Affective Psychosis, BipolarNCT00454883
Non-interventional Study of Ziprasidone in the Treatment of Bipolar and Schizoaffective Disorders.
An observational study of Affective Psychosis, Bipolar and Mania, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc..
Trial summary
Assessment of ziprasidone safety and efficacy in the treatment of bipolar and schizoaffective disorders. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Affective Psychosis, Bipolar, Mania, Manic-Depressive Psychosis
- What is being tested?
- ziprasidone
- How many people
- 379 participants
- Where
- No sites listed yet
- Study dates
- Apr 2007to Dec 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patients were identified in in- and outpatients settings (university departments, hospital wards, outpatients clinics, daily psychiatric hospitals)
Who may be able to join
- Manic and mixed episodes of up to moderate severity in patients with Type I and II bipolar disorder and schizoaffective disorder; either first diagnosed or repeated episodes
Who cannot join
- Hypersensitivity to ziprasidone
- prolonged QTc interval
- coadministration with substances that are prolonging the QTc interval
- recent acute MI, cardiac failure, patients with arrhythmias treated with class IA or III medicaments
About this study
Official title: Treatment Of Manic Or Mixed Episodes Of Up To Moderate Severity In Patients With Bipolar Disorder And Schizoaffective Disorder
Assessment of ziprasidone safety and efficacy in the treatment of bipolar and schizoaffective disorders.
Read the detailed description
Method: Consecutive patient sampling. Patients were included in the study in consecutive manner if they fulfilled the inclusion criteria and any of the exclusion criteria were not present.
- Being tested
- ziprasidone
- Keywords
- Safety of ziprasidone, efficacy of ziprasidone, manic episodes in bipolar disorder, mixed episodes in bipolar disorder, schizoaffective disorder.
- Medical subject headings
- Bipolar Disorder, Mania, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ziprasidoneDrug
Also called Geodon, Zeldox
Ziprasidone 40 mg twice daily taken with food. Daily dosage may subsequently be adjusted on the basis of individual clinical status up to a maximum of 80 mg twice daily. If indicated, the maximum recommended dose may be reached as early as day 3 of treatment.
| Study group | Role | What they receive |
|---|---|---|
| 1 cohort of patients treated with ziprasidone | Not described Receives: Drug: ziprasidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical global impression
Measured: 3 months
Recording of extrapyramidal symptoms
Measured: 3 months
Changes in manic symptoms over course of treatment
Measured: 3 months
Secondary outcomes (2)
Severity of disease
Measured: 3 months
Adverse Events
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2007 (estimated)
- Study startApr 2007
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Affective Psychosis, BipolarStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 379 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00454883
- Sponsor's protocol ID
- A1281159
- Status last verified
- Feb 2021
- First submitted
- 29 Mar 2007
- Last updated
- 21 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Of Manic Or Mixed Episodes Of Up To Moderate Severity In Patients With Bipolar Disorder And Schizoaffective Disorder
- ClinicalTrials.gov ID
- NCT00454883
- Acronym / sponsor ID
- A1281159
- Keywords
- Safety of ziprasidone, efficacy of ziprasidone, manic episodes in bipolar disorder, mixed episodes in bipolar disorder, schizoaffective disorder.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 379 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 2 Apr 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Assessment of ziprasidone safety and efficacy in the treatment of bipolar and schizoaffective disorders.
Detailed description
Method: Consecutive patient sampling. Patients were included in the study in consecutive manner if they fulfilled the inclusion criteria and any of the exclusion criteria were not present.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 cohort of patients treated with ziprasidone | – | Drug: ziprasidone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients were identified in in- and outpatients settings (university departments, hospital wards, outpatients clinics, daily psychiatric hospitals)
Key inclusion criteria (1 listed)
- Manic and mixed episodes of up to moderate severity in patients with Type I and II bipolar disorder and schizoaffective disorder; either first diagnosed or repeated episodes
Key exclusion criteria (4 listed)
- Hypersensitivity to ziprasidone
- prolonged QTc interval
- coadministration with substances that are prolonging the QTc interval
- recent acute MI, cardiac failure, patients with arrhythmias treated with class IA or III medicaments
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ziprasidoneAlso: Geodon, ZeldoxZiprasidone 40 mg twice daily taken with food. Daily dosage may subsequently be adjusted on the basis of individual clinical status up to a maximum of 80 mg twice daily. If indicated, the maximum recommended dose may be reached as early as day 3 of treatment. | Drug | 1 cohort of patients treated with ziprasidone |
Primary outcome
Clinical global impression
Time frame: 3 months
Recording of extrapyramidal symptoms
Time frame: 3 months
Changes in manic symptoms over course of treatment
Time frame: 3 months
2 secondary outcomes
Severity of disease
Time frame: 3 months
Adverse Events
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
Questions about this trial
What is this clinical trial studying?
An observational study of Affective Psychosis, Bipolar and Mania, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical global impression (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2021.