A 10-Week, Open-Label, Flexible Dose Adaptive Study Evaluating the Efficacy of Vortioxetine in Subjects With Panic Disorder

NCT02395510 | Completed Phase 4

• 1 other identifier: VOR-ITT-0024
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Panic Disorder

Outcome Measures

Primary Outcomes (1)

• Mean Change from Baseline in the Panic Disorder Severity Scale (PDSS) score

  10 weeks

Secondary Outcomes (2)

• Improvement on the Quality of Life Scale (QLOS) from Baseline

  10 weeks

• Information from the Monitoring of Side Effects Scale (MOSES)

  10 weeks

Study Arms (1)

Flexible, open label dosing

OTHER

Flexible dosing 5-20mg

Drug: Vortioxetine

Interventions

Vortioxetine DRUG

Vortioxetine 5-20mg

Flexible, open label dosing

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Siyan Clinical Corporation: lead

Study Sites (1)

Siyan Clinical Corporation

Santa Rosa, California, 95401, United States

Location

Related Publications (1)

• 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.

  PMID: 29760763 DERIVED

MeSH Terms

Conditions

Panic Disorder

Interventions

Vortioxetine

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2015
• First Posted: March 23, 2015
• Study Start: May 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: July 25, 2016

Record last verified: 2016-07

Locations

US (1)