Trial · Interventional
CompletedPhase 2Results postedRegistry dataUnited States
1 trial · 1 completed · 1 with posted results
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
The investigators are conducting this research study to examine whether oxytocin enhances social safety learning (learning safety through the experience of another individual) in people with social anxiety disorder (SAD) compared to healthy volunteers. Oxytocin is a hormone that can also act as a chemical messenger in the brain. Oxytocin plays a role in a number of functions, including responding to fear and social interactions. In this study, the investigators would like to compare the effects of oxytocin and placebo nasal sprays in adults with SAD and healthy adults. This research study will compare an oxytocin nasal spray to a placebo nasal spray. About 120 people will take part in this research study, all at the University of Washington (UW).
Experimental
Clinical
This group consists of individuals with at least moderate symptoms of social anxiety disorder. This group will receive either an oxytocin or placebo administration (blind randomization).
Placebo comparator
Controls
This group consists of a healthy sample of individuals (no lifetime diagnoses of mania or psychotic disorders). This group will receive either an oxytocin or placebo administration (blind randomization).
Outcomes the sponsor listed as primary.
Neural Responses in the CS+R vs CS+S Contrast in the Insula During the Extinction Phase
Time frame · immediately (45 minutes) after receiving drug
Change in task-related blood oxygen level dependent (BOLD) responses in the insula during vicarious extinction (specifically for CS+R (reinforced) versus CS+S (non-reinforced) conditions). Changes in BOLD responses refer to differences in neural responses between these two task conditions, which were extracted from the insula region of interest and estimated using a general linear model. Higher mean responses reflect greater discrimination (better able to distinguish between threat and safety cues) between the task conditions.
Neural Responses in the CS+R vs CS+S Contrast in the Hippocampus During the Extinction Phase
Time frame · immediately (45 minutes) after receiving drug
Change in task-related blood oxygen level dependent (BOLD) responses in the hippocampus during vicarious extinction (specifically for CS+R (reinforced) versus CS+S (non-reinforced) conditions). Changes in BOLD responses refer to differences in neural responses between these two task conditions, which were extracted from the hippocampus region of interest and estimated using a general linear model. Higher mean responses reflect greater discrimination (better able to distinguish between threat and safety cues) between the task conditions.
Neural Responses in the CS+R vs CS+S Contrast in the Anterior Cingulate Cortex During the Extinction Phase
Time frame · immediately (45 minutes) after receiving drug
Change in task-related blood oxygen level dependent (BOLD) responses in the anterior cingulate cortex during vicarious extinction (specifically for CS+R (reinforced) versus CS+S (non-reinforced) conditions). Changes in BOLD responses refer to differences in neural responses between these two task conditions, which were extracted from the anterior cingulate cortex region of interest and estimated using a general linear model. Higher mean responses reflect greater discrimination (better able to distinguish between threat and safety cues) between the task conditions.
Neural Responses in the CS+R vs CS+S Contrast in the Ventromedial Prefrontal Cortex During the Extinction Phase
Time frame · immediately (45 minutes) after receiving drug
Change in task-related blood oxygen level dependent (BOLD) responses in the ventromedial prefrontal cortex during vicarious extinction (specifically for CS+R (reinforced) versus CS+S (non-reinforced) conditions). Changes in BOLD responses refer to differences in neural responses between these two task conditions, which were extracted from the ventromedial prefrontal cortex region of interest and estimated using a general linear model. Higher mean responses reflect greater discrimination (better able to distinguish between threat and safety cues) between the task conditions.
Neural Responses in the CS+R vs CS+S Contrast in the Anterior Cingulate Cortex During the Reinstatement Phase
Time frame · immediately (45 minutes) after receiving drug
Change in task-related blood oxygen level dependent (BOLD) responses in the anterior cingulate cortex during fear reinstatement, which tests for the return of fear (specifically for CS+R (reinforced) versus CS+S (non-reinforced) conditions). Changes in BOLD responses refer to differences in neural responses between these two task conditions, which were extracted from the anterior cingulate cortex region of interest and estimated using a general linear model. Higher mean responses reflect greater discrimination (better able to distinguish between threat and safety cues) between the task conditions.
