Trial Outcomes & Findings for The Effects of Antipsychotic Drugs on Brain Metabolism in Healthy Individuals (NCT NCT02536846)

NCT ID: NCT02536846

Last Updated: 2022-10-03

Results Overview

Change in brain nicotinamide adenine dinucleotide NAD+/NADH metabolite ratio as measured by in vivo 31P magnetic resonance spectroscopy

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 35 participants
• Primary outcome timeframe: Baseline and after 15 days medication period
• Results posted on: 2022-10-03

Participant Flow

Individuals between 21-50 years old without a psychiatric or serious medical diagnosis or family history or first degree relative with a psychotic disorder.

Participant milestones

Measure	Olanzapine Participants will take olanzapine, Zyprexa Zydis, 5mg daily for 15 days.
Overall Study STARTED	10
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Olanzapine Participants will take olanzapine, Zyprexa Zydis, 5mg daily for 15 days.
Overall Study Withdrawal by Subject	1

Baseline Characteristics

The Effects of Antipsychotic Drugs on Brain Metabolism in Healthy Individuals

Baseline characteristics by cohort

Measure	Second Generation Antipsychotic Drug n=10 Participants Olanzapine; a single 2.5 mg dose PO daily followed by 5 mg dose PO daily for 14 days Olanzapine: All subjects will take a single 2.5 mg dose of olanzapine (Zyprexa Zydis) followed by a 5 mg dose for 14 days. (2.5 mg/d for 1 day, 5 mg/d for 14 days).
Age, Continuous	25.42 years STANDARD_DEVIATION 2.23 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	7 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and after 15 days medication period

Change in brain nicotinamide adenine dinucleotide NAD+/NADH metabolite ratio as measured by in vivo 31P magnetic resonance spectroscopy

Outcome measures

Measure	Olanzapine n=7 Participants Participants will take olanzapine, Zyprexa Zydis, 5mg daily for 15 days.
Change in Brain Nicotinamide Adenine Dinucleotide Metabolites NAD+/NADH	-0.79 ratio Standard Deviation 2.37

PRIMARY outcome

Timeframe: Baseline and after 15 days medication period

Change in Phosphocreatine (PCr) metabolite concentration as measured by in vivo 31P magnetic resonance spectroscopy

Outcome measures

Measure	Olanzapine n=8 Participants Participants will take olanzapine, Zyprexa Zydis, 5mg daily for 15 days.
Change in Brain Phosphocreatine (PCr)	0.01 ratio Standard Deviation 0.11

PRIMARY outcome

Timeframe: Baseline and after 15 days medication period

Change in forward reaction rate constant (kf) of the creatine kinase (CK) as measured by in vivo 31P magnetic resonance spectroscopy magnetization transfer

Outcome measures

Measure	Olanzapine n=4 Participants Participants will take olanzapine, Zyprexa Zydis, 5mg daily for 15 days.
Change in Brain Creatine Kinase (CK) Forward Reaction Rate	-0.04 s-1 Standard Deviation 0.08

PRIMARY outcome

Timeframe: baseline and after 15 days medication period

Change in brain parenchymal pH as measured by in vivo 31P magnetic resonance spectroscopy

Outcome measures

Measure	Olanzapine n=8 Participants Participants will take olanzapine, Zyprexa Zydis, 5mg daily for 15 days.
Change in Brain Parenchymal pH	0.00 pH Standard Deviation 0.01

SECONDARY outcome

Timeframe: baseline and after 15 day medication period

Change in the gray matter volumes (cubic millimeters) of the frontal, parietal and temporal lobes as defined by Freesurfer's Desikan-Killiany Brain Atlas. Data was acquired using structural magnetic resonance imaging (MRI) at 3T.

