PTSDPhase 2NCT02733614
Proof-of-concept Study to Assess the Efficacy and Safety of SRX246 in Adults With PTSD
A Phase 2 study testing SRX246 in people with PTSD, run by Azevan Pharmaceuticals at 1 site in United States.
Trial summary
18-week, crossover, double-blind, randomized, placebo controlled proof-of-concept study to assess the efficacy and safety of SRX246 (160 mg bid) vs placebo in 52 adult veterans and civilians with a primary diagnosis of PTSD. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- PTSD
- 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
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2016to 31 Mar 2021
- Phase
- Phase 2
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Medically stable, current diagnosis of PTSD
Who cannot join
- Medically unstable
Trial locations and contacts
1 site in 1 country.
United States1 site
Weill Cornell Medical College
New York, New York, 10065
About this study
Official title: A Proof of Concept (POC) Clinical Trial for Post-Traumatic Stress Disorder (PTSD) With a First-In-Class Vasopressin 1a Receptor Antagonist (SRX246)
18-week, crossover, double-blind, randomized, placebo controlled proof-of-concept study to assess the efficacy and safety of SRX246 (160 mg bid) vs placebo in 52 adult veterans and civilians with a primary diagnosis of PTSD. Subjects will be randomly assigned in a double-blind fashion to 2 groups in a crossover design. The first group will receive SRX246 for 8 weeks followed by 8 weeks of placebo, while the second group will receive placebo for 8 weeks followed by 8 weeks of SRX246. Both groups will engage in a 7-day washout period between treatments. Subjects will be assessed at baseline and then every 2 weeks during the trial using the CAPS.
- Conditions
- PTSD
- Being tested
- SRX246, Placebo
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SRX246Drug
novel V1a receptor antagonist
PlaceboDrug
matching placebo
| Study group | Role | What they receive |
|---|---|---|
| SRX246 | Experimental | SRX246 160 mg BID, oral administration, capsules, daily for 8 weeks Receives: Drug: SRX246 |
| Placebo | Placebo comparator | oral administration, capsules, daily for 8 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of overall clinical improvement
Measured using the Clinician Administered PTSD Scale (CAPS)
Measured: 18 weeks
Secondary outcomes (7)
Number of participants with treatment-related adverse events
Assessments of adverse events (AEs), dose reductions and dropouts due to AEs
Measured: 18 weeks
Reduction in depressive symptoms
Measured using the Beck Depression Inventory (BDI)
Measured: 18 weeks
Reduction in anger and aggression
Measured using the Overt Aggression Scale-Modified (OAS-M)
Measured: 18 weeks
Reduction in irritability
Measured using the Sheehan Irritability Scale (SIS)
Measured: 18 weeks
Improvement in overall functioning
Measured using the Medical Outcomes Study Short-Form 12-Item Health Survey (SF-12)
Measured: 18 weeks
Improvement in quality of life
Measured using the Sheehan Disability Scale (SDS)
Measured: 18 weeks
Improvement in sleep quality
Measured using the Pittsburgh Sleep Quality Index (PSQI)
Measured: 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2016 (estimated)
- Study startDec 2016
- Primary completionOct 2020
- Study completion31 Mar 2021
Why it stopped: funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSDStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azevan Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Weill Medical College of Cornell University, United States Department of Defense, U.S. Army Medical Research and Development Command
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02733614
- Sponsor's protocol ID
- AVN010
- Status last verified
- Oct 2021
- First submitted
- 29 Mar 2016
- Last updated
- 1 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Proof of Concept (POC) Clinical Trial for Post-Traumatic Stress Disorder (PTSD) With a First-In-Class Vasopressin 1a Receptor Antagonist (SRX246)
- ClinicalTrials.gov ID
- NCT02733614
- Acronym / sponsor ID
- AVN010
- Conditions
- PTSD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: funding
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Azevan PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Weill Medical College of Cornell University, United States Department of Defense, U.S. Army Medical Research and Development Command
- Study start
- Dec 2016 (actual)
- Primary completion
- Oct 2020 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 11 Apr 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.
18-week, crossover, double-blind, randomized, placebo controlled proof-of-concept study to assess the efficacy and safety of SRX246 (160 mg bid) vs placebo in 52 adult veterans and civilians with a primary diagnosis of PTSD. Subjects will be randomly assigned in a double-blind fashion to 2 groups in a crossover design. The first group will receive SRX246 for 8 weeks followed by 8 weeks of placebo, while the second group will receive placebo for 8 weeks followed by 8 weeks of SRX246. Both groups will engage in a 7-day washout period between treatments. Subjects will be assessed at baseline and then every 2 weeks during the trial using the CAPS.
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 160 mg BID, oral administration, capsules, daily for 8 weeks |
| Placebo | Placebo comparator | Drug: Placebooral administration, capsules, daily for 8 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Medically stable, current diagnosis of PTSD
Key exclusion criteria (1 listed)
- Medically unstable
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 |
|---|---|---|
| SRX246novel V1a receptor antagonist | Drug | SRX246 |
| Placebomatching placebo | Drug | Placebo |
Primary outcome
Assessment of overall clinical improvement
Time frame: 18 weeks
Measured using the Clinician Administered PTSD Scale (CAPS)
7 secondary outcomes
Number of participants with treatment-related adverse events
Time frame: 18 weeks
Reduction in depressive symptoms
Time frame: 18 weeks
Reduction in anger and aggression
Time frame: 18 weeks
Reduction in irritability
Time frame: 18 weeks
Improvement in overall functioning
Time frame: 18 weeks
Improvement in quality of life
Time frame: 18 weeks
Improvement in sleep quality
Time frame: 18 weeks
Results and safety
The study was stopped early (reason given: funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2021.
- Individual participant dataSharing planned: No
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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 2 study testing SRX246 in people with PTSD, 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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 1 Nov 2021. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: funding). 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?
Assessment of overall clinical improvement (time frame: 18 weeks). 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 1 Nov 2021.