Neural Responses in the CS+R vs CS+S Contrast in the Insula During the Reinstatement Phase
Time frame · immediately (45 minutes) after receiving drug
Change in task-related blood oxygen level dependent (BOLD) responses in the insula during fear reinstatement, which tests for the return of fear (specifically for CS+R (reinforced) versus CS+S (non-reinforced) conditions). Changes in BOLD responses refer to differences in neural responses between these two task conditions, which were extracted from the insula region of interest and estimated using a general linear model. Higher mean responses reflect greater discrimination (better able to distinguish between threat and safety cues) between the task conditions.
Neural Responses in the CS+R vs CS+S Contrast in the Hippocampus During the Reinstatement Phase
Time frame · immediately (45 minutes) after receiving drug
Change in task-related blood oxygen level dependent (BOLD) responses in the hippocampus during fear reinstatement, which tests for the return of fear (specifically for CS+R (reinforced) versus CS+S (non-reinforced) conditions). Changes in BOLD responses refer to differences in neural responses between these two task conditions, which were extracted from the hippocampus region of interest and estimated using a general linear model. Higher mean responses reflect greater discrimination (better able to distinguish between threat and safety cues) between the task conditions.
Neural Responses in the CS+R vs CS+S Contrast in the Amygdala During the Reinstatement Phase
Time frame · immediately (45 minutes) after receiving drug
Change in task-related blood oxygen level dependent (BOLD) responses in the amygdala during fear reinstatement, which tests for the return of fear (specifically for CS+R (reinforced) versus CS+S (non-reinforced) conditions). Changes in BOLD responses refer to differences in neural responses between these two task conditions, which were extracted from the amygdala region of interest and estimated using a general linear model. Higher mean responses reflect greater discrimination (better able to distinguish between threat and safety cues) between the task conditions.
Skin Conductance Responses (SCR) to CS- During Extinction
Time frame · immediately (45 minutes) after receiving drug
mean skin conductance responses (SCR) for CS- stimuli during Extinction
Skin Conductance Responses (SCR) to CS+S During Extinction
Time frame · immediately (45 minutes) after receiving drug
mean skin conductance responses (SCR) for CS+S stimuli during Extinction
Skin Conductance Responses (SCR) to CS+R During Extinction
Time frame · immediately (45 minutes) after receiving drug
mean skin conductance responses (SCR) for CS+R stimuli during Extinction
Skin Conductance Responses (SCR) to CS- During Reinstatement
Time frame · immediately (45 minutes) after receiving drug
mean skin conductance responses (SCR) for CS- stimuli during Reinstatement
Skin Conductance Responses (SCR) to CS+S During Reinstatement
Time frame · immediately (45 minutes) after receiving drug
mean skin conductance responses (SCR) for CS+S stimuli during Reinstatement
Skin Conductance Responses (SCR) to CS+R During Reinstatement
Time frame · immediately (45 minutes) after receiving drug
mean skin conductance responses (SCR) for CS+R stimuli during Reinstatement
Neural Responses in the CS+R vs CS- Contrast in the Insula During the Extinction Phase
Time frame · immediately (45 minutes) after receiving drug
Change in task-related blood oxygen level dependent (BOLD) responses in the insula during vicarious extinction (specifically for CS+R (reinforced) versus CS+S (non-reinforced) conditions). Changes in BOLD responses refer to differences in neural responses between these two task conditions, which were extracted from the insula region of interest and estimated using a general linear model. Higher mean responses reflect greater discrimination (better able to distinguish between threat and safety cues) between the task conditions.