Outcome measures

Measure	Olanzapine n=8 Participants Participants will take olanzapine, Zyprexa Zydis, 5mg daily for 15 days.
Change in Volumes of the Frontal, Parietal and Temporal Lobe Regions Frontal Lobe	-2500.44 cubic mm Standard Deviation 4304.17
Change in Volumes of the Frontal, Parietal and Temporal Lobe Regions Parietal Lobe	-600 cubic mm Standard Deviation 1264.79

SECONDARY outcome

Timeframe: baseline and after 15 days medication period

Change in the cortical surface area (millimeters squared) of the frontal, parietal and temporal lobes as defined by Freesurfer's Desikan-Killiany Brain Atlas. Data was acquired using structural magnetic resonance imaging (MRI) at 3T.

Outcome measures

Measure	Olanzapine n=8 Participants Participants will take olanzapine, Zyprexa Zydis, 5mg daily for 15 days.
Change in Surface Area of the Frontal, Parietal and Temporal Regions Frontal lobe	-801.19 mm^2 Standard Deviation 1563.02
Change in Surface Area of the Frontal, Parietal and Temporal Regions Parietal lobe	-581.56 mm^2 Standard Deviation 1272.93

SECONDARY outcome

Timeframe: baseline and after 15 days medication period

Population: Number of voxels that showed significant change in connectivity following administration of olanzapine.

Change in resting state functional connectivity to the medial prefrontal cortex and superior parietal lobules following olanzapine administration period. Whole-brain, seed-to-voxel analyses were conducted utilizing anatomically-defined seed regions and age-corrected within-subjects f-tests were run to determine the presence and size (in voxels) of clusters where connectivity changed significantly following olanzapine administration. Results are reported in units of voxels for each cluster meeting a threshold of voxel-level uncorrected p<.001 and cluster-level p-FDR<.05. A result of zero indicates that no clusters were identified within subjects as changed in connectivity relative to the seed regions.

Outcome measures

Measure	Olanzapine n=7 Participants Participants will take olanzapine, Zyprexa Zydis, 5mg daily for 15 days.
Change in fMRI Resting State Functional Connectivity medial prefrontal cortex	0 Voxels
Change in fMRI Resting State Functional Connectivity superior parietal lobule	0 Voxels

SECONDARY outcome

Timeframe: baseline and after 15 days medication period

Change in GABA concentration measured by proton magnetic resonance spectroscopy.

Outcome measures

Measure	Olanzapine n=9 Participants Participants will take olanzapine, Zyprexa Zydis, 5mg daily for 15 days.
Change in GABA Concentration	0.11 mmol Standard Deviation 0.20

SECONDARY outcome

Timeframe: baseline and after 15 days medication period

Change in fractional anisotropy (FA), a scalar measure of diffusivity, of water in the brain assessed by DTI at 3T. FA values range from 0 (isotropic, meaning diffusion is equally restricted in 3D space) to 1 (anisotrophic, meaning that diffusion is completely restricted to a single direction).

Outcome measures

Measure	Olanzapine n=8 Participants Participants will take olanzapine, Zyprexa Zydis, 5mg daily for 15 days.
Change in Fractional Anisotropy (FA) Measured by Diffusion Tensor Imaging (DTI) Core FA	0.0007 Units on a scale Standard Deviation 0.01
Change in Fractional Anisotropy (FA) Measured by Diffusion Tensor Imaging (DTI) Genu of corpus callosum	-0.003 Units on a scale Standard Deviation 0.013
Change in Fractional Anisotropy (FA) Measured by Diffusion Tensor Imaging (DTI) Cingulum	-0.008 Units on a scale Standard Deviation 0.027
Change in Fractional Anisotropy (FA) Measured by Diffusion Tensor Imaging (DTI) Inferior fronto-occipital fasciculus	-0.002 Units on a scale Standard Deviation 0.012
Change in Fractional Anisotropy (FA) Measured by Diffusion Tensor Imaging (DTI) Anterior thalamic radiation	0.002 Units on a scale Standard Deviation 0.015

SECONDARY outcome

Timeframe: baseline and after 15 days medication period

Change in glutamate metabolite concentration measured by proton magnetic resonance spectroscopy.

