The Bipolar Disorder in the Longitudinal Course- Genom-wide Analysis of the genotype1 - phenotype2- Relationships in the Longitudinal Course of Psychosis
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 560
- 试验地点
- 1
- 主要终点
- CVLT- california verbal learning test
研究概览
简要总结
The BIPLONG (The Bipolar Disorder in the Longitudinal Course ) study is a longitudinal study on the course of bipolar disorders and comprises two sub-studies: On the one hand, BIPLONG examines the genetic foundation and change in bipolar disorder, on the other hand, metabolic changes, clinical symptoms and cognition in bipolar disorders is evaluated. A current subproject of BIPLONG is the analysis of the psychological response of the COVID-19 (Corona virus disease) pandemic. With the parameters examined in BIPLONG, it is hoped to gain better understanding of the bipolar disorder in the longitudinal course.
详细描述
Study Procedure:
In addition to the bipolar patients, healthy controls will also be included. The same inventories will be used for the control subjects and the same examinations or visits will be performed; bipolar-specific disease questions will not be asked in controls.
Intervention: Longitudinal study
Method:
All patients and controls undergo several assessments every six months:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
CVLT- california verbal learning test
时间窗: at six months
The California Verbal Learning Test (CVLT) provides a brief and individualized assessment of verbal learning strategies and processes. The higher the score, the better the outcome
STROOP Farbe-Wort-Interferenz-Test (FWIT)
时间窗: at six months
As an objective and reliable multidimensional performance test, the Color-Word. The Interference Test measures elementary information processing skills (selection, encoding, and decoding) in the visual-verbal functional domain. The lower the score, the better the outcome.
D2-R
时间窗: at six months
To measure the subject's ability to concentrate and the speed and accuracy in distinguishing similar visual stimuli. The higher the score, the better the outcome.
"Reading the eyes of the mind" =Theory of mind
时间窗: at six months
measurement of the ability to detect social cues. The higher the score, the better the outcome.
Trail Making Test A/B, TMT-A
时间窗: at six months
Measurement of cognitive processing speed, as well as linguistic, executive, and attentional components. The lower the score, the better the outcome.
Mehrfachwahl Wortschatz Test (MWT-B)
时间窗: at six months
Measurement of the general intelligence level. The higher the score, the better the outcome.
Number Symbol Test
时间窗: at six months
Measurement of processing speed. The higher the score, the better the outcome.
Number Repeat
时间窗: at six months
Measurement of working memory. The higher the score, the better the outcome.
Beck Depressions Inventar II (BDI-II)
时间窗: at six months
Measurement of depression severity; 21 items on a scale of 0-3 (ascending). The higher the score, the worse the outcome.
World Health Organisation Quality of Life (WHOQOL Bref)
时间窗: at six months
Measurement of life-quality and health; 26 items on a scale of 1-5 (ascending).
Life Event Questionnaire (LEQ)
时间窗: at six months
Measurement of life events and their influence; 79 items on a scale of 0-3 (ascending)
Anthropometric Data - blood pressure
时间窗: at six months
Measurement of blood pressure
Clinical Global Impression (CGI)
时间窗: at six months
External rating of a symptom severity; 2 items on a scale of 0-7 (ascending). The higher the score, the better the outcome.
Manie-Selbstbeurteilungsskala (MSS) (self-rating scale)
时间窗: at six months
Measurement of manic symptoms; 48 items (dichotomous). The higher the score, the worse the outcome.
Questionnaire of religiosity
时间窗: at six months
socio-demographic assesment of religiosity; 2 items.
Big Five Inventory-10 (BFI-10)
时间窗: at six months
Measurement of personality variables; 10 items on a scale of 1-5 (ascending).
Temperament and affective disorders (TEMPS-A)-Scale
时间窗: at six months
35 items on a scale of 1-5 (ascending). The higher the score, the better the outcome.
Maslach Burnout Inventory (MBI-GS-D)
时间窗: at six months
Measurement of burnout symptoms; 16 items on a scale of 1-6 (ascending). The higher the score, the worse the outcome.
Brief symptom inventory (BSI)
时间窗: at six months
Measurement of psychological symptoms; 53 items on a scale of 0-4 (ascending). The higher the score, the worse the outcome.
Anhedonia scale (AS)
时间窗: at six months
Measurement of Anhedonia; 14 items on a scale of 1-4 (ascending). The higher the score, the worse the outcome.
Satisfaction in the couple relationship (ZIP)
时间窗: at six months
Measurement of relationship satisfaction; 7 items on a scale of 1-5 (ascending), 3 items open questioned. The higher the score, the better the outcome.
Demographic Data
时间窗: at six months
Measurement of demographic data
Questionnaire of current life situation
时间窗: at six months
Measurement of demographic and diagnostic data;
Resources in Sexuality and Partnership (RSP)
时间窗: at six months
Measurement of relationship emotions; 25 items on a scale of 1-5 (ascending).The higher the score, the better the outcome.
Anthropometric Data - weight
时间窗: at six months
Measurement of weight
Global Assessment Scale of Functioning (GAF)
时间窗: at six months
External rating of level of functioning; 1 item on a scale of 1-100 (ascending). The higher the score, the better the outcome.
Anthropometric Data- height
时间窗: at six months
Measurement of height
Anthropometric Data - waist-to-hip ratio
时间窗: at six months
Measurement of waist-to-hip ratio
Hamilton Depression Scale (HAMD)
时间窗: at six months
External rating of depression symptoms; 21 items on a scale of 0-4 (ascending).The higher the score, the worse the outcome.
Young Mania Rating Scale (YMRS)
时间窗: at six months
External rating of manic symptoms; 11 items on a scale of 0-4/0-8 (ascending). The higher the score, the worse the outcome.
Specific Level of Functioning Assessment and Physical health Inventory (SLOF)
时间窗: at six months
External rating of functioning; 43 items on a scale of 1-5 (ascending), 2 items open questioned. The higher the score, the better the outcome.
Supplementary Data for External Rating
时间窗: at six months
External rating of bipolar symptoms; 7 items.
次要结局
未报告次要终点