Neural Responses in the CS+R vs CS- Contrast in the Amygdala During the Extinction Phase
Time frame · immediately (45 minutes) after receiving drug
Change in task-related blood oxygen level dependent (BOLD) responses in the amygdala during vicarious extinction (specifically for CS+R (reinforced) versus CS+S (non-reinforced) conditions). Changes in BOLD responses refer to differences in neural responses between these two task conditions, which were extracted from the amygdala region of interest and estimated using a general linear model. Higher mean responses reflect greater discrimination (better able to distinguish between threat and safety cues) between the task conditions.
Neural Responses in the CS+R vs CS+S Contrast in the Ventromedial Prefrontal Cortex During the Reinstatement Phase
Time frame · immediately (45 minutes) after receiving drug
Change in task-related blood oxygen level dependent (BOLD) responses in the ventromedial prefrontal cortex during fear reinstatement, which tests for the return of fear (specifically for CS+R (reinforced) versus CS+S (non-reinforced) conditions). Changes in BOLD responses refer to differences in neural responses between these two task conditions, which were extracted from the ventromedial prefrontal region of interest and estimated using a general linear model. Higher mean responses reflect greater discrimination (better able to distinguish between threat and safety cues) between the task conditions.
Neural Responses in the CS+R vs CS- Contrast in the Hippocampus During the Extinction Phase
Time frame · immediately (45 minutes) after receiving drug
Change in task-related blood oxygen level dependent (BOLD) responses in the hippocampus during vicarious extinction (specifically for CS+R (reinforced) versus CS+S (non-reinforced) conditions). Changes in BOLD responses refer to differences in neural responses between these two task conditions, which were extracted from the hippocampus region of interest and estimated using a general linear model. Higher mean responses reflect greater discrimination (better able to distinguish between threat and safety cues) between the task conditions.
Neural Responses in the CS+R vs CS- Contrast in the Anterior Cingulate Cortex During the Extinction Phase
Time frame · immediately (45 minutes) after receiving drug
Change in task-related blood oxygen level dependent (BOLD) responses in the anterior cingulate cortex during vicarious extinction (specifically for CS+R (reinforced) versus CS+S (non-reinforced) conditions). Changes in BOLD responses refer to differences in neural responses between these two task conditions, which were extracted from the anterior cingulate cortex region of interest and estimated using a general linear model. Higher mean responses reflect greater discrimination (better able to distinguish between threat and safety cues) between the task conditions.
Neural Responses in the CS+R vs CS- Contrast in the Ventromedial Prefrontal Cortex During the Extinction Phase
Time frame · immediately (45 minutes) after receiving drug
Change in task-related blood oxygen level dependent (BOLD) responses in the ventromedial prefrontal cortex during vicarious extinction (specifically for CS+R (reinforced) versus CS+S (non-reinforced) conditions). Changes in BOLD responses refer to differences in neural responses between these two task conditions, which were extracted from the ventromedial prefrontal cortex region of interest and estimated using a general linear model. Higher mean responses reflect greater discrimination (better able to distinguish between threat and safety cues) between the task conditions.
Neural Responses in the CS+R vs CS- Contrast in the Amygdala During the Reinstatement Phase
Time frame · immediately (45 minutes) after receiving drug
Change in task-related blood oxygen level dependent (BOLD) responses in the amygdala during fear reinstatement, which tests for the return of fear (specifically for CS+R (reinforced) versus CS- (non-reinforced) conditions). Changes in BOLD responses refer to differences in neural responses between these two task conditions, which were extracted from the amygdala region of interest and estimated using a general linear model. Higher mean responses reflect greater discrimination (better able to distinguish between threat and safety cues) between the task conditions.
Neural Responses in the CS+R vs CS- Contrast in the Insula During the Reinstatement Phase
Time frame · immediately (45 minutes) after receiving drug
Change in task-related blood oxygen level dependent (BOLD) responses in the insula during fear reinstatement, which tests for the return of fear (specifically for CS+R (reinforced) versus CS- (non-reinforced) conditions). Changes in BOLD responses refer to differences in neural responses between these two task conditions, which were extracted from the insula region of interest and estimated using a general linear model. Higher mean responses reflect greater discrimination (better able to distinguish between threat and safety cues) between the task conditions.
