Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT01674673 |
| Other study ID # |
2011-10-130 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
August 24, 2012 |
| Last updated |
December 26, 2013 |
| Start date |
February 2012 |
| Est. completion date |
October 2014 |
Study information
| Verified date |
August 2012 |
| Source |
Samsung Medical Center |
| Contact |
Bum-Hee Yu, MD, PhD |
| Phone |
0234101385 |
| Email |
bh.yu[@]samsung.com |
| Is FDA regulated |
No |
| Health authority |
United States: Food and Drug Administration |
| Study type |
Observational
|
Clinical Trial Summary
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.
Description:
Panic disorder SSRI medication and long-term effects of the combined treatment on the
Hamilton Rating Scale more effective treatment compared with the Scale for Anxiety (HAM-A),
Clinical Psychology, I try to find the law. Drug and combination therapy of panic disorder
from affecting the long-term effects on clinical (demographic and economic Factors), and to
check for navigation and biological factors. - Improved quality of life to some extent due
to the long-term treatment of patients with panic disorder, if you want to check
2.3 Expected Effects Panic disorder in a comparative study of the long-term effects of the
combined treatment with SSRI medication until now very rare, and most of the research to
target Westerners, Asians to study is almost wholly lacking. Also to investigate the nature
of the clinical course of panic disorder, long-term study also little or no sleep. Elapsed
for the treatment of long-term treatment of panic disorder and its impact on various
clinical variables to be able to figure out if, through the analysis of the results of this
study, the future could be a very useful background material, used in the development of
clinical care guidelines is expected. Leading researchers in various studies for panic
disorder at home and abroad, and also, therefore, the results obtained in this research is
very useful in the pathogenesis and in the treatment of panic disorder is expected. The
results of this study will be introduced in the Domestic Society and International Society,
will finally be published in major journals of SCI related.
3 Research plan 3.1 Research information and how to
- The selection of subjects Diagnosis by the DSM-IV diagnostic criteria for major panic
attacks in patients with disabilities will be conducted by a clinical psychologist or
psychiatrist: Mini International Neuropsychiatric Interview Plus (MINI-plus) of structured
skilled diagnostic tool.
In the case of patients who were taking medication Airlines sulfur existing at least 2 weeks
(hydrochloric acid flu Jade Satin scheduled to participate in a study of the existing 4
weeks) and stop taking the drug. All other prescription non-drug (herbal medicine), forbids
smoking within 24 hours before the test, caffeine drink, drinking is prohibited in the state
to proceed with a test is scheduled.
Treatment conditions Randomization Randomization table belonging goes: medication alone
group and the combined treatment group on either side Will be determined by the SSRIs Tx
group -> Korean panic disorder treatment algorithm (Korean Medication Algorithm for Panic
Disorder 2008: Initial Treatment Strategies. J. C. Yang et al., 2008) according to the
treatment by applying Standardized treatment is expected to be performed. Single use only,
benzodiazepine (alprazolam) and tapering zolpidem use, but only occasionally, within 3
months of treatment, so that Should, in principle, (using the PRN as alprazolam available).
- Combined Tx group SSRIs Tx group, and the same drug treatment to be carried out once a
week underwent 10 sessions of CBT, and, after 3 Once a month booster session is
scheduled to be performed.
- Therapists
- Treatment conducted by a psychiatrist skilled in both groups, but CBT case of a
qualified clinical psychology Scholars will participate as an adjunct therapy in the
treatment session.
- Assessment Is scheduled to visit (24 months) to assess the clinical
manifestations: a total of 11 times.
