Major Depressive Disorder (MDD)Phase 2NCT01912196
Add-On Study of MSI-195 (S-Adenosyl-L-Methionine, SAMe) for Patients With Major Depressive Disorder (MDD)
A Phase 2 study testing MSI-195 in people with Major Depressive Disorder (MDD), run by MSI Methylation Sciences, Inc. at 35 sites in United States.
Trial summary
The purpose of this study is to determine the efficacy and safety of 800 mg MSI-195 in reducing symptoms of depression in Major Depressive Disorder (MDD)patients with inadequate response to current antidepressant therapy. Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Major Depressive Disorder (MDD)
- What is being tested?
- MSI-195
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 376 participants
- Where
- 35 sitesUnited States
- Study dates
- Oct 2013to Sep 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meets the Diagnostic and Statistical Manual of Mental Disorder, 4th Edition, Text Revision (DSM-IV-TR) criteria for Major Depressive Disorder (MDD)
- A total score of 16 or higher on the Hamilton Rating Scale for Depression- 17 item version (HAM-D17) at the Screening and Baseline Visits, with a score of ≥2 on mood item 1.
- Have experienced 1-4 prior Major Depressive Episodes. Patients with more than 5 lifetime episodes (including current episode) will require discussion with the medical monitor prior to inclusion.
- Failed 1-3 treatment regimens in the current depressive episode
- Received an adequate dose and duration of Antidepressant Therapy (ADT) (on ADT for at least 6 weeks with a stable dose for at least 3 weeks)
Who cannot join
- Failed 4 or more adequate treatment regimens in current episode of depression
- patient may have a significant risk for suicidal behavior during the course of their participation in the study
- Intolerance to SAMe; Prior use of MSI-195
- History of any of the following psychiatric disorders: eating disorder within 6 months; obsessive compulsive disorder, psychotic disorder, bipolar disorder, mental retardation, dementia or other forms of cognitive impairment at any time or alcohol or substance abuse
- >3X upper limit of normal (ULN) Alkaline Phosphatase, aspartate aminotransferase (AST), alanine aminotransferase (ALT); >1.5X ULN total bilirubin
- Pregnant or lactating women
- Any history of seizures, excluding febrile seizures
- Known positivity for human immunodeficiency virus
Trial locations and contacts
35 sites in 1 country.
35 sites in 1 country
United States35 sites
MSI Investigational Site
Albuquerque, New Mexico, 87109
MSI Investigational Site
Atlanta, Georgia, 30328
MSI Investigational Site
Austin, Texas, 78731
MSI Investigational Site
Austin, Texas, 78754
MSI Investigational Site
Bellevue, Washington, 98007
MSI Investigational Site
Birmingham, Alabama, 35216
MSI Investigational Site
Canton, Ohio, 44718
MSI Investigational Site
Dallas, Texas, 75231
MSI Investigational Site
Dayton, Ohio, 45417
MSI Investigational Site
Encino, California, 91316
MSI Investigational Site
Escondido, California, 92025
MSI Investigational Site
Flowood, Mississippi, 39232
MSI Investigational Site
Garden Grove, California, 92845
MSI Investigational Site
Hoffman Estates, Illinois, 60169
MSI Investigational Site
Houston, Texas, 77008
MSI Investigational Site
Houston, Texas, 77098
MSI Investigational Site
Jacksonville, Florida, 32256
MSI INvestigational Site
Kissimmee, Florida, 34741
MSI Investigational Site
Las Vegas, Nevada, 89102
MSI Investigational Site
Lauderhill, Florida, 33319
MSI Investigational Site
Los Alamitos, California, 90720
MSI Investigational Site
Los Angeles, California, 90024
MSI Investigational Site
Marlton, New Jersey, 08053
MSI Investigational Site
Memphis, Tennessee, 38119
MSI Investigational Site
Murray, Utah, 84123
MSI Investigational Site
National City, California, 91950
MSI Investigational Site
New York, New York, 10128
MSI Investigational Site
Newport Beach, California, 92660
MSI Investigational Site
Oakland, California, 94612
MSI Investigational Site
Oceanside, California, 92056
MSI Investigational Site
Orlando, Florida, 32806
MSI Investigational Site
Portland, Oregon, 97210
MSI Investigational Site
Rochester, New York, 14618
MSI Investigational Site
Torrance, California, 90502
MSI Investigational Site
Towson, Maryland, 21285
About this study
Official title: A Double-Blind, Placebo-Controlled, Randomized Add-On Study of MSI-195 (Methylation Sciences Inc. S-Adenosyl-L-Methionine, SAMe) For Patients With Major Depressive Disorder(MDD) Who Have Had An Inadequate Response to Current Antidepressant Therapy
The purpose of this study is to determine the efficacy and safety of 800 mg MSI-195 in reducing symptoms of depression in Major Depressive Disorder (MDD)patients with inadequate response to current antidepressant therapy.
