A Long-term Observational Study on the Efficacy of SSRIs or Combined Treatment(SSRIs+ CBT) in Panic Disorder Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2012 by Samsung Medical Center
Sponsor:
Information provided by (Responsible Party):
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01674673
First received: August 24, 2012
Last updated: December 26, 2013
Last verified: August 2012
  Purpose

It is known that the treatment of panic disorder with medication and psychotherapy are both effective. Representative as a treatment for panic disorder, Selective serotonin reuptake inhibitors (SSRIs) are recommended as first-line treatment of panic disorder. In general, the initial reaction rate of panic disorder medication known to be frequently stopped early recurrence 70-80% It's too early, it is recommended that the duration of drug treatment for at least one year to be long-lasting. But whether it is appropriate for the duration of drug treatment to maintain a certain extent remains controversial, and maintain the medication for more than one year, even if the long-term effects known to be approximately 50% less than beyond being negative when remission based. Meanwhile, the typical method for the treatment of panic disorder psychology, cognitive behavioral therapy (Cognitive behavioral therapy) and looked comparable to the effect of the drug in the treatment of the known, especially in recent years when the combined treatment with medication can increase the long-term treatment of sexual reported that there's has been the subject of attention.

But prospectively compare the long-term effects of these two treatments, research, especially the research about the long-term effects of the combined treatment with the drug treatment of panic disorder is very low, and almost nil is Researchers, drug treatment and the effect of the combined treatment in patients with panic disorder over two years prospective study to compare the plans were. And verification, the researchers performed only through this study by comparing the long-term effects of the combined treatment with medication combined treatment of medication to be more effective than if the reaction to the long-term treatment of panic disorder that can affect the clinical and biological factors navigate to evaluate them. In addition, long-term observational study, panic disorder patients' subjective quality of life actually improved to some extent on the map together proven to.


Condition
Panic Disorder

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: A Long-term Observational Study on the Efficacy of SSRIs Pharmacotherapy or Combined Treatment(SSRIs Pharmacotherapy + CBT) in Panic Disorder Patients

Resource links provided by NLM:


Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • PDSS [ Time Frame: one year ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

whole blood


Estimated Enrollment: 110
Study Start Date: February 2012
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Panic disorder patients 20 years of age or older to visit the Samsung Seoul Hospital, and the Department of Mental Health, a foreign patients, patients who agreed to participate in this study will be of. Plan the patient-specific total of 100 patients on each drug treatment group and combined treatment group, 55 patients recruited by the first year of study commences 1 years F / U to enforce the number of subjects.

Criteria

Inclusion Criteria:

  • Outpatients with panic disorder at the SMC
  • PD patients who agree to participate in the clinical study
  • PD patients who are over 20 years old

Exclusion Criteria:

  • PD patients who have either severe medical illnesses or other psychiatric illnesses
  • PD patients who are pregnant, or lactating
  • PD patients who have suicidal idea
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01674673

Contacts
Contact: Bum-Hee Yu, MD, PhD 0234101385 bh.yu@samsung.com

Locations
Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 000000
Contact: Bum-Hee Yu, MD, PhD    0234103583    bh.yu@samsung.net   
Sponsors and Collaborators
Samsung Medical Center
Investigators
Principal Investigator: BumHee BH Yu, Ph.D Samsung Medical Center
  More Information

No publications provided

Responsible Party: Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01674673     History of Changes
Other Study ID Numbers: 2011-10-130
Study First Received: August 24, 2012
Last Updated: December 26, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Samsung Medical Center:
panic disorder
SSRIs pharmacotherapy
Cognitive Behavioral therapy

Additional relevant MeSH terms:
Panic Disorder
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 18, 2014