Bipolar Disorder Clinical Trial
Official title:
Comparative Effectiveness of a Second Generation Antipsychotic Mood Stabilizer And a Classic Mood Stabilizer for Bipolar Disorder
Verified date | March 2018 |
Source | Massachusetts General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to compare the effectiveness of lithium and quetiapine for the treatment of individuals with bipolar disorder.
Status | Completed |
Enrollment | 482 |
Est. completion date | September 2013 |
Est. primary completion date | April 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 68 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | University of Michigan | Ann Arbor | Michigan |
United States | University of Alabama at Birmingham | Birmingham | Alabama |
United States | Massachusetts General Hospital | Boston | Massachusetts |
United States | Case Western Reserve University School of Medicine | Cleveland | Ohio |
United States | The Lindner Center of HOPE | Mason | Ohio |
United States | Vanderbilt University | Nashville | Tennessee |
United States | Weill Cornell Medical College | New York | New York |
United States | University of Pennsylvania | Philadelphia | Pennsylvania |
United States | University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania |
United States | The University of Texas Health Science Center | San Antonio | Texas |
United States | Stanford University School of Medicine | Stanford | California |
Lead Sponsor | Collaborator |
---|---|
Massachusetts General Hospital | Agency for Healthcare Research and Quality (AHRQ) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical Global Impression-Efficacy Index (CGI-EI) | The CGI-EI integrates benefits and harms and yields a score that can be compared across interventions. It is made up of 2 subscales: therapeutic effects and side effects. Each rating is on a scale from 1 to 4. To combine these two subscales into the CGI-EI we report as our primary outcome, we subtracted the side effects subscale from the therapeutic effects subscale. Thus, the CGI-EI we report ranges the integers from -3 to +3 (i.e. possible scores are -3,-2,-1,0,1,2,3). A score of -3 is the most burdensome side effect score (4) and the least therapeutic effect score (1) and a score of +3 is the least burdensome side effect score (1) and the highest therapeutic effect score (4). Higher CGI-EI signifies better outcome (minimal side effects, maximal therapeutic effect). Lower CGI-EI signifies worse outcome (maximal side effects, minimal therapeutic effect).To compute CGI-EI score, we subtract the side effect score from the therapeutic effect score. | Average 6 month score minus Average baseline score | |
Primary | Necessary Clinical Adjustments | Necessary Clinical Adjustment (NCA): The Medication Recommendation Tracking Form was developed and successfully implemented in a previous study to capture recommended medication changes at each study visit 17. Clinicians record dosage changes, missed doses, new medications added or discontinued, and specify the reason for each change. Any change in psychotropic medications, or medications used to treat side effects, is coded along with the reason for the change. NCAs include those changes made for lack of effectiveness or intolerance, but not changes for planned dose titrations. | 6 Months | |
Secondary | Risk of Cardiovascular Disease - Framingham Risk Score | The Framingham risk score captures the classic risk factors for cardiovascular disease, including age, sex, systolic blood pressure, total and high density lipoprotein cholesterol, diabetes mellitus, and smoking. The Framingham risk score is used as a simple predictive tool to determine 10-year (short term) risk for developing cardiovascular disease (CHD), with higher scores indicating higher risk. Established benchmarks exist for scores from 0 to 25--though it can exceed this value--that are meant to translate to the probability of developing heart disease. | Average baseline score minus Average 6 month score | |
Secondary | Longitudinal Interval Follow up Evaluation Range of Impaired Functioning Tool (LIFE-RIFT) | The LIFE-RIFT asses the extent to which psychopathology has impacted current functioning in work, household chores, interpersonal relationships with partner, family, and friends, recreational activities, and life, satisfaction, leisure activities and social relationships. Summary scores can range from 4 to 20, with higher scores indicating greater functional impairment. | Average baseline score minus Average 6-month score |
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