Ziprasidone And Olanzapine's Outcomes In Mania

NCT ID: NCT00329108

Last Updated: 2021-03-29

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2008-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Mania Bipolar Disorder, Manic

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

A

Group Type EXPERIMENTAL

ziprasidone hydrochloride

Intervention Type DRUG

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

Group Type ACTIVE_COMPARATOR

olanzapine

Intervention Type DRUG

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Geodon, Zeldox

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

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

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Pfizer Investigational Site

Aachen, , Germany

Site Status

Pfizer Investigational Site

Augsburg, , Germany

Site Status

Pfizer Investigational Site

Freiburg im Breisgau, , Germany

Site Status

Pfizer Investigational Site

Athens, , Greece

Site Status

Pfizer Investigational Site

S. Arsenio, Salerno, Italy

Site Status

Pfizer Investigational Site

Bari, , Italy

Site Status

Pfizer Investigational Site

Guardiagrele (CH), , Italy

Site Status

Pfizer Investigational Site

Lido Di Camaiore (LU), , Italy

Site Status

Pfizer Investigational Site

Partinico (Pa), , Italy

Site Status

Pfizer Investigational Site

Perugia, , Italy

Site Status

Pfizer Investigational Site

Siena, , Italy

Site Status

Pfizer Investigational Site

Torino, , Italy

Site Status

Pfizer Investigational Site

Trieste, , Italy

Site Status

Pfizer Investigational Site

Terrassa, Barcelona, Spain

Site Status

Pfizer Investigational Site

Alava, Vitoria, Spain

Site Status

Pfizer Investigational Site

Granada, , Spain

Site Status

Pfizer Investigational Site

Málaga, , Spain

Site Status

Pfizer Investigational Site

Ankara, , Turkey (Türkiye)

Site Status

Pfizer Investigational Site

Istanbul, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany Greece Italy Spain Turkey (Türkiye)

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

A1281147

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.