Panic DisorderPhase 4NCT02395510
A 10-Week, Open-Label, Flexible Dose Adaptive Study Evaluating the Efficacy of Vortioxetine in Subjects With Panic Disorder
A Phase 4 study testing Vortioxetine in people with Panic Disorder, run by Siyan Clinical Corporation at 1 site in United States.
Trial summary
The primary aim of this study is to evaluate the efficacy of Vortioxetine in an adult population with a diagnosis of PD. PD is generally treated with benzodiazepines which are very effective but have a high risk for addiction, fall, and cognitive impairment. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Panic Disorder
- What is being tested?
- Vortioxetine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to Jun 2016
- Phase
- Phase 4
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- The subject voluntarily agrees to participate in the study under their own free will.
- The subject meets the DSM-V criteria for PD with or without Agoraphobia or has a PDSS score > 8 at the Baseline visit.
- The subject is between the ages of 18-60 years old inclusive at the time of consent.
- The subject is capable of understanding and complying with protocol requirements.
- The subject has signed the Informed Consent Form. No study-related procedures may be performed before the subject has signed the form.
Who cannot join
- Female subjects who are pregnant or nursing, or may become pregnant during the course of the study. In addition, all subjects of childbearing potential who are sexually active most use adequate contraception from signing of informed consent and throughout the duration of the study. Male subjects who have been surgically sterilized, are at least one year post-vasectomy, are not required to use contraceptives. Females not of childbearing potential are defined as those who have been surgically sterilized (hysterectomy, bilateral oophorectomy or tubal ligation) or who are postmenopausal (defined as one year since last regular menses).
- Subjects who have a past or present primary diagnosis with a psychotic disorder other than PD with or without Agoraphobia.
- Subjects who have a current uncontrolled co-morbid psychiatric disorder other than PD with or without agoraphobia.
- Subject who have a history of alcohol abuse or dependence within the 12 months prior to screening, as defined by the DSM-V criteria.
- Subjects who have a comorbid severe medical diagnosis such as Cancer, adults with chronic heart failure, uncontrolled, long-term type 2 Diabetes, etc.
- Subjects with a history of liver disease such as cirrhosis of liver, neoplasm of the liver, or active Hepatitis C.
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- Subjects weighing less than 100lbs at the Baseline visit.
- Subjects with a history of cardiac abnormalities including but not limited to, acute cardiovascular events, serious cardiovascular risk, myocardial infarction (MI), unstable angina (UA), percutaneous coronary intervention, coronary artery bypass graft, stroke, or deep vein thrombosis/pulmonary embolism within 1 year of screening, or have planned cardiovascular surgery or percutaneous coronary angioplasty.
- Subjects who are reasonably judged by the Investigator based on interview or information collected in the Columbia-Suicide Severity Rating Scale (C-SSRS) at the Baseline visit to present a significant suicide risk, or who are likely to require psychiatric hospitalization during the course of the study.
- Subjects who are unable to fully understand the potential risks and benefits of the study and unable to give informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
Siyan Clinical Corporation
Santa Rosa, California, 95401
About this study
The primary aim of this study is to evaluate the efficacy of Vortioxetine in an adult population with a diagnosis of PD. PD is generally treated with benzodiazepines which are very effective but have a high risk for addiction, fall, and cognitive impairment. There is still a need for better treatment for PD for longer term use. There are other drugs within the SSRI/SNRI class which have proven to be effective in treating patients with this diagnosis.
Read the detailed description
The primary objective of the study is to evaluate the efficacy of Vortioxetine (5, 10, or 20mg) over a period of 10 weeks in subjects with PD, with or without Agoraphobia. The efficacy of Vortioxetine will be evaluated using the Mean Change from Baseline in the Panic Disorder Severity Scale (PDSS) score and the reduction in occurrence of panic attacks as measured by item 1 in the PDSS Scale after 10 weeks of treatment with Vortioxetine. This study is an open-label, adaptive study with flexible dose strategies lasting 10 weeks. Approximately 20 male and female subjects over the age of 18aged 18-60 years who currently meet DSM-IV criteria for PD with or without Agoraphobia or who have a PDSS score > 8 at Baseline will be enrolled in this study.
