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
observational survey consecutive patient sampling
Study Type
OBSERVATIONAL
Enrollment
471
no intervention
no intervention
Clinical Global Impression of Severity (CGI-S) Scores (Bipolar Population)
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.
Time frame: Baseline
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Mental Health?
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.
Time frame: Baseline and final visit (week 12)
Young Mania Rating Scale (YMRS) Scores (Bipolar Population): Change From Baseline
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.
Time frame: Baseline to final visit (12 weeks)
Montgomery Asberg Depression Rating Scale (MADRS) Scores (Bipolar Population): Change From Baseline
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.
Time frame: Baseline to final visit (12 weeks)
Clinical Global Impressions Change (CGI-C) Scores (Bipolar Population)
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.
Time frame: Final visit (week 12)
Clinical Global Impressions Change (CGI-C) Scores (Schizoprenia Population)
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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.
Time frame: Final visit (week 12)
Brief Psychiatric Rating Scale (BPRS) Scores (Schizophrenia Population): Change From Baseline
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.
Time frame: Baseline to final visit (week 12)
Extrapyramidal Symptom (EPS) Scores (Schizophrenia Population: Baseline and Final Visit
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.
Time frame: Baseline and final visit (week 12)
Global Efficacy Evaluation Scores (Bipolar Population)
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.
Time frame: Final visit (week 12)
Global Efficacy Evaluation Scores (Schizophrenia Population)
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.
Time frame: Final visit (week 12)
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?
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.
Time frame: Baseline and final visit (week 12)
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Job?
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.
Time frame: Baseline and final visit (week 12)
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Financial Situation?
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.
Time frame: Baseline and final visit (week 12)
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: Do You Have Anyone You Would Call a Close Friend?
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.
Time frame: Baseline and final visit (week 12)
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: In the Last Week Have You Seen a Friend?
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.
Time frame: Baseline and final visit (week 12)
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?
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.
Time frame: Baseline and final visit (week 12)
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Accomodation?
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.
Time frame: Baseline and final visit (week 12)
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Leisure Activities?
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.
Time frame: Baseline and final visit (week 12)
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?
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.
Time frame: Baseline and final visit (week 12)
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?
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.
Time frame: Baseline and final visit (week 12)
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Personal Safety?
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.
Time frame: Baseline and final visit (week 12)
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With the People You Live With?
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.
Time frame: Baseline and final visit (week 12)
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Sex Life?
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.
Time frame: Baseline and final visit (week 12)
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Relationship With Your Family?
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.
Time frame: Baseline and final visit (week 12)
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Health?
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.
Time frame: Baseline and final visit (week 12)
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Mental Health?
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.
Time frame: Baseline and final visit (week 12)
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?
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.
Time frame: Baseline and final visit (week 12)
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Job?
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.
Time frame: Baseline and final visit (week 12)
Manchester Short Assessment of Quality of Life (MANSA) Scores(Schizophrenia Population) in Answer to: How Satisfied Are You With Your Financial Situation?
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.
Time frame: Baseline and final visit (week 12)
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: Do You Have Anyone You Would Call a Close Friend?
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.
Time frame: Baseline and final visit (week 12)
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: In the Last Week Have You Seen a Friend?
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.
Time frame: Baseline and final visit (week 12)
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?
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.
Time frame: Baseline and final visit (week 12)
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Leisure Activities?
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.
Time frame: Baseline and final visit (week 12)
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Accomodation?
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.
Time frame: Baseline and final visit (week 12)
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?
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.
Time frame: Baseline and final visit
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?
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.
Time frame: Baseline and final visit (week 12)
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Personal Safety?
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.
Time frame: Baseline and final visit (week 12)
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With the People You Live With?
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.
Time frame: Baseline and final visit (week 12)
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Sex Life?
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.
Time frame: Baseline and final visit (week 12)
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Relationship With Your Family?
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.
Time frame: Baseline and final visit (week 12)
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Health?
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.
Time frame: Baseline to final visit (week 12)
Clinical Global Impression of Severity (CGI-S) Scores (Schizophrenia Population)
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.
Time frame: Baseline