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Efficacy and Safety of Lu AA34893 in Patients With Bipolar Depression

NCT00622245 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 166

Last updated 2010-09-27

No results posted yet for this study

Summary

This study will evaluate the efficacy and safety of different doses of Lu AA34893 in the treatment of depression in patients with bipolar disorder.

Conditions

  • Depression in Patients With Bipolar Disorder

Interventions

DRUG

Lu AA34893

per oral doses, divided in twice daily administrations as capsules, during 12 weeks, followed by a one-week tapering period

DRUG

Quetiapine fumarate

per oral, once daily, during 12 weeks, followed by a one-week tapering period

DRUG

Placebo

per oral doses, twice daily as capsules during 13 weeks

Sponsors & Collaborators

  • H. Lundbeck A/S

    lead INDUSTRY

Principal Investigators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2009-01-31
Completion
2009-11-30

Countries

  • Australia
  • Austria
  • Belgium
  • Bulgaria
  • Canada
  • France
  • Germany
  • Lithuania
  • Malaysia
  • Philippines
  • Poland
  • Romania
  • Slovakia
  • South Korea
  • Sweden
  • Taiwan
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

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 NCT00622245 on ClinicalTrials.gov