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Antipsychotic/Antidepressant Combination
Multiple Medications for Bipolar Depression (SMART-BD Trial)
Phase 4
Waitlist Available
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Aged between 18 years to 75 years
Meets criteria for DSM-V Bipolar I disorder with a history of manic episodes and current major depressive episode lasting at least 6 weeks
Must not have
Meets current criteria for a manic episode, rapid cycling within the past year (history of 4 or more mood episodes per year)
A history of non-response for depressive episodes, to any of the study medications, when given at adequate doses for at least 6 weeks
Timeline
Screening 3 weeks
Treatment Varies
Follow Up investigators will administer this measure every 2 weeks for the first 12 weeks (weeks:0,2,4,6,8,10,12), and then at each study visit during the follow up phase until they are discharged from the study (weeks:20,28,36,44,52 ).
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial
Summary
This trial is testing four different medications to find the best treatment for adults with bipolar disorder type 1 who are currently depressed. The medications work by balancing brain chemicals that affect mood. The goal is to help patients recover from depression and stay well.
Who is the study for?
Adults over 18 with bipolar disorder type 1 who are currently in a depressive episode can join this trial. It's not specified, but typically participants need to meet certain health criteria and may be excluded for various reasons such as other medical conditions or treatments that could interfere with the study.
What is being tested?
The trial is testing four treatments for bipolar depression: Cariprazine, Quetiapine, Lurasidone (all FDA-approved), and an Aripiprazole/Escitalopram combo. Patients will be randomly assigned to one of these treatments in sequence to see which works best.
What are the potential side effects?
Possible side effects from these medications might include dizziness, sleepiness, weight gain, digestive issues, restlessness or agitation. Each medication has its own set of potential side effects that can vary from person to person.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 75 years old.
Select...
I have been diagnosed with Bipolar I disorder and am currently experiencing a major depressive episode that has lasted for at least 6 weeks.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have experienced rapid mood changes, including 4 or more episodes in the last year.
Select...
My depression didn't improve after 6 weeks on certain medications.
Select...
I am not currently at risk of suicide requiring hospitalization.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ investigators will administer this measure every 2 weeks for the first 12 weeks (weeks:0,2,4,6,8,10,12), and then at each study visit during the follow up phase until they are discharged from the study (weeks:20,28,36,44,52 ).
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~investigators will administer this measure every 2 weeks for the first 12 weeks (weeks:0,2,4,6,8,10,12), and then at each study visit during the follow up phase until they are discharged from the study (weeks:20,28,36,44,52 ).
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
The Remission from Depression Questionnaire
Secondary study objectives
Frequency and Intensity of Side Effects Ratings - Burden
Frequency and Intensity of Side Effects Ratings - Frequency
Frequency and Intensity of Side Effects Ratings - Intensity
+1 moreOther study objectives
Altman Self-Rating Mania Scale
Generalized Anxiety Disorder Assessment
Medication Reconciliation Tracking Form
+5 moreAwards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
4Treatment groups
Experimental Treatment
Group I: QuetiapineExperimental Treatment1 Intervention
Group II: LurasidoneExperimental Treatment1 Intervention
Group III: CariprazineExperimental Treatment1 Intervention
Group IV: Aripiprazole /Escitalopram combinationExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cariprazine
2010
Completed Phase 3
~11050
Quetiapine
2003
Completed Phase 4
~3220
Lurasidone
2008
Completed Phase 4
~4600
Find a Location
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
3,026 Previous Clinical Trials
13,411,094 Total Patients Enrolled
193 Trials studying Depression
31,436 Patients Enrolled for Depression
Patient-Centered Outcomes Research InstituteOTHER
579 Previous Clinical Trials
27,085,033 Total Patients Enrolled
31 Trials studying Depression
119,830 Patients Enrolled for Depression