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Effects of SRX246 on an Experimental Model of Fear and Anxiety in Humans

Effects of SRX246, a Vasopressin Receptor (V1a) Antagonist, on an Experimental Model of Fear and Anxiety in Humans

NCT02922166•Azevan Pharmaceuticals

Summary

To determine the effects of SRX246 on fear and anxiety based on fear-potentiated startle in humans. Additionally, the effects of the compound on emotion recognition will be explored.

Detailed Description

The study will use a double-blind, cross-over design in which each subject will receive placebo and SRX246 for 5-7 days before testing (given in counter-balanced order). The study will examine the effect of the drug on the potentiation of startle using a well-established paradigm that involves anticipation of no-shock, predictable shock, and unpredictable shock. Drug effects on emotion recognition will also be explored.

Eligibility

Age

21 - 50 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Healthy male and female volunteers, ages 21-50, inclusive.
•Subjects able to give their consent and have signed informed consent forms indicating that they understand the purpose and procedures of the study and are willing to participate in the study procedures and restrictions.
•Body mass index (BMI) of 18.5 to 34.0 kg/m2, inclusive, and a total body weight of \>50kg (110 pounds).

Exclusion Criteria

•Non-English speakers
•Current or history of Axis I psychiatric disorder(s) as identified with the Structured Clinical Interview for DSM-IV-TR, non-patient edition (SCID-np) and clinical evaluation.
•Active or history of active suicidal ideation.
•Lifetime alcohol or drug dependence according to the Structured Clinical Interview for DSM-IV-TR, non-patient edition (SCID-np).
•All prescription and non-prescription medications and herbal remedies are prohibited within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication and until at least 7 days or 5 half-lives (whichever is longer) after last dose of study medication, except hormonal contraceptives in females.
•Clear evidence of a first-degree relative with history of psychosis, bipolar disorder or major depression as determined by the family history method; specifically, participant will know diagnosis or treatment in order to confirm presence of disorder.
•Subject is currently participating in another clinical trial in which (s)he is or will be exposed to an investigational or non-investigational drug or device, or has done so within the preceding month.
•Current evidence or history of significant medical illness or organic brain impairment, including syndrome of inappropriate antidiuretic hormone secretion (SIADH), diabetes insipidus (DI), stroke, epilepsy, CNS tumor, demyelinating disease, cardiac, pulmonary, gastrointestinal, renal or hepatic impairment that would likely interfere with the action, absorption, distribution, metabolism, or excretion of SRX246, or influence psychophysiological responses.
•Current evidence of median nerve entrapment or carpal tunnel syndrome.
•Any laboratory abnormality that in the investigators' judgment is considered to be clinically significant (ECG, TSH, LFT, etc.).
+14 more criteria

Locations (1)

National Institute of Mental Health

Bethesda, Maryland, United States

Key Dates

Start Date

February 3, 2017

Primary Completion Date

May 10, 2019

Completion Date

December 1, 2019

Last Updated

June 10, 2019

Enrollment

ACTUAL participants

Conditions

FearAnxiety

Interventions

SRX246

DRUG

Placebo

DRUG

Readiness and Progress in Emotion Regulation Therapy

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RuminationWorry+4 more

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 10, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Effects of SRX246 on an Experimental Model of Fear and Anxiety in Humans

Inclusion Criteria

Exclusion Criteria

Readiness and Progress in Emotion Regulation Therapy

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