Who is sponsoring NCT03786952?

NCT03786952 is sponsored by Ohio Northern University.

What drugs are being tested in NCT03786952?

Interventions in NCT03786952: Stress immediately before learning in males, Sham control immediately before learning in males, Stress 30 minutes before learning in males, Sham control 30 minutes before learning in males, Stress immediately before learning in females, Sham control immediately before learning in females, Stress 30 minutes before learning in females, Sham control 30 minutes before learning in females.

What condition does NCT03786952 study?

NCT03786952 studies Psychological Stress.

Is NCT03786952 still recruiting?

NCT03786952 is currently completed. Last updated 23 March 2023.

Are results published for NCT03786952?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2023-03-23 · How we verify

NCT03786952

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Stress, Sex, and the Generalization of Fear

Completed NA Results posted Last updated 23 March 2023

What this trial tests

NA trial testing Stress immediately before learning in males in Psychological Stress in 606 participants. Completed in 30 June 2022.

Timeline

25 January 2019

Primary endpoint
30 June 2022

30 June 2022

Quick facts

Lead sponsor	Ohio Northern University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	double
Primary purpose	basic science
Enrollment	606
Start date	25 January 2019
Primary completion	30 June 2022
Estimated completion	30 June 2022
Sites	1 location across United States

Drugs / interventions tested

Stress immediately before learning in males
Sham control immediately before learning in males
Stress 30 minutes before learning in males
Sham control 30 minutes before learning in males
Stress immediately before learning in females
Sham control immediately before learning in females
Stress 30 minutes before learning in females
Sham control 30 minutes before learning in females

Conditions studied

Psychological Stress — all drugs for Psychological Stress →

Sponsor

Ohio Northern University

Who can join

18 and older, any sex, with Psychological Stress. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Fear-potentiated Startle Responses to the CS+ and CS- During Acquisition Primary · Average of the responses from trial block 13, trial block 14, trial block 15, and trial block 16 on Day 1

Peak eyeblink startle responses 20-200 ms following presentation of a startle probe were measured. Startle responses were assessed for each of 3 trial types: (1) following the startle probe alone \[noise alone (NA) trials\], (2) following the CS+ and startle probe (CS+ trials), and (3) following the CS- and startle probe (CS- trials). Participants were exposed to 16 blocks of trials, and each block included 1 presentation of each trial type. During the last 12 blocks, CS+ trials also included the presentation of an aversive US. For each block, startle responses to NA trials were subtracted fro

Group	Value	95% CI
Stress, Immediate, Males, CS+	52.059	± 9.46
Stress, Immediate, Males, CS-	19.162	± 7.955
Stress, Delayed, Males, CS+	44.388	± 9.46
Stress, Delayed, Males, CS-	9.732	± 7.955
Sham Control, Immediate, Males, CS+	42.123	± 9.972
Sham Control, Immediate, Males, CS-	20.215	± 8.385
Sham Control, Delayed, Males, CS+	47.904	± 9.581
Sham Control, Delayed, Males, CS-	26.64	± 8.056
Stress, Immediate, Females, CS+	64.313	± 7.051
Stress, Immediate, Females, CS-	14.437	± 5.929
Stress, Delayed, Females, CS+	75.269	± 7.365
Stress, Delayed, Females, CS-	33.479	± 6.193

EMG Responses to CS+, CS-, and Generalization Stimuli During Generalization Testing Primary · Average of responses from all trials on Day 2

Peak eyeblink startle responses 20-200 ms following the presentation of a startle probe were measured. Startle responses were assessed for each of 10 trial types: (1) following the startle probe alone \[noise alone (NA) trials\], (2) following the CS+ and startle probe (CS+ trials), (3) following each of 7 generalization stimuli and startle probe (GS trials), and (4) following the CS- and startle probe (CS- trials). Participants were exposed to 3 blocks of trials, and each block included 1 presentation of each trial type. For each block, startle responses to the NA trials were subtracted from

Group	Value	95% CI
Stress, Immediate, Males, CS+	52.059	± 9.552
Stress, Immediate, Males, GS1	42.389	± 8.467
Stress, Immediate, Males, GS2	24.461	± 8.215
Stress, Immediate, Males, GS3	36.099	± 7.563
Stress, Immediate, Males, GS4	25.637	± 7.085
Stress, Immediate, Males, GS5	13.225	± 7.130
Stress, Immediate, Males, GS6	36.013	± 7.759
Stress, Immediate, Males, GS7	16.838	± 7.797
Stress, Immediate, Males, CS-	19.063	± 7.897
Stress, Delayed, Males, CS+	51.595	± 9.552
Stress, Delayed, Males, GS1	47.292	± 8.467
Stress, Delayed, Males, GS2	23.265	± 8.215

Skin Conductance Responses to CS+ and CS- During Acquisition Primary · Average of the responses from trial block 13, trial block 14, trial block 15, and trial block 16 on Day 1

