Trial Outcomes & Findings for Brain Imaging Changes in Fear and Anxiety (NCT NCT00047853)

Last Updated: 2024-03-12

Results Overview

The average bed nucleus of the stria terminalis (BNST) correlations between all averaged time series were extracted from the raters' individual masks. Blood Oxygenation Level Dependent (BOLD) signals were used to extract a mean time series from the BNST masks. This time series was correlated across the rest of the brain using 3dTcorr1D, which computes the correlation coefficient between each voxel time series. Raters were blinded to subject identity for subjective sensory effects at high field and inter-rater and volume measurements for the drawn BNST masks. Correlations were calculated between average time series extracted between all raters' masks for each subject. Two separate analyses for the left and right BNSTs were performed.

Recruitment status

COMPLETED

Study phase

Target enrollment

1080 participants

Primary outcome timeframe

10 minutes

Results posted on

2024-03-12

Participant Flow

15 participants were screen failure and two participants withdrew prior to start of study.

Participants had the option to volunteer for one or more sub-study

Participant milestones

Participant milestones
Measure	Healthy Volunteers Healthy volunteers participated in one or more sub-studies: Perception, Memory, Resting State, Passive Presentation, Loss Aversion Task, Motivation/reward, valence/salience study (ValSal Task)) and underwent Functional magnetic resonance imaging (fMRI) and/or magneto-encephalography (MEG).	Patients Participants with diagnosis of generalized anxiety disorder (GAD), panic disorder, social anxiety disorder (SAD), specific phobia, posttraumatic stress disorder (PTSD), or major depression participated in one or more sub-studies: Perception, Memory, Resting State, Passive Presentation, Loss Aversion Task, Motivation/reward, valence/salience study (ValSal Task)) and underwent Functional magnetic resonance imaging (fMRI).
Overall Study Participants STARTED	921	142
Overall Study Participants COMPLETED	921	142
Overall Study Participants NOT COMPLETED	0	0
Perception Study STARTED	396	4
Perception Study COMPLETED	396	4
Perception Study NOT COMPLETED	0	0
Memory Study STARTED	165	50
Memory Study COMPLETED	165	50
Memory Study NOT COMPLETED	0	0
Resting State Study STARTED	218	57
Resting State Study COMPLETED	218	57
Resting State Study NOT COMPLETED	0	0
Passive Presentation Study STARTED	57	0
Passive Presentation Study COMPLETED	57	0
Passive Presentation Study NOT COMPLETED	0	0
Loss Aversion Task STARTED	14	22
Loss Aversion Task COMPLETED	14	22
Loss Aversion Task NOT COMPLETED	0	0
Motivation Task STARTED	264	37
Motivation Task COMPLETED	264	37
Motivation Task NOT COMPLETED	0	0
Valence/Salience Study (ValSal Task) STARTED	118	32
Valence/Salience Study (ValSal Task) COMPLETED	118	32
Valence/Salience Study (ValSal Task) NOT COMPLETED	0	0
Active Avoidance and Sustained Attention STARTED	162	58
Active Avoidance and Sustained Attention COMPLETED	162	58
Active Avoidance and Sustained Attention NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Analysis is a breakout of the two groups in the study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Perception Study n=400 Participants Participants identified the expression on faces or identified the emotion of a word and were asked to respond during these stimuli themselves and during neutral pictures which were paired with these stimuli. Participants could also be asked to judge how long stimuli remained on the screen by making a button press denoting the relative duration of these stimuli compared to durations they learned.	Memory Study n=147 Participants Participants performed one or more memory tasks: a) navigated a virtual reality water maze with a joystick to learn the location of an escape platform; b) Behavioral Pattern Separation (BPS) task which consisted of two phases - first participants assign an indoor/outdoor verdict to pictures of neutral objects and completed a memory test. Lastly, participants were asked to remember verbal and nonverbal stimuli which consisted of words, pictures, letters or spatial locations in series of stimuli.	Resting State Study n=243 Participants Participants laid still with their eyes open and stared at a fixation cross for 6-9 minutes without falling asleep. During a resting state run, participants did not engage in any task. However, on some rest runs, they were under the threat of a shock or safe from shock.	