Designing Clinical Studies and Keeping Research Ethics

Data from clinical studies are needed for psychiatrists to make quick and scientific decisions based on the best available evidence in clinical settings. Various methods of clinical studies are useful for clinicians to have reliable answers to unmet clinical needs. Although randomized controlled trials may provide high-quality information about major issues, well-designed, naturalistic and observational studies often give us unbiased explanation for real-world phenomena. Adequate selection of clinical variables and appropriate number of participants are key factors of well-designed clinical studies. Statistical methods can add an extra dimension to initial design of clinical studies. Given ethical issues in clinical studies on psychiatric disorders, special regards should be paid to participants' ability to provide informed consents. New strategies of clinical studies need to be developed to meet clinical needs and protect the rights and welfare of study participants.

The Impact of Posttraumatic Stress Disorder on Clinical Outcomes in Patients with Schizophrenia / 신경정신의학

OBJECTIVES: This study investigated the prevalence of trauma and posttraumatic stress disorder (PTSD) in patients with schizophrenia and compared the clinical outcomes in the PTSD group and the non-PTSD group. METHODS: Among 38 patients, a total of 35 schizophrenic patients completed the Positive and Negative Syndrome Scale (PANSS), Life Stressor Checklist-Revised (LSCL-R), and Clinician-Administered PTSD Scale (CAPS). RESULTS: Thirty three patients (94.2%) had at least one trauma and average 3.9 traumatic events in their life time. There were 12 patients (34.3%) who were diagnosed with PTSD. There were no differences of sociodemographic, duration of illness, number of admission, and duration of admission between the PTSD and non-PTSD groups. After one year treatment, the non-PTSD group had significantly improved in PANSS positive, negative, and general psychopathology scale. However, the PTSD group demonstrated no significant changes in PANSS negative and general psychopathology scale. CONCLUSION: In this study, there were high rate of prevalence of trauma and PTSD in patients with schizophrenia. PTSD had negative effects on clinical outcomes in patients with schizophrenia. Careful trauma-focused approach is necessary within this population.

Changes of Appetite and Eating Behavior in Bipolar Disorder Patients: Measurement with General-Food Craving Questionnaire-Trait and the Drug-Related Eating Behavior Questionnaire

OBJECTIVES: In the current study, we quantitatively estimated changes in appetite and eating behavior of bipolar disorder patients during the pharmacotherapy. We also investigated their contribution to the weight gain and their association with specific food-craving characteristics of the patients. METHODS: Subjects included forty-one bipolar disorder patients and fifty-six controls. Currently sustained natures of food craving were assessed using the General-Food Craving Questionnaire-Trait (G-FCQ-T) and changes in appetite and eating behavior were measured using the Drug-Related Eating Behavior Questionnaire (DR-EBQ). RESULTS: Compared to the control group, the patients' group showed significantly higher body mass index (t=2.028, p=0.045). The patients' group had significantly higher 'Preoccupation with food' factor score of G-FCQ-T (p=0.016) than that of the control group. Hierarchical multiple regression analysis showed that only 'preoccupation with food' factor independently predicted psychotropic medication-induced appetite change. CONCLUSIONS: Appetite change while receiving psychotropic medication seems to be related to the weight-gain and associated with craving natures of 'preoccupation with food' in bipolar disorder. Appetite and/or eating behavioral changes measured by G-FCQ-T and DR-EBQ could be regarded as an important mediating factor in future studies exploring biological mechanisms of weight gain related with pharmacotherapy for bipolar disorder.

Comorbidity of Posttraumatic Stress Disorder and Its Effect on Treatment Outcomes in Patients with Schizophrenia : One-Year Prospective Follow-Up Study

OBJECTIVES: The aims of this study were to assess a) the prevalence of trauma and posttraumatic stress disorder(PTSD) in schizophrenic patients and b) the differences in symptomatology and outcome after 1year treatment between those with and without PTSD. METHODS: Twenty eight schizophrenia and schizoaffective disorder patients completed the Positive and Negative Syndrome Scale(PANSS), Life Stressor Checklist-Revised(LSCL-R), Clinician-Administered PTSD Scale (CAPS), Dissociative Experiences Scale(DES), Hamilton Psychiatry Rating Scale for Depression(HAM-D), and Rosenberg Self-Esteem Scale(RSE). RESULTS: Twenty six patients(92.9%) had at least one trauma in their life time. Eleven patients(39.3%) were diagnosed with PTSD. PTSD group had significantly higher scores on HAM-D and DES but lower scores on RSE. PTSD group also had significantly lower score in the baseline PANSS Negative score. Higher CAPS scores were significantly correlated with lower baseline PANSS Negative score and greater change after 1year of PANSS Negative score. CONCLUSION: These results showed that the prevalences of trauma and PTSD are high in schizophrenic patients and suggested that PTSD and trauma-related symptoms affected the symptomatology and treatment outcome. More research is warranted to better understand the effects of PTSD in schizophrenic patients.