Depression
Conditions
Keywords
Selective Serotonin Reuptake Inhibitors, S-adenosyl Methionine, SSRI, SAMe
Brief summary
This study will determine the effectiveness of adding S-adenosyl methionine to antidepressant drug treatment in reducing depressive symptoms in depressed people who have not responded to antidepressants alone.
Detailed description
Some people with depression do not respond well to antidepressant treatment. S-adenosyl methionine (SAMe) is a naturally occurring compound that may have antidepressant effects. SAMe may also enhance the effectiveness of other antidepressants, such as selective serotonin reuptake inhibitors (SSRIs). This study will determine the effectiveness of oral SAMe in enhancing the effects of SSRIs in patients currently not responding to SSRI treatment. This study will last 6 weeks. No follow-up visits will occur. Participants will be randomly assigned to add either oral SAMe or placebo to their existing SSRI regimen for 6 weeks. Depression scales and self-report questionnaires regarding depressive symptoms will be used to assess participants at the end of the study.
Interventions
DRUGS-adenosyl methione (SAMe)
Oral SAMe tosylate, up to 1600 mg per day for 6 weeks
DRUGPlacebo
Placebo to be taken daily for 6 weeks
Sponsors
National Institute of Mental Health (NIMH)
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Major depressive disorder * Use of an SSRI for at least 6 weeks prior to study entry with partial or no response
Exclusion criteria
* History of psychosis * Allergy to SAMe * Alcohol or drug abuse in the past 3 months prior to study entry
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hamilton Depression Rating Scale Remission Rates | Measured at Week 6 | The proportion of remitters for SAMe versus placebo was 46.1% versus 17.6%. Remission is defined as a final score of 7 or less on Hamilton Depression Rating Scale 17 item . |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HDRS17 Responders | Measured at Week 6 | 35.8% versus 11.7%. Response is defined as a 50 percent or more score reduction on on Hamilton Depression Rating Scale 17 item . |
Countries
United States
Participant flow
Recruitment details
73 outpatients with major depressive disorder who were partial- or non-responders to SSRI/SNRI therapy were enrolled in this trial conducted at Massachusetts General Hospital.
Pre-assignment details
This was a randomzized (1:1) double-blind, placebo-controlled adjunct study of oral SAMe tosylate (target doses of 800mg PO BiD) to standard SSRI and SNRI antidepressants for patients with MDD.
Participants by arm
| Arm | Count |
|---|---|
| Adjunct Oral SAMe Tosylate 800mg PO BiD Participants receiving the oral SAMe tosylate | 39 |
| Oral Adjunct Placebo Participants receiving placebo | 34 |
| Total | 73 |
Baseline characteristics
| Characteristic | Oral Adjunct Placebo | Adjunct Oral SAMe Tosylate 800mg PO BiD | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 6 Participants | 8 Participants |
| Age, Categorical Between 18 and 65 years | 32 Participants | 33 Participants | 65 Participants |
| Age, Continuous | 48.5 years STANDARD_DEVIATION 11.3 | 51.4 years STANDARD_DEVIATION 14.1 | 50.0 years STANDARD_DEVIATION 12.9 |
| Region of Enrollment United States | 34 participants | 39 participants | 73 participants |
| Sex: Female, Male Female | 23 Participants | 21 Participants | 44 Participants |
| Sex: Female, Male Male | 11 Participants | 18 Participants | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 20 / 39 | 19 / 34 |
| serious Total, serious adverse events | 0 / 39 | 0 / 34 |
Outcome results
Primary
Hamilton Depression Rating Scale Remission Rates
The proportion of remitters for SAMe versus placebo was 46.1% versus 17.6%. Remission is defined as a final score of 7 or less on Hamilton Depression Rating Scale 17 item .
Time frame: Measured at Week 6
Population: ITT LOCF
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adjunct Oral SAMe Tosylate 800mg PO BiD | Hamilton Depression Rating Scale Remission Rates | 46.1 Percentage of Remitters HDRS17 |
| Oral Adjunct Placebo | Hamilton Depression Rating Scale Remission Rates | 17.6 Percentage of Remitters HDRS17 |
Secondary
HDRS17 Responders
35.8% versus 11.7%. Response is defined as a 50 percent or more score reduction on on Hamilton Depression Rating Scale 17 item .
Time frame: Measured at Week 6
Population: ITT LOCF
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adjunct Oral SAMe Tosylate 800mg PO BiD | HDRS17 Responders | 35.8 Percentage of Responders HDRS17 |
| Oral Adjunct Placebo | HDRS17 Responders | 11.7 Percentage of Responders HDRS17 |