- Conditions
- Major Depressive Disorder (MDD)
- Being tested
- MSI-195, Placebo
- Keywords
- Depressive Disorder
- Medical subject headings
- Depressive Disorder, Major, Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MSI-195Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| MSI-195 | Experimental | Patients randomized to the MSI-195 arm will receive treatment with 2 tablets (800 mg) of MSI-195 plus on-going antidepressant therapy (ADT).
MSI-195 800 mg (two tablets) taken orally once a day in the morning on an empty stomach with water (food should be avoided for at least 1 hr after taking the study drug) Receives: Drug: MSI-195 |
| Placebo | Placebo comparator | Patients randomized to the placebo arm will receive 2 tablets placebo plus on-going antidepressant therapy (ADT).
Placebo (two tablets) taken orally once a day in the morning on an empty stomach with water (food should be avoided for at least 1 hr after taking the study drug). Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the total Hamilton Depression Rating Scale (HAM-D17) between randomization and end of study.
Based on historical data, the standard deviation is assumed to range between 9 and 12. With a standard effect size of 0.367 a total of at least 120 evaluable patients per group are needed to provide 80% power with a two-sided 5% significance level. HAM-D17 will be derived from the Combined HAM-D28-MADRS Instrument.
Measured: assessed from baseline to week 8 (end of study)
Secondary outcomes (5)
change in the total score of the Montgomery-Asberg Depression Rating Scale (MADRS)
for the MADRS, the number and proportion of patients who are responders at the end of the study and the number and proportion of patients who are in remission at the end of the study will be summarized by treatment group, along with the difference and 95% confidence interval for the difference (based on the Wilson Score method).
Measured: collected at baseline, weeks 2, 4, 6, 7 and 8 (end of study)
change in total score of the Clinical Global Impression Improvement Scale (CGI-S)
the number and proportion of patients who are responders at the end of the study and the number and proportion of patients who are in remission at the end of the study will be summarized by treatment group, along with the difference and 95% confidence interval for the difference (based on the Wilson Score method). Remission is defined as a score of 1 or 2.
Measured: assessed from baseline, weeks 2, 4, 7 and 8 (end of study)
change from randomization to each study visit in the total score of the Inventory of Depressive Symptomatology-Self Rated (IDS-SR30)
A response is defined as a reduction in the IDS-SR30 score of ≥50% and remission is defined as a score of ≤14.
Measured: assessed on baseline visit, Week 2, 4, 6, and 8 (end of study).
Adverse events
collected from signing informed consent through 7 days after the last dose of study treatment. Ascertained by qualified clinician.
Measured: collected at baseline, weeks 1, 2, 3, 4, 6, 8 and 9 (follow up)
Columbia Suicide Severity Rating Scale (C-SSRS)
administered by qualified clinician
Measured: assessed at baseline, weeks 2, 4, 6 and 8 (end of study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2013 (estimated)
- Study startOct 2013
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major Depressive Disorder (MDD)Studies of the same condition, open and under way.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 376 participants (actual)
Sponsor and investigators
- Lead sponsor
- MSI Methylation Sciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01912196
- Sponsor's protocol ID
- MSI-CP.002
- Status last verified
- Mar 2016
- First submitted
- 26 Jul 2013
- Last updated
- 18 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Targum SD, Cameron BR, Ferreira L, MacDonald ID. An augmentation study of MSI-195 (S-adenosylmethionine) in Major Depressive Disorder. J Psychiatr Res. 2018 Dec;107:86-96. doi: 10.1016/j.jpsychires.2018.10.010. Epub 2018 Oct 18.
