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3-week Study to Evaluate Efficacy and Safety of Ziprasidone With Either Lithium or Divalproex in Acutely Manic Subjects

NCT00312494 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 680

Last updated 2021-03-29

Study results available
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Summary

3-week study to evaluate efficacy and safety of ziprasidone with either lithium or divalproex in acutely manic subjects

Conditions

Interventions

DRUG

Placebo

Placebo with mood stabilizer (either lithium or divalproex)

DRUG

Ziprasidone

Flexible dosing, 20-40mg BID, with a mood stabilizer (either lithium or divalproex)

DRUG

Ziprasidone

Flexible dosing, 60-80mg BID, with a mood stabilizer (either lithium or divalproex)

Sponsors & Collaborators

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

    lead INDUSTRY

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-04-30
Primary Completion
2008-12-31
Completion
2008-12-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00312494 on ClinicalTrials.gov