跳至主要内容
临床试验/NCT00538629
NCT00538629已完成不适用

NON INTERVENTIONAL STUDY (NIS) IN PATIENTS WITH BIPOLAR DISCORDER (MANIC OR MIXED EPISODES) AND SCHIZOPHRENIA UNDERGOING TREATEMENT WITH ZELDOX

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.0 个研究点目标入组 471 人开始时间: 2007年10月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
471
主要终点
Montgomery Asberg Depression Rating Scale (MADRS) Scores (Bipolar Population): Change From Baseline

研究概览

简要总结

Investigation of the impact of Zeldox on metabolic parametres in patients with bipolar disorder or with schizophrenia and impact of the treatment for the quality of life

详细描述

observational survey consecutive patient sampling

研究设计

研究类型
Observational
观察模型
Other
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

入选标准

  • Manic and mixed episodes of up to moderate severity in patients with type I and II bipolar disorder and schizophrenia; either first diagnosed or repeated episodes.

排除标准

  • Patients with a history of hypersenzitivity to Ziprasidone. Previous insufficiency of the Ziprasidone´s treatment. The break of the previous therapeutic condition.

结局指标

主要结局

Montgomery Asberg Depression Rating Scale (MADRS) Scores (Bipolar Population): Change From Baseline

时间窗: Baseline to final visit (12 weeks)

MADRS measures treatment effect on depression severity. MADRS assesses apparent and reported sadness, inner tension, sleep, appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Higher score indicates greater severity of disease. Change: score at final visit minus score at baseline.

Clinical Global Impressions Change (CGI-C) Scores (Bipolar Population)

时间窗: Final visit (week 12)

CGI-C assesses change in severity of the conditionusing a scale that ranges from (1) very much improved to (7) very much worse. Higher score indicates increasing severity of disease.

Brief Psychiatric Rating Scale (BPRS) Scores (Schizophrenia Population): Change From Baseline

时间窗: Baseline to final visit (week 12)

BPRS is an 18-item scale with 11 general symptom items, 5 positive-symptom items, and 2 negative symptom items. The physician completes the BPRS, and each item is scored on a 7-point scale, with higher score indicating greater severity of symptom. Change: score at final visit minus score at baseline.

Extrapyramidal Symptom (EPS) Scores (Schizophrenia Population: Baseline and Final Visit

时间窗: Baseline and final visit (week 12)

EPS assesses 4 items: akathisia, dystonia, dyskinesia, and parkinsonism. Each item is scored on a 5-point severity scale ranging from 1 to 5, with higher score indicating greater severity of symptom. Change: score at final visit minus score at baseline.

Clinical Global Impression of Severity (CGI-S) Scores (Bipolar Population)

时间窗: Baseline

CGI-S assesses the severity of the condition at baseline using a scale that ranges from (1)Normal, not ill at all to (7) Among the most severely ill patients.

Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Mental Health?

时间窗: Baseline and final visit (week 12)

MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction.

Young Mania Rating Scale (YMRS) Scores (Bipolar Population): Change From Baseline

时间窗: Baseline to final visit (12 weeks)

The YMRS is an 11-item questionnaire that rates the severity of bipolar disorder, with higher score indicating greater severity of disease. Change: score at final visit minus score at baseline.

Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With the Number and Quality of Your Friendships?

时间窗: Baseline and final visit (week 12)

MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction.

Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Job?

时间窗: Baseline and final visit (week 12)

MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher number indicating higher satisfaction.

Manchester Short Assessment of Quality of Life (MANSA) Scores(Schizophrenia Population) in Answer to: How Satisfied Are You With Your Financial Situation?

时间窗: Baseline and final visit (week 12)

MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher number indicating higher satisfaction.

Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: Do You Have Anyone You Would Call a Close Friend?

时间窗: Baseline and final visit (week 12)

MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher number indicating higher satisfaction.

Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: In the Last Week Have You Seen a Friend?

