Ziprasidone And Olanzapine's Outcomes In Mania (ZOOM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00329108
Recruitment Status : Terminated (Please see Brief Summary for Termination Reason.)
First Posted : May 24, 2006
Results First Posted : March 13, 2009
Last Update Posted : May 1, 2009
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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
Acute Mania Bipolar Disorder, Manic Drug: ziprasidone hydrochloride Drug: olanzapine Phase 4

Study Type : Interventional  (Clinical Trial)
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 : November 2006
Actual Primary Completion Date : July 2007
Actual Study Completion Date : January 2008

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 Name: 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.

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

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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 4, 6 and 10 weeks ]
  4. Time to Symptomatic Remission in the Double Blind Phase. [ Time Frame: up to 10 weeks ]
  5. Percentage of Patients With Clinical Response After 6 Weeks of Double-Blind Treatment. [ Time Frame: 6 weeks ]
  6. Percentage of Patients With Symptomatic Relapse of Mania and/or Symptomatic Relapse of Depression During the Open Label Phase. [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00329108

Pfizer Investigational Site
Aachen, Germany, 52074
Pfizer Investigational Site
Augsburg, Germany, 86156
Pfizer Investigational Site
Freiburg, Germany, 79104
Pfizer Investigational Site
Athens, Greece, 124 62
Pfizer Investigational Site
S. Arsenio, Salerno, Italy, 84037
Pfizer Investigational Site
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
Terrassa, Barcelona, Spain, 08227
Pfizer Investigational Site
Alava, Vitoria, Spain, 01004
Pfizer Investigational Site
Granada, Spain, 18014
Pfizer Investigational Site
Malaga, Spain, 29009
Pfizer Investigational Site
Ankara, Turkey, 06100
Pfizer Investigational Site
Istanbul, Turkey, 34440
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc Identifier: NCT00329108     History of Changes
Other Study ID Numbers: A1281147
First Posted: May 24, 2006    Key Record Dates
Results First Posted: March 13, 2009
Last Update Posted: May 1, 2009
Last Verified: April 2009

Additional relevant MeSH terms:
Bipolar Disorder
Bipolar and Related Disorders
Mental Disorders
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Serotonin Antagonists
Dopamine Antagonists
Dopamine Agents