Depression Clinical Trial
— SMART-BDOfficial title:
Sequential Multiple Assignment Randomized Trial for Bipolar Depression
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 antipsychotic/antidepressant combination (Aripiprazole/Escitalopram).
Status | Not yet recruiting |
Enrollment | 2726 |
Est. completion date | February 28, 2030 |
Est. primary completion date | February 28, 2030 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: 1. Aged between 18 years to 75 years 2. Meets criteria for DSM-V Bipolar I disorder with a history of manic episodes and current major depressive episode lasting at least 6 weeks 3. Can be managed as an outpatient and participate in the study 4. Willing to be randomized; able to perform study assessments 5. Women of childbearing potential must agree to use adequate contraception (e.g. oral contraceptives, intrauterine device, barrier methods, or total abstinence; Depo Provera is acceptable if it is started 3 months prior to enrollment), and inform staff of their plans to conceive. Exclusion Criteria: 1. Meets current criteria for a manic episode, rapid cycling within the past year (history of 4 or more mood episodes per year) 2. History of schizophrenia or other nonaffective psychosis 3. Current substance use disorder that will interfere with participation in the study 4. Currently taking the study medications or a history of serious adverse events to any of the study medications, to the extent that as determined by site PI, another trial would not be clinically indicated 5. A history of non-response for depressive episodes, to any of the study medications, when given at adequate doses for at least 6 weeks 6. Current acute suicidal risk that requires inpatient treatment 7. Pregnancy or breastfeeding |
Country | Name | City | State |
---|---|---|---|
Canada | University of Toronto | Toronto | Ontario |
Canada | University of British Columbia | Vancouver | British Columbia |
United States | University of New Mexico Health Sciences Center Albuquerque | Albuquerque | New Mexico |
United States | University of Michigan | Ann Arbor | Michigan |
United States | University of Texas at Austin | Austin | Texas |
United States | John Hopkins | Baltimore | Maryland |
United States | Sheppard Pratt Health System | Baltimore | Maryland |
United States | McLean Hospital | Belmont | Massachusetts |
United States | University of Alabama Birmingham | Birmingham | Alabama |
United States | Massachusetts General Hospital | Boston | Massachusetts |
United States | University of North Carolina at Chapel Hill | Chapel Hill | North Carolina |
United States | Case Western Reserve University | Cleveland | Ohio |
United States | University of Texas at Southwestern Medical Center | Dallas | Texas |
United States | UT Health Houston Texas | Houston | Texas |
United States | Montefiore Medical Center and Albert Einstein College of Medicine | New York | New York |
United States | New York University Grossman School of Medicine NYU | New York | New York |
United States | University of Pennsylvania | Philadelphia | Pennsylvania |
United States | University of Pittsburgh | Pittsburgh | Pennsylvania |
United States | Mayo Clinic | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Massachusetts General Hospital | Patient-Centered Outcomes Research Institute |
United States, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Altman Self-Rating Mania Scale | self-rating mania scale designed to assess the presence and/or severity of manic symptoms in children and adolescents
The range is from 5-25, higher scores reflect increased symptoms of of mania |
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 ). | |
Other | Generalized Anxiety Disorder Assessment | A seven-item instrument that is used to measure or assess the severity of generalized anxiety disorder (GAD).
The range is from 0-21, higher scores reflect increased symptoms of of anxiety |
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 ). | |
Other | Medication Reconciliation Tracking Form | The MRTF generates the average number of necessary clinical adjustments per month, which provides a method to compare long-term outcomes in a pragmatic trial.
There is no range or scoring necessary for this assessment. |
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 ). | |
Other | Patient Health Questionnaire | The PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression
The range is from 0-27, higher scores reflect increased symptoms of of depression |
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 ). | |
Other | PROMIS Item Bank v2.0 Cognitive Functioning- Short Form | Cognitive deficits will be assessed with the PROMIS- Cognitive Function-Short Form. This 8-item self-report questionnaire has good construct validity and psychometric properties and has been used as an outcome in multiple studies.