Neural Responses in the CS+R vs CS- Contrast in the Hippocampus During the Reinstatement Phase
Time frame · immediately (45 minutes) after receiving drug
Change in task-related blood oxygen level dependent (BOLD) responses in the hippocampus during fear reinstatement, which tests for the return of fear (specifically for CS+R (reinforced) versus CS- (non-reinforced) conditions). Changes in BOLD responses refer to differences in neural responses between these two task conditions, which were extracted from the hippocampus region of interest and estimated using a general linear model. Higher mean responses reflect greater discrimination (better able to distinguish between threat and safety cues) between the task conditions.
Neural Responses in the CS+R vs CS- Contrast in the Anterior Cingulate Cortex During the Reinstatement Phase
Time frame · immediately (45 minutes) after receiving drug
Change in task-related blood oxygen level dependent (BOLD) responses in the anterior cingulate cortex during fear reinstatement, which tests for the return of fear (specifically for CS+R (reinforced) versus CS- (non-reinforced) conditions). Changes in BOLD responses refer to differences in neural responses between these two task conditions, which were extracted from the anterior cingulate cortex region of interest and estimated using a general linear model. Higher mean responses reflect greater discrimination (better able to distinguish between threat and safety cues) between the task conditions.
Neural Responses in the CS+S vs CS- Contrast in the Hippocampus During the Extinction Phase
Time frame · immediately (45 minutes) after receiving drug
Change in task-related blood oxygen level dependent (BOLD) responses in the hippocampus during vicarious extinction (specifically for CS+S versus CS- conditions). Changes in BOLD responses refer to differences in neural responses between these two task conditions, which were extracted from the hippocampus region of interest and estimated using a general linear model. A lack of difference between these two task conditions is desirable, indicating processing both task conditions as safety cues.
Neural Responses in the CS+R vs CS- Contrast in the Ventromedial Prefrontal Cortex During the Reinstatement Phase
Time frame · immediately (45 minutes) after receiving drug
Change in task-related blood oxygen level dependent (BOLD) responses in the ventromedial prefrontal cortex during fear reinstatement, which tests for the return of fear (specifically for CS+R (reinforced) versus CS- (non-reinforced) conditions). Changes in BOLD responses refer to differences in neural responses between these two task conditions, which were extracted from the ventromedial prefrontal cortex region of interest and estimated using a general linear model. Higher mean responses reflect greater discrimination (better able to distinguish between threat and safety cues) between the task conditions.
Neural Responses in the CS+S vs CS- Contrast in the Amygdala During the Extinction Phase
Time frame · immediately (45 minutes) after receiving drug
Change in task-related blood oxygen level dependent (BOLD) responses in the amygdala during vicarious extinction (specifically for CS+S versus CS- conditions). Changes in BOLD responses refer to differences in neural responses between these two task conditions, which were extracted from the amygdala region of interest and estimated using a general linear model. A lack of difference between these two task conditions is desirable, indicating processing both task conditions as safety cues.
Neural Responses in the CS+S vs CS- Contrast in the Insula During the Extinction Phase
Time frame · immediately (45 minutes) after receiving drug
Change in task-related blood oxygen level dependent (BOLD) responses in the insula during vicarious extinction (specifically for CS+S versus CS- conditions). Changes in BOLD responses refer to differences in neural responses between these two task conditions, which were extracted from the insula region of interest and estimated using a general linear model. A lack of difference between these two task conditions is desirable, indicating processing both task conditions as safety cues.
Neural Responses in the CS+S vs CS- Contrast in the Ventromedial Prefrontal Cortex During the Extinction Phase
Time frame · immediately (45 minutes) after receiving drug
Change in task-related blood oxygen level dependent (BOLD) responses in the ventromedial prefrontal cortex during vicarious extinction (specifically for CS+S versus CS- conditions). Changes in BOLD responses refer to differences in neural responses between these two task conditions, which were extracted from the ventromedial prefrontal cortex region of interest and estimated using a general linear model. A lack of difference between these two task conditions is desirable, indicating processing both task conditions as safety cues.
