders | Systematic Assessment | Any report of tremors anytime during the past 7 days. |
|
| Tremor-1 hour post meal | General disorders | Systematic Assessment | Any report of tremors 1 hour following the meal (after the clamp procedure). |
|
| Nausea-during past week | General disorders | Systematic Assessment | Any report of nausea anytime during the past 7 days. |
|
| Nausea-prior to injection | General disorders | Systematic Assessment | Any report of nausea prior to injection of antipsychotic or saline. |
|
| Nausea-end of clamp | General disorders | Systematic Assessment | Any report of nausea at the end of the clamp procedure. |
|
| Vomiting-during past week | General disorders | Systematic Assessment | Any report of vomiting anytime during the past 7 days. |
|
| Weakness-30 minutes post injection | General disorders | Systematic Assessment | Any report of weakness 30 minutes following an injection of antipsychotic or saline. |
|
| Weakness-end of clamp | General disorders | Systematic Assessment | Any report of weakness at the end of the clamp procedure. |
|
| Weakness-1 hour post meal | General disorders | Systematic Assessment | Any report of weakness 1 hour following the meal (after the clamp procedure). |
|
| Hungry-during past week | General disorders | Systematic Assessment | Any report of hunger anytime during the past 7 days. |
|
| Hungry-prior to injection | General disorders | Systematic Assessment | Any report of hunger prior to injection of antipsychotic or saline. |
|
| Hungry-30 minutes post injection | General disorders | Systematic Assessment | Any report of hunger 30 minutes following an injection of antipsychotic or saline. |
|
| Hungry-end of clamp | General disorders | Systematic Assessment | Any report of hunger at the end of the clamp procedure. |
|
| Hungry-1 hour post meal | General disorders | Systematic Assessment | Any report of hunger 1 hour following the meal (after the clamp procedure). |
|
| Pain-during past week | General disorders | Systematic Assessment | Any report of pain anytime during the past 7 days. |
|
| Pain-prior to injection | General disorders | Systematic Assessment | Any report of pain prior to injection of antipsychotic or saline. |
|
| Pain-30 minutes post injection | General disorders | Systematic Assessment | Any report of pain 30 minutes following an injection of antipsychotic or saline. |
|
| Pain-end of clamp | General disorders | Systematic Assessment | Any report of pain at the end of the clamp procedure. |
|
| Pain-1 hour post meal | General disorders | Systematic Assessment | Any report of pain 1 hour following the meal (after the clamp procedure). |
|
| Other-Neck uncomfortable (end of clamp) | General disorders | Systematic Assessment | Other-neck uncomfortable, "pillow too big" at the end of the clamp procedure. |
|
| Other-Neck uncomfortable (1 hour post meal) | General disorders | Systematic Assessment | Other-neck uncomfortable, "pillow too big" 1 hour following the meal (after the clamp procedure). |
|
| Dizziness-end of clamp | General disorders | Systematic Assessment | Any report of dizziness at the end of the clamp procedure. |
|
Not provided
Not provided
| D052439 | Lipid Metabolism Disorders |
| D001519 | Behavior |
| D009377 | Multiple Endocrine Neoplasia |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009378 | Neoplasms, Multiple Primary |
| D009386 | Neoplastic Syndromes, Hereditary |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D004700 | Endocrine System Diseases |
| D006946 | Hyperinsulinism |
| D006571 | Heterocyclic Compounds |