Visit 1: Screening & Baseline Visit 2,3,4: every visit per month. / CBT once a week about 3
months, 10 sessions of treatment Visit 5-11: every 3 months to visit / CBT Booster session
in three months, once implemented
- Visit 1 (Screening & Baseline)
- MINI-plus diagnostic tool
- Obtaining research consent
- Determine whether severe medical or psychiatric diseases
- Demographic data survey (In the future, when compared to the quality of life,
according to the therapeutic, marital status, educational And income levels
yuksujun compensation, and demographic and economic variables according to the
comparison of the response to treatment in order) Age of onset (early onset and
late-onset separated) survey
- Clinical data (Baseline severity and panic frequency) survey
- Duration of disease survey A comorbidity (need to MINI-plus disease
confirmed) Whether other drugs: Prescription
- Alcohol and substance combination presence Past medication or CBT, such as
whether to perform
- Hamilton Rating Scale for Anxiety (HAM-A), Hamilton Rating Scale for
Depression (HAM-D), Clinical Global Impression-Severity (CGI-S), PDSS (Panic
Disorder Severity Scale), Evaluate the PSR (Psychiatric status ratings)
- As a self-assessment item MMPI-II, Anxiety Sensitivity Index-Revised (ASI-R),
Albany Panic and Phobic Questionnaire (APPQ), WHOQOL-BREF, Stress Response
Inventory (SRI) measurement
- Clinical Response Remission rate Response rate and survey (No panic attack and
PDSS scores <5 on standards)
- Pharmacological Tx Drug administration and dosage, drug side effects, Compliance
Survey
- Anxiety-related biomarkers measured
- CBC and lipid battery tests blood samples
- Heart rate variability (HRV), Biofeedback (EMG, EDR, measuring peripheral
skin temperature)
- Cytokine (IL-1b, 2,6, TNF-alpha, IFN-r, IL-12 / IL-4, 10) measurements →
blood samples
- Genetic factor survey → blood samples
- Serotonin related genes (5-HTTLPR & serotonin 2A receptor genetic
polymorphism gene)
- COMT, BDNF, DRD2, MAOA genetic polymorphism gene
- Personality factor Psychiatrist skilled clinical interview of DSM-IV Axis II
diagnosis enforcing
- Visit 2, 3, 4 (every 1 month, after 1, 2, and 3 Month)
- Clinicians additional item (Clinical Global Impression-Improvement (CGI-I) rating)
- Item self-assessment (MMPI-II)
- Clinical Response
- Pharmacological Tx History
- Anxiety-related biomarkers measured (Visit 4, 3-month period)
- Visit 5-11 (every 3 months, after 6, 9 12, 15, 18, 21, 24 Month)
- visit 2,3,4 same as the one measuring anxiety-related biomarker for 6 months, 12
months, 18 months, 24 months, and only at the point
- Statistical analyses Methods of treatment: comparison between the two
treatment groups for baseline anxiety severity, and status as a covariate
Will be analyzed under analysis of covariance (ANCOVA) model using For
comparison: two treatments according to the degree of improvement between the
groups (remitters) the Cochran- It is planned to use the Mantel-Haenszel
test. Personality or reaction and make a difference, according to the genetic
factor gene to gene on gene interaction, and gene to environment interaction
multiple regression or MDR (multidimensional reduction) using the statistical
program is expected to be analyzed.
- Plan for the subject's right to privacy and information protection Effect
from September 30, 2011, in accordance with the Privacy Act, personal
information collected purposes, the subject's right to privacy and
information protection for subject identification is not possible to encrypt
your name and personal number of participants in the study, and you want to
collect personal items of information, the right description of the subjects
for the duration of the protection of personal information and use, and is
expected to obtain this consent. Information obtained from the study to the
Clinical Trials Committee of the Food and Drug Administration to be used only
for the purpose of analysis and clinical research information to connect to,
and comply with the relevant provisions. The results of this trial will be
published if the subject's identity will remain secret, and all relevant data
will be managed under the supervision of the Principal Investigator.
3.2 Subjects plan 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 110 patients on
each drug treatment group and combined treatment group, 55 patients recruited by the first
year of study commences 2 years F / U to enforce the number of subjects. Which G * Power
3.0.10 version program (Erdfelder, E., Faul, F., & Buchner, A. (1996)), using the power 80%,
significance level of 5%, effect size 0.6, and the case and control groups equal number
allocation to treatment in panic disorder seems common rate, the percentage of Asian
American about 20% and Samsung Seoul Hospital, Department of Mental Health, panic disorder
patients for many years to visit when you consider that approximately 2,300 (initial 200
patients, at least), the appropriate is suggested by the number of subjects.
Subject selection 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
Subject 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
3.3 Subjects for Risk / Benefit Risk: every 3, 6, 12, 18, and 24 months after treatment with
at the time, be conducted sampling method is typically performed venous blood 60 ml (6
times). Accordingly, the subcutaneous blood or mild pain on the puncture site hematoma and
bruising and discomfort of the byeolun.
In addition, the possible side effects be used to study aviation sulfur drugs, selective
serotonin reuptake inhibitors, such as nausea, vomiting, dry mouth, dizziness, diarrhea,
insomnia, somnolence, ejaculation delay or erectile impairment sexual interference and can
be.
Suspended for the duration of existing drugs, on recurrence gonghwangjeung and cause a
worsening of the subjects were taking the existing air sulfur drugs, if may be.
Interests: while participating in a clinical trial for two years, the state of mental
health, and balance the autonomic nervous system, the degree and temperament / personality
traits in the individual subjects to learn. Blood through the analysis of the primary
results of a blood test before and after treatment may also be associated with various
psychological tests, can receive free of charge.
4 Annual Research Plan (3-year study performed)
- 1st year (2012): Patient recruitment and conduct research
- 2nd year (2013): Studies performed
- 3rd year (2014): conduct research and data analysis