Neural Responses in the CS+S vs CS- Contrast in the Anterior Cingulate Cortex During the Extinction Phase
Time frame · immediately (45 minutes) after receiving drug
Change in task-related blood oxygen level dependent (BOLD) responses in the anterior cingulate cortex during vicarious extinction (specifically for CS+S versus CS- conditions). Changes in BOLD responses refer to differences in neural responses between these two task conditions, which were extracted from the anterior cingulate cortex region of interest and estimated using a general linear model. A lack of difference between these two task conditions is desirable, indicating processing both task conditions as safety cues.
Neural Responses in the CS+S vs CS- Contrast in the Amygdala During the Reinstatement Phase
Time frame · immediately (45 minutes) after receiving drug
Change in task-related blood oxygen level dependent (BOLD) responses in the amygdala during fear reinstatement, which tests the return of fear (specifically for CS+S versus CS- conditions). Changes in BOLD responses refer to differences in neural responses between these two task conditions, which were extracted from the amygdala region of interest and estimated using a general linear model. A lack of difference between these two task conditions is desirable, indicating processing both task conditions as safety cues.
Neural Responses in the CS+S vs CS- Contrast in the Insula During the Reinstatement Phase
Time frame · immediately (45 minutes) after receiving drug
Change in task-related blood oxygen level dependent (BOLD) responses in the insula during fear reinstatement, which tests the return of fear (specifically for CS+S versus CS- conditions). Changes in BOLD responses refer to differences in neural responses between these two task conditions, which were extracted from the insula region of interest and estimated using a general linear model. A lack of difference between these two task conditions is desirable, indicating processing both task conditions as safety cues.
Neural Responses in the CS+S vs CS- Contrast in the Hippocampus During the Reinstatement Phase
Time frame · immediately (45 minutes) after receiving drug
Change in task-related blood oxygen level dependent (BOLD) responses in the hippocampus during fear reinstatement, which tests the return of fear (specifically for CS+S versus CS- conditions). Changes in BOLD responses refer to differences in neural responses between these two task conditions, which were extracted from the hippocampus region of interest and estimated using a general linear model. A lack of difference between these two task conditions is desirable, indicating processing both task conditions as safety cues.
Neural Responses in the CS+S vs CS- Contrast in the Anterior Cingulate Cortex During the Reinstatement Phase
Time frame · immediately (45 minutes) after receiving drug
Change in task-related blood oxygen level dependent (BOLD) responses in the anterior cingulate cortex during fear reinstatement, which tests the return of fear (specifically for CS+S versus CS- conditions). Changes in BOLD responses refer to differences in neural responses between these two task conditions, which were extracted from the anterior cingulate cortex region of interest and estimated using a general linear model. A lack of difference between these two task conditions is desirable, indicating processing both task conditions as safety cues.
Neural Responses in the CS+S vs CS- Contrast in the Ventromedial Prefrontal Cortex During the Reinstatement Phase
Time frame · immediately (45 minutes) after receiving drug
Change in task-related blood oxygen level dependent (BOLD) responses in the ventromedial prefrontal cortex during fear reinstatement, which tests the return of fear (specifically for CS+S versus CS- conditions). Changes in BOLD responses refer to differences in neural responses between these two task conditions, which were extracted from the ventromedial prefrontal cortex region of interest and estimated using a general linear model. A lack of difference between these two task conditions is desirable, indicating processing both task conditions as safety cues.
