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Bipolar II Depression: Lithium, SSRI, or the Combination

NCT00276965 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 139

Last updated 2013-05-10

No results posted yet for this study

Summary

This study will compare the safety and effectiveness of a mood stabilizing medication, an antidepressant medication, and a combination of both medications to treat symptoms of bipolar type II depression.

Conditions

Interventions

DRUG

Sertraline

Sertraline or placebo for sertraline starting at 25 mg per day, up to maximum of 200 mg per day

DRUG

Lithium carbonate

Lithium or placebo for lithium starting at 150 mg per day; target dose of 900mg per day. Maximum dose based on clinical response and serum levels (maximum serum level of 1.2 mEq/L).

Sponsors & Collaborators

Principal Investigators

  • Lori Altshuler, MD · UCLA Mood Disorders Research Program

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2006-09-30
Primary Completion
2012-03-31
Completion
2012-07-31

Countries

  • United States

Study Locations

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Entities

Diseases
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 NCT00276965 on ClinicalTrials.gov