Trial Outcomes & Findings for Safety and Effectiveness of S-adenosyl-l-methionine (SAMe) for the Treatment of Major Depression (NCT NCT00101452)
NCT ID: NCT00101452
Last Updated: 2017-04-04
Results Overview
The change in total HAM-D score between baseline and endpoint was the primary outcomes measure. This measure is a clinician rated inventory of depressive symptoms. All items are scored on a scale of zero to four and the sum of the scores provides the total score for the measure. Scores can range from 0- 68. On this scale, higher scores indicate poorer outcomes.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
199 participants
Primary outcome timeframe
baseline and 24 weeks
Results posted on
2017-04-04
Participant Flow
Participants were recruited through general advertising at both the Depression Clinical and Research Program of MGH in Boston, MA and Butler Hospital in Providence, RI. Recruitment also took place at Family Doctors, LLC, in Swampscott, MA. We began recruiting participants in April 2005 and closed the study in December of 2009.
Only five participants completed the allowed wash-out period prior to randomization. Participants screened at Day 0-7 and were asked to return for a baseline visit at Day 0. Subjects not randomized were excluded for being ineligible at the baseline or for being lost to follow-up between screen and baseline.
Participant milestones
| Measure |
1. SAMe
Patients start with 1600mg/day for the first. If they do not feel better after 6 weeks, they may increase to 3200mg/day if their lab tests are normal.
|
2. Escitalopram
Patients start with 10mg/day for the first 6 weeks. If they do not feel better after 6 weeks, they can increase to 20mg/day.
|
3. Placebo
Placebo is a non-active treatment, sometimes called a sugar pill.
|
|---|---|---|---|
|
Overall Study
STARTED
|
65
|
69
|
65
|
|
Overall Study
COMPLETED
|
21
|
26
|
22
|
|
Overall Study
NOT COMPLETED
|
44
|
43
|
43
|
Reasons for withdrawal
| Measure |
1. SAMe
Patients start with 1600mg/day for the first. If they do not feel better after 6 weeks, they may increase to 3200mg/day if their lab tests are normal.
|
2. Escitalopram
Patients start with 10mg/day for the first 6 weeks. If they do not feel better after 6 weeks, they can increase to 20mg/day.
|
3. Placebo
Placebo is a non-active treatment, sometimes called a sugar pill.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
13
|
8
|
14
|
|
Overall Study
Withdrawal by Subject
|
10
|
14
|
9
|
|
Overall Study
Baseline Fail
|
2
|
1
|
2
|
|
Overall Study
Physician Decision
|
0
|
3
|
2
|
|
Overall Study
Protocol Violation
|
2
|
1
|
3
|
|
Overall Study
Other
|
15
|
16
|
12
|
Baseline Characteristics
Safety and Effectiveness of S-adenosyl-l-methionine (SAMe) for the Treatment of Major Depression
Baseline characteristics by cohort
| Measure |
1. SAMe
n=59 Participants
a naturally occurring substance
|
2. Escitalopram
n=55 Participants
A selective serotonin reuptake inhibitor (SSRI)
|
3. Placebo
n=52 Participants
Sugar Pill- contains no active ingrediants
|
Total
n=166 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
56 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
157 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Age, Continuous
|
45.25 years
STANDARD_DEVIATION 13.98 • n=5 Participants
|
44.67 years
STANDARD_DEVIATION 14.29 • n=7 Participants
|
44.34 years
STANDARD_DEVIATION 15.19 • n=5 Participants
|
44.75 years
STANDARD_DEVIATION 14.43 • n=4 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
86 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
80 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
59 participants
n=5 Participants
|
55 participants
n=7 Participants
|
52 participants
n=5 Participants
|
166 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: baseline and 24 weeksPopulation: Based on having at least one post-baseline visit.
The change in total HAM-D score between baseline and endpoint was the primary outcomes measure. This measure is a clinician rated inventory of depressive symptoms. All items are scored on a scale of zero to four and the sum of the scores provides the total score for the measure. Scores can range from 0- 68. On this scale, higher scores indicate poorer outcomes.