Outcome measures

Measure	Olanzapine n=9 Participants Participants will take olanzapine, Zyprexa Zydis, 5mg daily for 15 days.
Change in Glutamate Metabolite Concentration	0.13 millimoles Standard Deviation 0.66

SECONDARY outcome

Timeframe: baseline and after 15 days medication period

Change in the MATRICS Cognitive Consensus Battery (MCCB), that includes 10 tasks that measure processing speed (Brief Assessment of Cognition in Schizophrenia - Symbol Coding, Animal Fluency, Trails A), attention (Continuous Performance Test), working memory (WMS-III Spatial Span, Letter-Number Span), verbal learning (Hopkins Verbal Learning Test - Revised), visual learning (Brief Visuospatial Memory Test - Revised), problem solving (Neuropsychological Assessment Battery Mazes) and social cognition (Mayer-Salovey-Caruso Emotional Intelligence Test). Scores from each subtest are normed and their T-scores are summed to yield a MCCB composite score, then the total composite T-score is standardized to normative data among a healthy population. The composite T-score has a mean of 50 and a standard deviation of 10. Higher total composite scores indicate better cognitive outcomes.

Outcome measures

Measure	Olanzapine n=8 Participants Participants will take olanzapine, Zyprexa Zydis, 5mg daily for 15 days.
Change in MATRICS Cognitive Consensus Battery (MCCB) Total Composite Score	3.63 Score on a scale Standard Deviation 4.72

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline and after 15 days medication period

Change in Montgomery-Asberg Depression Rating Scale (MADRS) score, a 0-60 point scale rating depressive symptoms. Higher scores indicate more severe clinical symptoms.

Outcome measures

Measure	Olanzapine n=8 Participants Participants will take olanzapine, Zyprexa Zydis, 5mg daily for 15 days.
Change in Montgomery-Asberg Depression Rating Scale (MADRS) Score	-0.88 score on a scale Standard Deviation 3.00

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline and after 15 days medication period

Change in Beck Depression Inventory (BDI) score, a self-report questionnaire measuring depressive symptoms on a scale of 0-63. Scores ranging 0-9 generally indicate minimal depressive symptoms, while scores 10-18 indicate mild, 19-29 indicates moderate, and 30-63 indicates severe depressive symptoms, respectively.

Outcome measures

Measure	Olanzapine n=8 Participants Participants will take olanzapine, Zyprexa Zydis, 5mg daily for 15 days.
Change in Beck Depression Inventory (BDI) Score	-0.63 score on a scale Standard Deviation 1.30

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline and after 15 days medication period

Change in Young Mania Rating Scale (YMRS) score, an interview-based, 11-item scale that measures the severity of core features of clinical mania. 7 items are scored on a 0-4 point scale, while the remaining 4 are scored on a 0-8 point scale, for a total possible range of 0-64. Higher scores indicate more severe manic symptoms.

Outcome measures

Measure	Olanzapine n=8 Participants Participants will take olanzapine, Zyprexa Zydis, 5mg daily for 15 days.
Change in Young Mania Rating Scale (YMRS) Score	-0.875 score on a scale Standard Deviation 1.126

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline and after 15 days medication period

Change in Beck Anxiety Inventory (BAI) score, a self-report measure of anxiety symptoms. Scores range from 0-63, with higher scores indicating more severe anxiety.

Outcome measures

Measure	Olanzapine n=8 Participants Participants will take olanzapine, Zyprexa Zydis, 5mg daily for 15 days.
Change in Beck Anxiety Inventory (BAI) Score	-0.63 score on a scale Standard Deviation 1.41

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline and 2, 5, 10, 15 days during medication period

Population: Data for this measure was collected for 10 participants.

Change in The Columbia Suicide Severity Rating Scale score, a self-report scale measuring suicidality. Only the total score, not subscale of suicidal ideation intensity, will be measured. Total scores can range from 0-10, with higher scores indicating increased suicidality.

