FearPhase 1NCT02922166
Effects of SRX246 on an Experimental Model of Fear and Anxiety in Humans
A Phase 1 study testing SRX246 in people with Fear and Anxiety, run by Azevan Pharmaceuticals at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 50 yearsHealthy volunteers can take part
- What is being tested?
- SRX246
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Feb 2017to Dec 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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.).
- Abnormal urine specific gravity (below 1.00 or above 1.03) as documented by urine sample refractometry.
- Subject who has resting blood pressure outside of a systolic blood pressure range of 90-140 mmHg or a diastolic blood pressure outside a range of 50-90 mmHg on two consecutive measurements taken up to 10 minutes apart.
- Subject who has resting pulse rate greater than 100 bpm or less than 50 bpm on two consecutive measurements taken up to 10 minutes apart.
- Consumption of illicit substances or positive urine toxicology screen throughout the study.
- Pregnancy, lactating/breastfeeding, or positive pregnancy test.
- A history of significant drug allergy or systemic allergic disease (e.g., urticaria, atopic dermatitis), or any known/suspected hypersensitivity to SRX246, or allergy to gelatin.
- Lack of measurable startle response (3 times the baseline EMG activity) for all 9 startles used during the habituation visit.
- Subjects who would be noncompliant with the visit schedule or study procedures. Possible noncompliance may include planned vacations or planned hospitalizations during the study.
- For women who are able to get pregnant and men who are able to father a child, unwillingness to use at least two effective birth control methods for 15 days prior to the time they enroll in the study, and for 15 days after their last exposure to the study drug. Effective methods of contraception for this study include:
- hormonal contraception (birth control pills, injected hormones or vaginal ring),
- intrauterine device,
- barrier methods (condom or diaphragm) combined with spermicide, and
- surgical sterilization (hysterectomy, tubal ligation, or vasectomy).
- Employee of NIMH or an immediate family member who is a NIMH employee
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Mental Health
Bethesda, Maryland, 20892
About this study
Official title: Effects of SRX246, a Vasopressin Receptor (V1a) Antagonist, on an Experimental Model of Fear and Anxiety in Humans
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.
Read the 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.
- Being tested
- SRX246, Placebo
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SRX246Drug
oral capsule
PlaceboDrug
oral capsule
| Study group | Role | What they receive |
|---|---|---|
| SRX246 | Experimental | SRX246 oral dosage capsules, daily dose to be taken bid, for up to 7 days Receives: Drug: SRX246 |
| Placebo | Placebo comparator | Placebo oral dosage capsules, daily dose to be taken bid, for up to 7 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in startle reflex between SRX246 and Placebo
Subjects will be exposed to none (N), predictable (P) and unpredictable (U) acoustic and electric shocks.
Measured: up to 7 days
Secondary outcomes (2)
Change in emotional expression recognition between SRX246 and Placebo
Subjects will be shown pictures of faces exhibiting anger, disgust, fear, happiness, sadness and surprise.
Measured: up to 7 days
Change in State Anxiety Scale between SRX246 and Placebo
Subjects will rate their anxiety level during assessments using a self-administered rating scale.
Measured: up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2016 (estimated)
- Study start3 Feb 2017
- Primary completion10 May 2019
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FearStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azevan Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02922166
- Sponsor's protocol ID
- AVN012
- Other IDs
- T-M-1970
- Status last verified
- Jun 2019
- First submitted
- 29 Sep 2016
- Last updated
- 10 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data and samples will be shared with Azevan Pharmaceuticals Inc., its affiliates and research partners working with Azevan Pharmaceuticals Inc.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of SRX246, a Vasopressin Receptor (V1a) Antagonist, on an Experimental Model of Fear and Anxiety in Humans
- ClinicalTrials.gov ID
- NCT02922166
- Acronym / sponsor ID
- AVN012
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Azevan PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 3 Feb 2017 (actual)
- Primary completion
- 10 May 2019 (actual)
- Study completion
- Dec 2019 (estimated)
- First posted
- 4 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SRX246 | Experimental | Drug: SRX246SRX246 oral dosage capsules, daily dose to be taken bid, for up to 7 days |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo oral dosage capsules, daily dose to be taken bid, for up to 7 days |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (24 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SRX246oral capsule | Drug | SRX246 |
| Placebooral capsule | Drug | Placebo |
Primary outcome
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.
2 secondary outcomes
Change in emotional expression recognition between SRX246 and Placebo
Time frame: up to 7 days
Change in State Anxiety Scale between SRX246 and Placebo
Time frame: up to 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2019.
- Individual participant dataSharing planned: Yes. Data and samples will be shared with Azevan Pharmaceuticals Inc., its affiliates and research partners working with Azevan Pharmaceuticals Inc.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SRX246 in people with Fear and Anxiety, run by Azevan Pharmaceuticals at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in startle reflex between SRX246 and Placebo (time frame: up to 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2019.