Outcome measures
| Measure |
1. SAMe
n=59 Participants
a naturally occurring substance
|
2. Escitalopram
n=55 Participants
A selective serotonin reuptake inhibitor (SSRI)
|
3. Placebo
n=52 Participants
Sugar Pill- contains no active ingrediants
|
|---|---|---|---|
|
Hamilton Rating Scale for Depression (HAM-D)
|
-6.7 units on a scale
Standard Deviation 7.3
|
-7.5 units on a scale
Standard Deviation 7.4
|
-5.7 units on a scale
Standard Deviation 7.0
|
Adverse Events
1. SAMe (Weeks 1-12)
Serious events: 0 serious events
Other events: 27 other events
Deaths: 0 deaths
2. Escitalopram (Weeks 1-12)
Serious events: 0 serious events
Other events: 32 other events
Deaths: 0 deaths
3. Placebo (Weeks 1-12)
Serious events: 0 serious events
Other events: 29 other events
Deaths: 0 deaths
4. SAMe (Weeks 12-24, Continuation)
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
5. Escitalopram (Weeks 12-24, Continuation)
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
6. Placebo (Weeks 12-24, Continuation)
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
7. SAMe Plus Escitalopram (Weeks 12-24, Cross-over)
Serious events: 0 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
1. SAMe (Weeks 1-12)
n=59 participants at risk
A naturally occurring substance (S-adenosyl methionine)
|
2. Escitalopram (Weeks 1-12)
n=55 participants at risk
A selective serotonin reuptake inhibitor (SSRI)
|
3. Placebo (Weeks 1-12)
n=52 participants at risk
Sugar Pill- contains no active ingredients
|
4. SAMe (Weeks 12-24, Continuation)
n=17 participants at risk
A naturally occurring substance (S-adenosyl methionine)
|
5. Escitalopram (Weeks 12-24, Continuation)
n=14 participants at risk；n=11 participants at risk
A selective serotonin reuptake inhibitor (SSRI)
|
6. Placebo (Weeks 12-24, Continuation)
n=15 participants at risk
Sugar Pill- contains no active ingredients
|
7. SAMe Plus Escitalopram (Weeks 12-24, Cross-over)
n=43 participants at risk
A naturally occurring substance (S-adenosyl methionine) plus a selective serotonin reuptake inhibitor (SSRI)
|
|---|---|---|---|---|---|---|---|
|
Reproductive system and breast disorders
Sexual dysfunction
|
8.5%
5/59 • Number of events 5 • Adverse events for SAMe, escitalopram, and placebo, were reported during the 12 week double blind course of the study and during the 12-week open cross over phase that followed the acute treatment phase.
|
9.1%
5/55 • Number of events 5 • Adverse events for SAMe, escitalopram, and placebo, were reported during the 12 week double blind course of the study and during the 12-week open cross over phase that followed the acute treatment phase.
|
9.6%
5/52 • Number of events 5 • Adverse events for SAMe, escitalopram, and placebo, were reported during the 12 week double blind course of the study and during the 12-week open cross over phase that followed the acute treatment phase.
|
17.6%
3/17 • Number of events 3 • Adverse events for SAMe, escitalopram, and placebo, were reported during the 12 week double blind course of the study and during the 12-week open cross over phase that followed the acute treatment phase.
|
27.3%
3/11 • Number of events 3 • Adverse events for SAMe, escitalopram, and placebo, were reported during the 12 week double blind course of the study and during the 12-week open cross over phase that followed the acute treatment phase.
|
13.3%
2/15 • Number of events 2 • Adverse events for SAMe, escitalopram, and placebo, were reported during the 12 week double blind course of the study and during the 12-week open cross over phase that followed the acute treatment phase.
|
17.5%
7/40 • Number of events 7 • Adverse events for SAMe, escitalopram, and placebo, were reported during the 12 week double blind course of the study and during the 12-week open cross over phase that followed the acute treatment phase.
|
|
Gastrointestinal disorders
Gastrointestinal
|
28.8%
17/59 • Number of events 17 • Adverse events for SAMe, escitalopram, and placebo, were reported during the 12 week double blind course of the study and during the 12-week open cross over phase that followed the acute treatment phase.
|
34.5%
19/55 • Number of events 19 • Adverse events for SAMe, escitalopram, and placebo, were reported during the 12 week double blind course of the study and during the 12-week open cross over phase that followed the acute treatment phase.
