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临床试验/NCT05064995
NCT05064995Unknown不适用

The Bipolar Disorder in the Longitudinal Course- Genom-wide Analysis of the genotype1 - phenotype2- Relationships in the Longitudinal Course of Psychosis

Medical University of Graz1 个研究点 分布在 1 个国家目标入组 560 人开始时间: 2013年6月13日最近更新:
适应症

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

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

研究者

发起方
Medical University of Graz
申办方类型
Other
责任方
Sponsor

研究点 (1)

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