Ziprasidone And Olanzapine's Outcomes In Mania

Bipolar Disorder, Manic Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00329108
• Other study ID #: A1281147
• Status: Terminated
• Phase: Phase 4
• Start date: November 2006
• Est. completion date: January 2008

Study information

• Verified date: March 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 29
• Est. completion date: January 2008
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Mania
• Bipolar Disorder
• Bipolar Disorder, Manic

Intervention

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.
• 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.

Locations

Country	Name	City	State
Germany	Pfizer Investigational Site	Aachen
Germany	Pfizer Investigational Site	Augsburg
Germany	Pfizer Investigational Site	Freiburg
Greece	Pfizer Investigational Site	Athens
Italy	Pfizer Investigational Site	Bari
Italy	Pfizer Investigational Site	Guardiagrele (CH)
Italy	Pfizer Investigational Site	Lido Di Camaiore (LU)
Italy	Pfizer Investigational Site	Partinico (Pa)
Italy	Pfizer Investigational Site	Perugia
Italy	Pfizer Investigational Site	S. Arsenio	Salerno
Italy	Pfizer Investigational Site	Siena
Italy	Pfizer Investigational Site	Torino
Italy	Pfizer Investigational Site	Trieste
Spain	Pfizer Investigational Site	Alava	Vitoria
Spain	Pfizer Investigational Site	Granada
Spain	Pfizer Investigational Site	Malaga
Spain	Pfizer Investigational Site	Terrassa	Barcelona
Turkey	Pfizer Investigational Site	Ankara
Turkey	Pfizer Investigational Site	Istanbul

Sponsors (1)

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

Countries where clinical trial is conducted

Germany,  Greece,  Italy,  Spain,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 weeks
Secondary	Change From Baseline in Clinical Global Impressions Scale for Use in Bipolar Illness Scores; Montgomery Asberg Depression Scale Scores in the Double Blind Phase.		up to 10 weeks
Secondary	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.		6 months
Secondary	Percentage of Patients With Symptomatic Remission After 4, 6 and 10 Weeks of Treatment and at the End of the Double-blind Phase.		4, 6 and 10 weeks
Secondary	Time to Symptomatic Remission in the Double Blind Phase.		up to 10 weeks
Secondary	Percentage of Patients With Clinical Response After 6 Weeks of Double-blind Treatment.		6 weeks
Secondary	Percentage of Patients With Symptomatic Relapse of Mania and/or Symptomatic Relapse of Depression During the Open Label Phase.		6 months

External Links

•   To obtain contact information for a study center near you, click here.