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OpenTrials
Completed

NCT Number: NCT00174447

Extension Study of Patients Successfully Treated by Ziprasidone in Study A1281031

Open label extension study of Ziprasidone, evaluation of safety of long term use of ziprasidone

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Pfizer Investigational Site, Avignon, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who successfully completed study A1281031 (CGI score of 1 or 2 at final visit) or ZIP-NY-98035 and with QTc <= 500 msec.

Exclusion criteria

  • All other patients who do not fit the inclusion criteria as stated above.

Treatment and study plan

Ziprasidone

Drug

Dosage may subsequently be adjusted according to clinical status, only at each protocol visit and step by step between 40, 60 and 80 mg bid

Primary outcomes

  1. Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I)

    Time frame: Baseline, 3 months, 6 months, 1 year, 3 years, 5 years, End of Study [LOCF]

    CGI-I consists of a 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale.

  2. Change From Baseline in CGI-I at End of Study (up to 5 Years)

    Time frame: Baseline, up to 5 years (End of Study [LOCF])

    CGI-I consists of a 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Change from baseline is score at observation minus score at baseline.

  3. Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S)

    Time frame: Baseline, 3 months, 6 months, 1 year, 3 years, 5 years, End of Study [LOCF]

    CGI-S Scale: standardized assessment tool to rate severity of subject's illness; assessed investigator's impression of subject's current illness state. Score: 1 (normal - not ill at all) to 7 (among the most extremely ill patients).

  4. Change From Baseline in CGI-S at End of Study (up to 5 Years)

    Time frame: Baseline, up to 5 years (End of Study [LOCF])

    CGI-S Scale: standardized assessment tool to rate severity of subject's illness; assesses investigator's impression of subject's current illness state. Score: 1 (normal - not ill at all) to 7 (among the most extremely ill). Change: score at observation minus score at baseline.

Secondary outcomes

  1. Number of Participants With Scores on Patient Preference Scale (PPS)

    Time frame: Baseline, up to 5 years (End of Study)

    Patient rated satisfaction scale with responses: Much better, I prefer this medication, Slightly better, About the same, Slightly worse, and Much worse, I much preferred my previous medication.

  2. Change From Baseline in Drug Attitude Inventory (DAI) at End of Study (up to 5 Years)

    Time frame: Baseline, up to 5 years (End of Study)

    DAI, a 10-item scale to assess how the attitude of schizophrenia patients toward their medications may affect compliance. Respondents indicate 'true' or 'false' for each item. An overall calculated score ranges from -10 to 10, where a positive score indicated a positive subjective response (compliant), whilst a negative score indicated non-compliance. Change: score at observation minus score at baseline.

Sponsors and collaborators

Lead sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Industry

Registry information

Official study title

Open Extension Study Evaluating The Long Term Efficacy , Safety And Tolerability Of Oral Ziprasidone In The Treatment Of Patients Who Have Successfully Completed The Previous Ziprasidone Study A1281031

Important dates

Study start
2001
Primary completion
2008
Study completion
2008
First posted
Sep 15, 2005
Registry last updated
Mar 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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