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Trial record 1 of 1 for:    siyan clinical corporation
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A 10-Week, Open-Label, Flexible Dose Adaptive Study Evaluating the Efficacy of Vortioxetine in Subjects With Panic Disorder

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02395510
First Posted: March 23, 2015
Last Update Posted: July 25, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Siyan Clinical Corporation
  Purpose
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.

Condition Intervention Phase
Panic Disorder Drug: Vortioxetine Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A 10-Week, Open-Label, Flexible Dose Adaptive Study Evaluating the Efficacy of Vortioxetine in Subjects With Panic Disorder

Resource links provided by NLM:


Further study details as provided by Siyan Clinical Corporation:

Primary Outcome Measures:
  • Mean Change from Baseline in the Panic Disorder Severity Scale (PDSS) score [ Time Frame: 10 weeks ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 27
Study Start Date: May 2015
Study Completion Date: June 2016
Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Flexible, open label dosing
Flexible dosing 5-20mg
Drug: Vortioxetine
Vortioxetine 5-20mg

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. The subject voluntarily agrees to participate in the study under their own free will.
  2. The subject meets the DSM-V criteria for PD with or without Agoraphobia or has a PDSS score > 8 at the Baseline visit.
  3. The subject is between the ages of 18-60 years old inclusive at the time of consent.
  4. The subject is capable of understanding and complying with protocol requirements.
  5. The subject has signed the Informed Consent Form. No study-related procedures may be performed before the subject has signed the form.

Exclusion Criteria:

  1. 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).
  2. Subjects who have a past or present primary diagnosis with a psychotic disorder other than PD with or without Agoraphobia.
  3. Subjects who have a current uncontrolled co-morbid psychiatric disorder other than PD with or without agoraphobia.
  4. Subject who have a history of alcohol abuse or dependence within the 12 months prior to screening, as defined by the DSM-V criteria.
  5. Subjects who have a comorbid severe medical diagnosis such as Cancer, adults with chronic heart failure, uncontrolled, long-term type 2 Diabetes, etc.
  6. Subjects with a history of liver disease such as cirrhosis of liver, neoplasm of the liver, or active Hepatitis C.
  7. Subjects weighing less than 100lbs at the Baseline visit.
  8. 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.
  9. 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.
  10. Subjects who are unable to fully understand the potential risks and benefits of the study and unable to give informed consent.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02395510


Locations
United States, California
Siyan Clinical Corporation
Santa Rosa, California, United States, 95401
Sponsors and Collaborators
Siyan Clinical Corporation
  More Information

Responsible Party: Siyan Clinical Corporation
ClinicalTrials.gov Identifier: NCT02395510     History of Changes
Other Study ID Numbers: VOR-ITT-0024
First Submitted: March 16, 2015
First Posted: March 23, 2015
Last Update Posted: July 25, 2016
Last Verified: July 2016

Additional relevant MeSH terms:
Disease
Panic Disorder
Pathologic Processes
Anxiety Disorders
Mental Disorders
Vortioxetine
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin 5-HT1 Receptor Antagonists
Serotonin Antagonists
Serotonin 5-HT3 Receptor Antagonists