The range is from 8-40, increased scores are associated with a person's increased perception of cognitive function in areas such as concentration, memory, and mental acuity |
Investigators will administer this measure at baseline (week 0), week 6, and week 12. Then at each study visit during the follow up phase until they are discharged from the study (weeks:20,28,36,44,52 ). | |
Other | PROMIS Item Bank v2.0 Satisfaction with Social Roles and Activities | This measure is an 8 item self-report questionnaire that assesses the individual's satisfaction with social roles and activities. The measure has clinical validity across a range of chronic conditions, including depression and responds to change in clinical state
The range is from 8-40 increased scores are associated with higher feelings of satisfaction with performing one's usual social roles and activities |
Investigators will administer this measure at baseline (week 0), week 6, and week 12. Then at each study visit during the follow up phase until they are discharged from the study (weeks:20,28,36,44,52 ). | |
Other | Young Mania Rating Scale | The YMRS is a rating scale used to evaluate manic symptoms at baseline and over time in individuals with mania.
The range is from 0-60, higher scores reflect increased risk for Bipolar Disorder. If the participant scores 18 or above on the YMRS, they will be considered manic and not in remission even if they meet criteria for remission with the RDQ |
Investigators can administer at any time between weeks 0 to 52. This assessment only applies if patients has a pseudo-remission from depression, indicated if the patient scores a 6 or higher on the self-rated Altman Scale for Rating Mania (ASRM) | |
Other | Quality of Life Scale | The QoL.BD93,94 measures 12 core domains (physical, sleep, mood, cognition, leisure, social, spirituality, finances, household, self-esteem, independence, identity) and 2 optional (work, education) domains
A brief 12-item version represents the core QoL domains and is scored on a five-point range (1: strongly disagree to 5: strongly agree). The range of scoring is 12-60 with higher scores reflecting a greater belief in ones quality of life. |
Investigators will administer this measure at baseline (week 0), week 6, and week 12. Then at each study visit during the follow up phase until they are discharged from the study (weeks:20,28,36,44,52 ). | |
Primary | The Remission from Depression Questionnaire | RDQ is a 41 items self report questionnaire used to assess the seven domains found in extensive previous research to be important to patients: depressive symptoms, anxiety, coping ability, positive mental health, functioning, life satisfaction and a general sense of well-being. Using a score of 27 as the cutoff, the RDQ scale has a sensitivity of 83.7% and specificity of 77.9% in predicting self-reported remission status. The RDQ has excellent internal consistency reliability (Cronbach's alpha of 0.97 for the total scale and above 0.80 for each of the 7 subscales with test-retest reliability of the total scale = 0.85 and > 0.60 for each subscale). The primary outcome will be remission as defined by a RDQ score < 27. This test will be administered in all assessment visits.
The RDQ scale ranges from 0-27 per domain, with higher scores indicating greater remission rates. |
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 ). | |
Secondary | Safety: Concise Health Risk Tracking Scale | CHRT is a 14 item self-report measure of suicidal ideation and behavior in individuals with mood disorders. The CHRT has excellent psychometric properties, with an internal consistency reliability (Cronbach's alpha) of 0.78 and a consistent factor structure with 3 independent factors (current suicidal thoughts and plans, perceived lack of social support, and hopelessness).
The range is from 14-70, higher scores reflect an increase in suicidality behaviors. |
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 ). | |
Secondary | Frequency and Intensity of Side Effects Ratings - Intensity | This subscale of the FIBSER scale is a reliable self-report measure of the intensity of side effects from medications in a population receiving treatment for depression. This scale measures the participants side effects intensity from the previous week and has them rate each on a scale from 0-6. The results will help the clinician determine the appropriate level of response.
The range is from 0-6, higher scores reflect an greater intensity in medication side effects. |
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 ). | |
Secondary | Frequency and Intensity of Side Effects Ratings - Frequency | This subscale of the FIBSER scale is a reliable and valid self-report measure on the frequency of medication side effects in a population receiving treatment for depression. This scale measures the participants side effects frequency from the previous week and has them rate each on a scale from 0-6. The results will help the clinician determine the appropriate level of response.
The range is from 0-6, higher scores reflect an greater frequency in medication side effects. |
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 ). | |
Secondary | Frequency and Intensity of Side Effects Ratings - Burden | This subscale of the FIBSER scale is a reliable self-report measure of the side effects burden of medications in a population receiving treatment for depression. This scale measures the participants side effects burden from the previous week and has them rate each on a scale from 0-6. The results will help the clinician determine the appropriate level of response.
The range is from 0-6, higher scores reflect an greater burden in medication side effects. |
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 ). |
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