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Ziprasidone And Olanzapine's Outcomes In Mania (ZOOM)

Primary Purpose

Acute Mania, Bipolar Disorder, Manic

Status

Terminated

Phase

Phase 4

Locations

International

Study Type

Interventional

Intervention

ziprasidone hydrochloride

olanzapine

About this trial

This is an interventional treatment trial for Acute Mania

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change From Baseline in Clinical Global Impressions Scale for Use in Bipolar Illness Scores; Montgomery Asberg Depression Scale Scores in the Double Blind Phase.

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.

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

Time to Symptomatic Remission in the Double Blind Phase.

Percentage of Patients With Clinical Response After 6 Weeks of Double-blind Treatment.

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

Full Information

NCT ID

NCT00329108

First Posted

May 5, 2006

Last Updated

March 2, 2021

Sponsor

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

1. Study Identification

Unique Protocol Identification Number

NCT00329108

Brief Title

Ziprasidone And Olanzapine's Outcomes In Mania

Acronym

ZOOM

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 Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Terminated

Why Stopped

Please see Brief Summary for Termination Reason.

Study Start Date

November 2006 (undefined)

Primary Completion Date

July 2007 (Actual)

Study Completion Date

January 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

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

4. Oversight

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Mania, Bipolar Disorder, Manic

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

29 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

ziprasidone hydrochloride

Other Intervention Name(s)

Geodon, Zeldox

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

olanzapine

Intervention Description

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.

Primary Outcome Measure Information:

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

Secondary Outcome Measure Information:

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.

Time Frame

up to 10 weeks

Title

Time Frame

6 months

Title

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

Title

Time to Symptomatic Remission in the Double Blind Phase.

Time Frame

up to 10 weeks

Title

Percentage of Patients With Clinical Response After 6 Weeks of Double-blind Treatment.

Time Frame

6 weeks

Title

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

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Pfizer Investigational Site

City

Aachen

ZIP/Postal Code

52074

Country

Germany

Facility Name

Pfizer Investigational Site

City

Augsburg

ZIP/Postal Code

86156

Country

Germany

Facility Name

Pfizer Investigational Site

City

Freiburg

ZIP/Postal Code

79104

Country

Germany

Facility Name

Pfizer Investigational Site

City

Athens

ZIP/Postal Code

124 62

Country

Greece

Facility Name

Pfizer Investigational Site

City

S. Arsenio

State/Province

Salerno

ZIP/Postal Code

84037

Country

Italy

Facility Name

Pfizer Investigational Site

City

Bari

ZIP/Postal Code

70100

Country

Italy

Facility Name

Pfizer Investigational Site

City

Guardiagrele (CH)

ZIP/Postal Code

66016

Country

Italy

Facility Name

Pfizer Investigational Site

City

Lido Di Camaiore (LU)

ZIP/Postal Code

55043

Country

Italy

Facility Name

Pfizer Investigational Site

City

Partinico (Pa)

ZIP/Postal Code

90047

Country

Italy

Facility Name

Pfizer Investigational Site

City

Perugia

ZIP/Postal Code

06127

Country

Italy

Facility Name

Pfizer Investigational Site

City

Siena

ZIP/Postal Code

53100

Country

Italy

Facility Name

Pfizer Investigational Site

City

Torino

ZIP/Postal Code

10126

Country

Italy

Facility Name

Pfizer Investigational Site

City

Trieste

ZIP/Postal Code

34126

Country

Italy

Facility Name

Pfizer Investigational Site

City

Terrassa

State/Province

Barcelona

ZIP/Postal Code

08227

Country

Spain

Facility Name

Pfizer Investigational Site

City

Alava

State/Province

Vitoria

ZIP/Postal Code

01004

Country

Spain

Facility Name

Pfizer Investigational Site

City

Granada

ZIP/Postal Code

18014

Country

Spain

Facility Name

Pfizer Investigational Site

City

Malaga

ZIP/Postal Code

29009

Country

Spain

Facility Name

Pfizer Investigational Site

City

Ankara

ZIP/Postal Code

06100

Country

Turkey

Facility Name

Pfizer Investigational Site

City

Istanbul

ZIP/Postal Code

34440

Country

Turkey

12. IPD Sharing Statement

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A1281147&StudyName=Ziprasidone%20And%20Olanzapine%27s%20Outcomes%20In%20Mania

Description

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Ziprasidone And Olanzapine's Outcomes In Mania (ZOOM)

Acute Mania, Bipolar Disorder, Manic

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial