ZOOM: Ziprasidone And Olanzapine's Outcomes In Mania

Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)
Overall Status
Terminated
CT.gov ID
NCT00329108
Collaborator
(none)
29
19
2
14
1.5
0.1

Study Details

Study Description

Brief 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. 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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
29 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Study Start Date :
Nov 1, 2006
Actual Primary Completion Date :
Jul 1, 2007
Actual Study Completion Date :
Jan 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Experimental: A

Drug: ziprasidone hydrochloride
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.
Other Names:
  • Geodon, Zeldox
  • Active Comparator: B

    Drug: olanzapine
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Mean Reduction in Young Mania Rating Scale (YMRS) Score During the Double Blind Phase. [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.

    Secondary Outcome Measures

    1. Change From Baseline in Clinical Global Impressions Scale for Use in Bipolar Illness Scores; Montgomery Asberg Depression Scale Scores in the Double Blind Phase. [up to 10 weeks]

    2. 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. [6 months]

    3. Percentage of Patients With Symptomatic Remission After 4, 6 and 10 Weeks of Treatment and at the End of the Double-blind Phase. [4, 6 and 10 weeks]

    4. Time to Symptomatic Remission in the Double Blind Phase. [up to 10 weeks]

    5. Percentage of Patients With Clinical Response After 6 Weeks of Double-blind Treatment. [6 weeks]

    6. Percentage of Patients With Symptomatic Relapse of Mania and/or Symptomatic Relapse of Depression During the Open Label Phase. [6 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • 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).

    Exclusion Criteria:
    • 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Pfizer Investigational Site Aachen Germany 52074
    2 Pfizer Investigational Site Augsburg Germany 86156
    3 Pfizer Investigational Site Freiburg Germany 79104
    4 Pfizer Investigational Site Athens Greece 124 62
    5 Pfizer Investigational Site S. Arsenio Salerno Italy 84037
    6 Pfizer Investigational Site Bari Italy 70100
    7 Pfizer Investigational Site Guardiagrele (CH) Italy 66016
    8 Pfizer Investigational Site Lido Di Camaiore (LU) Italy 55043
    9 Pfizer Investigational Site Partinico (Pa) Italy 90047
    10 Pfizer Investigational Site Perugia Italy 06127
    11 Pfizer Investigational Site Siena Italy 53100
    12 Pfizer Investigational Site Torino Italy 10126
    13 Pfizer Investigational Site Trieste Italy 34126
    14 Pfizer Investigational Site Terrassa Barcelona Spain 08227
    15 Pfizer Investigational Site Alava Vitoria Spain 01004
    16 Pfizer Investigational Site Granada Spain 18014
    17 Pfizer Investigational Site Malaga Spain 29009
    18 Pfizer Investigational Site Ankara Turkey 06100
    19 Pfizer Investigational Site Istanbul Turkey 34440

    Sponsors and Collaborators

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

    Investigators

    • Study Director: Pfizer CT.gov Call Center, Pfizer

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
    ClinicalTrials.gov Identifier:
    NCT00329108
    Other Study ID Numbers:
    • A1281147
    First Posted:
    May 24, 2006
    Last Update Posted:
    Mar 29, 2021
    Last Verified:
    Mar 1, 2021
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details 47 centers in Europe.
    Pre-assignment Detail After a wash out period of at least 24 hours, patients were randomized to ziprasidone or olanzapine.
    Arm/Group Title Ziprasidone Olanzapine
    Arm/Group Description Ziprasidone was initiated at a dosage of 80 mg/day (40 mg BID) on Day 1 and then was titrated to 120 mg/day (60 mg BID) from Day 3. From Day 7, the dosage was adjusted between 120 to 160 mg/day on the basis of clinical status at the investigator's discretion. Olanzapine was started at 15 mg/day (15 mg once daily [QD]) on Day 1, and remained at this dosage until Day 7. The dosage was adjusted on the basis of clinical status up to 20 mg/day at the investigator's discretion.
    Period Title: Overall Study
    STARTED 15 14
    COMPLETED 5 2
    NOT COMPLETED 10 12

