Trial Outcomes & Findings for Incorporating Patient Treatment Choice to Improve Treatment Retention in Depressed Hispanics (NCT NCT00742573)
NCT ID: NCT00742573
Last Updated: 2020-03-03
Results Overview
Average number of weeks of retention of Hispanics in the treatment of MDD
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
170 participants
Primary outcome timeframe
52 weeks
Results posted on
2020-03-03
Participant Flow
Participant milestones
| Measure |
1 Texas Medication Algorithm
Participants will receive medication treatment according to the Texas Medication Algorithm (TMA) for depression
Antidepressants through Texas Medication Algorithm (TMA): Treatment with medication will follow the TMA for depression. Antidepressant medications may include any of the following: citalopram, escitalopram, paroxetine, sertraline, venlafaxine XR, bupropion SR, duloxetine, nortriptyline, and mirtazapine.
|
2 Patient Choice
Participants will be offered brief interpersonal psychotherapy (IPT-B) alone or combined with the TMA for depression
Antidepressants through Texas Medication Algorithm (TMA): Treatment with medication will follow the TMA for depression. Antidepressant medications may include any of the following: citalopram, escitalopram, paroxetine, sertraline, venlafaxine XR, bupropion SR, duloxetine, nortriptyline, and mirtazapine.
Brief Interpersonal Psychotherapy (IPT-B): IPT-B consists of twelve 50-minute sessions, divided into three phases, focusing on an interpersonal problem or problems.
|
|---|---|---|
|
Overall Study
STARTED
|
83
|
87
|
|
Overall Study
Week 12
|
46
|
51
|
|
Overall Study
Week 24
|
39
|
37
|
|
Overall Study
Week 52
|
26
|
25
|
|
Overall Study
COMPLETED
|
26
|
25
|
|
Overall Study
NOT COMPLETED
|
57
|
62
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Incorporating Patient Treatment Choice to Improve Treatment Retention in Depressed Hispanics
Baseline characteristics by cohort
| Measure |
1 Texas Medication Algorithm
n=83 Participants
Participants will receive medication treatment according to the Texas Medication Algorithm (TMA) for depression
Antidepressants through Texas Medication Algorithm (TMA): Treatment with medication will follow the TMA for depression. Antidepressant medications may include any of the following: citalopram, escitalopram, paroxetine, sertraline, venlafaxine XR, bupropion SR, duloxetine, nortriptyline, and mirtazapine.
|
2 Patient Choice
n=87 Participants
Participants will be offered brief interpersonal psychotherapy (IPT-B) alone or combined with the TMA for depression
Antidepressants through Texas Medication Algorithm (TMA): Treatment with medication will follow the TMA for depression. Antidepressant medications may include any of the following: citalopram, escitalopram, paroxetine, sertraline, venlafaxine XR, bupropion SR, duloxetine, nortriptyline, and mirtazapine.
Brief Interpersonal Psychotherapy (IPT-B): IPT-B consists of twelve 50-minute sessions, divided into three phases, focusing on an interpersonal problem or problems.
|
Total
n=170 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
79 Participants
n=99 Participants
|
85 Participants
n=107 Participants
|
164 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Age, Continuous
|
38.2 years
STANDARD_DEVIATION 12.5 • n=99 Participants
|
40.8 years
STANDARD_DEVIATION 11.2 • n=107 Participants
|
39.5 years
STANDARD_DEVIATION 11.9 • n=206 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=99 Participants
|
49 Participants
n=107 Participants
|
97 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=99 Participants
|
38 Participants
n=107 Participants
|
73 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
83 participants
n=99 Participants
|
87 participants
n=107 Participants
|
170 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 52 weeksPopulation: Adult Hispanics with MDD
Average number of weeks of retention of Hispanics in the treatment of MDD
Outcome measures
| Measure |
1 Texas Medication Algorithm
n=83 Participants
Participants will receive medication treatment according to the Texas Medication Algorithm (TMA) for depression
Antidepressants through Texas Medication Algorithm (TMA): Treatment with medication will follow the TMA for depression. Antidepressant medications may include any of the following: citalopram, escitalopram, paroxetine, sertraline, venlafaxine XR, bupropion SR, duloxetine, nortriptyline, and mirtazapine.
|
2 Patient Choice
n=87 Participants
Participants will be offered brief interpersonal psychotherapy (IPT-B) alone or combined with the TMA for depression
Antidepressants through Texas Medication Algorithm (TMA): Treatment with medication will follow the TMA for depression. Antidepressant medications may include any of the following: citalopram, escitalopram, paroxetine, sertraline, venlafaxine XR, bupropion SR, duloxetine, nortriptyline, and mirtazapine.
Brief Interpersonal Psychotherapy (IPT-B): IPT-B consists of twelve 50-minute sessions, divided into three phases, focusing on an interpersonal problem or problems.
|
|---|---|---|
|
Mean Time of Retention
|
27.08 weeks
Standard Deviation 22.4
|
25.84 weeks
Standard Deviation 20.54
|
PRIMARY outcome
Timeframe: BaselinePopulation: Adult Hispanics with MDD and Non-missing HAMD Total Score
Hamilton Depression Scale (HAMD-17): Scoring is based on the 17-item scale of 0-4, the higher the worse. 0-7 are considered as being normal, 8-16 suggest mild depression, 17-23 moderate depression, over 24 severe depression Minimum is 0 and the maximum score being 52
Outcome measures
| Measure |
1 Texas Medication Algorithm
n=37 Participants
Participants will receive medication treatment according to the Texas Medication Algorithm (TMA) for depression
Antidepressants through Texas Medication Algorithm (TMA): Treatment with medication will follow the TMA for depression. Antidepressant medications may include any of the following: citalopram, escitalopram, paroxetine, sertraline, venlafaxine XR, bupropion SR, duloxetine, nortriptyline, and mirtazapine.
|
2 Patient Choice
n=38 Participants
Participants will be offered brief interpersonal psychotherapy (IPT-B) alone or combined with the TMA for depression
Antidepressants through Texas Medication Algorithm (TMA): Treatment with medication will follow the TMA for depression. Antidepressant medications may include any of the following: citalopram, escitalopram, paroxetine, sertraline, venlafaxine XR, bupropion SR, duloxetine, nortriptyline, and mirtazapine.
Brief Interpersonal Psychotherapy (IPT-B): IPT-B consists of twelve 50-minute sessions, divided into three phases, focusing on an interpersonal problem or problems.
|
|---|---|---|
|
Hamilton Depression Scale (HAMD-17)
|
23.89 score on a scale
Standard Deviation 3.96
|
22.42 score on a scale
Standard Deviation 3.64
|
Adverse Events
1 Texas Medication Algorithm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
2 Patient Choice
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Mark Olfson, MD, MPH
New York State Psychiatric Institute
Phone: 646-774-6413
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place