Trial Outcomes & Findings for Differentiating Unipolar and Bipolar Depression in Young Adults Using fMRI (NCT NCT01811147)
NCT ID: NCT01811147
Last Updated: 2019-12-02
Results Overview
Hamilton depression rating scale (17-item HAM-D): Scores can range from 0 to 52: No depression (0-7); Mild depression (8-16); Moderate depression (17-23); and Severe depression (≥24).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
192 participants
Primary outcome timeframe
24 months
Results posted on
2019-12-02
Participant Flow
After enrollment 3 subject were excluded form the study since it was later discovered that they did not meet the criteria.
Participant milestones
| Measure |
High Risk Depression
Interventions will include the prescribing of Selective serotonin reuptake inhibitor or Serotonin-norepinephrine reuptake inhibitor antidepressants, bupropion or other antidepressant.
Selective Serotonin Reuptake Inhibitor (SSRI): Subjects with depression will be treated with a Selective Serotonin Reuptake Inhibitor (SSRI) or a Serotonin-norepinephrine reuptake inhibitor (SNRI) for 24 months.
|
Low Risk Depression
Interventions will include the prescribing of Selective serotonin reuptake inhibitor or Serotonin-norepinephrine reuptake inhibitor antidepressants, bupropion or other antidepressant..
Selective Serotonin Reuptake Inhibitor (SSRI): Subjects with depression will be treated with a Selective Serotonin Reuptake Inhibitor (SSRI) or a Serotonin-norepinephrine reuptake inhibitor (SNRI) for 24 months.
|
Healthy Control
There is no intervention, but rather phone follow ups conducted as check ins to determine the continued eligibility of the healthy control participant.
|
Bipolar
Bipolar participants are checked in with via phone conversations every three months, and have the opportunity to be scheduled for non-study visits to manage their symptoms.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
51
|
56
|
49
|
33
|
|
Overall Study
COMPLETED
|
15
|
11
|
6
|
4
|
|
Overall Study
NOT COMPLETED
|
36
|
45
|
43
|
29
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Differentiating Unipolar and Bipolar Depression in Young Adults Using fMRI
Baseline characteristics by cohort
| Measure |
High Risk Depression
n=51 Participants
Interventions will include the prescribing of Selective serotonin reuptake inhibitor or Serotonin-norepinephrine reuptake inhibitor antidepressants, bupropion or other antidepressant.
Selective Serotonin Reuptake Inhibitor (SSRI): Subjects with depression will be treated with a Selective Serotonin Reuptake Inhibitor (SSRI) or a Serotonin-norepinephrine reuptake inhibitor (SNRI) for 24 months.
|
Low Risk Depression
n=56 Participants
Interventions will include the prescribing of Selective serotonin reuptake inhibitor or Serotonin-norepinephrine reuptake inhibitor antidepressants, bupropion or other antidepressant..
Selective Serotonin Reuptake Inhibitor (SSRI): Subjects with depression will be treated with a Selective Serotonin Reuptake Inhibitor (SSRI) or a Serotonin-norepinephrine reuptake inhibitor (SNRI) for 24 months.
|
Healthy Control
n=49 Participants
There is no intervention, but rather phone follow ups conducted as check ins to determine the continued eligibility of the healthy control participant.
|
Bipolar
n=33 Participants
Bipolar participants are checked in with via phone conversations every three months, and have the opportunity to be scheduled for non-study visits to manage their symptoms.
|
Total
n=189 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
22.67 years
STANDARD_DEVIATION 3.433 • n=93 Participants
|
25.27 years
STANDARD_DEVIATION 3.661 • n=4 Participants
|
24.24 years
STANDARD_DEVIATION 3.339 • n=27 Participants
|
23.52 years
STANDARD_DEVIATION 3.784 • n=483 Participants
|
23.99 years
STANDARD_DEVIATION 3.655 • n=36 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=93 Participants
|
38 Participants
n=4 Participants
|
28 Participants
n=27 Participants
|
22 Participants
n=483 Participants
|
128 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=93 Participants
|
18 Participants
n=4 Participants
|
21 Participants
n=27 Participants
|
11 Participants
n=483 Participants
|
61 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
37 Participants
n=93 Participants
|
50 Participants
n=4 Participants
|
37 Participants
n=27 Participants
|
26 Participants
n=483 Participants
|
150 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
African American
|
13 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
7 Participants
n=483 Participants
|
30 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
9 Participants
n=36 Participants
|
|
Region of Enrollment
United States
|
51 participants
n=93 Participants
|
56 participants
n=4 Participants
|
49 participants
n=27 Participants
|
33 participants
n=483 Participants
|
189 participants
n=36 Participants
|
PRIMARY outcome
Timeframe: 24 monthsHamilton depression rating scale (17-item HAM-D): Scores can range from 0 to 52: No depression (0-7); Mild depression (8-16); Moderate depression (17-23); and Severe depression (≥24).
