Trial · NCT02536846
Registered outcomes33
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 33
Download this page as JSON| 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. |
| Secondary | Change in MATRICS Cognitive Consensus Battery (MCCB) Total Composite Score | 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. |
| Other | Change in Montgomery-Asberg Depression Rating Scale (MADRS) Score | 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. |
| Other | Change in Beck Depression Inventory (BDI) Score | 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. |
| Other | Change in Young Mania Rating Scale (YMRS) Score | 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. |
| Other | Change in Beck Anxiety Inventory (BAI) Score | 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. |
| Other | Change in The Columbia Suicide Severity Rating Scale Score | baseline and 2, 5, 10, 15 days during medication period | 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. |
| Other | Change in Pittsburgh Sleep Quality Index Score | 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. |
| Other | Change in LUNSERS (Liverpool University Neuroleptic Side Effect Rating Scale) Score | baseline and 2, 5, 10 and 15 days (or final assessment) during medication period | 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. |
| Other | Change in Body Weight | baseline and 2, 5, 10 and 15 days (or final assessment) during medication period | Change in participant body weight in kg, as measured using a standing scale. |
| Other | Change in Hip Circumference | baseline and 2, 5, 10 and 15 days (or final assessment) during medication period | Change in the hip circumference measurement, taken as an average of 3 measures by tape measure |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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