Acute ManiaPhase 4ZOOMNCT00329108
Ziprasidone And Olanzapine's Outcomes In Mania
A Phase 4 study testing ziprasidone hydrochloride and olanzapine in people with Acute Mania and Bipolar Disorder, Manic, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 19 sites in 5 countries.
Trial summary
The purpose of this study is to compare the efficacy and tolerability of ziprasidone versus olanzapine in the treatment of acute mania. An open label extension will further evaluate the efficacy, safety, and tolerability of ziprasidone compared with olanzapine. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Mania, Bipolar Disorder, Manic
- What is being tested?
- ziprasidone hydrochloride and olanzapine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 19 sitesin 5 countries
- Study dates
- Nov 2006to Jan 2008
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a primary diagnosis of Bipolar I Disorder, current episode manic (DSM-IV 296.4x) or mixed (DSM-IV296.6x) as determined by a structured clinical interview (Mini International Neuropsychiatric Interview (MINI)) at screening.
- A minimum score of 20 on the YMRS (Youngs Mania Rating Scale).
Who cannot join
- Have a diagnosis of learning disability or organic brain syndrome.
- Have a substance-induced psychotic disorder or behavioral disturbance thought to be due to substance abuse.
Trial locations and contacts
19 sites in 5 countries.
19 sites in 5 countries
Italy9 sites
Pfizer Investigational Site
Bari, 70100
Pfizer Investigational Site
Guardiagrele (CH), 66016
Pfizer Investigational Site
Lido Di Camaiore (LU), 55043
Pfizer Investigational Site
Partinico (Pa), 90047
Pfizer Investigational Site
Perugia, 06127
Pfizer Investigational Site
S. Arsenio, Salerno, 84037
Pfizer Investigational Site
Siena, 53100
Pfizer Investigational Site
Torino, 10126
Pfizer Investigational Site
Trieste, 34126
Spain4 sites
Pfizer Investigational Site
Alava, Vitoria, 01004
Pfizer Investigational Site
Granada, 18014
Pfizer Investigational Site
Málaga, 29009
Pfizer Investigational Site
Terrassa, Barcelona, 08227
Germany3 sites
Pfizer Investigational Site
Aachen, 52074
Pfizer Investigational Site
Augsburg, 86156
Pfizer Investigational Site
Freiburg im Breisgau, 79104
Turkey (Türkiye)2 sites
Pfizer Investigational Site
Ankara, 06100
Pfizer Investigational Site
Istanbul, 34440
About this study
Official title: A Multicenter, Randomized, Double-Blind, Parallel Group Study, Comparing The Efficacy And Tolerability Of Ziprasidone (Zeldox, Geodon) vs. Olanzapine (Zyprexa) In The Treatment And Maintenance Of Response In Patients With Acute Mania
The purpose of this study is to compare the efficacy and tolerability of ziprasidone versus olanzapine in the treatment of acute mania. An open label extension will further evaluate the efficacy, safety, and tolerability of ziprasidone compared with olanzapine. Study recruitment was stopped due to difficulty in enrolling the targeted number of patients on July 30, 2007. Subjects that were enrolled at the time completed the study as per protocol. There were no safety concerns involved in the decision to stop enrollment. The Last Subject Last Visit was January 10, 2008.
- Conditions
- Acute Mania, Bipolar Disorder, Manic
- Being tested
- ziprasidone hydrochloride, olanzapine
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ziprasidone hydrochlorideDrug
Also called Geodon, Zeldox
Ziprasidone will be initiated at 80 mg/day on Day 1 and titrated to 120 mg/day from Day 3. From Day 7 the dosage may be adjusted on the basis of clinical status between 120 and 160 mg/day.
olanzapineDrug
Olanzapine will be started at 15 mg/day on Day 1 until Day 7. The dosage will then be adjusted on the basis of clinical status between 15 and 20 mg/day.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: ziprasidone hydrochloride |
| B | Active comparator | Not described Receives: Drug: olanzapine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Reduction in Young Mania Rating Scale (YMRS) Score During the Double Blind Phase.
YMRS is 11-item instrument with scales between 0 to 4 for 7 items and scales between 0 and 8 for 4 items. 0 is normal and either 4 or 8 is the highest level of abnormal, depending on the item.
Measured: 4 weeks
Secondary outcomes (6)
Change From Baseline in Clinical Global Impressions Scale for Use in Bipolar Illness Scores; Montgomery Asberg Depression Scale Scores in the Double Blind Phase.
Measured: up to 10 weeks
Change From Baseline in Global Assessment of Functioning Scale Scores, Treatment Satisfaction Questionnaire for Medication, Quality of Life Enjoyment and Satisfaction Questionnaire in the Double Blind Phase.
Measured: 6 months
Percentage of Patients With Symptomatic Remission After 4, 6 and 10 Weeks of Treatment and at the End of the Double-blind Phase.