Passive Presentation Study n=4 Participants Participants engaged in simple, passive experience (visual, auditory, tactile) to measure sensory responses under threat and safe conditions. Participants were asked to remain attentive to whether they were at risk of receiving shock or safe from shocks but did not need to respond to the stimuli.	Loss Aversion Task n=13 Participants Participants decided between taking or dismissing a series of monetary gambles.	Motivation Task (Monetary Incentive Delay (MID) Subjects) n=197 Participants Participants performed one of two versions of the MID task. The first version of the task examined the effect of threat of shock on goal driven/motivational stimuli where subjects made speeded responses to a central target under conditions of potential monetary gain, loss, or neutrality during threat of shock and during safety. During the second version, participants performed the MID task within the MRI scanner.	Valence/Salience Study (ValSal Task) n=52 Participants Participants completed the ValSal task involving two motivated behaviors, valence and salience. Valence compared the positive versus negative values tagged to stimuli/situations. Salience examined the subjective importance of stimuli/situations.	Active Avoidance and Sustained Attention Tasks n=7 Participants In the active avoidance signal task (AAST), participants performed a modified version of the threat paradigm during which, they held down a button and view sequentially presented pairs of colored squares and were instructed to lift their finger when they see the medium-medium color combination (i.e. "go" trials), and to refrain from lifting their finger during all other combinations (i.e. "stop" trials). Participants performed alternating blocks in safe and threat conditions, and each block consisted of a series of "go" and "stop" trials. In the sustained attention to response task (SART), subjects participated in go/nogo during periods of threat of shocks and periods of safety, when no shock could be administered.	Total n=1063 Participants Total of all reporting groups
Age, Categorical Healthy Volunteers · <=18 years	0 Participants n=396 Participants • Analysis is a breakout of the two groups in the study	0 Participants n=97 Participants • Analysis is a breakout of the two groups in the study	0 Participants n=190 Participants • Analysis is a breakout of the two groups in the study	0 Participants n=4 Participants • Analysis is a breakout of the two groups in the study	0 Participants n=4 Participants • Analysis is a breakout of the two groups in the study	0 Participants n=187 Participants • Analysis is a breakout of the two groups in the study	0 Participants n=36 Participants • Analysis is a breakout of the two groups in the study	0 Participants n=7 Participants • Analysis is a breakout of the two groups in the study	0 Participants n=921 Participants • Analysis is a breakout of the two groups in the study
Age, Categorical Healthy Volunteers · Between 18 and 65 years	396 Participants n=396 Participants • Analysis is a breakout of the two groups in the study	97 Participants n=97 Participants • Analysis is a breakout of the two groups in the study	190 Participants n=190 Participants • Analysis is a breakout of the two groups in the study	4 Participants n=4 Participants • Analysis is a breakout of the two groups in the study	4 Participants n=4 Participants • Analysis is a breakout of the two groups in the study	187 Participants n=187 Participants • Analysis is a breakout of the two groups in the study	36 Participants n=36 Participants • Analysis is a breakout of the two groups in the study	7 Participants n=7 Participants • Analysis is a breakout of the two groups in the study	921 Participants n=921 Participants • Analysis is a breakout of the two groups in the study
Age, Categorical Healthy Volunteers · >=65 years	0 Participants n=396 Participants • Analysis is a breakout of the two groups in the study	0 Participants n=97 Participants • Analysis is a breakout of the two groups in the study	0 Participants n=190 Participants • Analysis is a breakout of the two groups in the study	0 Participants n=4 Participants • Analysis is a breakout of the two groups in the study	0 Participants n=4 Participants • Analysis is a breakout of the two groups in the study	0 Participants n=187 Participants • Analysis is a breakout of the two groups in the study	0 Participants n=36 Participants • Analysis is a breakout of the two groups in the study	0 Participants n=7 Participants • Analysis is a breakout of the two groups in the study	0 Participants n=921 Participants • Analysis is a breakout of the two groups in the study
