DepressionPhase 2NCT00093847
Optimizing the Effectiveness of Selective Serotonin Reuptake Inhibitors (SSRIs) in Treatment-Resistant Depression
A Phase 2 study testing S-adenosyl methione (SAMe) in people with Depression, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Depression
- What is being tested?
- S-adenosyl methione (SAMe)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 73 participants
- Where
- 1 siteUnited States
- Study dates
- May 2004to Feb 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Major depressive disorder
- Use of an SSRI for at least 6 weeks prior to study entry with partial or no response
Who cannot join
- History of psychosis
- Allergy to SAMe
- Alcohol or drug abuse in the past 3 months prior to study entry
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: S-adenosyl Methionine (SAMe) Augmentation of Selective Serotonin Reuptake Inhibitors (SSRIs) for Treatment-Resistant Depression (TRD)
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.
Read the 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.
- Conditions
- Depression
- Being tested
- S-adenosyl methione (SAMe), Placebo
- Keywords
- Selective Serotonin Reuptake Inhibitors, S-adenosyl Methionine, SSRI, SAMe
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S-adenosyl methione (SAMe)Drug
Also called Oral SAMe tosylate
Oral SAMe tosylate, up to 1600 mg per day for 6 weeks
PlaceboDrug
Also called Pill identical in appearance to drug but placebo
Placebo to be taken daily for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 Oral SAMe Tosylate | Experimental | Participants receiving the oral SAMe tosylate Receives: Drug: S-adenosyl methione (SAMe) |
| 2 Oral Placebo Pill Twice Daily | Placebo comparator | Participants receiving placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 .
Measured: Measured at Week 6
Secondary outcomes (1)
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 .
Measured: Measured at Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2004 (estimated)
- Study startMay 2004
- Primary completionFeb 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, George I. Papakostas, Massachusetts General Hospital
- Investigators
- George I. Papakostas, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00093847
- Sponsor's protocol ID
- K23MH069629
- Other IDs
- K23MH069629
- Status last verified
- Oct 2014
- First submitted
- 6 Oct 2004
- Last updated
- 13 Oct 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Papakostas GI, Alpert JE, Fava M. S-adenosyl-methionine in depression: a comprehensive review of the literature. Curr Psychiatry Rep. 2003 Dec;5(6):460-6. doi: 10.1007/s11920-003-0085-2.
PubMed 14609501Papakostas GI, Mischoulon D, Shyu I, Alpert JE, Fava M. S-adenosyl methionine (SAMe) augmentation of serotonin reuptake inhibitors for antidepressant nonresponders with major depressive disorder: a double-blind, randomized clinical trial. Am J Psychiatry. 2010 Aug;167(8):942-8. doi: 10.1176/appi.ajp.2009.09081198. Epub 2010 Jul 1.
PubMed 20595412Mischoulon D, Alpert JE, Arning E, Bottiglieri T, Fava M, Papakostas GI. Bioavailability of S-adenosyl methionine and impact on response in a randomized, double-blind, placebo-controlled trial in major depressive disorder. J Clin Psychiatry. 2012 Jun;73(6):843-8. doi: 10.4088/JCP.11m07139. Epub 2012 May 15.
PubMed 22687580Dording CM, Mischoulon D, Shyu I, Alpert JE, Papakostas GI. SAMe and sexual functioning. Eur Psychiatry. 2012 Aug;27(6):451-4. doi: 10.1016/j.eurpsy.2011.01.003. Epub 2011 Mar 12.
PubMed 21398094
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- S-adenosyl Methionine (SAMe) Augmentation of Selective Serotonin Reuptake Inhibitors (SSRIs) for Treatment-Resistant Depression (TRD)
- ClinicalTrials.gov ID
- NCT00093847
- Acronym / sponsor ID
- K23MH069629
- Conditions
- Depression
- Keywords
- Selective Serotonin Reuptake Inhibitors, S-adenosyl Methionine, SSRI, SAMe
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- May 2004
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 8 Oct 2004 (estimated)
- Results
- Posted 13 Oct 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 Oral SAMe Tosylate | Experimental | Drug: S-adenosyl methione (SAMe)Participants receiving the oral SAMe tosylate |
| 2 Oral Placebo Pill Twice Daily | Placebo comparator | Drug: PlaceboParticipants receiving placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Major depressive disorder
- Use of an SSRI for at least 6 weeks prior to study entry with partial or no response
Key exclusion criteria (3 listed)
- History of psychosis
- Allergy to SAMe
- Alcohol or drug abuse in the past 3 months prior to study entry
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| S-adenosyl methione (SAMe)Also: Oral SAMe tosylateOral SAMe tosylate, up to 1600 mg per day for 6 weeks | Drug | 1 Oral SAMe Tosylate |
| PlaceboAlso: Pill identical in appearance to drug but placeboPlacebo to be taken daily for 6 weeks | Drug | 2 Oral Placebo Pill Twice Daily |
Primary outcome
Hamilton Depression Rating Scale Remission Rates
Time frame: 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 .
1 secondary outcome
HDRS17 Responders
Time frame: Measured at Week 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 14609501Papakostas GI, Alpert JE, Fava M. S-adenosyl-methionine in depression: a comprehensive review of the literature. Curr Psychiatry Rep. 2003 Dec;5(6):460-6. doi: 10.1007/s11920-003-0085-2.
- Results publication: PubMed 20595412Papakostas GI, Mischoulon D, Shyu I, Alpert JE, Fava M. S-adenosyl methionine (SAMe) augmentation of serotonin reuptake inhibitors for antidepressant nonresponders with major depressive disorder: a double-blind, randomized clinical trial. Am J Psychiatry. 2010 Aug;167(8):942-8. doi: 10.1176/appi.ajp.2009.09081198. Epub 2010 Jul 1.
- Derived from this study: PubMed 22687580Mischoulon D, Alpert JE, Arning E, Bottiglieri T, Fava M, Papakostas GI. Bioavailability of S-adenosyl methionine and impact on response in a randomized, double-blind, placebo-controlled trial in major depressive disorder. J Clin Psychiatry. 2012 Jun;73(6):843-8. doi: 10.4088/JCP.11m07139. Epub 2012 May 15.
- Derived from this study: PubMed 21398094Dording CM, Mischoulon D, Shyu I, Alpert JE, Papakostas GI. SAMe and sexual functioning. Eur Psychiatry. 2012 Aug;27(6):451-4. doi: 10.1016/j.eurpsy.2011.01.003. Epub 2011 Mar 12.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
George I. Papakostas, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing S-adenosyl methione (SAMe) in people with Depression, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamilton Depression Rating Scale Remission Rates (time frame: Measured at Week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00093847, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2014.