Trial Outcomes & Findings for Study of 6(S)-5-MTHF Among Selective Serotonin Reuptake Inhibitor-Resistant Outpatients With Major Depressive Disorder (NCT NCT00955955)
NCT ID: NCT00955955
Last Updated: 2017-04-28
Results Overview
The HAM-D-17 is a multiple choice questionnaire that clinicians may use to rate the severity of a patient's major depression. Items are scored on a scale of zero to four and higher scores indicate greater impairment. This scale is scored by summing the scores on each item and scores can range from 0-68. When assessing changes in HAMD score, negative changes indicate improvement (i.e. the score has decreased) and positive scores indicate a worsening of symptoms (i.e. scores have increased).
COMPLETED
PHASE4
75 participants
Baseline and Day 60
2017-04-28
Participant Flow
Participant milestones
| Measure |
Deplin/Deplin
Participants will receive 15 mg/day of Deplin (6(S)-5-MTHF) for 8 weeks.
|
Placebo/Deplin
Participants will receive placebo for the first 4 weeks, and then 15 mg/day of Deplin (6(S)-5-MTHF) for the next 4 weeks.
|
Placebo/Placebo
Both tablets of study medication will be placebo during both phases of the study.
|
|---|---|---|---|
|
Overall Study
STARTED
|
19
|
28
|
28
|
|
Overall Study
COMPLETED
|
17
|
28
|
28
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
0
|
Reasons for withdrawal
| Measure |
Deplin/Deplin
Participants will receive 15 mg/day of Deplin (6(S)-5-MTHF) for 8 weeks.
|
Placebo/Deplin
Participants will receive placebo for the first 4 weeks, and then 15 mg/day of Deplin (6(S)-5-MTHF) for the next 4 weeks.
|
Placebo/Placebo
Both tablets of study medication will be placebo during both phases of the study.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
0
|
Baseline Characteristics
Study of 6(S)-5-MTHF Among Selective Serotonin Reuptake Inhibitor-Resistant Outpatients With Major Depressive Disorder
Baseline characteristics by cohort
| Measure |
Deplin/Deplin
n=19 Participants
Participants will receive 15 mg/day of Deplin (6(S)-5-MTHF) for 8 weeks.
|
Placebo/Deplin
n=28 Participants
Participants will receive placebo for the first 4 weeks, and then 15 mg/day of Deplin (6(S)-5-MTHF) for the next 4 weeks.
|
Placebo/Placebo
n=28 Participants
Both tablets of study medication will be placebo during both phases of the study.
|
Total
n=75 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
74 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Age, Continuous
|
49.58 years
STANDARD_DEVIATION 14.64 • n=99 Participants
|
50.86 years
STANDARD_DEVIATION 10.58 • n=107 Participants
|
45.39 years
STANDARD_DEVIATION 11.60 • n=206 Participants
|
48.49 years
STANDARD_DEVIATION 12.17 • n=7 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
53 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
22 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
19 participants
n=99 Participants
|
28 participants
n=107 Participants
|
28 participants
n=206 Participants
|
75 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Baseline and Day 60Population: The phase II dataset of interest is limited to patients treated with placebo in phase I, completed phase I, did not experience a clinical response and entered phase II. Drug is compared to placebo in phase II for this subset alone. Some patients received Deplin in both phases of the study, but those patients are not included in these analyses.
The HAM-D-17 is a multiple choice questionnaire that clinicians may use to rate the severity of a patient's major depression. Items are scored on a scale of zero to four and higher scores indicate greater impairment. This scale is scored by summing the scores on each item and scores can range from 0-68. When assessing changes in HAMD score, negative changes indicate improvement (i.e. the score has decreased) and positive scores indicate a worsening of symptoms (i.e. scores have increased).
Outcome measures
| Measure |
Adjunct 6(S)-5-MTHF(Deplin) Phase 1
n=19 Participants
Participants will receive 15 mg/day of Deplin (6(S)-5-MTHF) for 4 weeks.
|
Adjunct Placebo Phase 1
n=56 Participants
Participants will receive placebo for the first 4 weeks
|
Adjunct 6(S)-5-MTHF(Deplin) Phase 2
n=18 Participants
Participants will receive 15 mg of Deplin (6(S)-5-MTHF) for 4 weeks.
|
Adjunct Placebo Phase 2
n=21 Participants
Patients in this group received placebo in both phases of the study for a total of 8 weeks,
|
Pooled Deplin
n=36 Participants
Patients in this group received Deplin at some point during the study. Results are pooled from phase I and II.
|
Pooled Placebo
n=75 Participants
Patients in this group received placebo at some point during the study. Results are pooled from phase I and II.
|
|---|---|---|---|---|---|---|
|
The 17-item Hamilton Depression Scale (HAM-D-17)
|
-7.4 Scores on a scale
Standard Deviation 5.2
|
-4.4 Scores on a scale
Standard Deviation 5.8
|
-3.8 Scores on a scale
Standard Deviation 6.2
|
-1.7 Scores on a scale
Standard Deviation 4.7
|
-5.58 Scores on a scale
Standard Deviation 5.7
|
-3.04 Scores on a scale
Standard Deviation 5.3
|
SECONDARY outcome
Timeframe: Baseline and Day 60Population: Data presented is mean score reduction for the QIDS. The dataset of interest is limited to patients treated with placebo in phase I, did not experience a clinical response and entered phase II. Drug is compared to placebo in phase II for this subset alone.