Age, Categorical Patients · <=18 years	0 Participants n=4 Participants • Analysis is a breakout of the two groups in the study	0 Participants n=50 Participants • Analysis is a breakout of the two groups in the study	0 Participants n=53 Participants • Analysis is a breakout of the two groups in the study	—	0 Participants n=9 Participants • Analysis is a breakout of the two groups in the study	0 Participants n=10 Participants • Analysis is a breakout of the two groups in the study	0 Participants n=16 Participants • Analysis is a breakout of the two groups in the study	0 Participants Analysis is a breakout of the two groups in the study	0 Participants n=142 Participants • Analysis is a breakout of the two groups in the study
Age, Categorical Patients · Between 18 and 65 years	4 Participants n=4 Participants • Analysis is a breakout of the two groups in the study	50 Participants n=50 Participants • Analysis is a breakout of the two groups in the study	53 Participants n=53 Participants • Analysis is a breakout of the two groups in the study	—	9 Participants n=9 Participants • Analysis is a breakout of the two groups in the study	10 Participants n=10 Participants • Analysis is a breakout of the two groups in the study	16 Participants n=16 Participants • Analysis is a breakout of the two groups in the study	0 Participants Analysis is a breakout of the two groups in the study	142 Participants n=142 Participants • Analysis is a breakout of the two groups in the study
Age, Categorical Patients · >=65 years	0 Participants n=4 Participants • Analysis is a breakout of the two groups in the study	0 Participants n=50 Participants • Analysis is a breakout of the two groups in the study	0 Participants n=53 Participants • Analysis is a breakout of the two groups in the study	—	0 Participants n=9 Participants • Analysis is a breakout of the two groups in the study	0 Participants n=10 Participants • Analysis is a breakout of the two groups in the study	0 Participants n=16 Participants • Analysis is a breakout of the two groups in the study	0 Participants Analysis is a breakout of the two groups in the study	0 Participants n=142 Participants • Analysis is a breakout of the two groups in the study
Sex: Female, Male Healthy Volunteers · Female	201 Participants n=396 Participants • Analysis is a breakout of the two groups in the study	48 Participants n=97 Participants • Analysis is a breakout of the two groups in the study	106 Participants n=190 Participants • Analysis is a breakout of the two groups in the study	1 Participants n=4 Participants • Analysis is a breakout of the two groups in the study	3 Participants n=4 Participants • Analysis is a breakout of the two groups in the study	83 Participants n=187 Participants • Analysis is a breakout of the two groups in the study	21 Participants n=36 Participants • Analysis is a breakout of the two groups in the study	3 Participants n=7 Participants • Analysis is a breakout of the two groups in the study	466 Participants n=921 Participants • Analysis is a breakout of the two groups in the study
Sex: Female, Male Healthy Volunteers · Male	195 Participants n=396 Participants • Analysis is a breakout of the two groups in the study	49 Participants n=97 Participants • Analysis is a breakout of the two groups in the study	84 Participants n=190 Participants • Analysis is a breakout of the two groups in the study	3 Participants n=4 Participants • Analysis is a breakout of the two groups in the study	1 Participants n=4 Participants • Analysis is a breakout of the two groups in the study	104 Participants n=187 Participants • Analysis is a breakout of the two groups in the study	15 Participants n=36 Participants • Analysis is a breakout of the two groups in the study	4 Participants n=7 Participants • Analysis is a breakout of the two groups in the study	455 Participants n=921 Participants • Analysis is a breakout of the two groups in the study