Outcome measures
| Measure |
High Risk Depression
n=15 Participants
Interventions will include the prescribing of Selective serotonin reuptake inhibitor or Serotonin-norepinephrine reuptake inhibitor antidepressants, bupropion or other antidepressant.
Selective Serotonin Reuptake Inhibitor (SSRI): Subjects with depression will be treated with a Selective Serotonin Reuptake Inhibitor (SSRI) or a Serotonin-norepinephrine reuptake inhibitor (SNRI) for 24 months.
|
Low Risk Depression
n=11 Participants
Interventions will include the prescribing of Selective serotonin reuptake inhibitor or Serotonin-norepinephrine reuptake inhibitor antidepressants, bupropion or other antidepressant..
Selective Serotonin Reuptake Inhibitor (SSRI): Subjects with depression will be treated with a Selective Serotonin Reuptake Inhibitor (SSRI) or a Serotonin-norepinephrine reuptake inhibitor (SNRI) for 24 months.
|
Healthy Control
n=6 Participants
There is no intervention, but rather phone follow ups conducted as check ins to determine the continued eligibility of the healthy control participant.
|
Bipolar
n=4 Participants
Bipolar participants are checked in with via phone conversations every three months, and have the opportunity to be scheduled for non-study visits to manage their symptoms.
|
|---|---|---|---|---|
|
HAM-D 17 Item: Hamilton Depression Rating Scale
|
6.6 score on a scale
Standard Deviation 6.62
|
4.91 score on a scale
Standard Deviation 4.11
|
2.333 score on a scale
Standard Deviation 2.732
|
3.75 score on a scale
Standard Deviation 4.992
|
SECONDARY outcome
Timeframe: 24 monthsYoung Mania Rating Scale: Scores can range from 0 to 60: In Remission/No Mania (0-8); Mild (9-12); Moderate (13-18); Severe (19-25); Very Severe (\>25)
Outcome measures
| Measure |
High Risk Depression
n=15 Participants
Interventions will include the prescribing of Selective serotonin reuptake inhibitor or Serotonin-norepinephrine reuptake inhibitor antidepressants, bupropion or other antidepressant.
Selective Serotonin Reuptake Inhibitor (SSRI): Subjects with depression will be treated with a Selective Serotonin Reuptake Inhibitor (SSRI) or a Serotonin-norepinephrine reuptake inhibitor (SNRI) for 24 months.
|
Low Risk Depression
n=11 Participants
Interventions will include the prescribing of Selective serotonin reuptake inhibitor or Serotonin-norepinephrine reuptake inhibitor antidepressants, bupropion or other antidepressant..
Selective Serotonin Reuptake Inhibitor (SSRI): Subjects with depression will be treated with a Selective Serotonin Reuptake Inhibitor (SSRI) or a Serotonin-norepinephrine reuptake inhibitor (SNRI) for 24 months.
|
Healthy Control
n=6 Participants
There is no intervention, but rather phone follow ups conducted as check ins to determine the continued eligibility of the healthy control participant.
|
Bipolar
n=4 Participants
Bipolar participants are checked in with via phone conversations every three months, and have the opportunity to be scheduled for non-study visits to manage their symptoms.
|
|---|---|---|---|---|
|
YMRS: Young Mania Rating Scale
|
0.2 score on a scale
Standard Deviation 0.561
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
1.75 score on a scale
Standard Deviation 3.5
|
Adverse Events
High Risk Depression
Serious events: 5 serious events
Other events: 3 other events
Deaths: 0 deaths
Low Risk Depression
Serious events: 3 serious events
Other events: 4 other events
Deaths: 0 deaths
Healthy Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Bipolar
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
High Risk Depression
n=51 participants at risk
Interventions will include the prescribing of Selective serotonin reuptake inhibitor or Serotonin-norepinephrine reuptake inhibitor antidepressants, bupropion or other antidepressant.
