Ziprasidone And Olanzapine's Outcomes In Mania (ZOOM)

March 2, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Aachen, Germany, 52074
        • Pfizer Investigational Site
      • Augsburg, Germany, 86156
        • Pfizer Investigational Site
      • Freiburg, Germany, 79104
        • Pfizer Investigational Site
  • Greece
      • Athens, Greece, 124 62
        • Pfizer Investigational Site
  • Italy
      • Bari, Italy, 70100
        • Pfizer Investigational Site
      • Guardiagrele (CH), Italy, 66016
        • Pfizer Investigational Site
      • Lido Di Camaiore (LU), Italy, 55043
        • Pfizer Investigational Site
      • Partinico (Pa), Italy, 90047
        • Pfizer Investigational Site
      • Perugia, Italy, 06127
        • Pfizer Investigational Site
      • Siena, Italy, 53100
        • Pfizer Investigational Site
      • Torino, Italy, 10126
        • Pfizer Investigational Site
      • Trieste, Italy, 34126
        • Pfizer Investigational Site
    • Salerno
      • S. Arsenio, Salerno, Italy, 84037
        • Pfizer Investigational Site
  • Spain
      • Granada, Spain, 18014
        • Pfizer Investigational Site
      • Malaga, Spain, 29009
        • Pfizer Investigational Site
    • Barcelona
      • Terrassa, Barcelona, Spain, 08227
        • Pfizer Investigational Site
    • Vitoria
      • Alava, Vitoria, Spain, 01004
        • Pfizer Investigational Site
  • Turkey
      • Ankara, Turkey, 06100
        • Pfizer Investigational Site
      • Istanbul, Turkey, 34440
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
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
4, 6 and 10 weeks
Time to Symptomatic Remission in the Double Blind Phase.
Time Frame: up to 10 weeks
up to 10 weeks
Percentage of Patients With Clinical Response After 6 Weeks of Double-blind Treatment.
Time Frame: 6 weeks
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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (Actual)

July 1, 2007

Study Completion (Actual)

January 1, 2008

Study Registration Dates

First Submitted

May 5, 2006

First Submitted That Met QC Criteria

May 22, 2006

First Posted (Estimate)

May 24, 2006

Study Record Updates

Last Update Posted (Actual)

March 29, 2021

Last Update Submitted That Met QC Criteria

March 2, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A1281147

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Acute Mania

Clinical Trials on ziprasidone hydrochloride

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Latvia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe