Efficacy and Safety of SPD417 in Treatment of Manic Symptoms in Adults With Bipolar I Disorder

NCT00150553 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2007-11-02

No results posted yet for this study

Summary

The purpose of this study is to compare the efficacy and safety of SPD417 in treating bipolar manic symptoms, when given once daily in the evening vs. twice daily.

Conditions

Interventions

DRUG

Extended-release carbamazepine

Sponsors & Collaborators

  • Validus Pharmaceuticals

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-01-31
Completion
2005-10-31

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Entities

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 NCT00150553 on ClinicalTrials.gov