Electrodermal activity was measured following presentation of the CS+ and CS- during acquisition on Day 1. Participants were exposed to 16 blocks of trials, with each block including a single presentation of each stimulus. During the last 12 blocks, CS+ trials included the presentation of an aversive US. For each block, skin conductance responses were quantified by calculating the average increase in electrodermal activity (from a 1 s pre-stimulus baseline) 3-6 s after CS+ or CS- onset. Average skin conductance responses to the CS+ and CS- during the last 4 blocks of trials were used as an ind

Group	Value	95% CI
Stress, Immediate, Males, CS+	.107	± .042
Stress, Immediate, Males, CS-	.070	± .039
Stress, Delayed, Males, CS+	.138	± .041
Stress, Delayed, Males, CS-	.090	± .038
Sham Control, Immediate, Males, CS+	.112	± .043
Sham Control, Immediate, Males, CS-	.102	± .040
Sham Control, Delayed, Males, CS+	.163	± .042
Sham Control, Delayed, Males, CS-	.105	± .039
Stress, Immediate, Females, CS+	.153	± .031
Stress, Immediate, Females, CS-	.084	± .029
Stress, Delayed, Females, CS+	.135	± .034
Stress, Delayed, Females, CS-	.078	± .032

Skin Conductance Responses to CS+, Generalization Stimuli, and CS- During Generalization Testing Primary · Average of responses from all trials on Day 2

Electrodermal activity was measured following presentation of the CS+, 7 generalization stimuli (GSs), and CS- during generalization testing on Day 2. Participants were exposed to 3 blocks of trials, with each block including a single presentation of each stimulus. For each block, skin conductance responses were quantified by calculating the average increase in electrodermal activity (from a 1 s pre-stimulus baseline) 3-6 s after onset of the CS+, 7 GSs, or CS- onset.. Average skin conductance responses to each stimulus across all 3 blocks were used as an indicator of fear expression. Greater

Group	Value	95% CI
Stress, Immediate, Males, CS+	.193	± .049
Stress, Immediate, Males, GS1	.156	± .047
Stress, Immediate, Males, GS2	.103	± .039
Stress, Immediate, Males, GS3	.114	± .043
Stress, Immediate, Males, GS4	.072	± .039
Stress, Immediate, Males, GS5	.046	± .040
Stress, Immediate, Males, GS6	.241	± .053
Stress, Immediate, Males, GS7	.246	± .049
Stress, Immediate, Males, CS-	.094	± .039
Stress, Delayed, Males, CS+	.270	± .047
Stress, Delayed, Males, GS1	.262	± .045
Stress, Delayed, Males, GS2	.140	± .037

US Expectancy Ratings to CS+ and CS- During Acquisition Primary · Average of the ratings from trial block 13, trial block 14, trial block 15, and trial block 16 on Day 1

Participants were exposed to 16 blocks of trials, and each block included 1 presentation of the CS+ and one presentation of the CS-. During the last 12 blocks, CS+ trials included the presentation of an aversive US. During each trial, participants pressed, within 3 seconds of stimulus onset, a button marked "+" if they expected the stimulus to be followed by the US, a button marked "-" if they did not expect the stimulus to be followed by the US, or a button marked "0" if they were uncertain. For the purpose of data analysis, + was scored as +1, - were scored as -1, and 0 was scored as 0. Aver

Group	Value	95% CI
Stress, Immediate, Males, CS+	.737	± .064
Stress, Immediate, Males, CS-	-.865	± .068
Stress, Delayed, Males, CS+	.964	± .062
Stress, Delayed, Males, CS-	-.954	± .066
Sham Control, Immediate, Males, CS+	.797	± .066
Sham Control, Immediate, Males, CS-	-.775	± .070
Sham Control, Delayed, Males, CS+	.860	± .061
Sham Control, Delayed, Males, CS-	-.907	± .065
Stress, Immediate, Females, CS+	.807	± .047
Stress, Immediate, Females, CS-	-.782	± .050
Stress, Delayed, Females, CS+	.867	± .050
Stress, Delayed, Females, CS-	-.845	± .053

US Expectancy Ratings to CS+, CS-, and Generalization Stimuli During Generalization Testing Primary · Average of ratings from all trials on Day 2

Participants were exposed to 3 blocks of trials, and each block included 1 presentation of the CS+, one presentation of each of 7 generalization stimuli (GSs), and one presentation of the CS-. Participants were instructed to press, within 3 seconds of stimulus onset, a button marked "+" if they expected the stimulus to be followed by the US, a button marked "-" if they did not expect the stimulus to be followed by the US, or a button marked "0" if they were uncertain. For the purpose of data analysis, + was scored as +1, - was scored as -1, and 0 was scored as 0. Average expectancy ratings for

Group	Value	95% CI
Stress, Immediate, Males, CS+	.217	± .119
Stress, Immediate, Males, GS1	.140	± .094
Stress, Immediate, Males, GS2	-.357	± .111
Stress, Immediate, Males, GS3	-.527	± .095
Stress, Immediate, Males, GS4	-.822	± .069
Stress, Immediate, Males, GS5	-.810	± .069
Stress, Immediate, Males, GS6	-.907	± .050
Stress, Immediate, Males, GS7	-.984	± .045
Stress, Immediate, Males, CS-	-.961	± .045
Stress, Delayed, Males, CS+	-.089	± .116
Stress, Delayed, Males, GS1	-.067	± .092
Stress, Delayed, Males, GS2	-.533	± .109

Change in Baseline Salivary Cortisol (Nmol/l) Secondary · Day 1 (change from baseline to 25 min post-stress)

Saliva samples were collected from participants prior to undergoing the stress or sham control condition (baseline) and then 25 min later. The change in salivary cortisol levels was analyzed. Greater levels indicated greater cortisol responses to stress.