Outcome measures

Measure	Olanzapine n=10 Participants Participants will take olanzapine, Zyprexa Zydis, 5mg daily for 15 days.
Change in The Columbia Suicide Severity Rating Scale Score Baseline	0 score on a scale Standard Deviation 0
Change in The Columbia Suicide Severity Rating Scale Score After 2 days medication	0 score on a scale Standard Deviation 0
Change in The Columbia Suicide Severity Rating Scale Score After 5 days medication	0 score on a scale Standard Deviation 0
Change in The Columbia Suicide Severity Rating Scale Score After 10 days medication	0 score on a scale Standard Deviation 0
Change in The Columbia Suicide Severity Rating Scale Score After 15 days medication	0 score on a scale Standard Deviation 0

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline and after 15 days medication period

Change in Pittsburgh Sleep Quality Index score, a measurement of sleep quality. The index measures 7 sleep components on a 0-3 scale; each of the 7 raw scores is summed to get a global score. The global score ranges from 0-21, with higher scores indicating poor sleep quality. Scores >5 are typically considered poor sleep quality.

Outcome measures

Measure	Olanzapine n=8 Participants Participants will take olanzapine, Zyprexa Zydis, 5mg daily for 15 days.
Change in Pittsburgh Sleep Quality Index Score	-0.63 score on a scale Standard Deviation 1.92

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline and 2, 5, 10 and 15 days (or final assessment) during medication period

Population: Data for this measure was collected for 10 participants.

Change in LUNSERS (Liverpool University Neuroleptic Side Effect Rating Scale) score, a self-report measure of antipsychotic side effects. The scale has 51 questions, 41 of which are about side-effects and 10 "red herrings" for validation purposes. The total neuroleptic side effect score is derived from the sum of the 41 side-effect questions, with a potential range of 0-164. Higher scores indicate more severe neuroleptic side effects.

Outcome measures

Measure	Olanzapine n=10 Participants Participants will take olanzapine, Zyprexa Zydis, 5mg daily for 15 days.
Change in LUNSERS (Liverpool University Neuroleptic Side Effect Rating Scale) Score Baseline	0.20 score on a scale Standard Deviation 0.63
Change in LUNSERS (Liverpool University Neuroleptic Side Effect Rating Scale) Score 2 days	4.50 score on a scale Standard Deviation 4.99
Change in LUNSERS (Liverpool University Neuroleptic Side Effect Rating Scale) Score 5 days	2.11 score on a scale Standard Deviation 3.02
Change in LUNSERS (Liverpool University Neuroleptic Side Effect Rating Scale) Score 10 days	2.22 score on a scale Standard Deviation 3.19
Change in LUNSERS (Liverpool University Neuroleptic Side Effect Rating Scale) Score Endpoint	3.90 score on a scale Standard Deviation 4.98

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline and 2, 5, 10 and 15 days (or final assessment) during medication period

Population: Data for this measure was collected for 10 participants

Change in participant body weight in kg, as measured using a standing scale.

Outcome measures

Measure	Olanzapine n=10 Participants Participants will take olanzapine, Zyprexa Zydis, 5mg daily for 15 days.
Change in Body Weight Baseline	0 kg Standard Deviation 0
Change in Body Weight 2 days	-0.29 kg Standard Deviation 1.13
Change in Body Weight 5 days	0.12 kg Standard Deviation 1.41
Change in Body Weight 10 days	0.21 kg Standard Deviation 0.88
Change in Body Weight Endpoint	0.73 kg Standard Deviation 1.34

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline and 2, 5, 10 and 15 days (or final assessment) during medication period

Population: Data for this measure was collected for 10 participants.

Change in the hip circumference measurement, taken as an average of 3 measures by tape measure

Outcome measures

Measure	Olanzapine n=10 Participants Participants will take olanzapine, Zyprexa Zydis, 5mg daily for 15 days.
Change in Hip Circumference Baseline	0 cm Standard Deviation 0
Change in Hip Circumference 2 days	-0.43 cm Standard Deviation 3.10
Change in Hip Circumference 5 days	-1.10 cm Standard Deviation 4.27
Change in Hip Circumference 10 days	-1.62 cm Standard Deviation 4.89
Change in Hip Circumference Endpoint	-1.24 cm Standard Deviation 3.54

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline and 2, 5, 10 and 15 days (or final assessment) during medication period

Population: Data was collected for 10 participants

Change in waist circumference measurements, taken as an average of 3 measures by tape measure.