Sex: Female, Male Patients · Female	2 Participants n=4 Participants • Analysis is a breakout of the two groups in the study	33 Participants n=50 Participants • Analysis is a breakout of the two groups in the study	41 Participants n=53 Participants • Analysis is a breakout of the two groups in the study	0 Participants Analysis is a breakout of the two groups in the study	9 Participants n=9 Participants • Analysis is a breakout of the two groups in the study	9 Participants n=10 Participants • Analysis is a breakout of the two groups in the study	10 Participants n=16 Participants • Analysis is a breakout of the two groups in the study	0 Participants Analysis is a breakout of the two groups in the study	104 Participants n=142 Participants • Analysis is a breakout of the two groups in the study
Sex: Female, Male Patients · Male	2 Participants n=4 Participants • Analysis is a breakout of the two groups in the study	17 Participants n=50 Participants • Analysis is a breakout of the two groups in the study	12 Participants n=53 Participants • Analysis is a breakout of the two groups in the study	0 Participants Analysis is a breakout of the two groups in the study	0 Participants n=9 Participants • Analysis is a breakout of the two groups in the study	1 Participants n=10 Participants • Analysis is a breakout of the two groups in the study	6 Participants n=16 Participants • Analysis is a breakout of the two groups in the study	0 Participants Analysis is a breakout of the two groups in the study	38 Participants n=142 Participants • Analysis is a breakout of the two groups in the study
Ethnicity (NIH/OMB) Healthy Volunteers · Hispanic or Latino	21 Participants n=396 Participants • Analysis is a breakout of the two groups in the study	5 Participants n=97 Participants • Analysis is a breakout of the two groups in the study	21 Participants n=190 Participants • Analysis is a breakout of the two groups in the study	0 Participants n=4 Participants • Analysis is a breakout of the two groups in the study	1 Participants n=4 Participants • Analysis is a breakout of the two groups in the study	15 Participants n=187 Participants • Analysis is a breakout of the two groups in the study	4 Participants n=36 Participants • Analysis is a breakout of the two groups in the study	0 Participants n=7 Participants • Analysis is a breakout of the two groups in the study	67 Participants n=921 Participants • Analysis is a breakout of the two groups in the study
Ethnicity (NIH/OMB) Healthy Volunteers · Not Hispanic or Latino	367 Participants n=396 Participants • Analysis is a breakout of the two groups in the study	92 Participants n=97 Participants • Analysis is a breakout of the two groups in the study	167 Participants n=190 Participants • Analysis is a breakout of the two groups in the study	4 Participants n=4 Participants • Analysis is a breakout of the two groups in the study	3 Participants n=4 Participants • Analysis is a breakout of the two groups in the study	165 Participants n=187 Participants • Analysis is a breakout of the two groups in the study	32 Participants n=36 Participants • Analysis is a breakout of the two groups in the study	7 Participants n=7 Participants • Analysis is a breakout of the two groups in the study	837 Participants n=921 Participants • Analysis is a breakout of the two groups in the study
Ethnicity (NIH/OMB) Healthy Volunteers · Unknown or Not Reported	8 Participants n=396 Participants • Analysis is a breakout of the two groups in the study	0 Participants n=97 Participants • Analysis is a breakout of the two groups in the study	2 Participants n=190 Participants • Analysis is a breakout of the two groups in the study	0 Participants n=4 Participants • Analysis is a breakout of the two groups in the study	0 Participants n=4 Participants • Analysis is a breakout of the two groups in the study	7 Participants n=187 Participants • Analysis is a breakout of the two groups in the study	0 Participants n=36 Participants • Analysis is a breakout of the two groups in the study	0 Participants n=7 Participants • Analysis is a breakout of the two groups in the study	17 Participants n=921 Participants • Analysis is a breakout of the two groups in the study
Ethnicity (NIH/OMB) Patients · Hispanic or Latino	0 Participants n=4 Participants • Analysis is a breakout of the two groups in the study	4 Participants n=50 Participants • Analysis is a breakout of the two groups in the study	7 Participants n=53 Participants • Analysis is a breakout of the two groups in the study	0 Participants Analysis is a breakout of the two groups in the study	0 Participants n=9 Participants • Analysis is a breakout of the two groups in the study	1 Participants n=10 Participants • Analysis is a breakout of the two groups in the study	1 Participants n=16 Participants • Analysis is a breakout of the two groups in the study	0 Participants Analysis is a breakout of the two groups in the study	13 Participants n=142 Participants • Analysis is a breakout of the two groups in the study