PubMed 30368163
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled, Randomized Add-On Study of MSI-195 (Methylation Sciences Inc. S-Adenosyl-L-Methionine, SAMe) For Patients With Major Depressive Disorder(MDD) Who Have Had An Inadequate Response to Current Antidepressant Therapy
- ClinicalTrials.gov ID
- NCT01912196
- Acronym / sponsor ID
- MSI-CP.002
- Conditions
- Major Depressive Disorder (MDD)
- Keywords
- Depressive Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 376 participants (actual)
- Lead sponsor
- MSI Methylation Sciences, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 31 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the efficacy and safety of 800 mg MSI-195 in reducing symptoms of depression in Major Depressive Disorder (MDD)patients with inadequate response to current antidepressant therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MSI-195 | Experimental | Drug: MSI-195Patients randomized to the MSI-195 arm will receive treatment with 2 tablets (800 mg) of MSI-195 plus on-going antidepressant therapy (ADT). MSI-195 800 mg (two tablets) taken orally once a day in the morning on an empty stomach with water (food should be avoided for at least 1 hr after taking the study drug) |
| Placebo | Placebo comparator | Drug: PlaceboPatients randomized to the placebo arm will receive 2 tablets placebo plus on-going antidepressant therapy (ADT). Placebo (two tablets) taken orally once a day in the morning on an empty stomach with water (food should be avoided for at least 1 hr after taking the study drug). |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Meets the Diagnostic and Statistical Manual of Mental Disorder, 4th Edition, Text Revision (DSM-IV-TR) criteria for Major Depressive Disorder (MDD)
- A total score of 16 or higher on the Hamilton Rating Scale for Depression- 17 item version (HAM-D17) at the Screening and Baseline Visits, with a score of ≥2 on mood item 1.
- Have experienced 1-4 prior Major Depressive Episodes. Patients with more than 5 lifetime episodes (including current episode) will require discussion with the medical monitor prior to inclusion.
- Failed 1-3 treatment regimens in the current depressive episode
- Received an adequate dose and duration of Antidepressant Therapy (ADT) (on ADT for at least 6 weeks with a stable dose for at least 3 weeks)
Key exclusion criteria (8 listed)
- Failed 4 or more adequate treatment regimens in current episode of depression
- patient may have a significant risk for suicidal behavior during the course of their participation in the study
- Intolerance to SAMe; Prior use of MSI-195
- History of any of the following psychiatric disorders: eating disorder within 6 months; obsessive compulsive disorder, psychotic disorder, bipolar disorder, mental retardation, dementia or other forms of cognitive impairment at any time or alcohol or substance abuse
- >3X upper limit of normal (ULN) Alkaline Phosphatase, aspartate aminotransferase (AST), alanine aminotransferase (ALT); >1.5X ULN total bilirubin
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 |
|---|---|---|
| MSI-195 | Drug | MSI-195 |
| Placebo | Drug | Placebo |
Primary outcome
Change in the total Hamilton Depression Rating Scale (HAM-D17) between randomization and end of study.
Time frame: assessed from baseline to week 8 (end of study)
Based on historical data, the standard deviation is assumed to range between 9 and 12. With a standard effect size of 0.367 a total of at least 120 evaluable patients per group are needed to provide 80% power with a two-sided 5% significance level. HAM-D17 will be derived from the Combined HAM-D28-MADRS Instrument.
5 secondary outcomes
change in the total score of the Montgomery-Asberg Depression Rating Scale (MADRS)
Time frame: collected at baseline, weeks 2, 4, 6, 7 and 8 (end of study)
change in total score of the Clinical Global Impression Improvement Scale (CGI-S)
Time frame: assessed from baseline, weeks 2, 4, 7 and 8 (end of study)
change from randomization to each study visit in the total score of the Inventory of Depressive Symptomatology-Self Rated (IDS-SR30)
Time frame: assessed on baseline visit, Week 2, 4, 6, and 8 (end of study).
Adverse events
Time frame: collected at baseline, weeks 1, 2, 3, 4, 6, 8 and 9 (follow up)
Columbia Suicide Severity Rating Scale (C-SSRS)
Time frame: assessed at baseline, weeks 2, 4, 6 and 8 (end of study)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2016.
- Derived from this study: PubMed 30368163Targum SD, Cameron BR, Ferreira L, MacDonald ID. An augmentation study of MSI-195 (S-adenosylmethionine) in Major Depressive Disorder. J Psychiatr Res. 2018 Dec;107:86-96. doi: 10.1016/j.jpsychires.2018.10.010. Epub 2018 Oct 18.
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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.
The record lists no contact. Use the official record to reach the sponsor.
35 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MSI-195 in people with Major Depressive Disorder (MDD), run by MSI Methylation Sciences, Inc. at 35 sites 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 5 inclusion and 8 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 18 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in the total Hamilton Depression Rating Scale (HAM-D17) between randomization and end of study. (time frame: assessed from baseline to week 8 (end of study)). 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 NCT01912196, which also lists 1 linked publication.
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 18 Mar 2016.