Outcome measures

Measure	Olanzapine n=10 Participants Participants will take olanzapine, Zyprexa Zydis, 5mg daily for 15 days.
Change in Waist Circumference Baseline	0 cm Standard Deviation 0
Change in Waist Circumference After 2 days medication	-0.47 cm Standard Deviation 3.21
Change in Waist Circumference After 5 days medication	0.22 cm Standard Deviation 1.36
Change in Waist Circumference After 10 days medication	-0.23 cm Standard Deviation 3.30
Change in Waist Circumference Endpoint	-0.15 cm Standard Deviation 3.06

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline and after 15 days during medication period

Change in fasting serum glucose levels.

Outcome measures

Measure	Olanzapine n=8 Participants Participants will take olanzapine, Zyprexa Zydis, 5mg daily for 15 days.
Change in Blood Glucose Levels	0.75 mg/dL Standard Deviation 6.18

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline and after 15 days medication period

Change in fasting total cholesterol level

Outcome measures

Measure	Olanzapine n=8 Participants Participants will take olanzapine, Zyprexa Zydis, 5mg daily for 15 days.
Change in Fasting Total Cholesterol Level	-1.75 mg/dL Standard Deviation 28.23

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline and after 15 days medication period

Change in fasting, Hemoglobin A1c level

Outcome measures

Measure	Olanzapine n=9 Participants Participants will take olanzapine, Zyprexa Zydis, 5mg daily for 15 days.
Change in Hemoglobin A1c Level	-0.01 mmol/mol Standard Deviation 0.11

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline and after 15 days medication period

Change in insulin fasting serum levels

Outcome measures

Measure	Olanzapine n=9 Participants Participants will take olanzapine, Zyprexa Zydis, 5mg daily for 15 days.
Change in Serum Insulin Levels	-0.94 uIU/mL Standard Deviation 1.73

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline and after 15 days medication period

Change prolactin serum levels

Outcome measures

Measure	Olanzapine n=9 Participants Participants will take olanzapine, Zyprexa Zydis, 5mg daily for 15 days.
Change in Prolactin Levels	11.77 ng/mL Standard Deviation 20.69

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline and after 15 days medication period

Change in total caloric intake as assessed by the ASA24 Dietary Recall and Food Frequency Questionnaire - Revised. The ASA24 is a self-administered 24-hour dietary recall assessment.

Outcome measures

Measure	Olanzapine n=7 Participants Participants will take olanzapine, Zyprexa Zydis, 5mg daily for 15 days.
Change in Total Caloric Intake	151.94 kcal Standard Deviation 1180.23

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline and after 15 days medication period

Change in Wisconsin Schizotypy Scales (WSS) Short Form score, a self-report questionnaire assessing schizotypy in clinical and non-clinical samples. The measure has four scales, each with 15 True/False questions. There are 13 red-herring questions, that, if answered "True" invalidate the test. Each "false" response is scored 0, and each "true" response is scored 1. Scores for each scale range from 0 - 15, with higher scores indicating greater schizotypy. The WSS positive schizotypy score consists of the summed score of the perceptual aberration and magical ideation scales and scores range from 0-30, with higher scores indicating greater positive schizotypy. The WSS negative schizotypy score sums scores from the physical anhedonia and social anhedonia scales and ranges from 0-30, with higher scores indicating greater negative schizotypy.

