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Efficacy and Safety of Quetiapine Versus Quetiapine Plus Lithium in Bipolar Depression

NCT00883493 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 421

Last updated 2012-07-11

Study results available
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Summary

The purpose of this study is to compare the efficacy of quetiapine fumarate monotherapy with quetiapine fumarate in combination with lithium in the treatment of a major depressive episode in patients with bipolar disorder.

Conditions

  • Acute Bipolar Depression

Interventions

DRUG

Quetiapine fumarate XR

Quetiapine XR (extended release) will be administered once daily at bedtime in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg.

DRUG

Lithium carbonate

Twice daily from Day 1 to Day 56. From Day 1 to Day 7, the total daily dose of lithium could be increased gradually within the dose range 300 mg/day to 1800 mg/day. From Day 8 to Day 56, the total daily dose could be adjusted from 600 to 1800 mg/day

Sponsors & Collaborators

Principal Investigators

  • Simavi Vahip, Prof. Dr. · Ege University Faculty of Medicine Psychiatry Department İzmir

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2011-03-31
Completion
2011-03-31

Countries

  • Argentina
  • Brazil
  • Chile
  • Colombia
  • Guatemala
  • Mexico
  • Peru
  • Turkey (Türkiye)
  • Venezuela

Study Locations

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Entities

Companies

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 NCT00883493 on ClinicalTrials.gov