Ethnicity (NIH/OMB) Patients · Not Hispanic or Latino	4 Participants n=4 Participants • Analysis is a breakout of the two groups in the study	44 Participants n=50 Participants • Analysis is a breakout of the two groups in the study	44 Participants n=53 Participants • Analysis is a breakout of the two groups in the study	0 Participants Analysis is a breakout of the two groups in the study	9 Participants n=9 Participants • Analysis is a breakout of the two groups in the study	9 Participants n=10 Participants • Analysis is a breakout of the two groups in the study	15 Participants n=16 Participants • Analysis is a breakout of the two groups in the study	0 Participants Analysis is a breakout of the two groups in the study	125 Participants n=142 Participants • Analysis is a breakout of the two groups in the study
Ethnicity (NIH/OMB) Patients · Unknown or Not Reported	0 Participants n=4 Participants • Analysis is a breakout of the two groups in the study	2 Participants n=50 Participants • Analysis is a breakout of the two groups in the study	2 Participants n=53 Participants • Analysis is a breakout of the two groups in the study	0 Participants Analysis is a breakout of the two groups in the study	0 Participants n=9 Participants • Analysis is a breakout of the two groups in the study	0 Participants n=10 Participants • Analysis is a breakout of the two groups in the study	0 Participants n=16 Participants • Analysis is a breakout of the two groups in the study	0 Participants Analysis is a breakout of the two groups in the study	4 Participants n=142 Participants • Analysis is a breakout of the two groups in the study
Race (NIH/OMB) Healthy Volunteers · American Indian or Alaska Native	0 Participants n=396 Participants • Analysis is a breakout of the two groups in the study	1 Participants n=97 Participants • Analysis is a breakout of the two groups in the study	0 Participants n=190 Participants • Analysis is a breakout of the two groups in the study	0 Participants n=4 Participants • Analysis is a breakout of the two groups in the study	0 Participants n=4 Participants • Analysis is a breakout of the two groups in the study	0 Participants n=187 Participants • Analysis is a breakout of the two groups in the study	0 Participants n=36 Participants • Analysis is a breakout of the two groups in the study	0 Participants n=7 Participants • Analysis is a breakout of the two groups in the study	1 Participants n=921 Participants • Analysis is a breakout of the two groups in the study
Race (NIH/OMB) Healthy Volunteers · Asian	47 Participants n=396 Participants • Analysis is a breakout of the two groups in the study	20 Participants n=97 Participants • Analysis is a breakout of the two groups in the study	40 Participants n=190 Participants • Analysis is a breakout of the two groups in the study	0 Participants n=4 Participants • Analysis is a breakout of the two groups in the study	1 Participants n=4 Participants • Analysis is a breakout of the two groups in the study	15 Participants n=187 Participants • Analysis is a breakout of the two groups in the study	12 Participants n=36 Participants • Analysis is a breakout of the two groups in the study	0 Participants n=7 Participants • Analysis is a breakout of the two groups in the study	135 Participants n=921 Participants • Analysis is a breakout of the two groups in the study
Race (NIH/OMB) Healthy Volunteers · Native Hawaiian or Other Pacific Islander	0 Participants n=396 Participants • Analysis is a breakout of the two groups in the study	1 Participants n=97 Participants • Analysis is a breakout of the two groups in the study	1 Participants n=190 Participants • Analysis is a breakout of the two groups in the study	0 Participants n=4 Participants • Analysis is a breakout of the two groups in the study	0 Participants n=4 Participants • Analysis is a breakout of the two groups in the study	0 Participants n=187 Participants • Analysis is a breakout of the two groups in the study	0 Participants n=36 Participants • Analysis is a breakout of the two groups in the study	0 Participants n=7 Participants • Analysis is a breakout of the two groups in the study	2 Participants n=921 Participants • Analysis is a breakout of the two groups in the study