Outcome measures

Measure	Olanzapine n=8 Participants Participants will take olanzapine, Zyprexa Zydis, 5mg daily for 15 days.
Change in The Wisconsin Schizotypy Scales - Short Form Scores Change in positive schizotypy subscales	0.06 score on a scale Standard Deviation 0.12
Change in The Wisconsin Schizotypy Scales - Short Form Scores Change in negative schizotypy subscales	0.09 score on a scale Standard Deviation 0.42

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline and after 15 days medication period

Change in the Early Psychosis Social Scale score item of missed absences from school or work. Scores range from 1-5, with higher scores indicating more absences from school or work.

Outcome measures

Measure	Olanzapine n=8 Participants Participants will take olanzapine, Zyprexa Zydis, 5mg daily for 15 days.
Change in the Early Psychosis Social Scale Survey Score	-0.13 score on a scale Standard Deviation 0.35

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline and after 15 days medication period

Change in the Prodromal Questionnaire, Brief Version score, a 21 item self-report questionnaire designed to help identify those at ultra-high risk for developing psychotic symptoms. The total score is derived as the sum of all 21 items, with a possible range of 0-21. Higher scores indicate greater psychopathology.

Outcome measures

Measure	Olanzapine n=7 Participants Participants will take olanzapine, Zyprexa Zydis, 5mg daily for 15 days.
Change in the Prodromal Questionnaire, Brief Version Total Score	0 score on a scale Standard Deviation 0

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline and after 15 days medication period

Changes in the Symptoms Checklist - 90 - Revised scale, which measures 9 domains of psychological dysfunction, summing to create an overall psychological distress (Global Severity Score). The scores of each of the 9 domains - somatization, obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation and psychoticism - combine for a total of 90 items, each measured on a 5-point scale. The sums of all 90 item scores, ranging 0-360, creates the Global Severity score. Higher scores indicate greater psychopathology.

Outcome measures

Measure	Olanzapine n=9 Participants Participants will take olanzapine, Zyprexa Zydis, 5mg daily for 15 days.
Change in the Symptoms Checklist - 90 - Revised Global Severity Score	-2.33 score on a scale Standard Deviation 5.66

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline and after 15 days medication period

Change in the State-Trait Anxiety Inventory for Adults, which measures both state and trait anxiety using 2 subscales for a total of 40 items. Each subscale has a range of 20-80, with higher scores indicating greater state or trait anxiety, respectively.

Outcome measures

Measure	Olanzapine n=8 Participants Participants will take olanzapine, Zyprexa Zydis, 5mg daily for 15 days.
Change in the State-Trait Anxiety Inventory for Adults Scores Change in State-anxiety scale	-0.25 score on a scale Standard Deviation 2.38
Change in the State-Trait Anxiety Inventory for Adults Scores Change in Trait-anxiety scale	-0.75 score on a scale Standard Deviation 2.38

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline and after 15 days medication period

Change in the World Health Organization Quality of Life questionnaire score, a 26-item assessment of overall quality of life. The questionnaire encompasses 4 domains: physical health, psychological health, social relationships, and environment. There are two additional questions, which assess the participant's perceptions of their own quality of life and physical health. Higher scores indicate better quality of life. Scores are summed within each domain. Total score is obtained by transforming for a total range of 0-100 within each domain.

Outcome measures

Measure	Olanzapine n=8 Participants Participants will take olanzapine, Zyprexa Zydis, 5mg daily for 15 days.
Change in the World Health Organization Quality of Life Questionnaire Score Change in physical health score	2.25 score on a scale Standard Deviation 7.61
Change in the World Health Organization Quality of Life Questionnaire Score Change in psychological health score	-4.38 score on a scale Standard Deviation 7.25
Change in the World Health Organization Quality of Life Questionnaire Score Change in social relationships score	0.75 score on a scale Standard Deviation 3.85
Change in the World Health Organization Quality of Life Questionnaire Score Change in environment score	-7.875 score on a scale Standard Deviation 12.15