    Baseline Characteristics

    Arm/Group Title Ziprasidone Olanzapine Total
    Arm/Group Description Ziprasidone was initiated at a dosage of 80 mg/day (40 mg BID) on Day 1 and then was titrated to 120 mg/day (60 mg BID) from Day 3. From Day 7, the dosage was adjusted between 120 to 160 mg/day on the basis of clinical status at the investigator's discretion. Olanzapine was started at 15 mg/day (15 mg once daily [QD]) on Day 1, and remained at this dosage until Day 7. The dosage was adjusted on the basis of clinical status up to 20 mg/day at the investigator's discretion. Total of all reporting groups
    Overall Participants 15 14 29
    Age, Customized (participants) [Number]
    18-44 years
    9
    60%
    7
    50%
    16
    55.2%
    45-64 years
    6
    40%
    7
    50%
    13
    44.8%
    Sex: Female, Male (Count of Participants)
    Female
    10
    66.7%
    5
    35.7%
    15
    51.7%
    Male
    5
    33.3%
    9
    64.3%
    14
    48.3%

    Outcome Measures

    1. Primary Outcome
    Title Mean Reduction in Young Mania Rating Scale (YMRS) Score During the Double Blind Phase.
    Description 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.
    Time Frame 4 weeks

    Outcome Measure Data

    Analysis Population Description
    Study was terminated due to poor recruitment and no efficacy data were summarized due to very low sample size. Only safety data were summarized.
    Arm/Group Title Ziprasidone Olanzapine
    Arm/Group Description Ziprasidone was initiated at a dosage of 80 mg/day (40 mg BID) on Day 1 and then was titrated to 120 mg/day (60 mg BID) from Day 3. From Day 7, the dosage was adjusted between 120 to 160 mg/day on the basis of clinical status at the investigator's discretion. Olanzapine was started at 15 mg/day (15 mg once daily [QD]) on Day 1, and remained at this dosage until Day 7. The dosage was adjusted on the basis of clinical status up to 20 mg/day at the investigator's discretion.
    Measure Participants 0 0
    2. Secondary Outcome
    Title Change From Baseline in Clinical Global Impressions Scale for Use in Bipolar Illness Scores; Montgomery Asberg Depression Scale Scores in the Double Blind Phase.
    Description
    Time Frame up to 10 weeks

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title
    Arm/Group Description
    3. Secondary Outcome
    Title 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.
    Description
    Time Frame 6 months

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title
    Arm/Group Description
    4. Secondary Outcome
    Title Percentage of Patients With Symptomatic Remission After 4, 6 and 10 Weeks of Treatment and at the End of the Double-blind Phase.
    Description
    Time Frame 4, 6 and 10 weeks

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title
    Arm/Group Description
    5. Secondary Outcome
    Title Time to Symptomatic Remission in the Double Blind Phase.
    Description
    Time Frame up to 10 weeks

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title
    Arm/Group Description
    6. Secondary Outcome
    Title Percentage of Patients With Clinical Response After 6 Weeks of Double-blind Treatment.
    Description
    Time Frame 6 weeks

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title
    Arm/Group Description
    7. Secondary Outcome
    Title Percentage of Patients With Symptomatic Relapse of Mania and/or Symptomatic Relapse of Depression During the Open Label Phase.
    Description
    Time Frame 6 months

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title
    Arm/Group Description