|
30.8%
16/52 • Number of events 16 • Adverse events for SAMe, escitalopram, and placebo, were reported during the 12 week double blind course of the study and during the 12-week open cross over phase that followed the acute treatment phase.
|
64.7%
11/17 • Number of events 11 • Adverse events for SAMe, escitalopram, and placebo, were reported during the 12 week double blind course of the study and during the 12-week open cross over phase that followed the acute treatment phase.
|
63.6%
7/11 • Number of events 7 • Adverse events for SAMe, escitalopram, and placebo, were reported during the 12 week double blind course of the study and during the 12-week open cross over phase that followed the acute treatment phase.
|
46.7%
7/15 • Number of events 7 • Adverse events for SAMe, escitalopram, and placebo, were reported during the 12 week double blind course of the study and during the 12-week open cross over phase that followed the acute treatment phase.
|
37.2%
16/43 • Number of events 16 • Adverse events for SAMe, escitalopram, and placebo, were reported during the 12 week double blind course of the study and during the 12-week open cross over phase that followed the acute treatment phase.
|
|
Psychiatric disorders
Psychiatric
|
3.4%
2/59 • Number of events 2 • Adverse events for SAMe, escitalopram, and placebo, were reported during the 12 week double blind course of the study and during the 12-week open cross over phase that followed the acute treatment phase.
|
1.8%
1/55 • Number of events 1 • Adverse events for SAMe, escitalopram, and placebo, were reported during the 12 week double blind course of the study and during the 12-week open cross over phase that followed the acute treatment phase.
|
5.8%
3/52 • Number of events 3 • Adverse events for SAMe, escitalopram, and placebo, were reported during the 12 week double blind course of the study and during the 12-week open cross over phase that followed the acute treatment phase.
|
35.3%
6/17 • Number of events 6 • Adverse events for SAMe, escitalopram, and placebo, were reported during the 12 week double blind course of the study and during the 12-week open cross over phase that followed the acute treatment phase.
|
45.5%
5/11 • Number of events 5 • Adverse events for SAMe, escitalopram, and placebo, were reported during the 12 week double blind course of the study and during the 12-week open cross over phase that followed the acute treatment phase.
|
40.0%
6/15 • Number of events 6 • Adverse events for SAMe, escitalopram, and placebo, were reported during the 12 week double blind course of the study and during the 12-week open cross over phase that followed the acute treatment phase.
|
11.6%
5/43 • Number of events 5 • Adverse events for SAMe, escitalopram, and placebo, were reported during the 12 week double blind course of the study and during the 12-week open cross over phase that followed the acute treatment phase.
|
|
General disorders
Somatic
|
5.1%
3/59 • Number of events 3 • Adverse events for SAMe, escitalopram, and placebo, were reported during the 12 week double blind course of the study and during the 12-week open cross over phase that followed the acute treatment phase.
|
12.7%
7/55 • Number of events 7 • Adverse events for SAMe, escitalopram, and placebo, were reported during the 12 week double blind course of the study and during the 12-week open cross over phase that followed the acute treatment phase.
|
9.6%
5/52 • Number of events 5 • Adverse events for SAMe, escitalopram, and placebo, were reported during the 12 week double blind course of the study and during the 12-week open cross over phase that followed the acute treatment phase.
|
52.9%
9/17 • Number of events 9 • Adverse events for SAMe, escitalopram, and placebo, were reported during the 12 week double blind course of the study and during the 12-week open cross over phase that followed the acute treatment phase.
|
81.8%
9/11 • Number of events 9 • Adverse events for SAMe, escitalopram, and placebo, were reported during the 12 week double blind course of the study and during the 12-week open cross over phase that followed the acute treatment phase.
|
66.7%
10/15 • Number of events 10 • Adverse events for SAMe, escitalopram, and placebo, were reported during the 12 week double blind course of the study and during the 12-week open cross over phase that followed the acute treatment phase.
|
34.9%
15/43 • Number of events 15 • Adverse events for SAMe, escitalopram, and placebo, were reported during the 12 week double blind course of the study and during the 12-week open cross over phase that followed the acute treatment phase.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place