- Conditions
- Panic Disorder
- Being tested
- Vortioxetine
- Medical subject headings
- Panic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VortioxetineDrug
Vortioxetine 5-20mg
| Study group | Role | What they receive |
|---|---|---|
| Flexible, open label dosing | Other | Flexible dosing 5-20mg Receives: Drug: Vortioxetine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change from Baseline in the Panic Disorder Severity Scale (PDSS) score
Measured: 10 weeks
Secondary outcomes (2)
Improvement on the Quality of Life Scale (QLOS) from Baseline
Measured: 10 weeks
Information from the Monitoring of Side Effects Scale (MOSES)
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2015 (estimated)
- Study startMay 2015
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Panic DisorderStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Siyan Clinical Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02395510
- Sponsor's protocol ID
- VOR-ITT-0024
- Status last verified
- Jul 2016
- First submitted
- 16 Mar 2015
- Last updated
- 25 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Shah A, Northcutt J. An open-label, flexible dose adaptive study evaluating the efficacy of vortioxetine in subjects with panic disorder. Ann Gen Psychiatry. 2018 May 11;17:19. doi: 10.1186/s12991-018-0190-6. eCollection 2018.
PubMed 29760763
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 10-Week, Open-Label, Flexible Dose Adaptive Study Evaluating the Efficacy of Vortioxetine in Subjects With Panic Disorder
- ClinicalTrials.gov ID
- NCT02395510
- Acronym / sponsor ID
- VOR-ITT-0024
- Conditions
- Panic Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Siyan Clinical CorporationUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 23 Mar 2015 (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.
The primary aim of this study is to evaluate the efficacy of Vortioxetine in an adult population with a diagnosis of PD. PD is generally treated with benzodiazepines which are very effective but have a high risk for addiction, fall, and cognitive impairment. There is still a need for better treatment for PD for longer term use. There are other drugs within the SSRI/SNRI class which have proven to be effective in treating patients with this diagnosis.
Detailed description
The primary objective of the study is to evaluate the efficacy of Vortioxetine (5, 10, or 20mg) over a period of 10 weeks in subjects with PD, with or without Agoraphobia. The efficacy of Vortioxetine will be evaluated using the Mean Change from Baseline in the Panic Disorder Severity Scale (PDSS) score and the reduction in occurrence of panic attacks as measured by item 1 in the PDSS Scale after 10 weeks of treatment with Vortioxetine. This study is an open-label, adaptive study with flexible dose strategies lasting 10 weeks. Approximately 20 male and female subjects over the age of 18aged 18-60 years who currently meet DSM-IV criteria for PD with or without Agoraphobia or who have a PDSS score > 8 at Baseline will be enrolled in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Flexible, open label dosing | Other | Drug: VortioxetineFlexible dosing 5-20mg |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- The subject voluntarily agrees to participate in the study under their own free will.
- The subject meets the DSM-V criteria for PD with or without Agoraphobia or has a PDSS score > 8 at the Baseline visit.
- The subject is between the ages of 18-60 years old inclusive at the time of consent.
- The subject is capable of understanding and complying with protocol requirements.
- The subject has signed the Informed Consent Form. No study-related procedures may be performed before the subject has signed the form.
Key exclusion criteria (10 listed)
- Female subjects who are pregnant or nursing, or may become pregnant during the course of the study. In addition, all subjects of childbearing potential who are sexually active most use adequate contraception from signing of informed consent and throughout the duration of the study. Male subjects who have been surgically sterilized, are at least one year post-vasectomy, are not required to use contraceptives. Females not of childbearing potential are defined as those who have been surgically sterilized (hysterectomy, bilateral oophorectomy or tubal ligation) or who are postmenopausal (defined as one year since last regular menses).
- Subjects who have a past or present primary diagnosis with a psychotic disorder other than PD with or without Agoraphobia.
- Subjects who have a current uncontrolled co-morbid psychiatric disorder other than PD with or without agoraphobia.
- Subject who have a history of alcohol abuse or dependence within the 12 months prior to screening, as defined by the DSM-V criteria.
- Subjects who have a comorbid severe medical diagnosis such as Cancer, adults with chronic heart failure, uncontrolled, long-term type 2 Diabetes, etc.
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 |
|---|---|---|
| VortioxetineVortioxetine 5-20mg | Drug | Flexible, open label dosing |
Primary outcome
Mean Change from Baseline in the Panic Disorder Severity Scale (PDSS) score
Time frame: 10 weeks
2 secondary outcomes
Improvement on the Quality of Life Scale (QLOS) from Baseline
Time frame: 10 weeks
Information from the Monitoring of Side Effects Scale (MOSES)
Time frame: 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2016.
- Derived from this study: PubMed 29760763Shah A, Northcutt J. An open-label, flexible dose adaptive study evaluating the efficacy of vortioxetine in subjects with panic disorder. Ann Gen Psychiatry. 2018 May 11;17:19. doi: 10.1186/s12991-018-0190-6. eCollection 2018.
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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 4 study testing Vortioxetine in people with Panic Disorder, run by Siyan Clinical Corporation 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 5 inclusion and 10 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: finished, as of the sponsor's last update on 25 Jul 2016. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mean Change from Baseline in the Panic Disorder Severity Scale (PDSS) score (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02395510, which also lists 1 linked publication.
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 25 Jul 2016.