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title Ziprasidone Olanzapine
    Arm/Group Description Ziprasidone was initiated at a dosage of 80 mg/day (40 mg BID) on Day 1 and then was titrated to 120 mg/day (60 mg BID) from Day 3. From Day 7, the dosage was adjusted between 120 to 160 mg/day on the basis of clinical status at the investigator's discretion. Olanzapine was started at 15 mg/day (15 mg once daily [QD]) on Day 1, and remained at this dosage until Day 7. The dosage was adjusted on the basis of clinical status up to 20 mg/day at the investigator's discretion.
    All Cause Mortality
    Ziprasidone Olanzapine
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    Ziprasidone Olanzapine
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 2/ (NaN) 0/ (NaN)
    Eye disorders
    Oculogyric crisis 1/15 (6.7%) 0/14 (0%)
    General disorders
    Disease progression 1/15 (6.7%) 0/14 (0%)
    Respiratory, thoracic and mediastinal disorders
    laryngospasm 1/15 (6.7%) 0/14 (0%)
    Other (Not Including Serious) Adverse Events
    Ziprasidone Olanzapine
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 7/ (NaN) 12/ (NaN)
    Blood and lymphatic system disorders
    Anemia 0/15 (0%) 1/14 (7.1%)
    Endocrine disorders
    Hyperprolactinaemia 0/15 (0%) 1/14 (7.1%)
    Gastrointestinal disorders
    Dry mouth 0/15 (0%) 2/14 (14.3%)
    flatulence 0/15 (0%) 1/14 (7.1%)
    gingivitis 0/15 (0%) 1/14 (7.1%)
    nausea 1/15 (6.7%) 1/14 (7.1%)
    vomiting 1/15 (6.7%) 1/14 (7.1%)
    General disorders
    fatigue 0/15 (0%) 2/14 (14.3%)
    pyrexia 0/15 (0%) 1/14 (7.1%)
    Immune system disorders
    hypersensitivity 0/15 (0%) 1/14 (7.1%)
    Infections and infestations
    nasopharyngitis 0/15 (0%) 1/14 (7.1%)
    pneumonia bacterial 0/15 (0%) 1/14 (7.1%)
    tonsillitis 0/15 (0%) 1/14 (7.1%)
    Injury, poisoning and procedural complications
    joint dislocation 0/15 (0%) 1/14 (7.1%)
    Investigations
    weight increased 1/15 (6.7%) 1/14 (7.1%)
    Metabolism and nutrition disorders
    fluid retention 0/15 (0%) 1/14 (7.1%)
    hyperlipidaemia 0/15 (0%) 1/14 (7.1%)
    increased appetite 0/15 (0%) 2/14 (14.3%)
    Nervous system disorders
    headache 1/15 (6.7%) 1/14 (7.1%)
    hypotonia 0/15 (0%) 1/14 (7.1%)
    somnolence 3/15 (20%) 1/14 (7.1%)
    tremor 1/15 (6.7%) 3/14 (21.4%)
    Psychiatric disorders
    anxiety 1/15 (6.7%) 1/14 (7.1%)
    binge eating 0/15 (0%) 1/14 (7.1%)
    delusion 0/15 (0%) 1/14 (7.1%)
    depressed mood 1/15 (6.7%) 0/14 (0%)
    depression 0/15 (0%) 1/14 (7.1%)
    insomnia 2/15 (13.3%) 0/14 (0%)
    mania 1/15 (6.7%) 0/14 (0%)
    Reproductive system and breast disorders
    breast enlargement 0/15 (0%) 1/14 (7.1%)
    sexual dysfunction 0/15 (0%) 1/14 (7.1%)
    Skin and subcutaneous tissue disorders
    eczema 0/15 (0%) 1/14 (7.1%)
    hyperhidrosis 0/15 (0%) 1/14 (7.1%)
    Surgical and medical procedures
    tooth extraction 0/15 (0%) 1/14 (7.1%)

    Limitations/Caveats

    The study was terminated due to poor recruitment. No efficacy data were summarized due to very low sample size. Only safety data were summarized.

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    Pfizer has the right to review disclosures, requesting a delay of <60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), <12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.

    Results Point of Contact

    Name/Title Pfizer ClinicalTrials.gov Call Center
    Organization Pfizer, Inc.
    Phone 1-800-718-1021
    Email ClinicalTrials.govCallCenter@pfizer.com
    Responsible Party:
    Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
    ClinicalTrials.gov Identifier:
    NCT00329108
    Other Study ID Numbers:
    • A1281147
    First Posted:
    May 24, 2006
    Last Update Posted:
    Mar 29, 2021
    Last Verified:
    Mar 1, 2021