Sequential Multiple Assignment Treatment for Bipolar Disorder

• Status: Completed
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare which of the two mood stabilizers (drugs that help to steady/stabilize mood in patients with bipolar disorder (BD)), lithium and divalproex, is more effective in patients with bipolar disorder over 26 weeks. The study will also compare if lithium or divalproex used alone versus lithium or divalproex used with quetiapine versus lithium or divalproex used with lamotrigine is more effective when symptoms of depression develop.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Texas Health Science Center at San Antonio
• Collaborator: National Institute of Mental Health (NIMH)
• Treatments: Anticonvulsants; Lamotrigine; Lithium Carbonate; Quetiapine Fumarate; Valproic Acid

Criteria

Inclusion Criteria:

• DSM-IV TR (Diagnostic and Statistical Manual Edition IV Text Revision) diagnosis BD I or II as assessed by MINI PLUS (Mini International Neuropsychiatric Interview PLUS)

• Male or female ≥ 18 years old

• Currently symptomatic with a CGI-BP-S ≥3 for mania/hypomania &/or depression for ≥ 2 weeks

• One of the following indicators of recent active illness: a depressive or manic or hypomanic or mixed episode in the past 12 months

• If female of child bearing age must use effective birth control.

Exclusion Criteria:

• Unwilling or unable to comply with study requirements

• Renal impairment (serum creatinine > 1.5 mg/dL)

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

• Patients who have had intolerable side effects to QTP, Li, Div, or LTG

• Patients whose clinical status requires inpatient care

• Drug/alcohol dependence within the past 30 days

• Pregnancy as determined by serum pregnancy test or breastfeeding

• History of poor response to Li at a serum Li of ≥ 0.5 mEq/L (milliequivalents per Liter) or Div at a serum level of ≥ 45 mg/dL for at least 2 weeks.