Measured: 4, 6 and 10 weeks
Time to Symptomatic Remission in the Double Blind Phase.
Measured: up to 10 weeks
Percentage of Patients With Clinical Response After 6 Weeks of Double-blind Treatment.
Measured: 6 weeks
Percentage of Patients With Symptomatic Relapse of Mania and/or Symptomatic Relapse of Depression During the Open Label Phase.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2006 (estimated)
- Study startNov 2006
- Primary completionJul 2007
- Study completionJan 2008
Why it stopped: Please see Brief Summary for Termination Reason.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute ManiaStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 29 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
- NCT00329108
- Sponsor's protocol ID
- A1281147
- Acronym
- ZOOM
- Status last verified
- Mar 2021
- First submitted
- 5 May 2006
- Last updated
- 29 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Parallel Group Study, Comparing The Efficacy And Tolerability Of Ziprasidone (Zeldox, Geodon) vs. Olanzapine (Zyprexa) In The Treatment And Maintenance Of Response In Patients With Acute Mania
- ClinicalTrials.gov ID
- NCT00329108
- Acronym / sponsor ID
- ZOOM / A1281147
- Conditions
- Acute Mania, Bipolar Disorder, Manic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Please see Brief Summary for Termination Reason.
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2006
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 24 May 2006 (estimated)
- Results
- Posted 13 Mar 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the efficacy and tolerability of ziprasidone versus olanzapine in the treatment of acute mania. An open label extension will further evaluate the efficacy, safety, and tolerability of ziprasidone compared with olanzapine. Study recruitment was stopped due to difficulty in enrolling the targeted number of patients on July 30, 2007. Subjects that were enrolled at the time completed the study as per protocol. There were no safety concerns involved in the decision to stop enrollment. The Last Subject Last Visit was January 10, 2008.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: ziprasidone hydrochloride |
| B | Active comparator | Drug: olanzapine |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Have a primary diagnosis of Bipolar I Disorder, current episode manic (DSM-IV 296.4x) or mixed (DSM-IV296.6x) as determined by a structured clinical interview (Mini International Neuropsychiatric Interview (MINI)) at screening.
- A minimum score of 20 on the YMRS (Youngs Mania Rating Scale).
Key exclusion criteria (2 listed)
- Have a diagnosis of learning disability or organic brain syndrome.
- Have a substance-induced psychotic disorder or behavioral disturbance thought to be due to substance abuse.
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 |
|---|---|---|
| ziprasidone hydrochlorideAlso: Geodon, ZeldoxZiprasidone will be initiated at 80 mg/day on Day 1 and titrated to 120 mg/day from Day 3. From Day 7 the dosage may be adjusted on the basis of clinical status between 120 and 160 mg/day. | Drug | A |
| olanzapineOlanzapine will be started at 15 mg/day on Day 1 until Day 7. The dosage will then be adjusted on the basis of clinical status between 15 and 20 mg/day. | Drug | B |
Primary outcome
Mean Reduction in Young Mania Rating Scale (YMRS) Score During the Double Blind Phase.
Time frame: 4 weeks
YMRS is 11-item instrument with scales between 0 to 4 for 7 items and scales between 0 and 8 for 4 items. 0 is normal and either 4 or 8 is the highest level of abnormal, depending on the item.
6 secondary outcomes
Change From Baseline in Clinical Global Impressions Scale for Use in Bipolar Illness Scores; Montgomery Asberg Depression Scale Scores in the Double Blind Phase.
Time frame: up to 10 weeks
Change From Baseline in Global Assessment of Functioning Scale Scores, Treatment Satisfaction Questionnaire for Medication, Quality of Life Enjoyment and Satisfaction Questionnaire in the Double Blind Phase.
Time frame: 6 months
Percentage of Patients With Symptomatic Remission After 4, 6 and 10 Weeks of Treatment and at the End of the Double-blind Phase.
Time frame: 4, 6 and 10 weeks
Time to Symptomatic Remission in the Double Blind Phase.
Time frame: up to 10 weeks
Percentage of Patients With Clinical Response After 6 Weeks of Double-blind Treatment.
Time frame: 6 weeks
Percentage of Patients With Symptomatic Relapse of Mania and/or Symptomatic Relapse of Depression During the Open Label Phase.
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Related trials for Acute Mania
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RecruitingObservational study
Immune Mechanisms of Antipsychotic Treatment Response
Psychosis
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
19 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ziprasidone hydrochloride and olanzapine in people with Acute Mania and Bipolar Disorder, Manic, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 19 sites in 5 countries.
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 2 inclusion and 2 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: stopped early, as of the sponsor's last update on 29 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Italy, Spain, Germany, Turkey (Türkiye), Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Mar 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Reduction in Young Mania Rating Scale (YMRS) Score During the Double Blind Phase. (time frame: 4 weeks). 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 29 Mar 2021.