Race (NIH/OMB) Healthy Volunteers · Black or African American	80 Participants n=396 Participants • Analysis is a breakout of the two groups in the study	26 Participants n=97 Participants • Analysis is a breakout of the two groups in the study	47 Participants n=190 Participants • Analysis is a breakout of the two groups in the study	0 Participants n=4 Participants • Analysis is a breakout of the two groups in the study	0 Participants n=4 Participants • Analysis is a breakout of the two groups in the study	42 Participants n=187 Participants • Analysis is a breakout of the two groups in the study	6 Participants n=36 Participants • Analysis is a breakout of the two groups in the study	2 Participants n=7 Participants • Analysis is a breakout of the two groups in the study	203 Participants n=921 Participants • Analysis is a breakout of the two groups in the study
Race (NIH/OMB) Healthy Volunteers · White	242 Participants n=396 Participants • Analysis is a breakout of the two groups in the study	45 Participants n=97 Participants • Analysis is a breakout of the two groups in the study	84 Participants n=190 Participants • Analysis is a breakout of the two groups in the study	4 Participants n=4 Participants • Analysis is a breakout of the two groups in the study	2 Participants n=4 Participants • Analysis is a breakout of the two groups in the study	111 Participants n=187 Participants • Analysis is a breakout of the two groups in the study	17 Participants n=36 Participants • Analysis is a breakout of the two groups in the study	4 Participants n=7 Participants • Analysis is a breakout of the two groups in the study	509 Participants n=921 Participants • Analysis is a breakout of the two groups in the study
Race (NIH/OMB) Healthy Volunteers · More than one race	8 Participants n=396 Participants • Analysis is a breakout of the two groups in the study	2 Participants n=97 Participants • Analysis is a breakout of the two groups in the study	8 Participants n=190 Participants • Analysis is a breakout of the two groups in the study	0 Participants n=4 Participants • Analysis is a breakout of the two groups in the study	0 Participants n=4 Participants • Analysis is a breakout of the two groups in the study	4 Participants n=187 Participants • Analysis is a breakout of the two groups in the study	1 Participants n=36 Participants • Analysis is a breakout of the two groups in the study	1 Participants n=7 Participants • Analysis is a breakout of the two groups in the study	24 Participants n=921 Participants • Analysis is a breakout of the two groups in the study
Race (NIH/OMB) Healthy Volunteers · Unknown or Not Reported	19 Participants n=396 Participants • Analysis is a breakout of the two groups in the study	2 Participants n=97 Participants • Analysis is a breakout of the two groups in the study	10 Participants n=190 Participants • Analysis is a breakout of the two groups in the study	0 Participants n=4 Participants • Analysis is a breakout of the two groups in the study	1 Participants n=4 Participants • Analysis is a breakout of the two groups in the study	15 Participants n=187 Participants • Analysis is a breakout of the two groups in the study	0 Participants n=36 Participants • Analysis is a breakout of the two groups in the study	0 Participants n=7 Participants • Analysis is a breakout of the two groups in the study	47 Participants n=921 Participants • Analysis is a breakout of the two groups in the study
Race (NIH/OMB) Patients · American Indian or Alaska Native	0 Participants n=4 Participants • Analysis is a breakout of the two groups in the study	0 Participants n=50 Participants • Analysis is a breakout of the two groups in the study	1 Participants n=53 Participants • Analysis is a breakout of the two groups in the study	0 Participants Analysis is a breakout of the two groups in the study	0 Participants n=9 Participants • Analysis is a breakout of the two groups in the study	0 Participants n=10 Participants • Analysis is a breakout of the two groups in the study	0 Participants n=16 Participants • Analysis is a breakout of the two groups in the study	0 Participants Analysis is a breakout of the two groups in the study	1 Participants n=142 Participants • Analysis is a breakout of the two groups in the study
