Clinical trial NCT00538629: Non Interventional Study In Bipolar Disorder And Schizophrenia With Zeldox
Official title: NON INTERVENTIONAL STUDY (NIS) IN PATIENTS WITH BIPOLAR DISCORDER (MANIC OR MIXED EPISODES) AND SCHIZOPHRENIA UNDERGOING TREATEMENT WITH ZELDOX
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bipolar Disorder
Schizophrenia
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-10-02
Enrollment: 471
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: psychiatric outpatients

Brief summary: 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

Detailed description: observational survey consecutive patient sampling

Eligibility criteria: Inclusion Criteria:

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.

Exclusion Criteria:

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

Primary outcomes:
measure: Clinical Global Impression of Severity (CGI-S) Scores (Bipolar Population)
timeFrame: Baseline
measure: Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Mental Health?
timeFrame: Baseline and final visit (week 12)
measure: Young Mania Rating Scale (YMRS) Scores (Bipolar Population): Change From Baseline
timeFrame: Baseline to final visit (12 weeks)
measure: Montgomery Asberg Depression Rating Scale (MADRS) Scores (Bipolar Population): Change From Baseline
timeFrame: Baseline to final visit (12 weeks)
measure: Clinical Global Impressions Change (CGI-C) Scores (Bipolar Population)
timeFrame: Final visit (week 12)
measure: Clinical Global Impressions Change (CGI-C) Scores (Schizoprenia Population)
timeFrame: Final visit (week 12)
measure: Brief Psychiatric Rating Scale (BPRS) Scores (Schizophrenia Population): Change From Baseline
timeFrame: Baseline to final visit (week 12)
measure: Extrapyramidal Symptom (EPS) Scores (Schizophrenia Population: Baseline and Final Visit
timeFrame: Baseline and final visit (week 12)
measure: Global Efficacy Evaluation Scores (Bipolar Population)
timeFrame: Final visit (week 12)
measure: Global Efficacy Evaluation Scores (Schizophrenia Population)
timeFrame: Final visit (week 12)
measure: 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?
timeFrame: Baseline and final visit (week 12)
measure: Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Job?
timeFrame: Baseline and final visit (week 12)
measure: Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Financial Situation?
timeFrame: Baseline and final visit (week 12)
measure: Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: Do You Have Anyone You Would Call a Close Friend?
timeFrame: Baseline and final visit (week 12)
measure: Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: In the Last Week Have You Seen a Friend?
timeFrame: Baseline and final visit (week 12)
measure: 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?
timeFrame: Baseline and final visit (week 12)
measure: Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Accomodation?
timeFrame: Baseline and final visit (week 12)
measure: Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Leisure Activities?
timeFrame: Baseline and final visit (week 12)
measure: 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?
timeFrame: Baseline and final visit (week 12)
measure: 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?
timeFrame: Baseline and final visit (week 12)
measure: Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Personal Safety?
timeFrame: Baseline and final visit (week 12)
measure: Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With the People You Live With?
timeFrame: Baseline and final visit (week 12)
measure: Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Sex Life?
timeFrame: Baseline and final visit (week 12)
measure: Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Relationship With Your Family?
timeFrame: Baseline and final visit (week 12)
measure: Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Health?
timeFrame: Baseline and final visit (week 12)
measure: Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Mental Health?
timeFrame: Baseline and final visit (week 12)
measure: 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?
timeFrame: Baseline and final visit (week 12)
measure: Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Job?
timeFrame: Baseline and final visit (week 12)
measure: Manchester Short Assessment of Quality of Life (MANSA) Scores(Schizophrenia Population) in Answer to: How Satisfied Are You With Your Financial Situation?
timeFrame: Baseline and final visit (week 12)
measure: Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: Do You Have Anyone You Would Call a Close Friend?
timeFrame: Baseline and final visit (week 12)
measure: Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: In the Last Week Have You Seen a Friend?
timeFrame: Baseline and final visit (week 12)
measure: 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?
timeFrame: Baseline and final visit (week 12)
measure: Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Leisure Activities?
timeFrame: Baseline and final visit (week 12)
measure: Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Accomodation?
timeFrame: Baseline and final visit (week 12)
measure: 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?
timeFrame: Baseline and final visit
measure: 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?
timeFrame: Baseline and final visit (week 12)
measure: Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Personal Safety?
timeFrame: Baseline and final visit (week 12)
measure: Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With the People You Live With?
timeFrame: Baseline and final visit (week 12)
measure: Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Sex Life?
timeFrame: Baseline and final visit (week 12)
measure: Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Relationship With Your Family?
timeFrame: Baseline and final visit (week 12)
measure: Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Health?
timeFrame: Baseline to final visit (week 12)
measure: Clinical Global Impression of Severity (CGI-S) Scores (Schizophrenia Population)
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: