Trial · NCT05347199
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | BOLD fMRI parameter estimates | during MID task at treatment day 1 | Blood oxygen level dependent (BOLD) fMRI parameter estimates (ß-weights within the GLM analysis) will be extracted from task-related regions of interest (average %BOLD signal change and 90th percentile thereof within ROIs) under the following task-specific contrasts: Monetary Incentive Delay (MID) task: Contrast of 'High-gain'vs. 'No-gain' condition during the task CUE period ROIs ventral striatum (including nucleus accumbens) |
| Other | Exploratory endpoint: average %BOLD signal change and 90th percentile thereof within ROIs during SID | during SID task at treatment day 2 | Blood oxygen level dependent (BOLD) fMRI parameter estimates (ß-weights within the GLM analysis) will be extracted from task-related regions of interest (average %BOLD signal change and 90th percentile thereof within ROIs) under the following task-specific contrasts: Social Incentive Delay (SID) task: Contrast of 'High-gain' vs. 'No-gain' condition during the task CUE period ROIs: ventral striatum (including nucelues accumbens), ventral tegmental area, dorsal anterior cingulate cortex, insula, ventromedial prefrontal cortex/ orbitofrontal cortex and ventral pallidum |
| Other | Exploratory endpoint: average %BOLD signal change and 90th percentile thereof within ROIs during intstrumental learning task | during instrumental learning task at treatment day 1 | Blood oxygen level dependent (BOLD) fMRI parameter estimates (ß-weights within the GLM analysis) will be extracted from task-related regions of interest (average %BOLD signal change and 90th percentile thereof within ROIs) under the following task-specific contrasts: Instrumental Learning task: Contrast of the Gain-cue vs. neutral cue conditions during the task cue and feedback periods ROIs: ventral striatum (including nucelues accumbens), ventral tegmental area, dorsal anterior cingulate cortex, insula, ventromedial prefrontal cortex/ orbitofrontal cortex and ventral pallidum |
| Other | Exploratory endpoint: average %BOLD signal change and 90th percentile thereof within ROIs during effort-based decision making task | during effort-based decision making task at treatment day 2 | Blood oxygen level dependent (BOLD) fMRI parameter estimates (ß-weights within the GLM analysis) will be extracted from task-related regions of interest (average %BOLD signal change and 90th percentile thereof within ROIs) under the following task-specific contrasts: Effort-based Decision Making task: Contrast of the High reward vs. Low reward conditions during the task CUE2 period Contrast of the High effort vs. Low effort conditions during the task CUE2 period ROIs: ventral striatum (including nucelues accumbens), ventral tegmental area, dorsal anterior cingulate cortex, insula, ventromedial prefrontal cortex/ orbitofrontal cortex and ventral pallidum |
| Other | Exploratory endpoint: reaction times in ms | during all tasks at treatment day 1 and day 2 | Reaction times in ms extracted from the in- scanner protocol log files |
| Other | Exploratory endpoint: response accuracy in percent | during all tasks at treatment day 1 and day 2 | Estimates of response accuracy extracted from the in- scanner protocol log files |
| Other | Exploratory endpoint:average %BOLD signal change and 90th percentile thereof within ROIs during resting state | during resting state at treatment day 1 | Blood oxygen level dependent (BOLD) fMRI signal magnitude and BOLD signal standard deviation during Resting State within the following a-priori defined regions: Default Mode Network (posterior cingulate, vmPFC and medial temporal lobe), Central Executive Network (dorsolateral prefrontal cortex, premotor cortex, precuneus), and Salience Network Network (amygdala, insula and dorsal anterior cingulate) |
| Other | Exploratory endpoint: Arterial Spin Labeling (ASL) | during asl at treatment day 1 | Changes in relative and absolute cerebral blood flow measured through Arterial Spin Labelling MR in whole brain and in the following brain regions: (bilateral): ventral striatum, ventromedial prefrontal cortex/ orbitofrontal cortex, ventral tegmental area, dorsal anterior cingulate cortex, insula, and ventral pallidum after amisulpride administration |
| Other | Exploratory endpoint (Correlation between BOLD signal and self-reported anhedonia ) | treatment day 1 and treatment day 2 | Correlation between magnitude of BOLD signal during reward-and motivation-related processing and self-reported anhedonia after amisulpride administration as compared to placebo in MDD patients relative to HV |
| Other | Exploratory endpoint (Correlation between BOLD signal and behavioral measures) | treatment day 1 and treatment day 2 | Correlation between magnitude of BOLD signal during reward-and motivation-related processing and behavioral measures after amisulpride administration as compared to placebo in MDD patients relative to HV |
| Other | Exploratory endpoint (Correlation between functional connectivity and self-reported anhedonia) | treatment day 1 and treatment day 2 | Correlation between resting state functional connectivity and self- reported anhedonia after amisulpride administration as compared to placebo in MDD patients relative to HV |
| Other | Exploratory endpoint (Correlation between functional connectivity and behavioral measures) | treatment day 1 and treatment day 2 | Correlation between resting state functional connectivity and behavioral measures after amisulpride administration as compared to placebo in MDD patients relative to HV |
| Other | Exploratory endpoint (Change in plasma levels of amisulpride) | treatment day 1 and treatment day 2 | Changes in plasma levels of amisulpride including correlation to changes in BOLD signal in MDD patients relative to HV |
| Other | Exploratory endpoint (Change in whole brain BOLD signal) | treatment day 1 and treatment day 2 | Changes in whole brain BOLD signal after amisulpride administration as compared to placebo in MDD patients relative to HV |
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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