Multicenter Clinical Trials for Efficacy and Safety of Mirtazapine in Moderate-to-Severe Major Depressive Patients / 대한정신약물학회지

OBJECTIVE: The purpose of this study is to evaluate the efficacy and safety of mirtazapine treatment in multicenter population consisting of Korean patients suffering from moderate-to-severe depression. METHODS: Total 163 of in and outpatients with a diagnosis of major depressive disorder (DSM-IV) and 18 or over scores of 17-items Hamilton Rating Scale for Depression (HAMD) received treatment with mirtazapine (15-45 mg/day) for 6 weeks. Efficacy was assessed by HAMD, Montgomery and Asberg Depression Rating Scale (MADRS), Beck's Depression Inventory (BDI), and Clinical Global Impression (CGI) scales and statistical analyses were performed on the intent-to-treat sample (143 patients) using the last-observation-carried-forward method. In addition, reported adverse events, routine laboratory parameters, and vital signs were investigated to evaluate the safety of mirtazapine. RESULTS: Mean daily dose of mirtazapine was 28.4 mg. At the end of the study, the response rate (50% or more reduction from baseline in HAMD scores) was 75.5% and the remission rate (7 or less in HAMD score) was 42.7%. Mirtazapine treatment induced significant reduction in depressive symptoms at the 4(th) day and substantial reduction along the treatment period, as assessed by changes in HAMD, MADRS, BDI, and CGI scales. At the 4(th) day and first week of mirtazapine treatment, the mean HAMD-17 total score was significantly reduced compared that of the baseline and the response rates were 11.9% and 28.7%, respectively. Mirtazapine was well tolerated in general, and somnolence and sedation were the most common adverse events reported. In addition, there were no clinically relevant changes in laboratory parameters and vital signs, although body weight was increased. CONCLUSION: Although this trial had many limitations of open non-comparative study, mirtazapine was demonstrated to an effective treatment for moderate to severe major depressive disorder and was well tolerated. A potentially rapid onset of overall therapeutic efficacy of mirtazapine was suggested by significant changes in all major variables of efficacy after 4(th) day of treatment.

Temperament and Charcater Dimensions of Posttraumatic Stress Disorder in Burn Patients

OBJECTIVE: The aim of this study was to evaluate the temperament and character profiles of the patients with posttraumatic stress disorder(PTSD) after burn injury. METHODS: The study subjects consisted of 23 PTSD patients after burn injury, 24 patients not being diagnosed as PTSD after burn injury(non-PTSD) and 53 healthy controls. The assessment of PTSD was performed using clinician administered PTSD scale. All participants were instructed to complete the Temperament and Character Inventory(TCI), the Beck Depression Inventory and the State and Trait Anxiety Inventory of Spielberger. RESULTS: The PTSD group after burn injury, compared with the non-PTSD group and the normal controls, had the higher novelty seeking and harm avoidance scores. But there were no differences in other dimensions in the TCI among the three groups. CONCLUSION: The results of this study suggest that the PTSD group after burn injury showed the specific properties of temperament and character compared with the non-PTSD group and the normal group.

Development and Validation of DIS-IV, Korean Version / 신경정신의학

OBJECTIVE: Appearance of DSM-IV has influenced greatly on the nosological classification of mental disorder, not considered as revised one of DSM-III-R but a new criteria. DIS-IV has been developed after revision of DIS-III in consideration of various changes in DSM-IV. This study is to develop and validate the DIS-IV, Korean version to activate Korean psychiatric research much more and to modivate more frequent international collaborative study. METHOD: Translation committee produced DIS-IV, Korean version through all the procedures of translation, back-translation, confirmation of retained original meaning of the English version, adaptation to Korean linguistic usage and preliminary study. Four medical students were trained during DIS-IV training course that retained the same contents and methods as of Washington University. Inter-rater reliability was measured by comparison between two diagnoses made from two interviewer who rated one patient at the same time. Procedural validity was measured by comparison between lay-interviewer's diagnosis and psychiatrist's diagnosis which were made after independent DIS-IV using interview. Subjects were 124 patients who were being treated at two University Hospital and National Forensic Psychiatric Hospital between January, 2000 and August, 2000. RESULTS: Average kappa value of inter-rater reliability was 0.74. Diagnoses showing over 0.7 in kappa value were bipolar I disorder, generalized anxiety disorder, depressive disorder, obsessive-compulsive disorder, oppositional defiant disorder, pain disorder, pathological gambling, post-traumatic stress disorder, specific phobia and almost all substance use disorder or substance- related disorder. Procedural validity, that compared lay-interviewer's diagnosis and psychiatrist's diagnosis, were as follows;For all diagnoses, sensitivity, specificity and kappa were 67.6%, 98.3% and 0.69. For diagnoses of substance use disorder or substance- related disorder, sensitivity, specificity and kappa were 79%, 98% and 0.77. For other diagnoses except substance use disorder or substance- related disorder, sensitivity, specificity and kappa were 60.5%, 98% and 0.64. This results are almost at the same level as that of Robins and her colleagues who first reported reliability and validity of DIS. CONCLUSION: We think that DIS-IV, Korean version has higher reliability and validity. It is very important that diagnoses of substance use disorder and substance-related disorder can be made reliably and validly by this instrument. We expect that it can help to improve diagnosability of mental disorder, activate clinical research and increase international scientific communication.

Delirium and Death in Burn Patients under Intensive Care

OBJECTIVE: This study was to estimate the prevalence of and identify the predisposing risk factors of delirium and to determine the effect of delirium on the prognosis, especially death in burn patients. METHOD: The study was completed by thorough examination of medical records, with additional confirmation, of the 245 patients who were admitted to the Burn ICU in Burn treatment center of Hangang Sacred Heart Hospital during last one year (Jan. 1. 1998-Dec. 31. 1998). Delirium was retrospectively diagnosed according to DSM-IV. Only when disturbance of consciousness and attention, cognitive dysfunction especially disorientation, or perceptual disturbance were observed, diagnosis of delirium were given. Final outcome such as death was discriminated through examination of medical records or question to those who knew the patient. RESULTS: One year prevalence of delirium in burn patients is 34.4%. Statistically significant predisposing risk factors of delirium were five;Age 65 and over (OR=45.51, 95% CI:6.07-341.11), burn size over 60% of total body surface (OR=6.48, 95% CI:3.16-13.28), current psychiatric disorder (OR=6.81, 95% CI:1.42-32.57), current medical disease (OR=3.00, 95% CI:1.40-6.45), alcohol abuse (OR=3.17, 95% CI:1.07-9.43) Statistically significant deathrelated risk factors were three;burn size over 60% of total body surface (OR=4.58, 95% CI:2.00-10.46), delirium (OR=2.94, 95% CI:1.25-6.94), current psychiatric disorder (OR=4.09, 95% CI:1.05-15.87). Aging is not the death-related factor in this study. CONCLUSION: Three factors, such as delirium, organic brain damage, and burn size over 60% of total body surface may predict higher risk of death in burn patients.