Effects of SRX246 on an Experimental Model of Fear and Anxiety in Humans
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|ClinicalTrials.gov Identifier: NCT02922166|
Recruitment Status : Unknown
Verified June 2019 by Azevan Pharmaceuticals.
Recruitment status was: Active, not recruiting
First Posted : October 4, 2016
Last Update Posted : June 10, 2019
|Condition or disease||Intervention/treatment||Phase|
|Fear Anxiety||Drug: SRX246 Drug: Placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||36 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Effects of SRX246, a Vasopressin Receptor (V1a) Antagonist, on an Experimental Model of Fear and Anxiety in Humans|
|Actual Study Start Date :||February 3, 2017|
|Actual Primary Completion Date :||May 10, 2019|
|Estimated Study Completion Date :||December 2019|
SRX246 oral dosage capsules, daily dose to be taken bid, for up to 7 days
Placebo Comparator: Placebo
Placebo oral dosage capsules, daily dose to be taken bid, for up to 7 days
- Change in startle reflex between SRX246 and Placebo [ Time Frame: up to 7 days ]Subjects will be exposed to none (N), predictable (P) and unpredictable (U) acoustic and electric shocks.
- Change in emotional expression recognition between SRX246 and Placebo [ Time Frame: up to 7 days ]Subjects will be shown pictures of faces exhibiting anger, disgust, fear, happiness, sadness and surprise.
- Change in State Anxiety Scale between SRX246 and Placebo [ Time Frame: up to 7 days ]Subjects will rate their anxiety level during assessments using a self-administered rating scale.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02922166
|United States, Maryland|
|National Institute of Mental Health|
|Bethesda, Maryland, United States, 20892|