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Sequential Multiple Assignment Treatment for Bipolar Disorder

Information source: The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Bipolar I Disorder; Bipolar II Disorder

Intervention: Lithium/Lithium Carbonate (Drug); Divalproex (Drug); Lamotrigine (Drug); Quetiapine (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: The University of Texas Health Science Center at San Antonio

Official(s) and/or principal investigator(s):
Charles L. Bowden, M.D., Principal Investigator, Affiliation: University of Texas
Joseph R Calabrese, M.D., Principal Investigator, Affiliation: Case Western Reserve University
Vivek Singh, M.D., Principal Investigator, Affiliation: University of Texas

Overall contact:
Melissa A. Bazan, MA, Phone: 210-567-5342, Email: bazanm@uthscsa.edu

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.

Clinical Details

Official title: Sequential Multiple Assignment Randomized Treatment (SMART)for Bipolar Disorder

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Bipolar Inventory of Symptoms Scale (BISS)

Secondary outcome: Global Assessment of Functioning Scale (GAF)

Detailed description: This open methods advancement study will randomize BD patients with clinically significant symptoms to treatment with one of two mood stabilizers (MS), lithium [LI] or divalproex [DV]. Those who develop protocol defined depression will then be randomized to a MS alone, MS + quetiapine [QT] or MS + lamotrigine [LM]. A SMART strategy employs a rule for adding new treatments based on each patient's current illness state and response during the trial, mimicking the adaptive nature of treatment selection which occurs in clinical settings, but in a controlled way which allows application of causal inference. By using early indices of response to dynamically alter treatment decisions to improve outcome, SMART eliminates unmeasured confounders associated with treatment decisions that are not randomized, as occurs in data mining exercises and in other non-randomized decisions in studies which randomize one variable at baseline. This sequential adaptive design represents a methodological innovation in bipolar trial history which will have particular implications for effectiveness studies. Specific Aim A. 1: Assess the feasibility of a SMART design in the conduct of an effectiveness study over 26 weeks in patients with BD. Aim A. 2 Compare the effectiveness of LI to DV as a primary component of treatment for BD over 26 weeks. Aim A. 3: Assess the effectiveness of MS + QT and MS + LM versus MS in subjects who develop depression. A4. Exploratory Aims: 1. Determine the effects of ethnicity, language facility, education and stress as moderators of treatment outcomes; 2. Explore the use of novel statistical methodologies to more informatively characterize illness trajectories in response to the interventions. In the aggregate these aims also will clarify whether the SMART confirms results provided by traditional, single point randomized controlled trials (RCTs).

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- DSM-IV TR diagnosis BD I or II as assessed by MINI 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 QT, LI, DV, or LM

- 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 or DV at a serum level of

≥ 45 mg/dL for at least 2 weeks.

Locations and Contacts

Melissa A. Bazan, MA, Phone: 210-567-5342, Email: bazanm@uthscsa.edu

Case Western Reserve University, Cleveland, Ohio 44106, United States; Recruiting
Carla Conroy, Phone: 216-844-2871, Email: carla.conroy@uhhospitals.org
Joseph Calabrese, M.D., Principal Investigator

University of Texas Health Science Center, San Antonio, Texas 78229-3900, United States; Recruiting
Melissa A. Bazan, MA, Phone: 210-567-5342, Email: bazanm@uthscsa.edu
Anna L. Hernandez, RN, Phone: 210-567-0780, Email: hernandeza6@uthscsa.edu
Vivek Singh, MD, Principal Investigator
Charles L. Bowden, MD, Principal Investigator

Additional Information

Starting date: June 2011
Last updated: April 21, 2015

Page last updated: August 23, 2015

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