Ziprasidone And Olanzapine's Outcomes In Mania (ZOOM)
This study has been terminated.
(Please see Brief Summary for Termination Reason.)
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00329108
First received: May 5, 2006
Last updated: April 1, 2009
Last verified: April 2009
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Acute Mania Bipolar Disorder, Manic |
Drug: ziprasidone hydrochloride Drug: olanzapine |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (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 |
Resource links provided by NLM:
MedlinePlus related topics:
Bipolar Disorder
Drug Information available for:
Ziprasidone hydrochloride
Olanzapine
Ziprasidone
Ziprasidone mesylate
Olanzapine pamoate
U.S. FDA Resources
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Mean Reduction in Young Mania Rating Scale (YMRS) Score During the Double Blind Phase. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
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. [ Time Frame: up to 10 weeks ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- Time to Symptomatic Remission in the Double Blind Phase. [ Time Frame: up to 10 weeks ] [ Designated as safety issue: No ]
- Percentage of Patients With Clinical Response After 6 Weeks of Double-Blind Treatment. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- Percentage of Patients With Symptomatic Relapse of Mania and/or Symptomatic Relapse of Depression During the Open Label Phase. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| Enrollment: | 29 |
| Study Start Date: | November 2006 |
| Study Completion Date: | January 2008 |
| Primary Completion Date: | July 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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.
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00329108
Locations
| Germany | |
| Pfizer Investigational Site | |
| Aachen, Germany, 52074 | |
| Pfizer Investigational Site | |
| Augsburg, Germany, 86156 | |
| Pfizer Investigational Site | |
| Freiburg, Germany, 79104 | |
| Greece | |
| Pfizer Investigational Site | |
| Athens, Greece, 124 62 | |
| Italy | |
| 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 | |
| Spain | |
| 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 | |
| Turkey | |
| Pfizer Investigational Site | |
| Ankara, Turkey, 06100 | |
| Pfizer Investigational Site | |
| Istanbul, Turkey, 34440 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer Inc |
| ClinicalTrials.gov Identifier: | NCT00329108 History of Changes |
| Other Study ID Numbers: | A1281147 |
| Study First Received: | May 5, 2006 |
| Results First Received: | December 22, 2008 |
| Last Updated: | April 1, 2009 |
| Health Authority: | Italy: Ministry of Health |
Additional relevant MeSH terms:
|
Bipolar Disorder Affective Disorders, Psychotic Mood Disorders Mental Disorders Olanzapine Ziprasidone Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses |
Psychotropic Drugs Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Serotonin Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Gastrointestinal Agents Serotonin Antagonists Dopamine Antagonists Dopamine Agents |
ClinicalTrials.gov processed this record on May 23, 2013