Race (NIH/OMB) Patients · Asian	0 Participants n=4 Participants • Analysis is a breakout of the two groups in the study	2 Participants n=50 Participants • Analysis is a breakout of the two groups in the study	5 Participants n=53 Participants • Analysis is a breakout of the two groups in the study	0 Participants Analysis is a breakout of the two groups in the study	3 Participants n=9 Participants • Analysis is a breakout of the two groups in the study	1 Participants n=10 Participants • Analysis is a breakout of the two groups in the study	1 Participants n=16 Participants • Analysis is a breakout of the two groups in the study	0 Participants Analysis is a breakout of the two groups in the study	12 Participants n=142 Participants • Analysis is a breakout of the two groups in the study
Race (NIH/OMB) Patients · Native Hawaiian or Other Pacific Islander	0 Participants n=4 Participants • Analysis is a breakout of the two groups in the study	0 Participants n=50 Participants • Analysis is a breakout of the two groups in the study	0 Participants n=53 Participants • Analysis is a breakout of the two groups in the study	0 Participants Analysis is a breakout of the two groups in the study	0 Participants n=9 Participants • Analysis is a breakout of the two groups in the study	0 Participants n=10 Participants • Analysis is a breakout of the two groups in the study	0 Participants n=16 Participants • Analysis is a breakout of the two groups in the study	0 Participants Analysis is a breakout of the two groups in the study	0 Participants n=142 Participants • Analysis is a breakout of the two groups in the study
Race (NIH/OMB) Patients · Black or African American	2 Participants n=4 Participants • Analysis is a breakout of the two groups in the study	11 Participants n=50 Participants • Analysis is a breakout of the two groups in the study	10 Participants n=53 Participants • Analysis is a breakout of the two groups in the study	0 Participants Analysis is a breakout of the two groups in the study	1 Participants n=9 Participants • Analysis is a breakout of the two groups in the study	1 Participants n=10 Participants • Analysis is a breakout of the two groups in the study	4 Participants n=16 Participants • Analysis is a breakout of the two groups in the study	0 Participants Analysis is a breakout of the two groups in the study	29 Participants n=142 Participants • Analysis is a breakout of the two groups in the study
Race (NIH/OMB) Patients · White	2 Participants n=4 Participants • Analysis is a breakout of the two groups in the study	28 Participants n=50 Participants • Analysis is a breakout of the two groups in the study	30 Participants n=53 Participants • Analysis is a breakout of the two groups in the study	0 Participants Analysis is a breakout of the two groups in the study	4 Participants n=9 Participants • Analysis is a breakout of the two groups in the study	8 Participants n=10 Participants • Analysis is a breakout of the two groups in the study	9 Participants n=16 Participants • Analysis is a breakout of the two groups in the study	0 Participants Analysis is a breakout of the two groups in the study	81 Participants n=142 Participants • Analysis is a breakout of the two groups in the study
Race (NIH/OMB) Patients · More than one race	0 Participants n=4 Participants • Analysis is a breakout of the two groups in the study	7 Participants n=50 Participants • Analysis is a breakout of the two groups in the study	4 Participants n=53 Participants • Analysis is a breakout of the two groups in the study	0 Participants Analysis is a breakout of the two groups in the study	0 Participants n=9 Participants • Analysis is a breakout of the two groups in the study	0 Participants n=10 Participants • Analysis is a breakout of the two groups in the study	2 Participants n=16 Participants • Analysis is a breakout of the two groups in the study	0 Participants Analysis is a breakout of the two groups in the study	13 Participants n=142 Participants • Analysis is a breakout of the two groups in the study
Race (NIH/OMB) Patients · Unknown or Not Reported	0 Participants n=4 Participants • Analysis is a breakout of the two groups in the study	2 Participants n=50 Participants • Analysis is a breakout of the two groups in the study	3 Participants n=53 Participants • Analysis is a breakout of the two groups in the study	0 Participants Analysis is a breakout of the two groups in the study	1 Participants n=9 Participants • Analysis is a breakout of the two groups in the study	0 Participants n=10 Participants • Analysis is a breakout of the two groups in the study	0 Participants n=16 Participants • Analysis is a breakout of the two groups in the study	0 Participants Analysis is a breakout of the two groups in the study	6 Participants n=142 Participants • Analysis is a breakout of the two groups in the study