Selective Serotonin Reuptake Inhibitor (SSRI): Subjects with depression will be treated with a Selective Serotonin Reuptake Inhibitor (SSRI) or a Serotonin-norepinephrine reuptake inhibitor (SNRI) for 24 months.
|
Low Risk Depression
n=56 participants at risk
Interventions will include the prescribing of Selective serotonin reuptake inhibitor or Serotonin-norepinephrine reuptake inhibitor antidepressants, bupropion or other antidepressant..
Selective Serotonin Reuptake Inhibitor (SSRI): Subjects with depression will be treated with a Selective Serotonin Reuptake Inhibitor (SSRI) or a Serotonin-norepinephrine reuptake inhibitor (SNRI) for 24 months.
|
Healthy Control
n=49 participants at risk
There is no intervention, but rather phone follow ups conducted as check ins to determine the continued eligibility of the healthy control participant.
|
Bipolar
n=33 participants at risk
Bipolar participants are checked in with via phone conversations every three months, and have the opportunity to be scheduled for non-study visits to manage their symptoms.
|
|---|---|---|---|---|
|
Psychiatric disorders
Sucidial Ideation
|
5.9%
3/51 • 24 months
|
3.6%
2/56 • 24 months
|
0.00%
0/49 • 24 months
|
0.00%
0/33 • 24 months
|
|
Psychiatric disorders
Hospitalization
|
2.0%
1/51 • 24 months
|
1.8%
1/56 • 24 months
|
0.00%
0/49 • 24 months
|
0.00%
0/33 • 24 months
|
|
Psychiatric disorders
Suicide Attempt
|
2.0%
1/51 • 24 months
|
0.00%
0/56 • 24 months
|
0.00%
0/49 • 24 months
|
0.00%
0/33 • 24 months
|
Other adverse events
| Measure |
High Risk Depression
n=51 participants at risk
Interventions will include the prescribing of Selective serotonin reuptake inhibitor or Serotonin-norepinephrine reuptake inhibitor antidepressants, bupropion or other antidepressant.
Selective Serotonin Reuptake Inhibitor (SSRI): Subjects with depression will be treated with a Selective Serotonin Reuptake Inhibitor (SSRI) or a Serotonin-norepinephrine reuptake inhibitor (SNRI) for 24 months.
|
Low Risk Depression
n=56 participants at risk
Interventions will include the prescribing of Selective serotonin reuptake inhibitor or Serotonin-norepinephrine reuptake inhibitor antidepressants, bupropion or other antidepressant..
Selective Serotonin Reuptake Inhibitor (SSRI): Subjects with depression will be treated with a Selective Serotonin Reuptake Inhibitor (SSRI) or a Serotonin-norepinephrine reuptake inhibitor (SNRI) for 24 months.
|
Healthy Control
n=49 participants at risk
There is no intervention, but rather phone follow ups conducted as check ins to determine the continued eligibility of the healthy control participant.
|
Bipolar
n=33 participants at risk
Bipolar participants are checked in with via phone conversations every three months, and have the opportunity to be scheduled for non-study visits to manage their symptoms.
|
|---|---|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
3.9%
2/51 • 24 months
|
1.8%
1/56 • 24 months
|
0.00%
0/49 • 24 months
|
0.00%
0/33 • 24 months
|
|
Social circumstances
Visit to Emergency Room
|
2.0%
1/51 • 24 months
|
1.8%
1/56 • 24 months
|
0.00%
0/49 • 24 months
|
0.00%
0/33 • 24 months
|
|
Psychiatric disorders
Substance Abuse Treatment
|
0.00%
0/51 • 24 months
|
3.6%
2/56 • 24 months
|
0.00%
0/49 • 24 months
|
0.00%
0/33 • 24 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place