Trial · NCT02536846

The Effects of Antipsychotic Drugs on Brain Metabolism in Healthy Individuals

NCT02536846, Phase 4, Completed, Dost Ongur; results first posted 2021-08-12

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. The Effects of Antipsychotic Drugs on Brain Metabolism in Healthy Individuals. Trials, record NCT02536846. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02536846

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: The Effects of Antipsychotic Drugs on Brain Metabolism in Healthy Individuals
NCT number: NCT02536846
Status: Completed
Phases: Phase 4
Enrollment: 35 participants, actual
Lead sponsor: Dost Ongur
Conditions: Healthy
Interventions: Olanzapine
First posted: 2015-09-01
Last updated: 2022-10-03
Results first posted: 2021-08-12

Source ClinicalTrials.gov

Registered outcomes33

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change in Brain Nicotinamide Adenine Dinucleotide Metabolites NAD+/NADH	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
Primary	Change in Brain Phosphocreatine (PCr)	Baseline and after 15 days medication period	Change in Phosphocreatine (PCr) metabolite concentration as measured by in vivo 31P magnetic resonance spectroscopy
Primary	Change in Brain Creatine Kinase (CK) Forward Reaction Rate	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
Primary	Change in Brain Parenchymal pH	baseline and after 15 days medication period	Change in brain parenchymal pH as measured by in vivo 31P magnetic resonance spectroscopy
Secondary	Change in Volumes of the Frontal, Parietal and Temporal Lobe Regions	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.
Secondary	Change in Surface Area of the Frontal, Parietal and Temporal Regions	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.
Secondary	Change in fMRI Resting State Functional Connectivity	baseline and after 15 days medication period	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.
Secondary	Change in GABA Concentration	baseline and after 15 days medication period	Change in GABA concentration measured by proton magnetic resonance spectroscopy.
Secondary	Change in Fractional Anisotropy (FA) Measured by Diffusion Tensor Imaging (DTI)	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).
Secondary	Change in Glutamate Metabolite Concentration	baseline and after 15 days medication period	Change in glutamate metabolite concentration measured by proton magnetic resonance spectroscopy.

1 to 10 of 33Source ClinicalTrials.gov

See all 33 registered outcomes

Outcomes33

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in Brain Nicotinamide Adenine Dinucleotide Metabolites NAD+/NADH	Baseline and after 15 days medication period		ratio	MEAN
PRIMARY	Change in Brain Phosphocreatine (PCr)	Baseline and after 15 days medication period		ratio	MEAN
PRIMARY	Change in Brain Creatine Kinase (CK) Forward Reaction Rate	Baseline and after 15 days medication period		s-1	MEAN
PRIMARY	Change in Brain Parenchymal pH	baseline and after 15 days medication period		pH	MEAN
SECONDARY	Change in Volumes of the Frontal, Parietal and Temporal Lobe Regions	baseline and after 15 day medication period		cubic mm	MEAN
SECONDARY	Change in Surface Area of the Frontal, Parietal and Temporal Regions	baseline and after 15 days medication period		mm^2	MEAN
SECONDARY	Change in fMRI Resting State Functional Connectivity	baseline and after 15 days medication period	Number of voxels that showed significant change in connectivity following administration of olanzapine.	Voxels	NUMBER
SECONDARY	Change in GABA Concentration	baseline and after 15 days medication period		mmol	MEAN
SECONDARY	Change in Fractional Anisotropy (FA) Measured by Diffusion Tensor Imaging (DTI)	baseline and after 15 days medication period		Units on a scale	MEAN
SECONDARY	Change in Glutamate Metabolite Concentration	baseline and after 15 days medication period		millimoles	MEAN

1 to 10 of 33Source ClinicalTrials.gov

See all 33 outcomes

Results by group65

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Change in Brain Nicotinamide Adenine Dinucleotide Metabolites NAD+/NADH	Olanzapine		-0.79	Standard Deviation 2.37	ratio
Change in Brain Phosphocreatine (PCr)	Olanzapine		0.01	Standard Deviation 0.11	ratio
Change in Brain Creatine Kinase (CK) Forward Reaction Rate	Olanzapine		-0.04	Standard Deviation 0.08	s-1
Change in Brain Parenchymal pH	Olanzapine		0.00	Standard Deviation 0.01	pH
Change in Volumes of the Frontal, Parietal and Temporal Lobe Regions	Olanzapine	Frontal Lobe	-2500.44	Standard Deviation 4304.17	cubic mm
Change in Volumes of the Frontal, Parietal and Temporal Lobe Regions	Olanzapine	Parietal Lobe	-600	Standard Deviation 1264.79	cubic mm
Change in Surface Area of the Frontal, Parietal and Temporal Regions	Olanzapine	Frontal lobe	-801.19	Standard Deviation 1563.02	mm^2
Change in Surface Area of the Frontal, Parietal and Temporal Regions	Olanzapine	Parietal lobe	-581.56	Standard Deviation 1272.93	mm^2
Change in fMRI Resting State Functional Connectivity	Olanzapine	medial prefrontal cortex	0		Voxels
Change in fMRI Resting State Functional Connectivity	Olanzapine	superior parietal lobule	0		Voxels

1 to 10 of 65Source ClinicalTrials.gov

See all 65 results by group

Participant flow3

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Olanzapine	10
Overall Study	COMPLETED	Olanzapine	9
Overall Study	NOT COMPLETED	Olanzapine	1

Source ClinicalTrials.gov

Adverse events19

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Drowsiness	Nervous system disorders	Olanzapine	10	10	10
other	Difficulty staying awake	Nervous system disorders	Olanzapine	5	10	5
other	Sleeping too much	Nervous system disorders	Olanzapine	4	10	4
other	Increased lipids	Metabolism and nutrition disorders	Olanzapine	3	10	3
other	Increased food cravings	Metabolism and nutrition disorders	Olanzapine	3	10	3
other	Weight gain	Metabolism and nutrition disorders	Olanzapine	2	10	2
other	Vivid dreaming	Psychiatric disorders	Olanzapine	2	10	2
other	Elevated LFTs	Hepatobiliary disorders	Olanzapine	2	10	2
other	Difficulty getting to sleep	Psychiatric disorders	Olanzapine	2	10	2
other	Shakiness	Nervous system disorders	Olanzapine	2	10	2

1 to 10 of 19Source ClinicalTrials.gov

See all 19 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Olanzapine	0	10
Total, other adverse events	Olanzapine	10	10
Total, serious adverse events	Olanzapine	0	10

Source ClinicalTrials.gov

Papers13

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
11027917	BACKGROUND	PubMed
15756305	BACKGROUND	PubMed
17063154	BACKGROUND	PubMed
17671875	BACKGROUND	PubMed
17712347	BACKGROUND	PubMed
17945195	BACKGROUND	PubMed
19131173	BACKGROUND	PubMed
19689326	BACKGROUND	PubMed
19906788	BACKGROUND	PubMed
20134408	BACKGROUND	PubMed

1 to 10 of 13

See all 13 papers

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests4

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

Test	Named as	Source
Category Fluency	Secondary outcome	ConductCognition
Continuous Performance Test	Secondary outcome	ConductCognition
Trail Making Test A	Secondary outcome	ConductCognition
Verbal Learning	Secondary outcome	ConductCognition

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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