Trial Outcomes & Findings for Deplin® P.L.U.S. Program (Progress Through Learning Understanding & Support) (NCT NCT01369030)
NCT ID: NCT01369030
Last Updated: 2014-06-03
Results Overview
The PHQ-9 is a depression scale used to assess brief depression severity by rating symptoms and functional impairment experienced in the last two weeks. The questionnaire contains a total of 9 questions, and each question is scored on a range from 0-3. The minimum value "0" represents not at all, "1" several days, "2" indicates more than half the days, and the maximum value "3" stands for nearly every day. The total possible range is 0-27. The total number of each 0, 1, 2, 3 is added and multiplied by its value (0=0, 1=1, etc.) to produce a total score generated from the subtotal sum. The PHQ-9 total score is interpreted as follows: 0-4 represents minimal depression, 5-9 as mild depression, 10-14 as moderate depression, 15-19 moderately severe depression, and 20-27 severe depression.
COMPLETED
554 participants
Baseline to Endpoint (90 days)
2014-06-03
Participant Flow
Between November 2010 and January 2012, patients of at least 18 years of age who had been prescribed Deplin® by their physician for the treatment of major depression were offered to participate in the study by their prescibing physician, consisting of about 550 participating physicians located at various clinical sites country-wide.
Participants may have excluded themselves from the overall study after self-enrolling in the program if they did not complete the designated surveys prior to using Deplin® (Baseline) or at the 90-day time point post-treatment initiation.
Participant milestones
| Measure |
Deplin®
Subjects with depression who have been prescribed Deplin® daily.
|
|---|---|
|
Overall Study
STARTED
|
594
|
|
Overall Study
COMPLETED
|
554
|
|
Overall Study
NOT COMPLETED
|
40
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Deplin® P.L.U.S. Program (Progress Through Learning Understanding & Support)
Baseline characteristics by cohort
| Measure |
Deplin®
n=554 Participants
Subjects with depression who have been prescribed Deplin® daily.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
470 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
84 Participants
n=5 Participants
|
|
Age, Continuous
|
49.9 years
STANDARD_DEVIATION 14.1 • n=5 Participants
|
|
Gender
Female
|
424 participants
n=5 Participants
|
|
Gender
Male
|
114 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
554 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Endpoint (90 days)Population: Analyses were performed on the 554 patients who had a baseline PHQ-9\>=5 and further analyzed by baseline depression severity groups defined by baseline PHQ-9 scores: 5\<=PHQ-9\<=9; 10\<=PHQ-9\<=14; 15\<=PHQ-9\<=19; and 20\<=PHQ-9\<=27.
The PHQ-9 is a depression scale used to assess brief depression severity by rating symptoms and functional impairment experienced in the last two weeks. The questionnaire contains a total of 9 questions, and each question is scored on a range from 0-3. The minimum value "0" represents not at all, "1" several days, "2" indicates more than half the days, and the maximum value "3" stands for nearly every day. The total possible range is 0-27. The total number of each 0, 1, 2, 3 is added and multiplied by its value (0=0, 1=1, etc.) to produce a total score generated from the subtotal sum. The PHQ-9 total score is interpreted as follows: 0-4 represents minimal depression, 5-9 as mild depression, 10-14 as moderate depression, 15-19 moderately severe depression, and 20-27 severe depression.
Outcome measures
| Measure |
Deplin®
n=554 Participants
Subjects with depression who have been prescribed Deplin® daily.
|
|---|---|
|
Change in Depression Severity as Measured by the 9-item Patient Health Questionnaire (PHQ-9)
Mean baseline PHQ-9 Score
|
14.6 units on a scale
Standard Deviation 5.8
|
|
Change in Depression Severity as Measured by the 9-item Patient Health Questionnaire (PHQ-9)
Mean endpoint PHQ-9 Score
|
6.1 units on a scale
Standard Deviation 5.0
|
|
Change in Depression Severity as Measured by the 9-item Patient Health Questionnaire (PHQ-9)
Mean reduction in PHQ-9 Score
|
8.5 units on a scale
Standard Deviation 6.3
|
SECONDARY outcome
Timeframe: Baseline to Endpoint (90 days)Outcome measures
| Measure |
Deplin®
n=554 Participants
Subjects with depression who have been prescribed Deplin® daily.
|
|---|---|
|
Proportion of Patients Reporting Difficulty in Daily Functioning Due to Depressive Symptoms
|
37.5 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Endpoint (90 days)Mean satisfaction with medication was rated on 1 to 9 point scale, 1 indicating "not at all satisfied" and 9 as "very satisfied."
Outcome measures
| Measure |
Deplin®
n=554 Participants
Subjects with depression who have been prescribed Deplin® daily.
|
|---|---|
|
Change in Overall Patient Satisfaction With Deplin® Using a 9-point Satisfaction Scale
|
7.0 units on a scale
Interval 1.0 to 9.0
|
Adverse Events
Deplin®
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Lori W Barrentine, MS, PA-C, Director of Clinical Affairs
Pamlab, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place