5 Years Follow-up of the Study: "Pharmacogenetics in Depressed Patients With Specific Focus on Difficult-to-treat Depresssion, Suicide Attempt and CYP2D6"
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Region Skane
- 入组人数
- 415
- 试验地点
- 4
- 主要终点
- Suicide attempt and suicide
研究概览
简要总结
The project investigates long-term prognosis and predictors of treatment outcomes for difficult-to-treat depression in patients in secondary psychiatric care. The current patient cohort was collected in 2012-2021 in the study "Pharmacogenetics in patients with depression with specific focus on difficult-to-treat depression, suicide attempt and CYP2D6". The cohort consists of 415 patients, examined carefully regarding diagnostic assessment and earlier treatment. All participants were also genotyped for the drug metabolizing enzymes CYP2D6 and CYP2C19. Blood samples were stored in biobank for other analyses linked to prognostic markers.
The patient cohort will now be followed up with a review of medical records and extraction of register data for a period of 5 years after their participation in the original study. The purpose of the study is to improve treatment and increase knowledge about long-term prognosis in difficult-to-treat depression. This is done by examining symptom profiles, monitoring clinical course and suicidality, and examining prognostic markers.
详细描述
BACKGROUND
It is very important to understand the course of depressive disorders over time in long time follow-up studies. A cross-sectional observational study "Pharmacogenetics in depressed patients with a special focus on difficult-to-treat depression, suicide attempts and CYP2D6" (n=415) was performed in Sweden 2012-2021. Participants were genotyped for enzymes within the Cytochrome P450 system - CYP2D6 and CYP2C19. Participants were also examined very carefully with regard to diagnostic assessment with structured and semi-structured diagnostic instruments: MINI neuropsychiatric interview (MINI) and structured clinical interview for DSM-IV-TR axis II (SCID-II). Comprehensive psychipatological rating scale (CPRS) was used as well as Montgomery Asberg depression rating scale (MADRS), the UKU side effect rating scale (UKU-SERS) , Suicidal assessment scale (SUAS) and Alcohol Use Disorder Identification Test (AUDIT) and Drug Use Disorder Identification Test (DUDIT) as well as thorough survey of the clinical course of psychiatric symptoms. Blood samples were collected and stored in biobank. The participants with CYP2D6UM and CYP2D6PM were offered pharmacological counseling to optimize treatment during 8 weeks.
The same patients will now be followed over a five-year period after participation in the original study, in order to better understand the long-term prognosis of depression and the factors that can predict the course of the disorder over time.
OBJECTIVE
The overall goal is to improve treatment and increase knowledge about difficult-to-treat depression, as well as to investigate how biological and clinical variables can predict treatment outcomes and long-term outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participation in the study "Pharmacogenetics in depressive patients with specific focus on difficult-to-treat depression, suicide attempt and CYP2D6"
排除标准
- •Not wanting to participate in the follow-up study
结局指标
主要结局
Suicide attempt and suicide
时间窗: 5 years follow-up after baseline visit.
The frequency of suicide attempts and completed suicides in the patient sample over the follow-up period of 5 years
Clinical course of depression
时间窗: 5 years follow-up after baseline visit
Course of depressive disorder during the follow-up period measured by information from medical records, where the reserach psychiatrist makes an assessment dichotomized as improved or not improved based on the available information.
Comparison of diagnostic assessment for personality disorders
时间窗: Baseline data and 5 years follow-up from inclusion.
Comparison of frequency of DSM-IV-TR personality disorders and ICD-11 personality disorders in the sample. ICD-11 personality disorders will also be divided into degree of difficulty as well as which specifiers of prominent traits are present in the population of difficult-to-treat depression
Course and diagnostic characteristics of bipolar disorder
时间窗: Baseline data and 5 years follow-up after inclusion.
Historical order of diagnoses before bipolar diagnosis and the development of diagnostic assessment during follow-up as well as personality assessment according to DSM-IV and ICD-11.
Results from pharmacological counseling for CYP2D6UM och CYP2D6PM
时间窗: Nine weeks of pharmacological counseling after baseline and 5 years follow-up from baseline visit
Change in score for Montgomery Åsberg Depression Rating Scale from week 0 to 8 (total of 9 weeks) during pharmacological counseling. Data from medical records for 5 years follow-up will be used to investigate adherence to recommendations during pharmacologic counseling and in a long term perspective.
Prediction of long-term prognosis of depressive symptom profiles
时间窗: 5 years follow-up from baseline visit
Data on clinical outcome over 5 years follow-up for depressive symptom profiles with specific focus on anhedonic symtom profile derived from the Comprehensive Psychopatholocial Rating Scale (CPRS) and depression characteristics.
Course of disease related to dopamine D3 receptor and other biomarkers
时间窗: 5 years follow-up from baseline visit
The relationship between the course of depressive disorder and biomarkers including dopamine D3 receptor, other biomarkers of dopaminergic function, inflammation and other types of biomarkers
次要结局
未报告次要终点