Group	Value	95% CI
Stress, Immediate, Males	1.413	± .308
Stress, Delayed, Males	1.014	± .315
Sham Control, Immediate, Males	-.039	± .333
Sham Control, Delayed, Males	.236	± .320
Stress, Immediate, Females	.728	± .227
Stress, Delayed, Females	.710	± .254
Sham Control, Immediate, Females	.558	± .231
Sham Control, Delayed, Females	-.091	± .223

Change in Baseline Salivary Alpha-amylase (U/ml) Secondary · Day 1 (change from baseline to immediately after stress)

Saliva samples were collected from participants prior to undergoing the stress or sham control condition (baseline) and then immediately after the manipulation. The change in salivary alpha-amylase levels was analyzed. Greater levels indicated greater alpha-amylase responses to stress.

Group	Value	95% CI
Stress, Immediate, Males	4.210	± 7.132
Stress, Delayed, Males	-12.943	± 7.042
Sham Control, Immediate, Males	7.656	± 7.528
Sham Control, Delayed, Males	-3.411	± 6.792
Stress, Immediate, Females	17.561	± 5.40
Stress, Delayed, Females	2.608	± 6.005
Sham Control, Immediate, Females	5.090	± 5.323
Sham Control, Delayed, Females	-3.601	± 5.213

Average Subjective Pain, as Assessed by Verbal Self Report Secondary · Stress or sham control condition on Day 1

During the stress or sham control manipulation, participants rated the painfulness of the water bath at 1-minute intervals on an 11-point scale ranging from 0-10, with 0 = lack of pain and 10 = unbearable pain. The obtained ratings were averaged and analyzed. Greater ratings indicated greater subjective pain during the stressor.

Group	Value	95% CI
Stress, Immediate, Males	6.089	± .228
Stress, Delayed, Males	6.415	± .223
Sham Control, Immediate, Males	.123	± .243
Sham Control, Delayed, Males	.159	± .226
Stress, Immediate, Females	6.806	± .167
Stress, Delayed, Females	6.765	± .181
Sham Control, Immediate, Females	.092	± .172
Sham Control, Delayed, Females	.131	± .163

Average Subjective Stress, as Assessed by Verbal Self Report Secondary · Stress or sham control condition on Day 1

During the stress or sham control manipulation, participants rated the stressfulness of the water bath at 1-minute intervals on an 11-point scale ranging from 0-10, with 0 = lack of stress and 10 = unbearable stress. The obtained ratings were averaged and analyzed. Greater ratings indicated greater subjective stress during the stressor.

Group	Value	95% CI
Stress, Immediate, Males	4.457	± .289
Stress, Delayed, Males	5.778	± .283
Sham Control, Immediate, Males	.675	± .307
Sham Control, Delayed, Males	.318	± .286
Stress, Immediate, Females	5.910	± .212
Stress, Delayed, Females	5.843	± .230
Sham Control, Immediate, Females	.184	± .217
Sham Control, Delayed, Females	.405	± .207

Change in Heart Rate (Bpm) Secondary · Day 1 (change from baseline to during stress or sham control manipulation)

Heart rate (bpm) measurements were aken via the PPG module of the Biopac MP150 system from participants prior to undergoing the stress or sham control condition (baseline) and then halfway through the manipulation.The change in heart rate was analyzed.

Group	Value	95% CI
Stress, Immediate, Males	4.924	± 1.159
Stress, Delayed, Males	3.922	± 1.120
Sham Control, Immediate, Males	-.379	± 1.235
Sham Control, Delayed, Males	.345	± 1.146
Stress, Immediate, Females	5.339	± .851
Stress, Delayed, Females	4.348	± .918
Sham Control, Immediate, Females	.096	± .873
Sham Control, Delayed, Females	-1.337	± .835

Change in Salivary Progesterone (pg/ml) Secondary · Day 1 (change from baseline to 25 min post-stress)

Saliva samples were collected from female participants prior to undergoing the stress or sham control condition (baseline) and then 25 min later. The change in salivary progesterone levels were analyzed.

Group	Value	95% CI
Stress, Immediate, Females	247.165	± 51.177
Stress, Delayed, Females	160.933	± 56.776
Sham Control, Immediate, Females	197.625	± 52.856
Sham Control, Delayed, Females	198.469	± 52.421

Sponsor's own description

The impact of well-known risk factors for such disorders (stress, biological sex, anxiety-related dispositions) on fear generalization will be examined. Findings from this study may provide insight into how these risk factors influence the development and/or maintenance of psychological disorders that involve overgeneralization of fear and could facilitate future approaches to their treatment.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03786952 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Ohio Northern University
Last refreshed: 23 March 2023

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