时间窗: Baseline and final visit (week 12)

MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher number indicating higher satisfaction.

Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Personal Safety?

时间窗: Baseline and final visit (week 12)

MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction.

Clinical Global Impressions Change (CGI-C) Scores (Schizoprenia Population)

时间窗: Final visit (week 12)

CGI-C assesses change in severity of the conditionusing a scale that ranges from (1) very much improved to (7) very much worse. Higher score indicates increasing severity of disease.

Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With the People You Live With?

时间窗: Baseline and final visit (week 12)

MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher number indicating higher satisfaction.

Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Relationship With Your Family?

时间窗: Baseline and final visit (week 12)

MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction.

Clinical Global Impression of Severity (CGI-S) Scores (Schizophrenia Population)

时间窗: Baseline

CGI-S assesses the severity of the condition at baseline using a scale that ranges from (1)Normal, not ill at all to (7) Among the most severely ill patients.

Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: In the Past Year Have You Been Accused of a Crime?

时间窗: Baseline and final visit (week 12)

MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher number indicating higher satisfaction.

Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Relationship With Your Family?

时间窗: Baseline and final visit (week 12)

MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction.

Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Leisure Activities?

时间窗: Baseline and final visit (week 12)

MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction.

Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Accomodation?

时间窗: Baseline and final visit (week 12)

MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction.

Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: In the Past Year, Have You Been a Victim of Physical Violence?

时间窗: Baseline and final visit (week 12)

MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher number indicating higher satisfaction.

Global Efficacy Evaluation Scores (Bipolar Population)

时间窗: Final visit (week 12)

The Global Efficacy Evaluation assesses the final efficacy of ziprasidone on bipolar symptoms using a 5-point scale that ranges from very good to worsening of the original disease.

Global Efficacy Evaluation Scores (Schizophrenia Population)

时间窗: Final visit (week 12)

The Global Efficacy Evaluation assesses the final efficacy of ziprasidone on schizophrenia symptoms using a 5-point scale that ranges from very good to worsening of the original disease.

Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Life as a Whole Today?

时间窗: Baseline and final visit (week 12)

MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction.

Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Financial Situation?

时间窗: Baseline and final visit (week 12)

MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher number indicating higher satisfaction.

Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: In the Last Week Have You Seen a Friend?

时间窗: Baseline and final visit (week 12)

MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher number indicating higher satisfaction.

Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Leisure Activities?

时间窗: Baseline and final visit (week 12)

MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction.

Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Mental Health?

时间窗: Baseline and final visit (week 12)

MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction.

Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Job?

时间窗: Baseline and final visit (week 12)

MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction.

Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: Do You Have Anyone You Would Call a Close Friend?

时间窗: Baseline and final visit (week 12)

MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher number indicating higher satisfaction.

Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Accomodation?

时间窗: Baseline and final visit (week 12)

MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher number indicating higher satisfaction.

Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: In the Past Year, Have You Been a Victim of Physical Violence?

时间窗: Baseline and final visit (week 12)

MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher number indicating higher satisfaction.

Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Personal Safety?

时间窗: Baseline and final visit (week 12)

MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction.

Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Sex Life?

时间窗: Baseline and final visit (week 12)

MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction.

Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Health?

时间窗: Baseline and final visit (week 12)

MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction.

Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Life as a Whole Today?

时间窗: Baseline and final visit (week 12)

MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction.

Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Health?

时间窗: Baseline to final visit (week 12)

MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction.

Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With the Number and Quality of Your Friendships?

时间窗: Baseline and final visit (week 12)

MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction.

Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: In the Past Year, Have You Been Accused of a Crime?

时间窗: Baseline and final visit

MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher number indicating higher satisfaction.

Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With the People You Live With?

时间窗: Baseline and final visit (week 12)

MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher number indicating higher satisfaction.

Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Sex Life?

时间窗: Baseline and final visit (week 12)

MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction.

次要结局

未报告次要终点

研究者

发起方
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
申办方类型
Industry
责任方
Sponsor

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