Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06433635
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-30
First Post:
2024-04-22
Brief Title:
Sequential Multiple Assignment Randomized Trial for Bipolar Depression
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Sequential Multiple Assignment Randomized Trial for Bipolar Depression
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SMART-BD
Brief Summary:
This is a sequential multiple assignment randomized trial for adults ages 18 with a bipolar disorder type 1 diagnosis currently experiencing a depressive episode It is a randomized pragmatic trial that will compare four commonly prescribed treatments for bipolar depression which includes three FDA-approved medications Cariprazine Quetiapine and Lurasidone and one antipsychoticantidepressant combination AripiprazoleEscitalopram
Detailed Description:
This is a comparative effectiveness study to address the critical questions of how best to treat people with bipolar disorder who have a major depressive episode how to get them well provide second-line treatment when they dont initially get well and keep them well after they get well This is a multisite Sequential Multiple Assignment Randomized Trial SMART comparative effectiveness design Investigators will recruit 2726 participants who have BD with a current major depressive episode In Stage 1 investigators will compare four treatment arms including three FDA approved monotherapies and the most widely used but understudied treatment for BD major depressive episode ie a non-FDA approved combination of an antipsychotic and antidepressant In Stage 2 participants who do not remit will be re-randomized to treatments not used in Stage 1 Investigators will follow all participants for a total of 52 weeks This study will be conducted in two phases a feasibility phase and a full study phase In the feasibility phase investigators will recruit at 8 of the 19 study sites based on readiness and interest to ensure the efficacy of the study design before launching the full study phase
Feasibility Aim 1 To ensure that 8 of the 19 selected sites can recruit randomize and retain participants During the feasibility phase the selected sites will recruit 133 participants administer baseline assessments randomize the participants at baseline and again at 6-weeks for non-remitters and conduct follow-up assessments at the end of Stage 1 6-weeks and the end of Stage 2 12-weeks and end of study 52 weeks or end of feasibility phase whichever is sooner and all other scheduled visits
Feasibility Aim 2 To refine and finalize all study standard operating procedures for the full-scale study After Aim 1 is complete any changes in standard operating procedures will be made as needed to be implemented in the full study phase
Full Scale Study Full-Scale Study Aim 1 To compare the effectiveness tolerability and safety of the four treatments for BD major depressive episodes
Hypothesis 1a There will be significant differences across the Stage 1 treatments in the proportion of remitters at week 6 primary endpoint effectiveness and in the average adverse event burden and suicidal ideationbehavior at week 6 secondary endpoints tolerability and safety
Hypothesis 1b Among non-remitters of a given Stage 1 treatment ie participants who do not remit by week 6 there will be significant differences across the three remaining Stage 2 treatments in the proportion of remitters at week 12 primary endpoint effectiveness and the average side effect burden and suicidal ideationbehavior at week 12 secondary endpoints tolerability and safety
Full-Scale Study Aim 2 To characterize the effectiveness tolerability and safety of the 12 adaptive interventions for BD major depressive episodes embedded within the SMART design
Hypothesis 2 On average there will be significant differences across the 12 embedded adaptive interventions in the proportion of remitters at week 12 primary endpoint effectiveness and in the average side effect burden and suicidal ideationbehavior at week 12 secondary endpoints tolerability and safety
Full-Scale Study Aim 3 To determine individual-level characteristics that predict heterogeneity of treatment effect HTE across the 12 adaptive interventions for BD major depressive episodes embedded within the SMART design
Hypothesis 3a Individual-level characteristics and symptoms assessed at baseline as well as symptom changes and side effect profiles at week 6 will predict HTE at weeks 12 and 52 Hypothesis 3b Investigators hypothesize that an optimal personalized adaptive intervention will perform significantly better than the best aggregate embedded adaptive intervention identified in Aim 2 in terms of the proportion of remitters at week 12 primary endpoint effectiveness and the side effect burden and suicidal ideationbehavior at week 12 secondary endpoints tolerability and safety
Feasibility Aim 1 To ensure that 8 of the 19 selected sites can recruit randomize and retain participants During the feasibility phase the selected sites will recruit 133 participants administer baseline assessments randomize the participants at baseline and again at 6-weeks for non-remitters and conduct follow-up assessments at the end of Stage 1 6-weeks and the end of Stage 2 12-weeks and end of study 52 weeks or end of feasibility phase whichever is sooner and all other scheduled visits
Feasibility Aim 2 To refine and finalize all study standard operating procedures for the full-scale study After Aim 1 is complete any changes in standard operating procedures will be made as needed to be implemented in the full study phase
Full Scale Study Full-Scale Study Aim 1 To compare the effectiveness tolerability and safety of the four treatments for BD major depressive episodes
Hypothesis 1a There will be significant differences across the Stage 1 treatments in the proportion of remitters at week 6 primary endpoint effectiveness and in the average adverse event burden and suicidal ideationbehavior at week 6 secondary endpoints tolerability and safety
Hypothesis 1b Among non-remitters of a given Stage 1 treatment ie participants who do not remit by week 6 there will be significant differences across the three remaining Stage 2 treatments in the proportion of remitters at week 12 primary endpoint effectiveness and the average side effect burden and suicidal ideationbehavior at week 12 secondary endpoints tolerability and safety
Full-Scale Study Aim 2 To characterize the effectiveness tolerability and safety of the 12 adaptive interventions for BD major depressive episodes embedded within the SMART design
Hypothesis 2 On average there will be significant differences across the 12 embedded adaptive interventions in the proportion of remitters at week 12 primary endpoint effectiveness and in the average side effect burden and suicidal ideationbehavior at week 12 secondary endpoints tolerability and safety
Full-Scale Study Aim 3 To determine individual-level characteristics that predict heterogeneity of treatment effect HTE across the 12 adaptive interventions for BD major depressive episodes embedded within the SMART design
Hypothesis 3a Individual-level characteristics and symptoms assessed at baseline as well as symptom changes and side effect profiles at week 6 will predict HTE at weeks 12 and 52 Hypothesis 3b Investigators hypothesize that an optimal personalized adaptive intervention will perform significantly better than the best aggregate embedded adaptive intervention identified in Aim 2 in terms of the proportion of remitters at week 12 primary endpoint effectiveness and the side effect burden and suicidal ideationbehavior at week 12 secondary endpoints tolerability and safety
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None