This measure is a 16 item self report questionnaire assessing symptoms of depression. For each item, scores range from 0 to 3 with higher scores indicating greater impairment. To score this measure: 1. Enter the highest score from questions 1-4 (sleep items): \_\_\_\_\_\_ 2. Enter score on item 5 \_\_\_\_ 3. Enter the highest score from questions 6-9 (appetite/weight): \_\_\_\_\_\_ 4. Enter score on item 10 \_\_\_\_ 5. Enter score on item 11 \_\_\_\_ 6. Enter score on item 12 \_\_\_\_ 7. Enter score on item 13 \_\_\_\_ 8. Enter score on item 14 \_\_\_\_ 9. Enter the highest score from questions 15-16 (psychomotor items): \_\_\_\_\_\_ Total score range 0-27: \_\_\_\_\_\_ When assessing changes in this measure over time, negative means indicate an improvement (i.e. the scores decreased over time) and positive means indicate worsening in functioning.
Outcome measures
| Measure |
Adjunct 6(S)-5-MTHF(Deplin) Phase 1
n=19 Participants
Participants will receive 15 mg/day of Deplin (6(S)-5-MTHF) for 4 weeks.
|
Adjunct Placebo Phase 1
n=56 Participants
Participants will receive placebo for the first 4 weeks
|
Adjunct 6(S)-5-MTHF(Deplin) Phase 2
n=18 Participants
Participants will receive 15 mg of Deplin (6(S)-5-MTHF) for 4 weeks.
|
Adjunct Placebo Phase 2
n=21 Participants
Patients in this group received placebo in both phases of the study for a total of 8 weeks,
|
Pooled Deplin
Patients in this group received Deplin at some point during the study. Results are pooled from phase I and II.
|
Pooled Placebo
Patients in this group received placebo at some point during the study. Results are pooled from phase I and II.
|
|---|---|---|---|---|---|---|
|
The Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR)
|
-8.1 Scores on a scale
Standard Deviation 5.3
|
-5.7 Scores on a scale
Standard Deviation 5.6
|
-1.3 Scores on a scale
Standard Deviation 4.9
|
0.5 Scores on a scale
Standard Deviation 5.0
|
—
|
—
|
Adverse Events
Deplin
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Deplin
n=42 participants at risk
Participants will receive 15 mg/day of Deplin (6(S)-5-MTHF).
|
Placebo
n=54 participants at risk
Adverse events for participants who received placebo during the study.
|
|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal
|
16.7%
7/42 • Number of events 12 • 60 days
Adverse events data was collected using the SAFTEE measure. Adverse events are reported across both phases of the study. They reflect the number of people who took either medication at any point in the study, not the total number of study participants.
|
14.8%
8/54 • Number of events 23 • 60 days
Adverse events data was collected using the SAFTEE measure. Adverse events are reported across both phases of the study. They reflect the number of people who took either medication at any point in the study, not the total number of study participants.
|
|
General disorders
Sleep
|
2.4%
1/42 • Number of events 5 • 60 days
Adverse events data was collected using the SAFTEE measure. Adverse events are reported across both phases of the study. They reflect the number of people who took either medication at any point in the study, not the total number of study participants.
|
5.6%
3/54 • Number of events 12 • 60 days
Adverse events data was collected using the SAFTEE measure. Adverse events are reported across both phases of the study. They reflect the number of people who took either medication at any point in the study, not the total number of study participants.
|
|
Psychiatric disorders
Psychological
|
9.5%
4/42 • Number of events 4 • 60 days
Adverse events data was collected using the SAFTEE measure. Adverse events are reported across both phases of the study. They reflect the number of people who took either medication at any point in the study, not the total number of study participants.
|
16.7%
9/54 • Number of events 12 • 60 days
Adverse events data was collected using the SAFTEE measure. Adverse events are reported across both phases of the study. They reflect the number of people who took either medication at any point in the study, not the total number of study participants.
|
|
General disorders
Somatic
|
14.3%
6/42 • Number of events 12 • 60 days
Adverse events data was collected using the SAFTEE measure. Adverse events are reported across both phases of the study. They reflect the number of people who took either medication at any point in the study, not the total number of study participants.
|
29.6%
16/54 • Number of events 22 • 60 days
Adverse events data was collected using the SAFTEE measure. Adverse events are reported across both phases of the study. They reflect the number of people who took either medication at any point in the study, not the total number of study participants.
|
|
Infections and infestations
Infectious
|
11.9%
5/42 • Number of events 8 • 60 days
Adverse events data was collected using the SAFTEE measure. Adverse events are reported across both phases of the study. They reflect the number of people who took either medication at any point in the study, not the total number of study participants.
|
13.0%
7/54 • Number of events 13 • 60 days
Adverse events data was collected using the SAFTEE measure. Adverse events are reported across both phases of the study. They reflect the number of people who took either medication at any point in the study, not the total number of study participants.
|
|
General disorders
Miscellaneous
|
2.4%
1/42 • Number of events 3 • 60 days
Adverse events data was collected using the SAFTEE measure. Adverse events are reported across both phases of the study. They reflect the number of people who took either medication at any point in the study, not the total number of study participants.
|
9.3%
5/54 • Number of events 5 • 60 days
Adverse events data was collected using the SAFTEE measure. Adverse events are reported across both phases of the study. They reflect the number of people who took either medication at any point in the study, not the total number of study participants.
|
Additional Information
Dr. George Papakostas- Director of Treatment Resistant Depression Studies
Massachusetts General Hospital- Depression Clinical and Research Program
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place