Ziprasidone And Olanzapine's Outcomes In Mania

NCT00329108 | Terminated Phase 4 Results

• 1 other identifier: A1281147
• Study Type: interventional
• Target: 29
• Locations: 5 countries
• Sites: 19

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.

Conditions

Acute Mania; Bipolar Disorder, Manic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

• 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

• 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

• Time to Symptomatic Remission in the Double Blind Phase.

  up to 10 weeks

• Percentage of Patients With Clinical Response After 6 Weeks of Double-blind Treatment.

  6 weeks

Study Arms (2)

A

EXPERIMENTAL

Drug: ziprasidone hydrochloride

B

ACTIVE COMPARATOR

Drug: olanzapine

Interventions

ziprasidone hydrochloride 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.

Also known as: Geodon, Zeldox

A

olanzapine 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.

B

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (19)

Pfizer Investigational Site

Aachen, 52074, Germany

Location

Pfizer Investigational Site

Augsburg, 86156, Germany

Location

Pfizer Investigational Site

Freiburg im Breisgau, 79104, Germany

Location

Pfizer Investigational Site

Athens, 124 62, Greece

Location

Pfizer Investigational Site

S. Arsenio, Salerno, 84037, Italy

Location

Pfizer Investigational Site

Bari, 70100, Italy

Location

Pfizer Investigational Site

Guardiagrele (CH), 66016, Italy

Location

Pfizer Investigational Site

Lido Di Camaiore (LU), 55043, Italy

Location

Pfizer Investigational Site

Partinico (Pa), 90047, Italy

Location

Pfizer Investigational Site

Perugia, 06127, Italy

Location

Pfizer Investigational Site

Siena, 53100, Italy

Location

Pfizer Investigational Site

Torino, 10126, Italy

Location

Pfizer Investigational Site

Trieste, 34126, Italy

Location

Pfizer Investigational Site

Terrassa, Barcelona, 08227, Spain

Location

Pfizer Investigational Site

Alava, Vitoria, 01004, Spain

Location

Pfizer Investigational Site

Granada, 18014, Spain

Location

Pfizer Investigational Site

Málaga, 29009, Spain

Location

Pfizer Investigational Site

Ankara, 06100, Turkey (Türkiye)

Location

Pfizer Investigational Site

Istanbul, 34440, Turkey (Türkiye)

Location

Related Links

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

MeSH Terms

Conditions

Bipolar Disorder

Interventions

ziprasidone; Olanzapine

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

The study was terminated due to poor recruitment. No efficacy data were summarized due to very low sample size. Only safety data were summarized.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.govCallCenter@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2006
• First Posted: May 24, 2006
• Study Start: November 1, 2006
• Primary Completion: July 1, 2007
• Study Completion: January 1, 2008
• Last Updated: March 29, 2021
• Results First Posted: March 13, 2009

Record last verified: 2021-03

Locations

TU (2); ES (4); DE (3); GR (1); IT (9)