Adverse Events

Olanzapine

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Olanzapine n=10 participants at risk Participants will take olanzapine, Zyprexa Zydis, 5mg daily for 15 days.
Nervous system disorders Drowsiness	100.0% 10/10 • Number of events 10 • Adverse event data were collected at all scheduled visits throughout the 15 day medication period at days 1, 2, 5, 10, and 15.
Nervous system disorders Difficulty staying awake	50.0% 5/10 • Number of events 5 • Adverse event data were collected at all scheduled visits throughout the 15 day medication period at days 1, 2, 5, 10, and 15.
Nervous system disorders Sleeping too much	40.0% 4/10 • Number of events 4 • Adverse event data were collected at all scheduled visits throughout the 15 day medication period at days 1, 2, 5, 10, and 15.
Metabolism and nutrition disorders Increased lipids	30.0% 3/10 • Number of events 3 • Adverse event data were collected at all scheduled visits throughout the 15 day medication period at days 1, 2, 5, 10, and 15.
Metabolism and nutrition disorders Increased food cravings	30.0% 3/10 • Number of events 3 • Adverse event data were collected at all scheduled visits throughout the 15 day medication period at days 1, 2, 5, 10, and 15.
Metabolism and nutrition disorders Weight gain	20.0% 2/10 • Number of events 2 • Adverse event data were collected at all scheduled visits throughout the 15 day medication period at days 1, 2, 5, 10, and 15.
Psychiatric disorders Vivid dreaming	20.0% 2/10 • Number of events 2 • Adverse event data were collected at all scheduled visits throughout the 15 day medication period at days 1, 2, 5, 10, and 15.
Hepatobiliary disorders Elevated LFTs	20.0% 2/10 • Number of events 2 • Adverse event data were collected at all scheduled visits throughout the 15 day medication period at days 1, 2, 5, 10, and 15.
Psychiatric disorders Difficulty getting to sleep	20.0% 2/10 • Number of events 2 • Adverse event data were collected at all scheduled visits throughout the 15 day medication period at days 1, 2, 5, 10, and 15.
Nervous system disorders Shakiness	20.0% 2/10 • Number of events 2 • Adverse event data were collected at all scheduled visits throughout the 15 day medication period at days 1, 2, 5, 10, and 15.
Gastrointestinal disorders Dry mouth	20.0% 2/10 • Number of events 2 • Adverse event data were collected at all scheduled visits throughout the 15 day medication period at days 1, 2, 5, 10, and 15.
Skin and subcutaneous tissue disorders Rash	20.0% 2/10 • Number of events 2 • Adverse event data were collected at all scheduled visits throughout the 15 day medication period at days 1, 2, 5, 10, and 15.
General disorders Increased thirst	20.0% 2/10 • Number of events 2 • Adverse event data were collected at all scheduled visits throughout the 15 day medication period at days 1, 2, 5, 10, and 15.
Endocrine disorders Elevated prolactin	20.0% 2/10 • Number of events 2 • Adverse event data were collected at all scheduled visits throughout the 15 day medication period at days 1, 2, 5, 10, and 15.
Nervous system disorders Tremor	10.0% 1/10 • Number of events 1 • Adverse event data were collected at all scheduled visits throughout the 15 day medication period at days 1, 2, 5, 10, and 15.
General disorders Slowing of movements	10.0% 1/10 • Number of events 1 • Adverse event data were collected at all scheduled visits throughout the 15 day medication period at days 1, 2, 5, 10, and 15.
Gastrointestinal disorders Stomach pain	10.0% 1/10 • Number of events 1 • Adverse event data were collected at all scheduled visits throughout the 15 day medication period at days 1, 2, 5, 10, and 15.
Cardiac disorders Palpitations	10.0% 1/10 • Number of events 1 • Adverse event data were collected at all scheduled visits throughout the 15 day medication period at days 1, 2, 5, 10, and 15.
Gastrointestinal disorders Diarrhea	10.0% 1/10 • Number of events 1 • Adverse event data were collected at all scheduled visits throughout the 15 day medication period at days 1, 2, 5, 10, and 15.

Additional Information

Dr. Dost Öngür

McLean Hospital

Phone: 617-855-3922

Email: dongur@partners.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place