Overview

Comparative Effectiveness Study for Bipolar Disorder

Status:
Completed

Trial end date:
2013-09-01

Target enrollment:
0

Participant gender:
All

Summary

The purpose of this study is to compare the effectiveness of lithium and quetiapine for the treatment of individuals with bipolar disorder.

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Massachusetts General Hospital

Collaborator:

Agency for Healthcare Research and Quality (AHRQ)

Treatments:

Lithium Carbonate
Quetiapine Fumarate

Criteria

Inclusion Criteria:

1. Meets DSM-IV criteria for BD I or II, which is the primary focus of treatment

2. Able to give written informed consent

3. Age > to 18 years and < 68 years

4. Women of child bearing potential must agree to use adequate contraception (e.g. oral
contraceptives, intrauterine device, barrier methods, or total abstinence from
intercourse; Depo Provera is acceptable if it is started 3 months prior to
enrollment), inform their doctor at the earliest possible time of their plans to
conceive, and to understand the risks of lithium and other study treatments to the
fetus and infant

5. Currently symptomatic, as defined as a Clinical Global Impression - Bipolar Disorder
Overall Severity (CGI-BP-S) score of at least 3 (mild)

6. If currently taking an SGA, participants would be required to be willing to either
discontinue or switch to QTP

7. Willing to be randomized to either QTP+APT or Li+APT.

Exclusion Criteria:

1. Unwilling or unable to comply with study requirements

2. If maintained on thyroid medication must be euthyroid for at least 1 month before
Visit 1

3. Patients who have had intolerable side effects with QTP or Li

4. Patients whose clinical status requires inpatient care

5. Drug/alcohol dependence within the past 30 days

6. Pregnancy as determined by urine pregnancy test or breastfeeding

7. History of nonresponse to Li at a serum level of ≥ 1.0 mEq/L ≥ 8 weeks

8. History of nonresponse to QTP at doses of at least 600 mg ≥ 8 weeks.