Neural Responses in the CS+R vs CS+S Contrast in the Ventromedial Prefrontal Cortex During the Reinstatement Phase
Time frame · immediately (45 minutes) after receiving drug
Change in task-related blood oxygen level dependent (BOLD) responses in the amygdala during fear reinstatement, which tests for the return of fear (specifically for CS+R (reinforced) versus CS+S (non-reinforced) conditions). Changes in BOLD responses refer to differences in neural responses between these two task conditions, which were extracted from the ventromedial prefrontal cortex region of interest and estimated using a general linear model. Higher mean responses reflect greater discrimination (better able to distinguish between threat and safety cues) between the task conditions.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (change in BOLD responses) | Spread |
|---|---|---|
| Clinical-Placebo | -0.30981097 | 1.26938756 |
| Clinical-Oxytocin | 0.30048434 | 1.18240582 |
| Controls-Placebo | -0.13914898 | 1.37320224 |
| Controls-Oxytocin | 0.15823593 | 1.17250848 |
| Group | Value (change in BOLD responses) | Spread |
|---|---|---|
| Clinical-Placebo | -0.54355789 | 1.335981511 |
| Clinical-Oxytocin | -0.43311088 | 1.093056486 |
| Controls-Placebo | -0.19255644 | 1.431375519 |
| Controls-Oxytocin | -0.76718325 | 1.20337605 |
| Group | Value (change in BOLD responses) | Spread |
|---|---|---|
| Clinical-Placebo | -0.07399244 | 1.07281373 |
| Clinical-Oxytocin | 0.063813396 | 1.38005297 |
| Controls-Placebo | 0.156824376 | 1.295934186 |
| Controls-Oxytocin | 0.279316489 | 1.259501388 |
| Group | Value (changes in BOLD responses) | Spread |
|---|---|---|
| Clinical-Placebo | -0.204600375 | 1.285989133 |
| Clinical-Oxytocin | 0.106625352 | 1.27655833 |
| Controls-Placebo | -0.306720406 | 1.245533541 |
| Controls-Oxytocin | -0.214274187 | 1.6338638 |
| Group | Value (change in BOLD responses) | Spread |
|---|---|---|
| Clinical-Placebo | 0.130227 | 1.372415 |
| Clinical-Oxytocin | 0.296665 | 1.181538 |
| Controls-Placebo | 0.295264 | 1.16357 |
| Controls-Oxytocin | 0.605202 | 1.608406 |
| Group | Value (change in BOLD responses) | Spread |
|---|---|---|
| Clinical-Placebo | 0.057116 | 1.260536 |
| Clinical-Oxytocin | 0.447198 | 1.340947 |
| Controls-Placebo | 0.151774 | 1.466662 |
| Controls-Oxytocin | 0.66191 | 1.598863 |
| Group | Value (change in BOLD responses) | Spread |
|---|---|---|
| Clinical-Placebo | -0.11068 | 1.31177 |
| Clinical-Oxytocin | -0.03876 | 1.292054 |
| Controls-Placebo | 0.145557 | 1.243421 |
| Controls-Oxytocin | -0.06121 | 1.285574 |
| Group | Value (change in BOLD responses) | Spread |
|---|---|---|
| Clinical-Placebo | -0.14044 | 1.142882 |
| Clinical-Oxytocin | 0.213951 | 1.122094 |
| Controls-Placebo | 0.114811 | 1.414787 |
| Controls-Oxytocin | 0.15224 | 1.207956 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Clinical-PlaceboThis group consists of individuals with at least moderate symptoms of social anxiety disorder. This group will receive a placebo administration (assigned via blind randomization). | 0 / 23 | 0 / 23 | 11 / 23 |
| Clinical-OxytocinThis group consists of individuals with at least moderate symptoms of social anxiety disorder. This group will receive an oxytocin administration (assigned via blind randomization) | 0 / 28 | 0 / 28 | 17 / 28 |
| Controls-PlaceboThis group consists of a healthy sample of individuals (no lifetime diagnoses of mania or psychotic disorders). This group will receive a placebo administration (assigned via blind randomization). | 0 / 28 | 0 / 28 | 16 / 28 |
| Controls-OxytocinThis group consists of a healthy sample of individuals (no lifetime diagnoses of mania or psychotic disorders). This group will receive an oxytocin administration (assigned via blind randomization). | 0 / 24 | 0 / 24 | 13 / 24 |
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