PRIMARY outcome

Timeframe: 10 minutes

Population: Analysis was done on a sample of healthy participants

Outcome measures

Outcome measures
Measure	Healthy Volunteers n=27 Participants Healthy volunteers underwent Functional magnetic resonance imaging (fMRI) and/or magneto-encephalography (MEG).	Healthy Volunteers - 7T fMRI Healthy volunteers underwent 7T Functional magnetic resonance imaging (fMRI) and participated in go/nogo trial under threat of shock or no shock
Average Correlations Between Average Time Series - Left & Right Hemisphere of the Brain Left BNST	0.9 correlation coefficient (r) Standard Deviation 0.08	—
Average Correlations Between Average Time Series - Left & Right Hemisphere of the Brain Right BNST	0.92 correlation coefficient (r) Standard Deviation 0.07	—

PRIMARY outcome

Timeframe: 10 minutes

Population: Analysis was done on a pilot sample of healthy volunteer participants

Images were acquired on a 7 T Siemens Magnetom MRI with a 32-channel head coil over 10 minutes. Participants were instructed to keep their eyes open and look at a white fixation cross on a black background during image acquisition. Following manual tracing of the habenula, the volumes of the left and right habenulae for each subject were computed separately. The left and right habenula volumes were then compared using a paired t-test.

Outcome measures

Outcome measures
Measure	Healthy Volunteers n=32 Participants Healthy volunteers underwent Functional magnetic resonance imaging (fMRI) and/or magneto-encephalography (MEG).	Healthy Volunteers - 7T fMRI Healthy volunteers underwent 7T Functional magnetic resonance imaging (fMRI) and participated in go/nogo trial under threat of shock or no shock
Difference in Volume - Left & Right Habenula Left Habenula	18.8 mm^3 Standard Deviation 6	—
Difference in Volume - Left & Right Habenula Right Habenula	14.9 mm^3 Standard Deviation 4	—

PRIMARY outcome

Timeframe: 2000 milliseconds during trial

Population: Analysis included only participants who completed the Sustained Attention to Response Task (SART)

Subjects participated in go/nogo (91% GO trials with the " = " symbol indicating button push and 9% NOGO trials with the "O" symbol indicating no push)) task condition during 3 Tesla (3T) or 7 Tesla (7T) functional MRI with periods of threat of shocks and periods of safety when no shock could be administered. During the GNG stimuli were presented on a monitor and randomly distributed. A correct go hit was a response recorded during these 2000 ms to a go trial. Similarly, a correct nogo omission was a no response during the same period to a nogo trial. Performance was first averaged across condition (threat, safe) and trial type (go, nogo) by dividing the number of correct responses by the total number of each trial type. The NOGO and GO behavioral effects were then separately compared between 3T and 7T strength. Accuracy was measured as a percent of correct button presses during fMRI (3T or 7T).

Outcome measures

Outcome measures
Measure	Healthy Volunteers n=31 Participants Healthy volunteers underwent Functional magnetic resonance imaging (fMRI) and/or magneto-encephalography (MEG).	Healthy Volunteers - 7T fMRI n=31 Participants Healthy volunteers underwent 7T Functional magnetic resonance imaging (fMRI) and participated in go/nogo trial under threat of shock or no shock
Percent of Correct No Button Presses During Functional MRI NOGO Trials	71 Percentage of accurate responses Standard Deviation 20	76 Percentage of accurate responses Standard Deviation 15
Percent of Correct No Button Presses During Functional MRI GO Trials	99 Percentage of accurate responses Standard Deviation 3	95 Percentage of accurate responses Standard Deviation 7

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Pao, Maryland

National Institute of Mental Health

Phone: +1 301 435 5770

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place