Ziprasidone And Olanzapine's Outcomes In Mania - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00329108

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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Investigator, Outcomes Assessor), Parallel Assignment, Safety Study
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

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
A: Experimental	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.
B: Active Comparator	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
Freiburg, Germany, 79104
Pfizer Investigational Site
Aachen, Germany, 52074
Pfizer Investigational Site
Augsburg, Germany, 86156
Greece
Pfizer Investigational Site
Athens, Greece, 124 62
Italy
Pfizer Investigational Site
Perugia, Italy, 06127
Pfizer Investigational Site
Bari, Italy, 70100
Pfizer Investigational Site
Torino, Italy, 10126
Pfizer Investigational Site
Guardiagrele (CH), Italy, 66016
Pfizer Investigational Site
Trieste, Italy, 34126
Pfizer Investigational Site
Partinico (Pa), Italy, 90047
Pfizer Investigational Site
Siena, Italy, 53100
Pfizer Investigational Site
Lido di Camaiore (LU), Italy, 55043
Italy, Salerno
Pfizer Investigational Site
S. Arsenio, Salerno, Italy, 84037
Spain
Pfizer Investigational Site
GRANADA, Spain, 18014
Pfizer Investigational Site
MALAGA, Spain, 29009
Spain, BARCELONA
Pfizer Investigational Site
TERRASSA, BARCELONA, Spain, 08227
Spain, VITORIA
Pfizer Investigational Site
ALAVA, VITORIA, Spain, 01004
Turkey
Pfizer Investigational Site
Istanbul, Turkey, 34440
Pfizer Investigational Site
Ankara, Turkey, 06100

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Link to ClinicalStudyResults.org Posting This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A1281147
Study First Received:	May 5, 2006
Results First Received:	December 22, 2008
Last Updated:	April 1, 2009
ClinicalTrials.gov Identifier:	NCT00329108 History of Changes
Health Authority:	Italy: Ministry of Health

Study placed in the following topic categories:

Neurotransmitter Agents
Tranquilizing Agents
Bipolar Disorder
Olanzapine
Psychotropic Drugs
Antiemetics
Central Nervous System Depressants
Antipsychotic Agents
Serotonin Uptake Inhibitors

Serotonin
Affective Disorders, Psychotic
Dopamine
Mental Disorders
Mood Disorders
Dopamine Agents
Psychotic Disorders
Peripheral Nervous System Agents
Ziprasidone

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Olanzapine
Psychotropic Drugs
Antiemetics
Affective Disorders, Psychotic
Serotonin Antagonists
Mental Disorders
Therapeutic Uses
Tranquilizing Agents
Bipolar Disorder

Gastrointestinal Agents
Central Nervous System Depressants
Dopamine Antagonists
Antipsychotic Agents
Serotonin Uptake Inhibitors
Pharmacologic Actions
Serotonin Agents
Autonomic Agents
Mood Disorders
Dopamine Agents
Peripheral Nervous System Agents
Ziprasidone
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 11, 2009